Pelage Announces Positive Results of Phase 2a Trials for Hair Loss Drug PP405
Update: June 17, 2025
Google Ventures (GV) backed Pelage Pharmaceuticals (US) just announced positive Phase 2a clinical trial results for PP405, its novel hair growth drug. The trial entails 78 men and women with androgenetic alopecia. Key quote:
“PP405 induced new hair growth from follicles where no hair was previously present — offering early validation of its regenerative potential.”
Note that the trial participants just had 4 weeks of treatment. At another 4 weeks after the completion of this treatment (“in men with a higher degree of hair loss”), 31% of those treated with PP405 exhibited a greater than 20% increase in hair density. In comparison, 0% of patients in the placebo group responded favorably. These results are incredibly rapid in comparison to existing treatments.
Pelage expects to begin Phase 3 trials in 2026. They will likely have no issues with fundraising.
New Update on Phase 2 Trials for PP405
Update: August 13, 2024
Pelage Pharmaceuticals (US) just announced that the first patients have been dosed in its Phase 2a clinical trial evaluating the safety and efficacy of PP405. This drug is a novel topical small molecule for the treatment of androgenetic alopecia. The company is enrolling 60 men and women in the clinical study. PP405 addresses the metabolic processes that regulate activation of hair follicle stem cells.
Also of significance, Pelage raised $14 million in Series A-1 financing that was led by Google Ventures (GV). This follows an initial $16.75 million Series A financing round in February 2024 (see bottom of this post). The Series A-1 is a result of positive Phase 1 data that demonstrated proof of mechanism and target engagement in patients with AGA.
Update: July 20, 2024
We now have more details on the Phase 2 trials for PP405. Including a short survey to determine eligibility. All 6 US states that I mentioned in the last update are now recruiting volunteers (with Texas having two locations). You have to be between the ages of 18-55, and once-a-week visits will be required for 16 weeks. The product comes in the form of a topical gel. Pelage Pharmaceuticals also has an update with the above link on its home page.
Update: June 12, 2024
Pelage Pharmaceuticals’ Phase 2 clinical trials of PP405 officially started on June 5, 2024. They are currently recruiting volunteers in Indiana, Minnesota, Texas and Utah. Still to come are California and Virginia. The primary completion date is December 2024, and the study completion date is February 2025. PP405 is an inhibitor of mitochondrial pyruvate carrier (MPC).
Update: May 6, 2024
Pelage Pharmaceuticals Phase 2 Clinical Trials Start in June 2024
Yesterday, a reader e-mailed a new link on Pelage Pharmaceuticals’ Phase 2 clinical trials for its PP405 inhibitor of mitochondrial pyruvate carrier (MPC). The Phase 2 trials are set to begin in June 2024 and will involve 60 participants. Half of these will take a PP405 0.05% topical gel once per day, and the other half will get a placebo vehicle daily gel. The study primary completion date is December 2024, and actual completion date is February 2025.
Recruitment will likely start soon, and I assume it will be in the US based on the listed contact person and phone number. The contact e-mail is listed as clinicaltrials@pelagepharma.com. Please DO NOT call them now as the recruitment has not yet commenced and they might get annoyed.
If you are between the ages of 18-55 and have androgenetic alopecia, you can participate. However, the inclusion criteria for men and women is specific:
- Males must have an AGA modified Norwood-Hamilton Classification score of Type III vertex, Type IV or Type V.
- Females must have a Savin classification score of I-2, I-3 or I-4.
Pelage Pharmaceuticals
I previously wrote about Pelage Pharmaceuticals in my 2019 post related to the research of its President and co-founder Dr. William Lowry. The other co-founders are Dr. Heather Christofk and Michael Jung. I also covered the findings of Dr. Lowry and Dr. Christofk’s UCLA team in a 2017 post.
These UCLA researchers discovered two topical compounds (RCGD423) and (UK5099) that regrew hair in mice via different mechanisms. Both drugs involve an increase in lactate production. This in turn activates hair follicle stem cells and leads to increased and quicker hair growth.
Dr. Lowry’s patent can be found here. Patent and technology rights to both topical drugs have been exclusively licensed to Pelage Pharmaceuticals by UCLA.
RCGD423
RCGD423 activates the JAK-STAT signaling pathway, which in turn leads to an increase in lactate production. This extra lactate activates hair follicle stem cells and results in quicker hair growth. The main 2017 study on RCGD423, lactate dehydrogenase activity and hair follicle stem cell activation can be read here. I also covered it in my earlier linked posts related to the work of Pelage co-founders Dr. William Lowry and Dr. Heather Christofk.
UK5099
UK5099, blocks pyruvate (a glucose metabolite) from entering cell mitochondria. This also results in an increase in lactate production in the hair follicle stem cells, and therefore accelerates hair growth. There is a 2015 study from China related to the application of mitochondrial pyruvate carrier blocker UK5099 and its effects on prostate cancer cells.
Update: March 9, 2024
Positive Phase 1 Clinical Trial Results
Earlier today, Pelage Pharmaceuticals gave a positive update on its novel small molecule PP405. Full summary can be read here. In Phase 1 clinical trials, PP405 reactivated dormant hair follicle stem cells and triggered hair growth. The company’s presentation was made by Dr. Christina Weng and titled: “Inhibition of pyruvate oxidation activates human hair follicle stem cells ex vivo”. Pelage will begin its multi-center Phase 2a trial of PP405 in mid-2024. It will recruit both men and women with androgenetic alopecia.
Their description of this unique hair growth molecule is as follows:
“PP405 is a potent topical mitochondrial pyruvate carrier (MPC) inhibitor that acts on the cellular metabolic pathway to upregulate lactate dehydrogenase (LDH).”
Stem cells are particularly sensitive to LDH, so this results in their activation and subsequent hair growth. PP405 demonstrates a statistically significant increase in Ki67 signaling in the hair follicle bulge. Ki67 is a well-established marker of stem cell proliferation.
February 27, 2024
Pelage Pharmaceuticals Raises $16.75 Million and Phase 2 Trials to Begin in 2024
Pelage Pharmaceuticals has raised $16.75 million in Series A Financing. More importantly, they will begin Phase 2 Clinical Trials for PP405 in mid-2024.
Phase I clinical data met primary safety endpoints. And they confirm that their was statistically significant stem cell activation in hair follicles after just one week of treatment with PP405.
Per CEO Daniel Gil, Ph.D.:
“Our scientific co-founders have uncovered a unique biological mechanism with the potential to reactivate hair growth in people with alopecia.”
The company will present translational data at the American Academy of Dermatology meeting in March 2024.
Recently, reader “Ben” made an very interesting discovery on Pelage Pharmaceuticals’ website. The following sentence at the bottom:
“Early Phase I clinical data shows statistically significant stem cell activation in the hair follicles after one week of treatment with PP405.”
This is super news. So their trials have started. I wonder if PP405 is RCGD423 or UK5099? I think it sounds like that latter. The company’s website homepage describes PP405 as:
“A novel, non-invasive, topical small molecule drug platform that activates stem cells in the hair follicles directly to stimulate robust hair growth. By targeting an intrinsic metabolic switch in hair follicles, Pelage’s platform is suitable for all genders, skin types, and hair types.”
In other recent news, Pelage appointed Dr. Qing Yu Christina Weng as Chief Medical Officer.
I wonder if this is going to be an every day for the rest of your life therapy or maybe front load with an every day application, then taper off to once a week.
I wonder if the rest of my life I’ll watch new drugs and chemicals come to us with a promise of hope that never delivers. Probably.
The new alopecia areata and weight loss drugs seem to have delivered :-)
This is why I’ve been saying that Dr Rassman was wrong when he said that the follicles after a while disappear. He must not be directly involved in the clinical trials of Amplifica. As Pelage has proven that the follicles ARE there, they’re just dormant. The next few years may be very transformative for the treatment of hair loss.
In alopecia areata patients who are completely bald, hair is regrown. So dr Tasman is completely wrong in here.
i thought we would have heard from Amplifica by now! Where is the robust hair growth on humans?
I have been thinking the same thing! Maksim was big news at one time. Like all the others they just vanish!
Relax they’re collecting their data and presenting it to the FDA it takes time it doesn’t happen when we want it to.
How hard is it to ” collect data?” I’m so sick of this “industry.”
Yoyo friend, I believe that inactive follicles end up disappearing over time. Imagine a completely bald person who has lived like this for most of his life, the stem cells from the inactive follicles will have escaped through the pores of the dermal papilla and become skin cells. That is why I believe that this and the other medications will be very useful and effective in people with lesser degrees of alopecia or who are beginning to experience it. That’s why I think the only way to give an NW7’s hair back is hair cloning…
If you have a look under “How our drug works” they state that the hair follicle is present but in a ‘resting state’. https://pelagepharma.com/
Right, so it’s not going to bring back lost hair. Or is it? Is the follicle dormant or dead once you’re bald? It’s wild we can’t (for sure) answer this question by now. You’d think we’d have a definitive answer but I’ve seen people (even experts) argue both ways.
If it’s gone, what kind of hair growth do they mean? Maybe baby hairs to thicker hairs? Maybe single hair follicles to multiple? Quite a few questions.
I’ve always been skeptical of a topical really curing anything (depending on your definition) but it sounds promising. Trial will tell us for sure. I’m to the point now where it’s photos (after the trial) or I write them off. My feeling is that lack of photos means “you got nothing.”
Niostem is supposed to work on a similar basis, and the pictures on their website appear promising (the results of their larger efficacy trial are due next quarter).
These are marketing photos on their website and the lighting is different in the before and after. At least it seems that way to me. I’ll be curious to read the results from the trial you mentioned. I hope the photos are more authentic.
Interesting…..not that it means anything is coming to market in the next few years but I really like the number of treatments on the horizon with new methods of action. There is HMI-115, TDM-105795, Amplifica, Pelage, Stemson. In the big pciture of things, I think this is emblematic of the evolution of the overall research and that real progress is being made. While PP405 is great news, I don’t see a clinical trial for this on clinical trials.gov using any possible search word related to Pelage. For that matter, I don’t see one for Amplifica either and their study was supposed to have started June 28, 2023. Given that PP405 has shown “statistically significant stem cell activation in the hair follicles after one week of treatment”, I am not sure how they would know that if the data was on human test subjects although I suppose they could take a very small biopsy. If PP405 does activate stem cells in humans within 7 days, they probably won’t need more than 2-3 months to show efficacy…….although since this molecule turns on pathways I would guess confirming safety would take a lot longer.
Pelage is not very active on giving updates on what they are doing or promoting their company much it seems, hopfully they dont need to, becouse they know that they have a good product. A lot of good news seem to be coming in lately, one of these will probably hit the target in the coming ten years, looking forward to who that might be!
Why did Pelage remove their news section lol, just keep it simple.
Phase 2 set for mid 2024 :) https://www.finsmes.com/2024/02/pelage-pharmaceuticals-raises-16-75m-in-series-a-funding.html
Thanks!
No problem admin, with them receiving $16.75M (slightly more than Stemson) do you think Pelage’s investors have confidence in believing that this treatment will (hopefully) become a huge success? They may have seen the successful effects of PP405 first hand?
Since Pelage can bring this to market much faster than Stemson, that might be the main attraction.
Insofar as actual hair regrowth goes, Stemson represents a cure! So it is much more significant than Pelage (if it ever comes to market of course).
For sure, but with a hair transplant and yearly top ups of Pelage’s solution that could provide some serious coverage for the time being until a more permanent treatment (such as Stemson) could fix the issue of hair loss indefinitely? Thanks again.
Sorry Admin I have one more question do you think this will be like Minoxidil in the sense that daily application will be required or do you think it will be like Amplifica where you have to apply the product 2/3 times a year? “Provided confirmation of a daily dosing regimen”
Not sure YoYo, but maybe the past study or patent mentioned in the below article will have something about dosage:
https://newsroom.ucla.edu/releases/ucla-scientists-identify-a-new-way-to-activate-stem-cells-to-make-hair-grow
Given that Pelage apparently completed Phase 1 without us knowing about it until very recently, and further given that they are planning phase 2 for the 2nd half of 2024, this company is moving at a far greater speed than we realized. I had been wondering what was taking them so long to get started (and thinking this was a red flag indicating possible early signs of a flop), but this company has been flying under our radar. This gives me confidence that they have the ability to race toward approval if phase 2 produces evidence of effectiveness. I do like the fact that, to date, they have spent little time publicly promoting themselves. And I also like their quote that pp405 has : “….the potential to disrupt the treatment landscape, moving beyond agents that merely slow the progression of hair loss to a treatment solution that actually helps to regrow hair”
Here are a few more quotes from Pelage:
“The phase 1 study was also designed to determine a dosing regimen for PP405. We compared 1x/day topical dosing with 2x/day topical dosing and discovered the same biological and safety response to both. Moving forward into phase 2a, we will proceed with 1x/day dosing.
“Our phase 1 study shows no detectable levels of drug in the blood, while simultaneously achieving the levels of PP405 in the scalp skin associated with hair growth from translational studies.”
They have kind of a secretive behavior towards the public, that’s clear. The funding was already being done last June and the first trial was never officially announced, it must have been initiated after their last big paper (https://onlinelibrary.wiley.com/doi/10.1111/exd.14307), probably in 2022?
Anyhow it’s absolutely great news that they are already starting phase 2 and have new staff plus sufficient funding. I always had a soft spot for Pelage, but we were kept in the dark. It’s also quite remarkable that some really big names in medical research are also involved in hair loss R&D (Terskikh,Bharti/Stemson, Christofk, Lowry/Pelage, Plikus/Amplifica) – all of them pursue more important topics like oncology too.
Contrary to your opinion admin I think this could possibly be very close to a cure, if they effectively awake HFSCs then this could cause some immense regrowth of hair. The published pictures speak for themselves.
#Stemson: I always said they are even more than a cure as it could supply people with more hair they ever had…but that’s semantics.
In the past I read that bald scalps still have all the hair, but the progenitor cells are gone as are the arrector pili muscles.
Hope those last two do not matter as much as we think. Or can be regenerated.
In mice, they do not matter for sure!
But Admin I understand what you’re saying about having certain doubts however Pelage have stated that their product results in massive hair regrowth so who’s to say it won’t be the closest thing to a cure? (obviously Stemson would supersede)
Yeah, perhaps I have become too biased towards Tsuji and Terskikh due to having read about their research for almost a decade. Too many others have come and gone.
Of course I could be wrong too only time will time (hopefully I’m right though lol)
It’s simple, the hair shafts grow from the hair follicle, which we have all seen in images of hair transplants… It is something visible, like a little ball from which the hair sprouts. If it is there, in a hair transplant operation, before transplanting the hair follicles from the donor area, you would first have to remove the inactive hair follicles from the bald area to make room for the others, right?
Not sure if their funder being GV adds any weight, but they look like a pretty serious VC.
Someone e-mailed me for the full paper link if available.
Below Sci-Hub version is working at present:
https://sci-hub.ru/https://onlinelibrary.wiley.com/doi/10.1111/exd.14307
Also, on a slightly related note, for Paywalled articles, the below works well for me these days:
https://archive.ph/
Archive.org stopped archiving most paywalled articles from well known sites.
You may remember this admin……..when the research underlying Pelage first came out from U Cal, I was excited about it, but it was also about the same time that Frequency Therapeutics had shown they could regrow ear hair. I was more excited about Frequency. Well, they have since folded but Pelage is on the move.
Yes, I remember well Pinotq.
https://www.hairlosscure2020.com/researchers-regenerate-ear-hair-cells-via-increasing-progenitor-cells-wnt-pathway-stimulation-also-involved/
I was too! I owned stock in Frequency!
https://medcitynews.com/2024/02/hair-loss-drug-regenerative-medicine-ucla-startup-pelage-gv/ More information for those interested. It looks like this is something that you have to apply daily :(. I’m starting to like Amplifica more now since you won’t be having to apply that everyday
Let’s be honest, if something truly seriously actually abundantly works, we’d apply it 5 times daily.
Love this quote: “Unlike pricey and lengthy cancer and gene therapy clinical trials, a hair loss clinical trial is quick to enroll and conduct, and therefore considerably less expensive.” I had always thought a hair loss clinical trial should be quicker and easier to assess but, until now, that does not appear to have been the case.
I also love this quote as it relates to safety, and therefore also possibly speed to market: ““It’s a very clear pathway, which is well understood from many years of study in the lab.”
Where do you always find those great articles YoYo…thanks for that.
I don’t care if I have to apply daily, I brush my teeth daily, wash my remaining hair daily, eat daily. It’s all routines. It has to be uncomplicated and easy to apply though, and not greasy or slimy. Quickly absorbed and I‘m happy, as long as it is effective.
I cannot help but laugh again:
„The following year, it reached an agreement that granted Allergan an option to acquire the startup. The agreement provided Pelage with non-dilutive financial support, Gil said. Allergan itself was acquired by AbbVie in 2020. After that deal closed, Pelage and AbbVie agreed to terminate the option“
So we probably lost 3 years again, just like with OrganTech. I don’t understand why those behemoths are so tight with those comparatively tiny amounts? The reward of a hair-loss-cure is huge! Also explains why they have been so quiet over the years, they were basically inactive…
Also worth noting:
„Unlike pricey and lengthy cancer and gene therapy clinical trials, a hair loss clinical trial is quick to enroll and conduct, and therefore considerably less expensive“
Makes it even less understandable. Well at least they have a proper CEO and business-strategy now. Let’s awaken those HFSCells now!
Thank you Ben, I have my resources lol. I wouldn’t mind putting the solution on everyday either it’s just having that much solution applied topically daily who knows what the accumulative systemic side effects will be over the years until a true cure will be found (ie stemson or Fukuda). That’s my only worry. With Amplifica it’s more of a one and done deal (until the next appointment)
Interestingly though, Pelage’s current CEO is a former Allergan executive, and in this piece (https://magnify.cnsi.ucla.edu/2024/02/27/february-27-2024-gv-backs-hair-loss-biotech-out-of-ucla-with-phii-set-for-mid-2024/) is quoted as saying “We had always been surveying the hair growth landscape quite a bit, and this was a technology that we really liked at that time,”. Also a positive quote from GV executive in that piece. All told, it looks like Pelage and Amplifica are the two California startups that will be the first to crack this problem.
Another good article providing a few more clues. I note that some posters didn’t like what they thought was the requirement of an every day application of PP405 but according to Cathy Friedman, the board member at GV venture partners, the trial “endpoints will be at three to six months and treatment will last four weeks.” Personally, I could care less if I had to apply daily for the rest of my life if it worked, but ultimately, this may be a treatment that you only need to apply once a quarter, once a year, as needed, etc.
I think that has the be found out in the next trial, dosing frequency.
But you might be on the right track: if they dose daily for 4 weeks and then measure after 3/6 months, they must have some preliminary data that this treatment lasts for a certain time without dosing.
A big question for me is, if you have more „bald surface“, how much more amount of topical would you need? And do you alse treat the area that is potentially gone in the future but has hair now?
Anyhow, big hopes for Pelage. They are on the verge of breaking into my personal Top 3: Amplifica, HopeMed, Fukuda – with Fukuda being the shaky candidate due to the recent uncertainty.
I was wondering about coverage myself. I don’t know how much a doctor could prescribe but if twice per day dosing was as safe and effective as once per day, I would think you could safely use the equivalent of 2 doses per day, covering different areas. Maybe not 2 doses at the same time but possiby covering a one area in the morning and another at night. I would want to treat as much of an area as I could to increase the density. Even where I have a decent amount of hair, its not what it used to be. My big question is what amount of statistical significance they found with only 7 days of treatment and how much that significance will increase with 4 weeks of application. Much to learn and I find it fascinating. I am guessing they might be planning to test for more than 1 variable, depnding on what they find, since the next test is a Phase 2a.
“What we’ve observed is that in people who experience hair loss, the actual hair follicle stem cells are still present but have reverted to a dormant state. We have uncovered a small molecule able to stimulate cellular metabolism to re-awaken hair follicle stem cells and spur new hair growth,” said William Lowry, PhD, Pelage’s scientific co-founder, in the news release.
https://www.dermatologytimes.com/view/new-topical-agent-for-alopecia-to-enter-phase-2-trials
In the niostem webinar today the presenter seemed to say as people live longer with hair loss the stem cells miniaturize past a point of no return :(
Years ago, I wrote about widely discussed findings related to how hair cells and follicles are always there, even in totally bald scalps. But progenitor cells get depleted. Later, we were told that arrector pili muscles also get depleted.
In any event, there have been way too many cases where long-time Norwood 5-6 bald people regrow a lot of hair. Including from things like burns, wounds, oral minoxidil and dutasteride. Plus future cloning, multiplication etc.
https://www.hairlosscure2020.com/so-it-seems-like-totally-balding-areas-of-the-scalp-can-regenerate-long-lost-hair/
https://www.hairlosscure2020.com/male-to-female-mtf-transition-hair-growth/
https://www.hairlosscure2020.com/reddit-oral-minoxidil-hair-growth-reviews/
Thanks for the white pill :)
Hey admin – is there a chance that you can change your settings on „recent comments“ to 5 or 7?
Would make it easier to follow the forum.
Good idea and done.
In the past, I got several errors/speed improvement suggestions in my page load speed tests if there were too many “recent comments” (plus the now removed “recent posts” and “category” menus).
That was quick – thanks!
Hello everyone!
Just a question for clarification. Since only males up to NW 5 are sought in phase 2, people with NW 6 and 7 will have to wait for the cloning of hair follicles. Thank you!
I’ve been saying that! lol
https://www.linkedin.com/posts/daniel-gil-165067aa_pelage-pharma-press-release-activity-7173133159922872320-N4Ei/?utm_source=share&utm_medium=member_desktop The chief executive officer on American Academy of Dermatology meeting
Thanks YoYo!
I’m here to serve you admin. Lmao I’m joking, no worries you put in so much work we should return the favour from time to time.
Dr. William Lowry presenting at WCHR2024 on April 9, 2024:
Topical Inhibition of the Electron Transport Chain Stimulates
the Hair Cycle
William Lowry, PhD | USA | University of California, Los Angeles
Pelage went from being skeptical to being one of my top 3 most intriguing companies.
Where is this Admin? I cant see it on the program for WCHR2024
https://hair2024.org/wp-content/uploads/2024/03/wchr24-final-program-guide-single.pdf page 45
Admin do you think that Pelage will release some form of pictures after the completion of Phase II? Or not until they finish all 3 phases?
They will release the data for sure. If growth is say 5 hairs per cm square, I am not sure if pictures will show much.
I now wonder if pictures are required to be released after Phase 2 trials.
I see, because this has the potential to cause massive hair growth which is why I thought they would like to release some photos to attract the general public as well as more investors.
If the results are excellent, I do not see why they would not want to release photos.
Hello everyone
Is there any news about Pelage? I hope you have a nice Sunday :-)
Initiating phase ll trials starting midway of this year.
Should we keep any hope on this?
Nah don’t.
“PP405 is a potent topical mitochondrial pyruvate carrier (MPC) inhibitor that acts on the cellular metabolic pathway to upregulate lactate dehydrogenase (LDH).”
I can tell you this as someone that has studied biochemistry extensively; pyruvate inhibition in the mitochondria is serious business. It is basically how all energy in the body is made. This might have heavy side effects.
Well that’s what trials are for, aren’t they?
I think it is great news that they said they could and would move quickly to begin a phase 2 trial, and they are doing just that! So now we know that gearing up for a trial doesn’t have to be an endlessly painful endeavor. They appear confident and motivated which makes me wonder what they have continued to see from the phase 1 trial. In their press release they said they could see evidence of newly emerging hair germs so they must have some idea by now of the quality of the hairs that have sprouted from the scalp.
Up to norwood 5 which is quite advanced stage. Would be good to see this treatment work well on advanced AGA. Fingers crossed when they release the phase 2 results next year it is good news!
Wow! revitalizing the hair follicle stem cells could be a game changer….i hope this works!
Will this help for DUPA guys?
Pelage says it “will begin its multi-center Phase 2a trial of PP405 in mid-2024, recruiting both men and women with androgenetic alopecia. PP405 may also have applications for other forms of alopecia, including telogen effluvium (stress-induced hair loss) and chemotherapy-induced hair loss.” DUPA is a form of androgenic alopecia so I don’t know why it would not work……..of course that assumes the trials will ultimately prove successful.
For sure… dupa is miniturization of the hair follicle on the sides and back of your head which is caused by typical androgenic alopecia. There is no reason to suspect it wouldn’t treat Dupa.
I am seeing nowdays the trend of GFC instead of PRP and people are saying the result is better than PRP. Admin Can you also cover this so we get to know more about that.
Trials started!
Thanks!
Actual Study Start Date = June 5, 2024.
Estimated Primary Completion Date = December 2024.
Estimated Study Completion Date = February 2025.
Thanks Admin for the update! I couldn’t find this online, was this something that was personally emailed to you? Thanks
It is in here:
https://classic.clinicaltrials.gov/ct2/show/NCT06393452
Would be great if you were able to get an interview with Pelage, Admin!
It varies on a monthly basis lol, but at the moment Pelage is my favorite.
The concept to jumpstart dormant HfScs seems to be the best way to have massive regrowth.
Well researched, well funded, well managed. I hope for all of us that this is the breakthrough we desperately need.
100% agree with you Ben, not only is the MOA understood but like you said, they are well funded and well research. This could definitely be a game changer alongside the fact that they are trucking along at a very good pace. We will have to wait until next year to see the results but by that time we should be updated by Amplifica and Stemson.
I mentioned it in the Stemson-thread, there’s something curious at Stemson.
They let go approximately 10 people since the Aderans-announcement. Their R&D-team is now down to 12 and all vacancies are erased from the website.
I don’t know what that means – could be nothing. Maybe they finished R&D and don’t need the people anymore, and clinical development is handed over to a CRO. Or they have financial difficulties…
What’s your take YoYo?
Oh wow Ben, so it seems like I wasn’t the only one who noticed that lol. Yea I’ve been eyeing it for some time and I too am conflicted on what that exactly means. Respectfully I have to disagree on the funding part, as they are heavily backed up by powerful investors and based off the results Stemson has been providing to their investors they seem to be confident in where their money is going so far. I could be 100% wrong, but based off the timelines that Geoff was giving, he was talking about basically refining the process at this point and gearing towards clinical trials as they are initiating to do so towards the end of next year. So it may be the case that they don’t require as many people, as when they needed while in the beginning/middle stages of Stemsons development, as that is a normal occurrence at tech startups. The reason I’m more confident towards this reasoning, is that Stemson is going to be speaking at the Precision Evolution Global event in October, and wouldn’t make any sense to do so unless they were confident in their product (which seems to be the case based off their recent interviews this year).
https://www.linkedin.com/posts/precision-evolution-global-inc_innovation-drugdiscovery-drugdevelopment-activity-7196502232769384449-YXWc/
But again what do I know lol.
YoYo thank you for the updates on Stemson. In your perspective when can we see an actual released product? 2030?
I don’t know, 2030 would be if things were to move smoothly. It honestly depends on where Stemson ultimately decide to conduct their trials. If it’s in Japan, South Korea or Australia for example it would be a lot better timeline wise. In USA, I’m not sure. However, with the introduction of something like Pelage or Amplifica it would greatly benefit hair loss suffers as (potentially) they can cause massive hair regrowth by “awakening the hair follicles”. We could use something like that alongside a decent hair transplant it would cover some serious ground. Remember Pelage’s goal is to be able to be the first drug that is “regenerative” which Min. or Finasteride are unable to do. But Stemson would be the ultimate “cure”. I’m still not sure on whether I should be more excited on Fukuda or Stemson, all depends on results and timeline for me.
Thanks, can you see this coming out fairly soon (in your expertise) I don’t follow hair loss news too closely but always check this website and your comments
Appreciate that, but it’s honestly difficult to answer. I would say for really good treatments to come I would say 2027. But for a cure I’m guessing between 2030-2032. But Fukuda did say that they will be able to release their product in the next several years, so who knows lol.
Thanks YoYo :)
Thanks!
I live in Los Angeles and will email them to see if I qualify. I do take Fin and oral Minoxidil, hopefully that doesn’t disqualify me.
Oddly, the study does not list as a primary or secondary outcome of the study an increase in terminal hair. The primary outcomes are listed as 1) percentage of subjects with treatment-related adverse events; and 2) Change in local dermal tolerability. The secondary outcome is listed as the assessment of concentration of PP405 in plasma. I recall Pelage referring to this as a phase 2a study in one of the press releases earlier this year. I hope this doesn’t mean there will be a phase 2b study before they get to phase 3.
Great observation Pinotq.
Pretty sure there has to be a 2b trial then with assessment of TAHC before moving to phase 3. No sense in moving on unless you know it grows hair, right?
Not happy about that.
Any topical treatment done at home will definitely not be a real cure. The actual treatments should be done in the clinic by the doctor. Pelage will not be better than min or fin. Expectations of a topical treatment performed at home should be reasonable.
Everything we know so far shows that Pelage has definitely the potential to be a cure or close to it.
„Pelage is pioneering an innovative approach with the potential to disrupt the treatment landscape, moving beyond agents that merely slow the progression of hair loss to a treatment solution that actually helps to regrow hair.”
“This therapy represents an exciting new option for not only treating but reversing hair loss. We look forward to advancing PP405 to Phase 2 clinical studies this year.”
Ben I disagree with you and I believe you are overly optimistic about Pelage due to its mechanism of action (which has an excellent and advanced mechanism of action). Time will tell if my prediction is correct or yours…
Understand the skepticsm..but it is interesting that this drug’s mechanism of action is to activate hair follicle stem cells, as far as I’m aware this is the first drug to activate the stem cells…so will be interesting to see how it pans out
Like Ben and YoYo, I am more optimistic about Pelage, for the reasons mentioned above, than anything else in the overall pipeline at this time. That doesn’t mean it won’t fail…..maybe it will turn out than not 1, but 2 or 3 pathways need to be turned on. Maybe 1 pathway only turns on enough to grow a vellus hair, or maybe the hair is terminal but only lasts 3 months. Who knows? That said, I don’t see how the fact that a treatment can be administered at home vs a doctor’s office has any scientific relevence to its effectivenss.
Baldness is not a simple problem that can be solved with a pill or a topical solution that can be done at home. You are not talking about the flu, you are talking about one of the most complex parts of the human body, «the hair follicle», which has many unknown aspects. To solve the related problems, complex and advanced methods such as gene therapy or pluripotent stem cells or treatments that should only be performed by a specialist should be used. With today’s human knowledge, no complex disease can be fixed with a simple method like rubbing and massaging a gel (!!) and it will only be a temporary solution like fin or min. Unfortunately, some facts are difficult to accept…
Looks like you’ve got it figured out Roman!
https://www.youtube.com/watch?v=m7IuuOWqDPQ
Pelage has updated their clincial trial page and, as of their July 1 post, has begun recruiting at all trial locations. They certainly look like a very well organized and efficient company, quickly delivering on their stated goal of launching a phase 2 trial in the second half of 2024. Great sign but still a very long way to go as this is only a phase 2a trial.
Did you see this press release admin, perhaps further validation of the concept?
https://www.manchester.ac.uk/discover/news/surprising-link-between-ancient-biology-and-restricted-human-hair-growth-found/
Pelage has updated their website if you scroll down to “The Pelage Solution”. They mention about their Phase 2 trials.
Well on that link to „Clinago“ it says phase „2 b“ now, on the website it’s „2 a“. I‘d prefer the former, otherwise there’s another extra trial.
I would like to now how many participants and the other arms.
The good thing is that this trial finishes this year, if we‘re lucky we also get the results in 2024. Fingers crossed!
Yup, I just hope we get to see pictures too :/
Interesting observation that they say 2b on Clinago vs 2a on clinicaltrials.gov. On clinicaltrials.gov (CTG), it says “The study is designed to validate safety results from the Phase 1 PP405-001 trial while also characterizing longer term safety and PK following 28 days of administration” The primary and secondary outcomes they list on CTG are also only safety related. But I noticed on Clinago they say “The main purpose of this study is to evaluate how safe and effective the investigational drug PP405 is”. And they clearly state they will take photos at 16 weeks. CTG still says its a phase 2a study but this leaves me wondering if ithey might be modifying to a combined 2a & b study. On CTG, they say the estimated enrollment is 60.
2024 and Im calling now that this will fold after a few years of delays, hype, missed endpoints, and nonsense.
@pinotq: What is your opinion on the type of sugar that they have found is beneficial for hair growth? Optimistic? If effective, will it take 5 years to get to market even though it’s a natural substance?
It is likely nothing much. But for those interested:
https://newatlas.com/medical/baldness-sugar-hydrogel/
Added a lot of new members and names onto the website. They’re definitely serious.
Most of these people have been in the company for quite some time (except the advisory board of course) – Sun and Flores since 2018 (!), I think the newest is Weng as CMO.
I still think it’s a tragedy that Pelage was in hibernation for 2 years due to lack of funding – only after Daniel Gil took over in 2021 things got traction.
Are you sure Ben? There were some members under “Team” whom I never heard of before
First patients dosed and new Finance
https://www.prnewswire.com/news-releases/pelage-pharmaceuticals-advances-clinical-program-with-first-patients-dosed-in-phase-2-study-for-hair-loss-and-gv-led-14m-series-a-1-302220301.html
Daniel Gil makes no jokes, this is FU-money in the world of hairloss. If I am correct, no company or start-up has ever accumulated more money than Pelage, including Stemson and Exicure.
They must be extremely confident that this works.
Given that this is „only“ a topical molecule in comparison to Stemson (cell-cultures, devices to extract and implant, machine learning, etc) they must already plan a phase 3 with this money. A 60 patients-trial cannot cost more than 16,75 million.
Anyhow, as money is the limiting factor, they are definitely not limited. Great news.
I wasn’t gonna share this, but I will. Best to keep expectations low. I tried to get into one of these trials and the person on the phone said they were only taking people who started losing hair in the past 5 years. It was also implied that the gel was for the crown and not the hairline. I might be wrong about that 2nd part but 100% said it was only for people losing in last 5 years. I take no joy in sharing this news but I gots to look out for my bald brothers and sisters.
That’s not true. I have been losing hair for 10 year and was accepted as a candidate as a NW4.
Would be great if you could update us on your progress?
The community would be grateful…a beacon of hope in sparse times.
@fake name when do you begin the trial?
Well you had a very different experience than me. I was told “good news, bad news” and told the 5-year thing. That said, I would advise against leaking anything that happens to you with respect to results. That’s what got that HMI guy on Tressless in trouble and almost got that entire trial reset. Best of luck though. I hope it works.
That does make sense to be fair, as they went to test the parameters and push it in their 3rd phase. But I wouldn’t be too worried about that because they’re trying to advertise it as hair follicles being present on your scalp and it’s just a matter of reactivating them. So we’ll wait and see but I don’t think it’s gonna be a hindrance just to have a gauge more so than anything.
Hello everyone!
According to the information on Pelage’s website, it sounds different. Perhaps Pelage should comment again himself. Or have I misunderstood something? Perhaps someone can explain this to me.
Why would they then ask for your NW-status (up until 7) in the application-form?
Wouldn’t make sense. They probably try every NW.
They ask for up to NW7 so people will give the most accurate answer for themselves and then they exclude people beyond a certain grade.
That actually makes sense, LJ.
Well, as with every medication against hairloss – they work better with lower Norwoods or in the earlier stages. This probably guarantees better results which are crucial for future funding. I‘m fine with that.
Regarding the comment of that user further up („Fake Name“) I advise every reader to remain skeptical of these comments – there have been too many trolls in the past.
A. I feel like a troll would say this definitely works knowing that it’s going to hurt more when you believe in something and it falls apart. I’m just saying keep expectations low. I literally hope it works but I don’t think it will.
B. Bro, you could just fact-check me. Fill out the form yourself and when they call see what they say.
They’re probably trialling it on the NW level they believe it will have the best effects up to, but I imagine if it’s approved as safe and effective for this many people with more advanced HL will use it ‘off label’
I studied all the clinical trials that used induced pluripotent stem cells to treat heart diseases, and interestingly, none of the clinical trials could treat heart disease with ipsc injections! Only iPSC injection caused mild to moderate improvements in heart disease progression. I said this to come to the conclusion that the reason Pelage raised a higher budget than Stemson is exactly this. Despite the very high cost, IPSC absolutely does not cure diseases (including baldness). For this reason, Stemson has not started clinical trials. But pelage can be an effective solution, although I believe that pelage is not only not a definitive cure, but it is not even close to a cure, but it is definitely stronger than fin and min.
I’m not sure about that take bill
Here’s the last I’m going to say about this subject. Here’s a comment from someone on Tressless (not me):
“I signed up for this trial and met with a participating dermatologist. They rejected me for 2 reasons; I’m currently taking min and fin, and I been experiencing mpb for longer than a couple of years.
Honestly could have saved a lot of time if they added a couple questions to their survey.”
Fin and Min is a standard denial, the FDA is never going to allow trial subjects on Fin and Min to be a part of a data set, but the MPB timeline is interesting. Maybe they are spliting up the data sets into more recent and further away MPB candidates?
I said I was done posting on this subject but let me try and give a rallying speech here.
All these companies make the same sorts of promises and yet they’re always letdowns. Pelage’s site clearly implies it’ll work for anyone and yet their actions say otherwise (in addition to their trial rules there was also a presentation given earlier this year that said it was for NW 3s-5s). Stemson is clearly dialing back, and Amplifica is MIA and will likely be a similar story as Pelage.
That said, I think there is hope. The irony of this site is that it’s called HLC2020…maybe there’s close to a cure already available and you can start working on it now.
If you want to stir up your stem cells try microneedling. Use topical fin/min or oral min to regrow. If you get enough regrowth get a transplant on the corners. Like getting into shape, it’s a process. Like brushing your teeth, it’s a daily thing. Just stick with it and see what happens instead of waiting for clinical trials for drugs that are ultimately disappointing or holding out hope in companies that repeat the same lies. People who can’t lose weight usually give up or cut corners. Why not just stick with a routine for awhile and see if it does anything for you?
Don’t know Fake, the study eligibility criteria mention the limitations regarding NW level and conmeds, but nothing about AGA duration….
https://clinicaltrials.gov/study/NCT06393452
Hey Fake Name, am I the only person who isn’t willing to mess with my hormones? Yes, my hair loss affects my mental health daily, unfortunately. But these new medications are the only hope I have remaining.
I mean, I don’t know, you’re probably not the only person afraid of that. You could give topical fin a shot and see if it works.
My real issue is these companies who pretend to find some amazing breakthrough and it’s no better than fin and min and we wait for years for a dud. My point is if you want hair use the tools available now, don’t let the years go by.
Im somewhat confused on the action mechanism. Is the goal to stimulate the stem cells that generate hair which are thought to be shut off due to DHT? Would this potentially color grey hair as well? What are the risks they are looking for?
Here is a link to an interview with Christina Weng: https://www.dermatologytimes.com/view/q-a-pelage-s-novel-pp405-advances-to-phase-2a-for-androgenetic-alopecia
There is more detail than I have seen before but maybe the most important is that she confirms that one of the endpoints of the phase 2a study is efficacy……….despite that not being mentioined in clinicaltrials.gov: “One of the end points that we’re looking at to assess is efficacy of hair growth. We’re doing 3 different measures of hair growth. First, we’re assessing what’s visible with the naked eye. Second, we’re using high-resolution photography to quantify hair growth at the single hair level. This allows us to identify changes in density in a very objective way. Third, we’re collecting tissue, and we’re able to assess markers of hair growth at the macroscopic level. Designing measures of hair growth across the full spectrum of microscopic to macroscopic was very intentional, and it gives us a more holistic picture.”
It’s strange because efficacy is mentioned in the title of the study on clinicaltrials.gov but you’re right the study record does not seem to list any efficacy endpoints….
https://www.clinicalleader.com/doc/pelage-embraces-diverse-patient-recruitment-for-non-hormonal-hair-loss-therapy-0001
Thanks YoYo, very encouraging.
I guess everything has to be diverse these days – I don’t know how that’s important for a trial, the stuff works or not, simple as that. If you’re black, white or Chinese, who cares? The MOA of Pelage is stem cell activation – so it’s even less important to include diverse participants imho.
This is plain virtue signalling.
I also don’t believe imaging technology has ever been a problem – medical photography and imaging has always been way better than anything’s in civil use.
Anyhow, please be woke, as long as you deliver our homerun, I don’t care!
Btw the only reason Pelage is not available already is AbbVie‘s purchase of Allergan. If that would not have happened, Allergan would have financed all trials. Instead AbbVie decided to terminate the option. How cynical is that lol.
True, I did not think of virtue signaling till you pointed it out.
Having said that, the Folix laser for hair growth (that I discussed earlier this year) is not meant to be used on dark scalp skin.
Also, based on my “long-term amazing finasteride results on Japanese men” post, I think there are racial/genetic differences to hair loss treatment responses.
And many people say that PRP works better in women than in men.
And somewhat related, for laser hair removal, skin and hair color are of paramount importance. Dark skin gets permanently burnt and damaged with the wrong laser. White hair cannot be removed with laser, the last time I checked a few years ago.
I just love these casual criticisms of woke. When I ask people to describe woke, and add that they can’t use the word transsexual, they suddenly get all tounge tied. Woke was first used by 1920s blues musicians as a reminder for Blacks to stay vigilant. Naturally right wingers try to reframe and appropriate the creative use of language to compensate for their own inadequate forms of expression.
For the love of Pete, can we not turn this into a political blog? Not directed at anyone, is directed at everyone.
Yeah I will not approve most of these any more.
That’s great news Admin. I think we’d all appreciate it if you could keep all the nutty virtue signaling and biased politics out of here, or I’m afraid we’ll lose a lot of readers.
Poor those investors who lost their money in the way of pelage company. Activating stem cells by increasing lactate is a stupid idea and doesn’t work. I wish they would give their money to Stemson.
I also agree with you. Pelage is bs. It is interesting that the capital received is even more than Stemson and its investors are really stupid.
Exactly David. Refreshing to hear someone being realistic. Nothing of substance will come out of Pelage.
Yes dhtterminator, it should be realistic. Most companies are just looking to fill their pockets without providing an effective solution. Of course, I have a lot of respect for stemson because I see that they are really looking for hair loss cure, but their progress is very slow and that is not good at all. I wish these companies would find a drug delivery system that would prevent systemic absorption of topical drugs. For example, suppose we take topical dutasteride at a very high dose without detectable systemic absorption into the blood. But unfortunately, no one follows it.
Yeah, it’s weird to me too that they raised even more money than Stimson.
I always wonder if these investors have sense.
do they think?
Who advises them?
The idea of activating stem cells is good, but not by increasing lactate. pelage has only one positive feature, and that is their good speed in starting clinical trials, which makes them declare failure faster after announcing their disastrous results. It’s good that they don’t make fun of people like some companies for years!
What an exciting discussion I love it here because the admin doesn’t censor comments and that’s great. thanks admin. I think stem cells remain in bald people’s scalp for a long time, but after a while, they disappear forever. So activation of stem cells does not work for everyone. With the research I did, I came to the conclusion that the increase in lactate instead of activation, causes the inactivation of stem cells! I prefer topical exosomes to pelage, but I don’t know how much they absorb through the skin without microneedling.
To be quite honest I’m surprised there isn’t much progress in also finding ways to regrow dead/lost ground, such as for the hairline for a NW3, or better yet for a NW7 throughout the top. I hope we are all just being pessimistic, but there have been so many disappointments this year.
I will be participating in Phase 2 trials. I will update here with info and links to pics if I’m allowed. I have this page bookmarked. Really REALLY looking forward to the possible results!
That is amazing!!! Keep us posted
Not as interested in pictures as a better understanding of the action mechanism. Is the goal to reactivate stem cells in the hair that are inactive?
That’s right AM
Seems like the study has finished recruiting patients. The clinicaltrials.gov page changed the status to “Active, not recruiting”. And the Clinago page that the main website links to no longer exists.
A person named “Chad” on one of the Discords posted some really interesting stuff about his clinical trial results from PP405. He got unbelievably fast hair growth after just 48 hrs and his Discord comments sound very legit, albeit with lots of typos. I doubt that he is a native English speaker, though he lives in California. He never responded to my request for him to post here. I know 48 hours sounds totally ridiculous, but my beard hair grows just as fast in 12 hours so, always possible if any new hair was created. It is really farfetched, but I can’t believe someone would just post so much detailed information just for giggles.
There are also some concerns that the photos he took of the clinic’s computer screen (in which his scalp images show clear hair growth) are not legally allowed. Some of his comments are pasted below.
=============================================
“i got invited by another member– we met on reddit, i posted some pics from a clinical trial i was just a part of… it was for pp440. the stemcell byproduct one they’re using to regrow hair. i did a 30 day trial, and they take all these crazy photos and stuff. its from pelage.”
“so when they did the photos, im not certain if i was necessarily ALLOWED to do this, but… i didn’t ask. and i double checked my contract with them and it doesnt say anything about doing that… but when they were all looking at something i just pulled out my phone and took a picture of the comparative results screen on the computer screen.”
“this is my baseline photo, and then literally 48 hours afterwards. 2 applications, that’s all. and these are my results.”
“so the way they take the pics i have is nuts. they literally flew a lady from across the country out just for my appointment— she like was some big shot at the company that made the photography equipment. it was a giant handheld single-shot camera, and it had a big clear flat lens on it, and all these super bright white LEDs around the entire ring, then they slather the lens with special gel, and my head with special gel, and they then take the pics by pressing the two together pretty decently hard, so it gets all the air bubbles out”
“but they had to shave these spots in my head– 3 of em– crown, vertex and temporal… and then i couldnt cut my hair for a month so i looked like an idiot with 3 big holes shaved in my head lmao”
“so that first one is my very first day, then after 2 applications of the medication.. and it wasn’t really 48 hours later, it was, like, maybe 36 hours later with how the timing of the appointments fell.”
“But the people at the clinic really seemed to think the pelange people had something special, because of how much money they were dumping into this. I have my next appointment tomorrow, actually, to go in and get my head shaved in those spots and take pics again. i’ll see if im able to sneak a few pics during the appointment. this is supposed to be (according to them) be a treatment for 30-days type thing. then, and again this is just me repeating what the doctor and nurses told me, you dont ever have to apply it again.”
“and they all seemed really excited about it. and they paid a damn decent amount. granted they had to tattoo my head in 3 places hahaha.. but yeah, i was surprised at the compensation i got.”
“im in southern california, and this was right around the chumash reservation, so… would make sense. it’s a group of doctors from stanford and ucla who collabed on it and made the company, if I remember correctly.”
“first phase they only did 7 days and it had such promising results they got a ton of money invested and now they had me take it for 28 days.”
“then, apparently, the people from the 7 day trial still had growth up to 84 days later (new growth, that is), but they all seemed stunned with my first 48 hour results.”
“well because just because it came back doesn’t mean it’ll be permanent– sure they have 90 days new growth in first rounders who only did 7 days but… you know the first 28 years of my life were fine on the ol hair too.. cant say that i’d want to let it fall out again. and if i can do something else that makes damn sure no more loss occurs… why wouldn’t I, you know?”
“I have another appointment literally for my 54 day check-in tomorrow morning. if you want me to ask anything specific i totally will.”
“i guess the participants they have had so far weren’t easy to work with, so when i didn’t care at all about getting stuck with needles twice on every visit (and they took a LOT of blood, too.. like 4 of those vials full each time), being hooked up to ekg machines every visit, applying the medicine, then waiting for 2 hours to do another blood test to see how it absorbed into my bloodstream… or even about having their head tattooed, or sitting for 3 hours while they do their weird photoshoot stuff… they just might let me take another dollop lol.. but niostem is already out, right? or do i have that wrong too? hahah”
“for sure my dude, im gunna try to snag some (pics) this time, too… and even if they “caught” me, I wouldn’t care. what are they gunna do? force me to take hair LOSS meds?
besides noting in the contract says i cant do it. so i didnt breach shit.
and they’ve already paid me”
“i tried asking the lady pelage flew in for my appointment, too, but she was just there to show them how to use the fancy camera system.”
“my wife says it’s not only thicker but its darker, too.. like it got rid of some of my gray, which i dont know about that i cant see the top of my head, so ill take her word for it.”
“oh bro i got nothing to hide, trust– i got no skin in the game on this. i tried to invest in pelage with my bro whose a financial advisor over at charles schwab and he was like yeah no its not a publicly traded company hahaha.”
“im just stoked to have some hair back and thought id share the info with any other dudes who’d be interested. the universer fortuitously chose me to go do it, so i feel like its just paying it forward.”
“i used it for 28 days, then the application portion of the trial was over.”
“i still have an appointment tomorrow for pictures, and then one on my 84th day. tomorrow is day 54.”
“if you look in the pictures, zoom in to the computer screen, you can see “baseline+48 hours” — there’s no misunderstanding, man. i was there. they’re pictures of my own head. i watched them take them, i watched them pop up on the computer screen after it was taken, like… i dunno what to tell you, but it even says it on the computer screen itself.”
I swear, why do people feel the need to gossip to strangers on the internet about clinical trial participation, I mean it’s useful information but imagine if this derails or delays the trial? Would all of us on here organise a crowdfund to hunt him down on Minecraft?
lol true, but if this product is really as good as this suggests, I doubt that the company will care about some leaked photo. “Chad” has not come back to post again in the past few days.
He originally posted on Reddit, but I could not find anything and think he might have removed the photo.
It’s a blinded trial isn’t it? If so he could be unblinding himself and compromised the data, I personally would delete these posts and not promote the content.
It is a double blinded trial: “A Randomized, Multicenter, Double-blind, Vehicle-controlled, Phase 2a Study to Assess the Safety, Pharmacokinetics, and Efficacy of PP405 in Adults With Androgenetic Alopecia. ” But, assuming the pics and story are legit, both Chad and the investigator still don’t know whether Chad is getting pp405 or placebo………..even though they might think that based on the photos.
Here an article by another ‘Chad’, shows there is a real risk of trial loss when participants fool around online discussing their participation (https://www.linkedin.com/pulse/reducing-risk-patient-unblinding-via-social-media-chad-childress). From some of the stories I’ve heard of like this and people spamming companies studying AGA, I’m convinced that many sufferers are sociopaths and don’t actually deserve a cure/treatment, it’d be better if they don’t reproduce.
His mom probably took his internet privileges away. Not buying it.
I don’t know if you can really see dormant hair follicles turn into visible hair in 48 hours. Could be. Maybe.
After the „Moeman-disaster“ I don’t take these kind of postings serious.
I think the best indicator for Pelage‘s potential is Gil‘s accomplishment to make 2 big funding rounds within one year even before phase 2 started.
30 million USD is staggering for a topical treatment and the biggest funding for a hairloss-treatment ever. The investors must have seen something truly superior, otherwise this would be impossible. It’s been a hard time for medical startups in the past four years, so this is more than noteworthy!
Thanks for remembering the name Ben, the “Moeman-disaster“ was exactly what I was thinking when I read “Chad’s” post. It’s definitely a case of one man’s trash is another man’s treasure, I read that stuff and instantly think troll. Admin, with all due respect I think “Chad” is a native English speaker” with lazy writing habits, and an over use of “cute” emojis”. For crying out loud, he even spelled Pelage wrong multiple times! You guys follow this kind of stuff a lot closer than me, I’m not saying I’m right but this kid smells like a troll to me…and poof, he’s gone! If he is a troll, hopefully for good.
Lol yeah I also thought of “Moeman” but had forgotten his name till Ben wrote his comment.
I am skeptical, but it is rare for a troll to put so much effort and give so many details. Was worth reading for me, even if it turns out all made up. I will never post his photo in this post.
Yeah the company name error struck me. I think I corrected several of his words, but left most as is.
What’s the ”“Moeman-disaster“ ? Are you saying he was lying about his experience and never took hmi-115? What happened?
It became a soap opera of too many deleted comments by “Moeman”, misaligned dates, fake photo allegations etc… I stopped following most of the drama, though my assumption was that he went for the trial, but the end results were likely not as good as he initially indicated.
It did not help that “Moeman” was often argumentative and combative.
His recent comments are not hair related:
https://www.reddit.com/user/moeman32/comments/
I just noticed that he has left one after photo from 10 months ago:
https://www.reddit.com/r/HMI_115/comments/16qnzgd/comment/kd0iema/
Oh i see. Yeah, I remember him being very aggressive in his comments. I didn’t follow the whole drama. Thanks for the links!
The Moeman-disaster…great name for a band! ;-)
I immediately thought of Moeman as well, and also remain skeptical. But there is an awful lot of detail that tracks with the Pelage trials. If “Chad” reads like he types, he probably wouldn’t know if he signed a confidentiality/non-disclosure. I suppose this could be a taste of AI generated BS, but what initially caught my attention was Chad’s detail about the camera. I saw an interview with Christina Weng where she specifically mentions that improvements in imaging quality have come a long way and will provide for better objective quantification:
https://www.dermatologytimes.com/view/q-a-pelage-s-novel-pp405-advances-to-phase-2a-for-androgenetic-alopecia
In the photos, they are using a Canfield imaging system. Canfield is huge in dermatology and clinical trial imaging, and they have cameras fitting Chad’s description. Their headquarters is located in Parsippany, New Jersey tracking with the statement that they “literally flew a lady from across the country”. The purported location is southern California which tracks with the Encinatas trial site. One of the pics identifies the “site ID” as 08. I have no way of knowing if 08 is Encinatas but there are 8 trial locations. All in all it is enough to make me curious. That said, and although encouraging if true, all the pics really show is that the hair is growing faster.
Excellent research Pinotq!
If Chad is a troll, this is way too much effort. And that too for a Discord community with just a few hundred active participants. It would make more sense if he was trolling on Reddit.
In any case, perhaps best to think of him like Yoda and Ben do.
Guys, our problem is we want to believe no matter what. It’s why snake oil has been so successful with hair loss sufferers since the dawn of time and continues to be to this day. Why I went to Klein’s hair care (lotions, potions, e-stimulation) before min and fin were a thing, had a guy use two prongs hooked to a car battery on my head and went for PRP in various points of desperation in my “journey”. Best to be optimistic but always skeptical.
I found this comment from a user on the Tressless subreddit who claims to be a participant in the trials.
“Before starting this clinical trial, I struggled with severe dandruff and dull, brittle hair. The product is applied only to specific areas of the scalp for 28 days, and since I began using it, I’ve noticed significant improvements. My scalp and hair are much more hydrated, shedding has decreased to almost nothing, and I no longer experience dandruff.”
As somebody who also developed sudden dandruff and scalp issues around the same time their hair loss began, this makes me feel very optimistic. They also mention some minor regrowth after 28 days:
“I have observed growth in the already established areas of my hair that aren’t experiencing loss. However, since my hair is long and the trial requires participants not to cut it, it’s difficult to determine if there is new growth in areas where it’s most needed.“
This is all from some random user on Reddit, so take it with a grain of salt.
For those who don’t know, the Dermatology Summit is a big thing in the Dermatology world, due to it being high profile. And Pelage will be presenting there in January of next year which is when the clinical trials for phase 2 will be completed. Hopefully we can hear/see some good news come out of that conference. https://advancing-derm.org/platform/conferences/dermatology-summit-2025/
So apparently the recruitment for the trial finished already, so it’s safe to assume that by November the dosing (28 consecutive days) is over.
But I think they want to have a longer look at the effects, at least a couple of weeks after the last dosage.
To have results ready to present by January would be very fast, it’s doubtful.
It’s a phase 2a. They’re still mostly focused on tolerability and safety rather than efficacy.
Ah yes, you‘re right JT. Just checked it on clinicaltrials.gov.
Which in turn means there must be a 2b trial pretty soon after (if safe!).
The only thing locked in is the candidate at 0.05 concentration. So I assume they also see efficacy too, even if not officially confirmed.
What do you think, in phase 2b they try different schedules like once a week or every second day? I am sure this is has to be taken permanently – for business reasons too of course. Not daily would be a blessing.
2b they’ll definitely shift focus to dosage strengths and frequency of applying. Assuming the drug passes the 2a phase.
“Chad” sent me the following message on Discord:
“Well, I did get a ‘hey wtf man’ call from Pelage about posting photos online. But I can TALK about my experience. In fact, I think in the actual contract I signed, it straight-up says “we encourage you to talk about the decision to be in the trial with as many people as you want or need to”, or something to that effect, so I’d be down to talk for sure.”
“I only have one more appointment, which is in like 2 weeks? i think? then I’m done for good. but I don’t have any of the things they had me do in the original appointments anymore since I’m not taking/applying the medication. No more tattoos on my scalp (although they redid them this past appointment since they faded so much), no more hooking me up to an EKG, or making me take a blood and urine test, then have me apply medication, then feed me lunch and make me wait 3 hours, then take ANOTHER blood test and give ANOTHER urine sample. that was the only part I wasn’t fond of, but… y’know, if getting stuck by a couple needles and peeing in a cup a few times is the worst thing that happens to me in a day, I’d say that’s not a very bad day at all, you know? especially if it’s in the process of stopping my hair loss and earning more money than I feel like my effort warranted lol.”
He also sent the below to one of the blog’s readers:
“Well, I did kinda get a “hey knock that posting of photos shit off” call from Pelage. But I can talk about my experience. In fact, I think in the contract I signed it straight-up says “we encourage you to talk about the decision to be in the trial with as many people as you want”, so I’d be down to talk for sure.”
“I told them, like, I’m not sure why you guys are mad– I had crazy results and did nothing but sing your praises, and the praises of the doctor’s office that ran the study since y’all were so great to me, and did nothing but say how lucky I felt to be picked to do it and grateful. Especially with the money y’all paid me to fix my problem, so like… just know it was literally all good shit. But they said they just weren’t ready to post photos yet, which I get, but.. lol… if a real dude like me having crazy awesome results, and telling everyone in a hairloss discord about it isn’t the best advertising on the planet, I’m not sure what is. Oh well! I’ll respect their wishes to not share my clinical photos, which they said were fine “for me to keep” but “weren’t ready to publicly post yet if I didn’t mind refraining from that”. And since they ASKED me not to do it, and didn’t TELL me not to, I respect the hell out of that and won’t put ’em anywhere else. But, like I said, I’m down to talk about it for sure. It was a great experience.”
This sounds a little erratic to me tbh…Moeman reloaded?
Honestly at this point I rather don’t get information from people in trials. Eventually it’s only anecdotal evidence which is scientifically speaking worthless (yet interesting nevertheless!).
Erratic, scientifically worthless and interesting for sure.
I’m somewhat confused by what he is saying here but I think this broadly correct:
-Scalp hair regrowth, which is interesting because Minoxidil and Finasteride provide mediocre results here especially on regrowth
-Visual growth when photos are taken zoomed in.
–Does this show multiple hairs growing from where a single hair once was?
-Nothing said on the front hairline
-Came from a 48 hour difference in topical application.
The photos were taked 48h later, so they are not really worth talking about
I mean any growth after 48 hours essentially proves the mechanism works right. Since it essnetially means they activated the stem cells to produce hair.
If this is all true all we can hope now is that it provides decent or complete coverage, especially for lost ground, that generally is the golden grail for what we hope for.
Fair enough, personally I’d interpret “talk about your decision to join the trial” as just that, my decision and the trial itself, but would draw the line at discussing my personal results (and certainly sneaking photos and posting them online), if for no other reason than I wouldn’t know if I waa receiving placebo.. This treatment is the first and only light in decades, so should be respected in my view. Don’t kill the goose that lays the golden egg.
I think this is Moeman with another account.
Let’s hang on, dissect and analyze every word this eloquent young man has to say. Tell me more Chad.
We will have BOTH Amplifica and Pelage presenting!
At the Aesthetics Tech Forum on January 9-10, 2025 at Pendry Newport Beach:
https://www.linkedin.com/posts/octane-oc_atf2025-hairrestoration-aestheticsinnovation-activity-7259600052455694336-zxan?utm_source=share&utm_medium=member_desktop
As the trial results have been out for a couple of weeks now I‘d much rather hear from Amplifica now what they are planning to do? Phase 2? Scrap it and start with the next candidate?
It’s been suspiciously quiet imho…
We might see phase 2 results from Pelage by the time the Octane conference is ongoing. If I am correct the last trial patient has already received his last dose. Or they instantly start with phase 2b without publicizing any outcomes.
Great find, thanks for this YoYo.
No worries LJ.
Not sure if this was posted before but I saw this LinkedIn post from the Chief Medical Officer from Pelage.
https://www.linkedin.com/posts/christinawengqy_hairloss-androgeneticalopecia-minoxidil-activity-7265049704281829376-goqB/
This quote caught my eye “Cell-based therapy is just much more complicated logistically”, says Lowry. “Maybe , one day it could be a way to restore follicles if you’ve lost all your follicles, but for most [regular male or female pattern baldness] the stem cells are still there and so our approach is just to wake them up”.
I assume by “most pattern baldness” Dr. Lowry is talking about is people with androgentic alopecia still having the stem cells, whereas people with maybe scarring alopecia or other conditions not having the stem cells.
Thanks.
If you have a device with Apple News, it seems like the article can be read here:
https://apple.news/A2xjLwfM9Q-ixrOcDMGTDvw
A section of it can be read here:
https://pocketmags.com/us/focus-science-and-technology-magazine/october-2024/articles/1464892/keep-your-hair-on
Following the comments by ‘Chad’, he states a “treatment for 30-days type thing”. This sounds like you are taking a course for a month? (like what you might do with antibiotics.)
Does anyone think the trial with Pelage will be much shorter?
The testers will only be taking bloods for 1 month?
Whereas if you were testing finasteride 2.0 you’d be taking bloods for 6 month.
Does anyone else think the trials for pelage will be really short?
Doing the math, This, at the least, must shorten trials by a minimum of 5 month?
Or is this wrong?
All trial data is public:
https://clinicaltrials.gov/study/NCT06393452
I assume „Primary Completion“ (December) means treatment and post-treatment is over and all data is collected and by February (Study Completion) analysis is done and results will be published (if they are published).
If successful, a phase 2b will be started shortly after – afaik this current study is 2a.
Pelage Pharmaceuticals is very well financed so there won’t be much time in between trials.
I really hope this is the breakthrough we‘ve all been hoping for. It looks very good for now. Keep your expectations in check.
I’m nervous but excited :/
Thanks.
100% share your feelings YoYo!
… and again, signals suggesting that efforts by other companies proposing more invasive strategies are weakening might indeed be a good news! Meaning they believe Pelage is arriving with THE solution. Fingers crossed!
Let‘s not get carried away…I highly doubt that any company involved in hair loss is slowing down because of Pelage. This is a speculative if not childish take, honestly.
And what ‚signals‘ are you seeing anyhow?
If anything is slowing down, then it’s because of – guess – money! Or lack thereof.
mmm… my take is childish. I am going to ignore this. To anyone, let us keep it polite in here, it is really the only way to show respect and appreciation to Admin and the huge work they are doing for all of us.
May I ask Pellata what is making you think that other companies are weakening?
~ YoYo : delayed trials (Kintor, Cassiopea, Hope Medicine + others); partial descope of the core business, employees being suddenly laid off, etc. None of this means necessarily they are giving up, of course!
But think about it, what if these companies smelled Pelage is going to fix it with a gel you rub a few times on your head… and what if that happens for real, the others would instantly vanish.
I mean (in my opinion) the only companies that I’m excited for, or are of any significance are Pelage, Amplifica and Stemson (and maybe Yokohama University). And Amplifica is using a different molecule to that of Pelage and still have Osteopontin that they have yet to introduce to clinical trials. I don’t think it has anything to do with Pelage specifically regarding any delays lol.
If Pelage is able to be released into the market it would more than likely motivate other companies to get more involved in the hair loss space or even have companies that are already working on their own modality to speed up the process. Even though Pelage would be amazing, having something like Stemson would be the best treatment as you would never have to play around with creams/gels/intradermal injections.
I agree with Yoyo, if Pelage’s product works and comes to market it would motivate other companies to make competitive treatments, not just quit.
I think a big reason we haven’t seen much innovation in the hairloss industry is because there’s been so many failures over the years and a prostate pill remains the staple treatment.
A new product that truly works on everyone would cause an explosion of innovation in the industry.
I see your point YoYo and what you say make indeed a lot of sense. On the other hand, isn’t having (already) millions and millions of potential customers a powerful enough driver for all these companies?
I am probably wrong on this but I feel that only a minority would prefer undergoing surgery rather then keep rubbing their head at home every few months.
I 100% agree that AMPLIFICA is not less of a deal than PELAGE. What distinguishes these two company is the rock solid academic background of the scientists behind.
I mean I’m not sure about that, because I for one would MUCH prefer just having a one time (or maybe 2 or 3 times more throughout my life) surgery to have a hair transplant like procedure and not worry about keeping with a schedule on when to apply a gel on my scalp. A few hours surgery and that’s it, that’s way easier and more convenient in my opinion. And both Amplifica and Pelage have intelligent people behind their company (as well as them being well funded which is also important)
Amplifica’s results so far are weak, perhaps they’ll do better with the other compounds in their pipeline, but we’re talking years away. And that’s the key thing, time, with every year that passes research is compounding (even more so with AI), getting closer to a cure, but we’re also all getting older, with our hair becoming less valuable to us.
Let’s be honest with ourselves, if something like Pelage came out with good results, even if it required twice daily application, the majority here would pay through the nose for it and be happy to do so, as we’d understand this would buy us time with hair and bridge the gap until something more effective/convenient came along.
Exactly LJ, one point though is that Amplifica’s results weren’t very clear and I hope by next year we can have a better understanding of their product and how effective it can be. Because it seems to be getting a lot of hype but I want to see why lol
Am I missing something or is everyone getting a little caught up in the hype? Has Pelage posted any official efficacy or safety results, or before and after pictures? If not, this all seems very speculative at this point.
It could very well be a dud.
I think a lot of us are hyping this because it’s the only thing in the pipeline worth talking about lol
But the company does have $30 million invested from one of the largest venture capital firms… surely that’s not nothing.
That’s definitely impressive, LJ. I get the excitement, I just personally will wait until there’s some solid evidence of efficacy before getting any hopes up.
The funding is nothing to scoff at, that’s for sure.
I think the fact that the drug appears safe (so far) and has a unique MOA that doesn’t involve hormones (scares off too many men) is why they secured such a whopping investment.
it could actually be a dud, and yes… we are hyping it (by definition, since we have no proofs), which reflects our hopes and/or state of despair, pick what you prefer! Nevertheless, the reason why we like Pelage (even more than Amplifica) is not because we are bunch of fools: their mechanism of action is pretty straightforward, DHT makes stem cells disappearing from the follicles, this gel re-activate them. Of this there are already proofs!
That being said, till we get convincing before/after pictures, everything can turn into smoke at any moment. Plikus is also solid, though Rassman says they are not going to delivery before 5 years (perhaps 4 now).
Well, let’s see what proof they deliver. Fingers crossed.
I believe Rassman is grifter though (my opinion) and if I had a dollar for every time I heard “5 more years”, I’d be wealthy enough to fund the research myself.
We’ll just have to wait and see how it goes.
So I said a while back on here I’d post some info. My last day (day 83) of the PP405 trial is December 13th. I haven’t applied the drug since October. So far I have noticed ZERO improvement. Keep in mind, this is a double blind study and I very well might have received the placebo. I will say the drug makes your scalp itch and it smells like rubbing alcohol. I was really really hopeful as I’ve heard amazing things but I just haven’t really noticed anything aside from some SLIGHT improvement in my vertex, honestly enough to be negligible. I was told in my last visit, I’ll be invited back for phase 2b if I only received the placebo. I should know in Febuary. For anyone wondering, Phase 2b is a 90 day application (Once daily) with 100 percent guaranteed PP405. No placebo. No more biopsies or tats. I’m not sure if they would want blood and urine samples still or not. I hope I did only receive the placebo this time around tbh. I’m disappointed. I went through a lot to make this trial work including driving there and back and it’s almost 3 hours each way. The compensation was great but I really just wanted to see improvement in my hair density. For the record, Chad has to have been a legit clinical participant.. Every single thing he said about the trial is spot on. There’s no way he knew all those details unless he participated. The fact that he had such great results really makes me feel like I didn’t actually receive PP405. I guess I’ll know more in February!
Thanks Delta!
Wow… what a great testimony. I can only send you a big thank, Delta! Fingers crossed that you were (unluckily for you) in the placebo group and will be invited for phase 2b. Good luck!!! If you can, please keep us posted…
Thanks Delta! Did they give you any indication when Phase 2 might start? And can you expand on your statement: “I was really really hopeful as I’ve heard amazing things”. I am curious if you can provide more detail on what was said and who said it.
Thanks Delta, I take it they won’t give you your TAHC measurements until Feb either?
You didn’t notice any side effects in addition to no visible hair improvements?
Big thanks for the update. So this confirms what some other people suspected, they’ll be launching phase 2b immediately after 2a (assuming the readout is positive). I’m a little confused about how they’re going to make a phase 2b work without a placebo group, though.
I was also wondering about the phase 2b with no placebo. You could speculate that they no longer need a placebo because it is clear from Phase 2a that the treatment works. But you could also speculate that because they are expanding the treatment period from 28 to 90 days, that the treatment doesn’t work as effectively as they had hoped. Can’t wait to find out and it is encouraging that, once again, they appear to be wasting little moving to the next phase.
Hey Pinotq, it has nothing to do with the treatment not being as effective as they’d hoped for. I’m sending a link, it tells you the difference between phase 2a and 2b. If it was the same duration (28 days) then it wouldn’t tell us anything different from Phase 2a. If it was shorter than 28 days, that’s not nearly enough to see the data required. It only makes sense that the length of days has increased.
https://revive.gardp.org/resource/phase-1234-trials/?cf=encyclopaedia#:~:text=Phase%202%20studies%20are%20sometimes,that%20provide%20data%20on%20efficacy.
I’d still say 2b is still comparing a placebo?
They are comparing the results of those that have both tried a placebo and PP405, in trials 2a and 2b. This can give a greater insight?
Thanks…………..all good points YoYo and KP! Really excited about this company. Much to be learned and hoping for a detailed update from Pelage by February. Also hoping that Delta got the placebo and doesn’t turn out to be a non-responder. In other words, I hope PP405 delivers consistent results and that Chad (if you believe him) isn’t just a 1 off super responder.
No problemo Pinotq.
One last thing Pinotq, I’m just guessing here, but I don’t believe that Chad is a one off case. The reason being is that Pelage was funded by one of the biggest ventures and obviously they were able to see the results first hand and are confident that due to the positive outcomes that Pelage have reported, this is an investment worth making it. And I don’t see why this shouldn’t have a positive outcome on every patient (or damn near close to it).
Pointless speculating on results tbh, I agree that GV willing to take a punt of $30M (of the $10B they have under management) is encouraging and implies they were presented with some promising early pre/clinical data, but let’s not forget 70% of drugs fail Ph2 and even if there are some freak responders, these may be statistically irrelevant. All we can sensibly do now is wait until readout…
Having said that though, according to a friend of one random Redditor, the results are MEGA lol
https://www.reddit.com/r/tressless/comments/1griqbl/any_news_on_pp405_pelage_pharma/
Yeah that comment’s talking about ‘Chad’ again and his claims of brand new hairs after less than 48 hours.
Can’t really take that seriously. Not doubting was in the trial. Just pretty sure he has 0 clue what he took pictures of.
I thought Chad’s growth, whether new hairs or accelerated growth of existing hairs (it loooked like just accelerated growth to me), did seem unbelievable. That’s why I asked Delta what some of the “amazing things” are that he had heard. I remain optimistic and like what I am seeing from Pelage so far but also realize the hair loss pipeline is batting zero for 1,000.
Great insights, Delta. Thanks for that.
Seems like it’s highly likely that you‘ve received placebo. The results from phase 1 were just too convincing that there would be close to no regrowth.
So I reckon phase 2b will start early next year, 90 days treatment, similar time for observation…by the end of 2025 we should know if this works or not. If it does, additional funding will be no problem, phase 3 in 2026…commercialization during 2027?
If things go perfectly well. Btw Technoderma had great results in their phase 2 last year, yet they haven’t started phase 3 yet. Sometimes many issues arise – mostly funding…
He didn’t have great results, all the hype was about 2 pics 48h difference.
Agreed we’re doomed, 2030 minimum for anything.
Hmm idk, seems too early. It would have to be known already now.
Nope it’s snake oil they’re all wasting their time and feeding us false hope.
Yoyo friend, don’t be discouraged, lately from your comments I see that in the end you think the same as me, calm down friend, I know my body and I know that I have androgenic alopecia and due to my nervous nature it accelerates. I had a hair transplant 4 years ago and I’m almost 29 and I take dutasteride daily and I see that the alopecia continues its course… The solution comes from treating the root problem and recovering the cells that the alopecia attacks, not by attacking routes with medications and minimize the effects because it is a GENETIC disease. Have hope in Shiseido for now friend just like the others…
Shiseido? You are living in 2016.
I appreciate your kind words Alvaro, but I was being sarcastic towards Tom, I have a good feeling that Pelage (& possibly Amplifica) will be good enough based on what we’ve been hearing to help us until something like Stemson can come into market. I’m excited for next year as Stemson will finally announce their plan for human trials for 2026 and hopefully break down how it would go and Pelage releasing photos/data in February. There’s definitely good enough reasons to be hopeful about the future, we just have to whack the pessimists back into their holes!
Being realistic is different from being pessimistic. All the current hype is based on a picture that showed a 48h difference and was wrong. That’s what I said. No need to wack mr yoda.
Are you indicating Yoda is the whacker or the whackee? It was not my intention to whack, nor do I feel whacked, just making a pun. Lighten up boys. No time for favorites here, may the best treatment win!
I think he mistakenly called YoYo Yoda:-)
I am at a bar, and you guys are more entertaining than the crowd here.
This is what I call friendly fire :)
Alvaro remarks: “my nervous nature it accelerates.” Well said sir. I’d wager most of us here are blessed not only with alopecia genes, but with a high score on innate neuroticism. ( Look up the “ocean” personality test if interested. It’s a widely used clinical exam.)
Thanks, Delta, for the update. The timeline for Phase IIb sounds good to me.
Hey all, someone in reddit shared pics with me of the supposed individual’s pelage trial results. Not sure how to share pics on here, but to me I definitely can’t tell if the current hair has just grown more or if new growth (dormant hairs reignited), has occurred. The pics are taken on a phone of a laptop in a doctor’s office, and on the laptop screen it says “pp405”, “baseline+48 hours”, and the subject (participant) number.
Definitely very very very interesting to see the pictures, as someone who took a base look at them would see thickness and new hair growht, but I think hairs just got longer. Can’t tell for sure. I’m not even sure if hair can grow as long is it did in the pic in 48 hours. I’m very happy to share those pics to whomever is interested.
Please post the reddit link here.
It wasn’t a reddit post, it was a dm. Ill try to put in on imgur and send it that way on a link.
The pics are also wrong, it’s mixed up. They are not before and after of the same area
Its chad again.
Im curious about their (the participants) self perception of growth. especially in the Vertex and and hair line.
https://imgur.com/a/lzbbjMf
Here are the photos. No I’m not the Chad guy lol. Also not sure where Tom is getting his info from that the pics are mixed up, that to me is misinformation, unless he can say how he knows that for sure.
Haha that user got the pics from me… anyway, back then we inspected the pics well and noticed that 2 pics were taken from the same area (even though on the right it says either temporal or vertex). If I remember correctly both the right pics show the same area.
These pictures were discussed earlier in the comments (see mine from October 12), as well as on Discord and Reddit. I avoided adding them in the post.
You seen this video summary of pp405 admin?
https://youtu.be/wbPqiqkNpaA?si=8eWVbuN2tNIWVelt
Only just come across this channel but seems to be a keen amateur who digs into the science and provides pretty comprehensive overviews.
I have mentioned and embedded his videos in several past posts. Did not watch this one yet.
Here is what I think, for what is worth: if I shave someone’s scalp, hairs will grow at least millimeter after two days, the condition of course is that hairs must be there. If the paradigm that hairs never really disappear, these pictures may simply show grown pre-existing (still) healthy hairs, in addition to a good number of new (previously unhealthy) hairs. We certainly need more than just these two pics to call it victory! The sole point I want to make here is that a 48 hrs timeframe may not be as unrealistic as it sounds…
Pellata, my beard hair definitely agrees. Even 24 hours is sufficient.
Yes, this is what I mentioned in my original comment. There could be new regrowth of dormant follicles, but we can’t tell for sure since pre-existing healthy hairs just grew longer
Great perspective regarding the beard hair growth. I hadn’t thought of that but it does provide a reasonable explanation of what looks like unbelievable growth. My guess is that the growth seen in those pics is primarily just accelerated growth of existing hairs. I base this on the fact that it took 7 days to see evidence of emering hair germs: “There was a statistically significant increase in the Ki67 signal compared to baseline after just seven days of 0.05% PP405 topical treatment. Evidence of newly emerging hair germs – the hallmark of the telogen to anagen transition – was also observed.”
As I said, the pics are flawed… forget about them.
Tom, please stop. You say the same thing like a cycle. WE GET IT!
Well people do not seem to get it. Besides, wtf is your problem.
Boooooo!!!! Boooo!!!!
I haven’t read all the comments but it sounds like they shave him every time to account for this growth.
So according to https://clinicaltrials.gov/study/NCT06393452 the primary completion for the 2a trial is December 2024? And the study completion February 2025?
We have to be getting details of the up coming 2b phase trial in the next few days or weeks?
Probably after the trail has finished/results published.
They can start phase 2b before announcing results of 2a i think kintor did that with one of their hairloss drugs.
Looking here https://advancing-derm.org/platform/conferences/dermatology-summit-2025/
The next date to look for is the 12 January?
No they don’t have the results yet.
It will still be an interesting event though? They might even give us details of this years phase 2b trial? and beyond?
Very interesting podcast from April with Heather Christofk, Co-founder of Pelage:
https://podcasts.apple.com/at/podcast/id-love-to-know/id1730821144?i=1000652866815
I listened to the whole thing, the two key-points from the top of my head are related to the regrowth of hair that’s gone for a long time;
• mouse experiments were partly done in *aged* mice, which is unusual. They wanted to prove that PP405 is working on older tissue too. It was successful and the mice grew back a fully covered fur, not just in patches. They also tested in pigs.
• Bill Lowry found that in most types of Alopecia the stem cells are still fully present (except Alopecia Areata, which is a immune problem), they are just quiescent. Dr. Lowry took punch biopsies from scalp skin that was bald „for decades“ (!). In PP405 culture the HFSc proliferated „like crazy“.
The whole podcast is a little unstructured, but if you pull through you‘ll find some very interesting insights, not just on hair loss. Christofk also shows how much R&D Pelage and her department did over the years without us lurkers ever knowing.
Here are some rough time stamps, which I think, also cite Ben:
16:31 how this technique behaves in growing hair follicles in old mice
18:47 potential therapeutic uses
19:53 over time they selected the right drug then created pelage
21:36 hair follicles are quiescent most of the time
22:10 they are excited about the strategy
24:40 hair follicle stem cells wait for signal.
24:50 Bill Lowry’s experiments that highlight constant quiescent stem cells
25:00 hair follicles stem cells retain the ability to proliferate.
29:31 Ki67 staining to shows hair follicle stem cell activation
29:35 seeing hair follicle stem cell activation on human tissue
Very interesting podcast from April with Heather Christofk, Co-founder of Pelage:
I listened to the whole thing, two key-points from the top of my head:
• mouse experiments were partly done in *aged* mice, which is unusual. They wanted to prove that PP405 is working on older tissue too. It was successful and the mice grew back a fully covered fur, not just in patches.
• Bill Lowry found that in most types of Alopecia the stem cells are fully present (except Alopecia Areata, which is a immune problem), they are just quiescent. Dr. Lowry took punch biopsies from scalp skin that was bald „for decades“ (!). In PP405 culture the HFSc proliferated „like crazy“.
The whole podcast is a little unstructured, but if you pull through you‘ll find some very interesting insights, not just on hair loss. It also shows how much R&D Pelage did over the years without us lurkers ever knowing.
Thanks Ben! While I think you still have to consider any candidate in the pipeline a long shot, I currently rank this posibility number one on my list. The podcast gives more insight into the depth of their research which inspires confidence. I also found it very interesting the way they opened with the analogy to what happens in skin when the stem cells go quiescent……the effect in hair is that it doen’t grow back while in skin it loses elasticity and sags. I have my fingers crossed that instead of statistics, we will shortly see some convincing photos.
The interview was crystal clear. The thing I picked up on is that they have put a lot of research into this. I have so much confidence in this through that podcast Ben highlighted. IMO the only thing we have to watch for with any treatment is fallacious misinformation. Things akin to PFS or ‘my neurosteriods’, And worries over the fact the drug is systemized like water, food, aspirin and every other drug known to man.
Here is a new video from KwRx on Pelage. Admin, he brings up your site and goes through the leaked pics.
https://www.youtube.com/watch?v=TRMxzwxJJXc
Thanks!
Seems like there has been a lot of buzz on Reddit recently regarding Pelage and PP405, coupled with the usual hype that its a forever cure and aggressive doomerism that its just vapourware/ nothing will ever happen. Both of which are probably unfounded as we really don’t know much about the effectiveness of the drug yet.
That being said I think it is interesting that the executives at Pelage will be presenting three separate times all within one week. The Aesthetics Tech Forum on January 9-10, the Innovation Dermatology Summit on January 12th, and the UCLA Startup Showcase on January 14th. I’m not too sure if this is just trying to drum up more investors or what, but I wouldn’t be surprised to see at least some new information revealed. Even if its just that they are progressing on schedule with no specific dates or data to be announced.
Any new message in the Innovation Dermatology Summit?
Joaquin Buckley.
Anyone seen any media or articles of these summits? The only think I have seen is a message of a fireside chat that I think Weng liked on LinkedIn.
Nothing at all, I also wonder where all that pp405 hype is now.
The term ‘fireside chat’ hints at informality and suggests a chat with no new info? They are probably preparing for the end of the 2a trials and the start of 2b trials in February 2025? I hope the likes of Pelage and Amplifica move on fast with no procrastination, imo.
I was looking at the meaning of the different completion dates for Phase 2a in anticipation of when they might disclose some reults…..I didn’t really understand what that was but the Primary Completion Date is the date that the last data point for the primary outcome measure was collected from the last enrolled participant. The Study Completion Date is the date that the last data point for all remaining outcome measures was collected from the last enrolled participant. The Primary Outcome measures were both safety related. The Secondary Outcome in Phase 2a is efficacy (although that outcome isn’t listed on clinicaltrials.gov). So it looks like they are still collecting the efficacy data with a probability they will wrap this up sometime in February…….given they were on time with their estimated primary completion date. Hopefully they will release at least a summary in the next 45 days.
An article that references PP405:
https://newsroom.ucla.edu/magazine/baldness-cure-pp405-molecule-breakthrough-treatment
Thanks! Great conclusion:
“FDA approvals always take some time, as they should,” Lowry says. “But it will be worth waiting for.”
Quite skeptical about this administrator?
What’s best case scenario for time to market (other than 5 years)?
I’d say this could be rapid? Especially if this is a short term course of treatment type of thing?
The phase 2b, started soon, completed this year? And the phase three started this or next year, depending on how everything is or is not procrastinated?
The average time to market after successful phase 3 trials is 6 to 12 months.
If it works, it would be awesome, fingers crossed but my hope is so low after the past decade :(
FYI On clinicaltrials.gov , its shows there is an update as of today. I don’t see any changes after a quick glance but the update may be in progress. …….and I will be traveling but it may be worth monitoring as the day unfolds.
Seems like they updated it with the phase 2B info, which will be an Open-label extension of part 1 of the study. Changing the Primary completion to November 2025 and the Study completion to December 2025. Also a new summary that reads as such:
“The study is a two part study, designed to validate safety results from the Phase 1 PP405-001 trial while also characterizing longer term safety and PK. Part 1 of the trial is the randomized controlled portion that will focus on safety and PK following 28 days of blinded treatment administration with either PP405 or vehicle control. Part 2 of the trial is an open-label extension that will validate the results of Part 1 with 3 months of treatment administration.”
I believe this is in line with what the commenter who said he was participating in the study wrote about. My only question now is if we will even see any publications about the first part of the study, or if we will have to wait a year for this Part 2 to finish.
To move from Phase 2a to 2b that quickly is insane. Has any company in the hair loss space ever accomplished such a thing?
Not even going to mention that they had two rounds of funding post Phase 1 to before Phase 2a even ended.
I’m a little confused.
Where does it say that study 2a has finished and we move on to 2b?
Why doesn’t it mention anything about effectiveness?
Interesting piece:
https://www.sciencefocus.com/the-human-body/balding-cure-we-may-finally-have-a-simple-way-to-reverse-hair-loss
The article says absolutely nothing of value. It’s what you’d expect from a commercial news outlet. I don’t mean to throw a wet blanket at you for posting that – it’s just that they cycle this kind of vague, feel-good vibe every year with no actual data.
Do not to be so naive buddy… a company would probably pay to be featured on websites and journals by major editors. The value of this article is not in the text itself, but the fact that Pelage is coming out more and more in the media.
I thought it was encouraging to see Weng describe the results of PP405 as “fantastic”…….which would seem to describe something far better than statistical significance: “Pelage recently attracted investment to continue clinical trials of its topical treatment for hair loss, PP405, which Weng says delivered “fantastic” results in initial safety trials in humans.”
1. Put that Weng ‘fantastic’ description alongside the Kristophf podcast above. 2. Then you have the fast pace? Example, as soon as Phase 1 finished they moved on to phase 2a. In the month 2a finished, 2b started. And 2b is finished in 2025. 3. Speculating but is phase 3 finished next year, 2026?
This all shows a fair reason for the encouragement?
All this evidence Pinotq is pointing to provides encouragement.
Or fantastically safe, the goal of the trial.
Could be and obviously it is all speculation at this point as we parse any information we can find for clues. But also recall that although efficacy is not mentioned as an endpoint in clincialtrials.gov, Weng said:
“One of the end points that we’re looking at to assess is efficacy of hair growth. We’re doing 3 different measures of hair growth. First, we’re assessing what’s visible with the naked eye. Second, we’re using high-resolution photography to quantify hair growth at the single hair level. This allows us to identify changes in density in a very objective way. Third, we’re collecting tissue, and we’re able to assess markers of hair growth at the macroscopic level.”
https://www.dermatologytimes.com/view/q-a-pelage-s-novel-pp405-advances-to-phase-2a-for-androgenetic-alopecia
The vp of pelage posted this on LinkedIn today
“Great article by UCLA on how far we’ve come with PP405 and the exciting future ahead of us at Pelage Pharmaceuticals! “
Is this confidence confirming great 2a results? Posted a few hours ago today…
In defense of Terrence the article does the same meandering explanation of what hairloss is and DHT and so on that only commercial news does. The article mentioned PP405 in passing. This is not the kind of article that means anything. We already know about what PP405 is. The article was useless. I’m not denying the potential of PP405 – we don’t need the BBC to catch up because they are not relevant.
I wonder if the user Delta has heard yet if he received the placebo, and if so, been invited back for phase 2b?
I wonder what Chad is up to to?
It is possible that because the completion date for phase 2 trial was initially February 29th (before the addition of phase 2b moved the entire study completion to December), that the placebo subjects of phase 2a might not hear back until the 29th. Unless phase 2b is already underway, in which case delta and chad have already found out what they received.
I often wonder that too, gee what’s Chad up to? I wonder what he’s wearing? He’s so Chad. Seriously, what a load of crap!
Admin feel free to move/delete this comment if there’s a better place for it, but it sorta relates I believe to Pelage’s idea of activating stem cells. I saw this article today https://news.virginia.edu/content/hair-today-gone-tomorrow-maybe-not-long.
Where researchers “identified a previously overlooked stem cell population in the upper and middle sections of the hair follicle that plays a crucial role in hair growth. When these cells are depleted, hair growth stops, suggesting that replenishing or activating these stem cells could restore hair growth. “
Thanks. Someone also emailed me the below new article concerning the same Dr. Lu Le. Both articles are from the University of Virginia, where the doctor practices.
https://newsroom.uvahealth.com/2025/02/19/discovery-reveals-potential-key-to-reversing-hair-loss/
I covered Dr. Lu Le in two posts in 2017 FYI:
https://www.hairlosscure2020.com/category/lu-le/
The current news pertains to these 2024 findings from Dr. Le and his team:
https://www.jci.org/articles/view/180160
So I guess no updates this month? Well nothing more outside of 2b starting…
I think the only way we were tipped off about phase 2b is that it was noticed on the clinical trail site when it was updated. Pelage doesn’t show anything on their website yet about 2b so I would expect some kind of offcial announcement sometime maybe in the next 30 days…possibly longer since the start date is listed as 6/2025. I would guess they would say at least something about the results of 2a at that time. I would hope for pictures but we may just get a generic statement without any real concrete data. I note that on clinicaltrial.gov, they state that they do not plan to share individual data……so who knows….I remain optimistic.
Pelage has been known to be under the radar when it comes to revealing information about their trials. I wouldn’t look too deep into it.
We got hurt through all the years, and it is understandable and wise to stay skeptical till photos will be published and guarantees will be given that PP405 is safe and does not have any insidious long term side effect, but… these guys are telling us they have a “breakthrough” molecule on an official UCLA channel: https://newsroom.ucla.edu/magazine/baldness-cure-pp405-molecule-breakthrough-treatment (link already posted). Yes, we are still in the realm of speculations, though I urge you not to forget UCLA is not a start-up… and that people involved in Pelage are serious academics who would not put their heads on the chop for nothing. That said, let us wait patiently till we have visual proofs and quantitative data… and hope!
Thanks for responding to my comment!!
I believe that our only hope for any updates until the end of this year is Delta, who should know soon, if not already, whether or not he received placebo. He said he had zero results, so the hope is he got placebo. I really hope he returns to let us know.
Personally I dont think they ever planned to release anything until both parts were complete.
I guess the one we were all hoping to see this month isn’t coming out with results for 2a. My heart must keeps breaking with this stuff.
It looks like Pelage are doing a talk, or presentation at the Aesthetics Innovation Summit in Austin, TX on 19 March 2025. https://www.linkedin.com/feed/update/urn:li:activity:7302803828670611456/
I wouldn’t be too hopeful just going to be the same pr shtick of how pelage pp405 is innovative using stem cells as mode of action.
Wish they would just release some 2a results to backup the drug.
You never know they may give out something? Its only two weeks away too.
Let’s hope so, I would love to hear some good news!
Me too :(
Eirion Therapeutics is listed as a presenting company as well. Fingers crossed we get some interesting news. Not to read too much into the tea leaves but I figure the more events the company attends is a positive sign, rather than a negative. At the very least for our sake it’s better to see this in my opinion than hear nothing for months/years on end.
A Stemson representative made a talk in a conference literally one day before Hamilton confirmed the end of the company.
Wow, I didn’t know that, quite unfortunate for the presenter. At least with Pelage it’s the Chief Medical Officer presenting, so you would assume she would be in the know on just about everything in the company, given its small size.
Speakers for conferences are decided months before and often people accept before they even fully know the results of the topic they are going to discuss.
I think it is reasonable to assume we might hear something in the next 30 days or so given the June start date to 2b. While Pelage remains at the top of my list of potential treatments, my hope is admittedly all based on circumstantial information….from the deep University research and well studied pathway, apparent success of Phase 1, speed of progress, Chad claiming he was a trial participant with great success, Delta claiming he was a participant and indicating Chad must have been a particpant given the details, Delta saying he had no response and that he would be invited to be a Phase b particpant, cinical trails update confirming that those who received the placebo in 2 A would be invited to 2 B, Weng describing the results as “fantastic”, etc. Also note how they describe Phase B on the clinical trials update: “an open-label extension that will validate the results of Part 1 with 3 months of treatment administration.” The word “validate” doesn’t speak to how successful Phase 2 B was, but it does suggest, in my view, there was at least some degree of success. So if your looking for hope or a glass half full, there is lot here lean on.
IMO, following the podcast which gave insight (I’d suggest people listen to it): the fact it stimulates ki67, the speed of progress, the fact that they are validating in phase 2b are all excellent signals
I like your optimism. However I’m betting we won’t be getting any update directly from Pelage anytime soon.
History would suggest I shouldn’t take that bet :)
Replies like this are why I check this site. Also, not sure it makes any difference but Eirion appear to be a sponsor rather than a speaker at the conference kp posted above.
I would forget about the Chad situation.
Who could forget about Chad? He was so epic, quite legendary really.
New paper by Will Lowry (President of Pelage), about stem cell and intermittent fasting, not good apparently:
https://www.nature.com/articles/s41422-025-01082-y
They are discussing a January 2025 Chinese study:
https://x.com/HLcure2020/status/1888410920466203023
Hype based on nothing.
Good old Tom, always with the incredible insight.
Just stating facts. Never seen you write anything meaningful.
You must be new here, 90% I post here is to provide updates. Can’t say the same about you Tom ;)
I was the one that made Chad post his pics, actually.
Any news on the aesthetics innovation conference?
I don’t see anything. But I know the summit has a youtube channel https://www.youtube.com/@AestheticsInnovationSummit
And they did post vids from last years event.
I also want to know.
Buckley?
Buckley is the new generation.
I can feel it in my heart of hearts that this will be the biggest disappointment in a while. The more I research mitochondrial pyruvate carrier inhibitors the less I have faith that this will be a breakthrough.
Why?
The only evidence that exists publicly anywhere so far that this compound works is on mice in a developmental study. Everything else is just based on the word of the researchers, or from one guy in the trial (Chad) who had no idea what he was even talking about. We have seen infinitely many times where a treatment works excellently in a rodent model and not in a human one.
I’m just getting a bad feeling about it. People have their expectations set disproportionately high, and why? Because of the amount of funding? We’ve seen heavily funded failures before. Leaked photos that don’t show what people think they do? Misleading and false.
I think the hype is just setting up for disappointment. I find it alarming that our one actually clear source of insider information, Delta, has not returned. I believe more each day that he actually received the drug and not the placebo, and had no results.
I really hope I’m wrong but I’m getting some serious deja vu here. We’ve been through this so many times before, even if this is a little different.
I agree with you – it’s better to temper ones expectations with Pelage.
There’s reasons to be optimistic of course (funding, academic background). But how many candidates fail in phase 3? Is it 80 %? I can’t remember…
The chances that Pelage is never coming to market are much higher than the other way around.
It’s statistics at the end of the day.
Actually, if drugs pass ph2 they’re more likely to to make it to market than not, on average, which makes sense if you think about it.
I’ll wager PP405 is coming to market and will be a step change in AA treatment, the question is by when, 2028 probably?
Agreed. As time goes on, my hope on this treatment is also fading as Delta hasn’t confirmed he was placed in the Placebo Group.
eR, Here is a quote from Christena Weng that while not conclusive PP405 will ultimatey grow hair or be successful, is at least a possible indicator of effectivness in human testing; “Secondly, we demonstrated a proof of mechanism. The drug is an inhibitor of MPC,
which is mitochondrial pyruvate carrier. It is a membrane transporter on mitochondria
that is able to shift the aerobic, anaerobic metabolism of the cell. Essentially what this
is able to do is modulate the levels of LDH within the cell, and essentially be able to
shift the metabolism so that it is able to activate stem cells that are otherwise dormant
within the hair follicle. Through biopsies taken in the phase 1 study of the hair follicle
and subsequent biomarker analysis, we were able to show that this is indeed the
mechanism by which this is working in human patients who received PP405 topically.” https://www.dermatologytimes.com/view/q-a-pelage-s-novel-pp405-advances-to-phase-2a-for-androgenetic-alopecia
Thanks for the insight, Pinotq. I recall this interview. You are right, it’s a little reassuring that they claim to be achieving the desired mechanistic effect in the hair follicle. However, you are also correct that this allows us to draw no conclusion about whether or not this will cause hair to grow. This is my main anxiety, as we have zero evidence yet to suggest it does.
It can activate all the stem cells it wants, but we really need proof that this action will spur hair follicles to recover. If this mechanism doesn’t, I honestly don’t know what will (besides the temporary effects of minoxidil). While I still hold the belief that this treatment wil make it to market, I am losing confidence in it’s ability to deminiatutize damaged hairs. I can only hope to be proven wrong, but the wait is killing me.
Dear „er“, I understand your take as we‘ve been disappointed so many times. I am also very cautious. But let me rephrase Heather Christofk‘s interview from last year:
• mouse experiments were partly done in *aged* mice, which is unusual. They wanted to prove that PP405 is working on older tissue too. It was successful and the mice grew back a fully covered fur, not just in patches.
• Bill Lowry found that in most types of Alopecia the stem cells are fully present (except Alopecia Areata, which is a immune problem), they are just quiescent. Dr. Lowry took punch biopsies from scalp skin that was bald „for decades“ (!). In PP405 culture the HFSc proliferated „like crazy“.
So no need for unjustified pessimism!
eR, You are 100% correct that there could still be an infinite number of ways this turns out not to produce cosmetic hairs. We’ll just have to wait but since the phase 2b start is just 2 months away, it’s not that long and with it hopefully a little more insight. Somebody metioned in a post recently that because many of us tend to want to believe, we interpret and buy into a positive analysis and false hope that really isn’t justified. I am certainly guilty of that from time to time as hard as I try to stay objetcive. That said, I believe the clues we do know weigh more in favor of optimism than pessimism. We’ll just have to keep our fingers crossed.
Who said phase 2b start is two months away? That was never communicated officially.
I‘m pretty sure 2b is already underway as 2a started in August and treatment was only 28 days.
I thought I saw that when they made the 02/04/2025 update but the record history doesn’t reflect anything other than the original start date so maybe I mis-read. The wayback machine does not work on the clinical trials site.
FYI ClinicalTrials.gov shows an update for Pelage on 3/25/2025. I don’t see much difference in substance yet since the February update but my guess is that we will see some changes shortly since the Record History does not reflect a change yet either.
Im not religious but im going to say a lil prayer tonight that we get an update!
I’m liking the doubtful energy! Let’s keep it up.
Conditioned to be this way unfortunately.
Still no Record History showing the changes made but it looks from memory like most of the changes were made to eliminate inconsistencies bewteen the original phase 2a language and the update posted in February related to the start of phase 2b. There will be 3 months of drug administration and the study completion date is still listed as 12/2025. It is also still listed as active and not recruiting………. but you would think that recruiting would begin fairly soon given the June start date…………and hopefully along with it at least an adjective or 2 about phase 2a. Neither the main or alternate Pelage website has any update.
I think the update will be a small one to flip it from “Active. not recruiting” to “Active, recruiting”. That and updates to recruitment locations, if any.
https://www.foxnews.com/health/men-going-bald-turn-new-botox-hair-loss-treatment
Hmm.. they don’t call it a cure by themselves. they talk about using it with other treatments as well. so how effective will it be.
Sad news :( hate to be a downer but I feel this isn’t the great news we are hoping for.
I’m hopeful he’s saying cure in the sense you need to keep taking it but I feel it’s performance is limited and you still need to reduce your hormones (dht).
My take would be the possibly the opposite.
Not saying a cure is actually encouraging to a degree.
They seem confident it could be a game changer and a game changer would be something that regrows hair in the vast majority of people with little to no side effects.
Perhaps its a treatment you need to top up every now and again…perhaps the hair will eventually succumb to what made it fall out in the first place.
Really until we see before and after pics, it’s all speculative but the noises are way more encouraging than not.
It’s mechanism increases ki67 in the follicle and ki67 is noted to start hair growth in follicles..
It’s targeted therapies are androgenetic alopecia, drug induced hair loss and telogen effluvium. It may also treat scarring alopecia and Areata.
I actually think this will be a revelation, especially in the targeted therapies.
Idk about scarring alopecia. Because the mechanism of the drug is to activate follicles that are already present but “asleep”. With scarring (due to burns, chemicals etc) the follicles aren’t there to be stimulated. That’s what I believe, but could be wrong.
Anyone have any news on this forum about the guy who participated in the 2a clinical trial?
Here is a new article dated April 1 from UCLA with a catchy headline. I don’t think it adds anything new. It states: “Preliminary trials showed significant hair regrowth after just one week of topical application.” https://www.techno-science.net/en/news/research-this-new-molecule-shows-terrifying-effectiveness-against-baldness-N26754.html
“Researchers are cautious and remind us that no treatment works for everyone.”
This is an honest act.
Since thats the case and since there are potentially known markers for potential successes, someone should create a personalized telehealth testing service to outline which combination would work best. via blood samples, pictures, skin description etc.
People have gotten this synthesised, and nobody had any results.
Ah okay, thanks for the information. Guess we just better believe it then!
Lol, this is so stupid.
Don’t comment if you have no idea what I am talking about. I’m just sharing info.
Ben has been one of the most knowledgeable commentators on this blog for several years now.
Thanks for stepping in.
I don’t know your numbers, but you probably have 100s but more likely 1000s of visitors per day. Most of them are young and desperate and come here to find positive news (which is rare already) and hope. And then there‘s commenters who spit out this garbage with no backing whatsoever – but these comments can hit deep to vulnerable men. I am old enough and made peace – if there‘s no cure in my lifetime that‘s alright.
But spreading half-baked obscure no-news based on rumours out of some shady Discords which are only negative and nothing else is just wrong.
Besides that: what was supposedly synthesized? It’s not even clear which molecule is used, or which combination of molecules. The patent doesn’t give it away fully. And what‘s the delivery vehicle? That’s as important as the molecule itself.
Dr. Michael Jung is one of the top experts is synthetic chemistry but some guys just bought the stuff from China or made it themselves? Give me a break.
Don’t get ne wrong I also remain skeptical and only about 30 % of new medications transition from phase 2 to phase 3. And after that it’s again only 50 % who succeed. All together only 10 % of all INDs make it to market. And then it still can be a mediocre treatment.
In the case of Tom, all of this comments are always one sentence long…sometimes half a sentence long. I suspect a lot of them are for trolling purposes, but some are reasonable.
I have probably disapproved less than 2% of comments on this blog since inception, but every few months someone repetitively pushes the boundary beyond acceptability.
Thanks for picking a side admin. Have been actively visiting your blog since 2016 and contributed. Anyway, I do not troll, but I do call out bs. Some find that annoying. There are multiple Tom’s btw.
You both somehow misinterpreted what I said. I said “you don’t know what I AM talking about”. I didn’t say that Ben is not knowledgeable in general. In fact, I’ve enjoyed many of Ben’s posts over the years.
@Ben, in hindsight it seems like you do understand what I was getting at. It’s just that, in broader online discussions, this topic tends to get a bad rap—when in reality, some GBs are quite sophisticated and not shady.
Some of your recent useful comments in response to other users:
“Don’t comment if you have no idea what I am talking about. I’m just sharing info.” — And I removed the actual insult in there before approving.
“Well people do not seem to get it. Besides, wtf is your problem.”
“Just give up on this. It’s not going to help you.”
“Shiseido? You are living in 2016.”
And I am pretty certain that you insulted me for having too many ads. I did not approve the comment, so can no longer verify if it was your version of Tom.
“Don’t comment if you have no idea what I am talking about. I’m just sharing info.”
was in response to “Lol, this is so stupid.”. Also, what insult?
“Well people do not seem to get it. Besides, wtf is your problem.”
was a response to someone trying to annoy me.
“Just give up on this. It’s not going to help you.”
yeah, as I said, I call out bullshit. He needs to get real, it’s not going to help him.
“Shiseido? You are living in 2016.”
same as the previous one. I think a comment like that is just playful banter.
And no, I never insulted you for having ads, I couldn’t care less.
Thanks.
I know of the group buys, I don’t find there’s any merit in them. I have been told/seen that they are never well managed, progress photos suck, and sometimes the entirely wrong thing is purchased. They’d have to show me a group buy that isn’t sketchy in some way or another, then I’ll agree to draw conclusions from it.
That’s pretty depressing, Tom, even placebo seems to inexplicably grow a few hairs in all these studies.
Can you tell me more?
Why are people commenting on this thread still unless they have actual concrete updates/articles?
Because I like the beat and it’s easy to dance to.
Like you?
Oh Ben go read a journal and tell us when the devil dances in the pale moonlight.
There’s a lot of strange characters on this blog ngl
Yoda, my favorite is.
Hey Admin Idk if you’ve seen this https://www.moneycontrol.com/health-and-fitness/this-key-protein-could-help-in-hair-growth-cure-baldness-protect-follicles-article-12981529.html
I wrote a post on this last month:
https://www.hairlosscure2020.com/mcl-1-hair-follicle-bodyguard-protein/
Not sure if this has been shared here yet, if it has feel free to delete.
https://youtu.be/bZA8qGiwmD8?si=TqC2smd1UVMn0A4b
Thanks for the link.
Christina Weng posted some new stuff on her LinkedIn in the past couple of weeks. Any of it new? Thanks
https://www.newbeauty.com/ucla-pp405-molecule-for-hair-growth/
https://www.foxnews.com/health/men-going-bald-turn-new-botox-hair-loss-treatment
Also presented at a conference
Yes, the articles seemed to have ramped up in the past few months. I wouldn’t pay too much attention to them.
“the data itself was statistically significant”, always a good sign. They have secured funding for Phase 2b, hence no reason to publish full data/photos until it ends.
Best unbiased indicator of true success would be if GV leads another round of funding for Phase 3 before the end of current Phase 2b in Dec 2025.
Thanks.
I posted above that on clinicaltrials.gov there was a “Last Update Posted” of 3/25/2025 which contained revisions related to phase 2b. Interestingly, the revisions are still there but the “Last Update Posted” has reverted back to 2/7/2025. I don’t think it means anything but sort of odd. The website still says “Active, Not Recruiting” so, as someone mentioned above, it may be that they did all of the recruiting for both phases prior to phase 2a so that they could move right in to phase 2b without delay. Which probably also means there is a higher probability we won’t see any sort of pre phase 2b announcment.
Somehow the part where they say something like “…can waken long-slumbering but undamaged follicles.” makes me think it will not produce much better results for vast amount of people then currently available Min or Fin. It might do something for those who have some sort of a medical related issue, stress, nutrition, etc and for those Min/Fin would do the trick anyway. Or those who notice some thinning and receding very early and are younger (under 30).
But what about those who really have genetic “male pattern” baldness (Androgenetic Alopecia) going norwood 3 and above (especially 5 and above) and there is nothing to be done about it and especially restoring hairline to some degree…this is where many millions of people are.
The questions are, how many of those still have “undamaged follicles”? What are the conditions to get follicles damaged vs undamaged? Is it when you are bald for like 10+ years then you are lost cause? If you are 40y+ and above or something? Are they even testing this, what is statistics or any other thoughts? What is their target “clients”, young dudes imaging hairline barely receding or norwood 5 dude being bald for at least 15 years?
I think those are important things they might want to talk about it more.
The answer is… drumroll please… we don’t know. And we aren’t going to know for a long time what makes it “too late.”
All that we know is that one of the recruitment requirements for phase 2 was that you had to be past a certain advanced stage of baldness. It may have been like 3 or 5 I can’t remember. For now all we can do is wait and see what happens. Best to assume that for the next 25 years it will still be finasteride.
These were the inclusion criteria related to Norwood: Males must have an AGA modified Norwood-Hamilton Classification score of Type III vertex, Type IV or Type V.
As per Heather Christofk, this should answer your questions:
• mouse experiments were partly done in *aged* mice, which is unusual. They wanted to prove that PP405 is working on older tissue too. It was successful and the mice grew back a fully covered fur, not just in patches.
• Bill Lowry found that in most types of Alopecia the stem cells are fully present (except Alopecia Areata, which is a immune problem), they are just quiescent. Dr. Lowry took punch biopsies from scalp skin that was bald „for decades“ (!). In PP405 culture the HFSc proliferated „like crazy“.
Whenever I read that quote from Lowry, I always wish it said that hair proliferated like crazy, rather than HFSCs.
Hair follicle stem cells can proliferate all they want, if it doesn’t spur the de miniaturization of follicles it’s pointless. I’d also be stumped at what MOA even would at that point if not stem cells!
I agree with you, it’s somewhat curious.
But I can‘t help: what else than hair growth would be the result of fully working stem cells?
I said it previously but is worth relaunching, I am curious to know what Admin and the community think about that…
at this point more than efficacy we should be concerned about safety. Anything that messes up with stem cells or mitochondria (even in a good way) can potentially have nasty sides. I do believe phase 2b was planned (also) for that purpose: to keep monitoring participants of phase 2a for a longer time, possibly also the ones of phase 1, before making any definitive statements on the efficacy on a human scalp.
Any thoughts?
So far supposedly the drug was undetectable in serum, hopefully this means side effects will be a non issue.
As far as I am aware, and correct me if I’m wrong, this drug has some properties akin to forcing your cells to respirate anaerobically. If that’s the case, the severity of hypothetical sides could range from light drowsiness to apoptosis. Though, considering no one in the trials has perished, I don’t think apoptosis is really on the table. It all depends on how much of the solution infiltrates the system, which as far as we know at this point is none. Fingers crossed it stays that way.
Dr. Weng just posted this: https://www.mensjournal.com/grooming/scientists-announce-breakthrough-in-race-to-cure-mens-baldness
Change anything? Thanks
Hey admin, I’m curious as to your stance on emailing Delta to inquire about an update on his status.
A guy on Reddit claims the PP405 phase 3 trial will start next year. IMO, this looks like this fits the rapid pace of the progress.
Source:
https://www.reddit.com/r/tressless/comments/1k8jfjb/promising_reply_to_pp405_inquiry_from_bill_lowry/
Thanks!
I saw only 8 comments on that Reddit post yesterday, and 11 today. Hope that really is Dr. Lowry who replied to that guy.
In any case, I will update the post with “Phase 3 trials start in 2026” when I get more clear information.
Madness, there’s so much junk in the comments on this blog about exosomes and DHT blockers for weeks and then we get the first taste of some important news about the next big treatment and..crickets. It’s also similarly quiet on Reddit, no-one is asking for proof of the email to Dr Lowry etc.
Thanks for the find kp, great news and if true effectively confirms now that the Ph2 results are decent.
This month, there were new posts on very important new companies Yunce Medical, Pola Chemical and Absci. Plus updates on mitochondria, Han Bio and woolly mammoths. Many new reader comments in all those posts too.
Exosomes remain a big deal at all hair loss conferences and in my doctor/surgeon/hair expert private group.
I have explained a few times now why certain posts have to be on top for various amounts of time. Please just ignore those posts and the comments in there if you are a regular reader and it bugs you. You will figure it out sooner or later on when to skip a repetitive post on the front page.
Maybe you also noticed that the video ads and in-post display ads have been gone for most of the past month? Doing the above allows me to reduce such ad days a lot.
Fair enough admin, I wasn’t critiquing the presence of those other posts, more the absence of comments on this update for Pelage. Wouldn’t you agree that’s more important and in line with the point of this blog (i.e., news on advanced AA research)?
I agree, though I will get more excited if Phase 3 finishes by the end of 2027 :-) And if “next year” does not end up being late 2026.
Likely at least H2 2026, as the current 2b trial only ends by the end of this year.
Similar hearsay to the Reddit post, but I saw a comment on one of the YouTube videos about PP405 where the guy said his friend works for GV who are known for only investing in companies with a huge ROI potential and a quick turnaround, so it seems as though the right ingredients are there for this to be taken seriously. The only other worthwhile potential in my view is Breezula, unless you can think of anything else (anything before Ph2 should be discounted IMO, as odds are it won’t make it to market)?
Kintor just posted their annual report, China 1% KX-826 finishes end of 2025.
Plan to submit for Chinese approval in 2026 and commercialisation in 2027.
KX-826 will beat Breezula to market in China but not worldwide as FDA won’t accept Chinese studies and US 0.5% KX-826 failed.
Of note, China Phase 2 GT20029 for acne finishes in Aug 2025.
What good are medicines approvals in China for those living outside China?
Thanks Rex!
Please post Kintor news in the Kintor post if possible.
I just wish we had more news. It’s pretty sure they must have an idea about if it works or not by now, no? These months leading up to the publishing of Phase 2 are going to be nerve-wrecking.
If the Reddit post linked above is to be believed Ph3 trials are already in the works, meaning Ph2 results are positive, just how positive remains to be seen, but surely better than anything currently available, which is all that matters.
I like your optimism, but many drugs go to p3 and still eventually fail reaching the market. It’s also only 3 months long, so it unfortunately cannot be conclusive in any way yet.
OK, but per my question above, since we’re on a website dedicated to news on advanced AA research and drugs that make it past Ph2 are more likely than not to come to market, is there anything else besides PP405 and Breezula currently worth discussing?
Nope, nothing else. Let’s hope you are right.
How about Eirion ET-02? They’re experimenting with a similar mechanism, and are also progressing steadily along the pipeline. If nothing else, they can serve as competition to Pelage which could force them to speed things up.
Remains to be seen. They wasted a lot of years before initiating p1, and what they did with the results could be considered p-hacking. Hope they still start p2 this year.
Drugs in Ph2 have a 30% chance of success and are at least 5 years from market, so probably only worth worrying about ET-02 if PP405/Breezula fail.
50 % of phase 3 make it to market.
The percentage of success is much lower in phase 1 and 2.
The analyses I’ve read suggest average 60% success rate of Ph3 clinical trials. Even if you’re right and it’s 50%, does it change my question above – is there anything else besides PP405 and Breezula currently worth discussing?
Man PP405 really does feel like my last hope on this crazy decade ride lol. Honestly, I just want to see it solved in my lifetime, even if im like 90, I just want to know that the next generation never has to suffer this, I’ll probably cry when it is solved.
New article dated May 11: https://wccftech.com/molecule-pp405-a-research-team-backed-by-google-ventures-has-discovered-one-of-the-most-promising-solutions-for-hair-loss-to-date/
It doesn’t provide anything new of substance but it does project that it will hit the market sometime as early as 2027 and as late as 2030.
Thanks so much Pinotq, in my view one of the best posters here, keeping a light shining in the darkness of this disease!
Thank You LJ Its been a long journey for all of us so I have a lot of respect for those who still have their optimism.
It’s just a scientific problem and numbers game.
I was looking into the treatment of chronic pain and this a disease with way bigger burden (and market value) than AA but nonetheless the current gold standard therapy was also approved 25 years ago and big pharma have been trying to develop new billion dollar drugs and keep failing, but loads are still in trials, so eventually one will make it, same goes here.
I have a hunch following the patterns, Pattern,: you had phase 1 trials. These trials went straight to phase 2a trials. Then these trials went straight onto phase 2b trials (which ends in October/November?). Do you see a pattern? Hence depending on procrastination, the phase 3 trial will begin this year in November or December 2025? There seems like there is no slack here, imo.
Do we even know how its performing though outside that one reddit post?
Not really. the Phase 2 results would tell us. I don’t know how long we’ll have to wait for them. In Amplifica case we waited for phase 1 results several months. some others post them sooner.
I don’t see how we can really before the company issues a press release, anecdotal reports from people supposedly in the trial are next to worthless in my opinion
It’s getting viral attention now https://www.tiktok.com/@saffnofilter/video/7503472175408778503?lang=en
Even Musk is watching – https://x.com/elonmusk/status/1921660016127336926
Great catch!
So, we are talking about 2027/2030 and you are happy???
Hopefully we’ll have Breezula next year to bridge the gap.
A DHT inhibitor + Breezula or KX-826 + Oral Minoxidil + Shiseido. If you are lucky, all four will work distinctly via their unique mechanisms of action on your scalp. Then add anything less proven (e.g., exosomes).
Ultimately, you will still need to have a significant portion of your hair left to get good results with all of the above, barring some random exceptional responders.
Nothing new, but the fact that it’s being talked about on a major platform like the Steve Harvey Show, is a great sign. (Unlike Stemson that did a poor job of advertising their product) https://www.steveharveyfm.com/featured/steve-harvey-morning-show/content/2025-05-15-new-ucla-discovery-could-help-regrow-real-hair-by-2027/
But what we know is that after 7 days it activates the cells, not that it makes hair grow.
What are you talking about man? Pelage are ready to release a product that activates cell which does nothing to make the hair grow? Like what are you SAYING??
Relax. I’m saying that the only thing I’ve read is that in trial 1, the cells were seen to be activated, but they don’t say at any point that hair grew. I hope it does
read under “pelage solution” https://pelagepharma.com/
What I mean is, that’s just the theory. In practice (Trial 1), it’s only shown that it activates stem cells. What I’m saying is, I have some doubts about whether this will actually make hair grow. Obviously, we’ll see in Phase 2 trials.
I think you’re right tbh, I feel like they’re going through these trials but aren’t really seeing any hair growth. I feel like Pelage are fooling their endorsors into thinking PP405 actually helps regrow hair. I might actually agree with you :/
I hope GV know what they’re doing.
is there something that makes you think this (aside from the absence of info currently available)?
irony?
Ahhh…
Just asking to Yoyo.
This happens.
I was being sarcastic.
The internet has been spammed with articles about PP405. This even included some high-profile news sites. Do you think this means that they’ve seen some positive preliminary results in the trials?
No.
They should have any idea by now about whether it works or not, shouldn’t they?
How would activating stem cells prevent dht from blocking the hair channel and killing it. Does this reactivation manipulate?
Petulant, demanding children here clearly don’t read any of the articles about PP405.
Share your wisdom.
I think the radio silence from Chad and Delta is actually a really good sign.
As we all know, PP405 is currently in phase 2b trials. Participants who received the placebo in phase 2a (Delta, most likely) are now also being administered the real stuff. At the same time, Pelage is aware that some participants are inclined to leak information and even pictures online.
I wouldn’t be surprised if they reminded everyone of the NDA they signed now that their focus is shifting from safety to efficacy. Again, ALL of them are now receiving actual PP405. They’re optimising the dosage and the application period is also longer. The participants could be regrowing their hair like crazy as we speak.
It would be hilarious if Delta suddenly shows up right after I post this comment. But seriously, I’m sure he or she would have posted an update by now, so something must have changed.
I’m really excited about this stuff and I check this website and Reddit daily for updates. I must say, this is a great place with a wonderful community!
fwiw….I was reading on one site (and maybe this is intuitive) that phase 2b trials won’t proceed if efficacy isn’t shown to be promising in phase 2a. Perhaps there’s someone with more knowledge about clinical trials who could confirm whether this is true across the board.
No, p2a trails are primarily for safety. When safety is established they can go into p2b. There may have been signs of efficacy, but to say that that’s why they are in p2b is wishful thinking unfortunately.
Thanks for clarifying.
Thanks!
Exactly. Everything points toward a positive direction. Someone on reddit received an email from Dr Lowry a few weeks ago, which confirms that there will be Phase 3 trials. Then suddenly articles pop up everywhere on the internet about PP405. I think they have seen positive results and are confident in their product.
https://www.vice.com/en/article/experimental-drugs-without-fda-approval-are-now-legal-in-montana/
In a nutshell, the website content is as follows: Recently, the Montana state legislature passed a bill allowing medical institutions to sell drugs that have only passed phase I clinical trials without the approval of the US FDA. Is this news true? If so, does it mean that companies confident in their products can go on sale in Montana first? For instance, pp405, dlq01, et02.
This legislation here is incredibly humane. There are loads of circumstances whereby people may need a kitchen sink opportunity.
Example someone’s has had chemo and they have a prom coming up. There are in psychological distress over having no eyebrows or hair through the chemo. Why hold back the kitchen sink in that scenario or other scenarios whereby there is intense distress?
Imo, someone in Montana should open some type of kitchen sink foundation.
Chat gpt
Informs consent requirements: Patients must receive a referral from their treating physician and sign a detailed informed consent form that explains the risks, potential benefits, and available alternatives
but interesting.
I’m wondering, if it gets approved in the US, how long will it take for PP405 to be available to us EU citizens? If it really does the thing they claim, I would even be willing to travel to the US just to buy it.
The EU has their own approval process through the EMA. Not sure if EU approval is in their plans, maybe it’s written in one of their documents.
Of course they’ll want to get it approved in the EU if it’s approved in the USA, Japan too at a minimum. I believe these agencies have mutual recognition agreements to speed up approvals of drugs already approved in certain countries.
It’s not always the case, hence I said to check their docs. Setting up supply chains takes time and effort.
Yeah, but typically that’s setup overlapping with conclusion of Ph3 trials if it looks like the drug will be approved. A drug and company like this, if successful, will go to developed countries, there’s just too much profit not to.
For what its worth, last week I was talking to my doctor and he said that the EU runs 5 years ahead of the FDA on approval of many drug/device candidates. So I would expect the EU would move relatively quickly. Also, not that it means anything, but 4 out of the last 7 days I have gotten google alerts on Pelage, all regurgitating basically the same thing.
Admin, I’m sorry to bother you. May I ask if the 2b clinical trial has started?
Dobronx, I don’t think there is anyway to know for sure whether 2b has started. I believe Pelage recruited enough participants for both 2a and 2b when they initially screened subjects for the 2a trial. Given the projected primary completion date of 11/2025, they would have otherwise had to have begun recruiting for 2b. There is no indication that they ever recuited for 2b and clinical trials.gov shows the trial as active/not recruiting. Phase2 b could have begun already although the Pelage website still says the Phase 2a study is still in progress (which I think is just lack of an update). I guess in theory they could wait to start 2b as late as August 1 but since they would seem to have everything in place for 2b…..I don’t know why they would wait……………….. my guess is that they have either already started or are just about to.
Pinotq is the MVP on this site.
It’s highly unlikely that phase 2b hasn‘t started yet. It’s more likely that the first patients will very soon already reach their final dosing day of phase 2b (90 days of dosing).
2a started in August and hat a duration of 28 days, fyi.
Btw the same happened with Amplifica: everybody was complaining why it took them so long to publish their results, truth was they made 2 phases back to back without anyone knowing.
The same people that completed 2a are the ones completing 2b. This shows it is fully recruited?
Thank you, you are the legend.
https://www.projectklabs.com/
I don’t know what to make of this? Is this serious or a total scam?
https://www.projectklabs.com/
Some of the pictures are really good – if that‘s PP405s outcome then it’s a homerun.
Highly skeptical of this though. Admin?
I never trust these sudden new entrants who have replicated an unreleased recently much hyped product. Soon people will say that they did a group buy, but no member got any good results…then conclude that this is yet another ineffective product, even prior to its official release by Pelage.
I have not tried to check the patent(s) yet to see if they can replicate the exact chemical structure. But maybe they can come close? I have no idea about this kind of chemistry.
https://www.reddit.com/r/tressless/comments/1kmfdql/any_chemists_want_to_manufacture_pp405_jxl069/
Thank you for your insight , you are right Admin.
I saw on Reddit that ProjectK successfully replicated PP405 and even publicly released the effect pictures on their website. As far as I know, the chemical formula of PP405 has never been made public. How did they do it? Moreover, the effect pictures on the website are simply too amazing. Currently, I highly doubt its authenticity, but deep down, I hope it’s true.
Do you have the link to the reddit for the replicated of PP405? It would be nice to see the results.
These pictures come from tressless, they are fake.
Are you talking about the projectklabs before and after photo?
https://www.projectklabs.com/cdn/shop/files/gempages_566033747372147519-ff4660d6-9a6b-4dbd-8bb7-f81dee9ae300.png?v=13345074012659951186
I would be wary about all of this. In fact I will probably delete a bunch of comments related to PKL at some point if we get swamped.
I 100% don’t believe this. But I 100% hope I am wrong lol.
Yes, these pictures can be found on tressless by doing a Google search.
Charles Oliveria?
Just a big fan.
I found them on their website called projectklabs dot com. I don’t know what to think about it. Maybe Admin can clarify this for us :)
So far I know, it’s impossible to know which component pelage pharma use for pp405. In the patent they write a lot of different compound from jxl-001(uk5099) to jxl-099. There are people they claim its jxl-069, but I don’t know why exactly. So I think it’s impossible for a different company to duplicate it. So it must be fake. I hope I’m wrong.
In the podcast with Christofk, I’m sure she mentions somewhere that they had tested hundreds of analogs.
Thought this was a pretty good summary:
https://minoxidilmax.com/pp405-a-new-frontier-in-hair-loss-treatment
Thanks! That was excellent.
FYI I copied and pasted the article into my AI and it said it couldn’t be conclusive as to whether it was AI generated but said it leaned slightly toward an AI generated summary. Regardless, I think it was a great overall summary keeping in mind some of it contains reasoned speculation. I think AI is often great at providing a framework from which to think forward from.
Interesting, admittedly I haven’t knowingly read much AI content, but if it is AI, I still think it’s the most comprehensive and reasoned summary I’ve seen about PP405 and done by an AI period, where did that diagram of the chemical series of UK-5099 analogues come from for example?
Admin, please feel free not to post it if that was previously posted: https://www.youtube.com/watch?v=bZA8qGiwmD8
Thanks Pellata!
LJ thanks for this! It was super informative. Seems like their estimate is 2028-2029.
Really? That’s some AI-summary-nonsense.
Some things are simply not true or pure speculation.
It’s nothing, seriously.
Can you point out the falsehoods in the piece?
None of us want this treatment to have the same level of efficacy as finasteride. Let’s see what’s the future holds for us. I hope they’ll provide some more insight into how the trials are progressing or at least some more detailed interviews before the results are published earlier next year.
Makes sense if you look at the timeline.
I have no idea where that diagram came from but I asked AI over a month ago about Pelage and it didn’t know very much about it. It gave a very accurate summary but it didn’t include anything more than I already knew. Maybe they used a different AI platform. I highly doubt that MinoxidilMax has any inside information regarding the trials so the statement that efficacy is estimated to be 20-30% “pending” had to have been pulled out of thin air.
Of course that prediction and the one about the timelines are speculative, but ultimately probably won’t end up being too far wrong, AI or not.
This post has aged fairly well I think
AI generated tabular data for the win!
The be fair, it might end up being that the majority of people got at least a 10% increase in hair growth.
Pinot my friend, whenever I see you post I start thinking in French. Beautiful language. Lumière sur ta route.
:-)
The article has all the hallmarks of AI which become obvious for anyone who’s used any of the LLMs frequently. Use of emojis for bullet points, bolding of key words, use of separators and tables. It doesn’t mean it’s wrong, it just means it’s not anything ground breaking.
How would AI know anything about this? As far as I know, none of the “real” articles contain any concrete data.
The more interesting question is if the scientists at Pelage know the actual efficacy. They should know by now if it works or not, shouldn’t they?
I see this sentiment everywhere, but logically the definition of a double blinded trial must mean the primary researchers wouldn’t see data until after the trial has finished, as this may introduce bias. Maybe the fact there was an open label extension means that some of the data has been unblinded, but all the hype about “they must have seen something good” seems unwarranted imo given the nature of a blinded study.
Agreed about the hype…………I am guilty of being overly optimist about Pelage based soley on circumstantial factors although I would say there seems to me more than the usual level of circumstantial reasons to be excited. Clinical trials does say that: “Subjects who were randomized to vehicle in Part 1 will be eligible to participate in the Open-label Extension in Part 2 of the study.”, so the study has definitely been unblinded.
The sad but true reality of pp405
Let’s say it does grow hair, the dht hormone or whatever will adapt and hair loss will restart. Then they will have to make a stronger version and that will cause more potential side effects.
These clinical trials only monitor for a few months. Side effects could happen after a year or 2 and they could be devastating.
Think about it. If finasteride which barely makes hair grow causes many side effects then imagine what pp405 will do.
They are only testing on people upto norwood 5 and not upto norwood 7. If what they said is true and it wakes up dormant follicles then surely it should grow back all hair so why not test it on norwood 7?
If by a miracle it does grow back hair and that’s a big if, the hair industry such as minoxidil, finasteride, hair system, hair transplants etc won’t let this happen and would either sue them or buy them out so they don’t go out of business.
I’m not sure how we can say any of that is “true” considering we don’t know how well the actual drug works at all in terms of regrowing hair. There has been as far as I am concerned no release of any efficacy from Pelage about how much hair will grow or if it will grow any at all.
As for DHT adapting I’m not sure that’s how the science works at all. Even if it was, I’m sure the numerous years spent researching at UCLA by people who understand the biology way better than anyone on forums or social media posting about PP40, and the millions of dollars raised to get to this point in phase 2 were not done with the idea that drug will be useless.
As for the clinical trials not catching side effects. There is a reason that drugs take so long to come out. Because the FDA and other health organizations require so much data before drugs can come to market. While I am not a biologist/chemist I am confident that the data they record through the blood samples, skin samples etc. Can be used to extrapolate things further into the future, as well as the fact that taking a prescription drug is a conscious decision that involves accepting the risks associated with it.
Lastly, companies come up with new products all the time that take market share from other companies and put them out of business. So the idea that what a drug potentially worth billions is going to be taken down by hair transplant surgeons is not at all how businesses work.
But why are they only testing upto norwood 5 and not upto norwood 7 if what they said is true and it makes dormant follicles grow again?
I would assume that they are only testing on those norwood levels because on average the results will be better on people who have been losing their hair for a shorter amount of time. Which would lead to a greater chance of further funding. Also, as far as I can tell studies in the past for fin and min also tested on levels 3-5. This would then make it easier for them to draw a direct comparison if PP405 greatly outperforms the current best offered medicine. I don’t think it’s wise to try to read into this information too much, just wait for the official sources from Pelage announcing what comes next after this trial.
Even if we somehow had undeniable proof that it works, lets say from a patient in the trial leaking pictures that they went from NW 5 back to NW 1 hair they had as a kid/teenager. So what? It’s not like suddenly we could pick the drug up from a pharmacy, we would still be years away from it being on the market as the FDA process needs to be completed. It’s best to just use whatever approved drugs that is available today or buzz/shave. Then if a new drug is actually approved you can have that conversation with your doctor.
Do you think pp405 will work on norwood 7?
Nobody knows how well it works for any NW as they have not published any data about how well it grows hair. Even Pelage themselves have stated that they do not know the timeline of hair growth or even if this drug is something that will be used continuously. That’s the whole point of the trials anyway. So until those are finished your best guess is as good as mine.
“For a study like this, where we are doing our readouts at 3 months, it is difficult to say it’s going to give us a preliminary idea of how the hair is growing, but the exact timeline of how long it will take, how this drug will be used long-term, whether it’s continuous dosing or not. All of that remains to be seen, but I think that’s part of the exciting part of the drug with a completely novel mechanism.” – Christina Weng from this interview https://www.dermatologytimes.com/view/q-a-pelage-s-novel-pp405-advances-to-phase-2a-for-androgenetic-alopecia
Then I don’t know what all the hype is about then. Looks like back to dreaming about hair.
This article was published last summer, when Phase 2 started. They probably have much more information since then. The real hype started around December.
Some comments:
– the last stage of clinical trials is monitoring the drug while being given to the public (to see more long term side effects on a larger and more diverse population) So you’re right about that information won’t be known right away but you can always wait a few years and see how the drug does in the general public
-PP405 doesn’t grow hair via the hormonal/DHT route. So not sure what you mean by the DHT will adapt. The goal of DHT is not to have you lose hair.
-People always bring up how the minoxidil market will throw a fit. Minoxidil is a drug with an expired patent. Literally any generic pharma/cosmetic (if topical) company can make it. No one company is making a killing of of it (compared to patented drugs) Fin is similar but clearly you need a script for it and many countries outside the US won’t even prescribe it for hair loss. Hence,
I don’t see this huge rising up by drug companies happening.
-Also, most likely PP405 (which admin has also mentioned) will probably be one of multiple drugs in the someone’s stack/protocol. Since we have seen most ppl need to attack hair loss from multiple angles and the treatment results normally compound. So again PP405 probably wont destroy the hair loss industry unless it worked for all genders for all hair loss conditions and worked so well on its own that adding other medications/procedures provided no additional gains. Personally, I find that unlikely, especially since Pelage isn’t even making promises for alopecia areata or scarring alopecias. There is much more to hair loss than just DHT if you look at the full spectum of ppl with hair loss conditions instead of only aging men with aga.
And that concludes today’s episode of Hair Today, Gone Tomorrow titled ‘The Sky Is Falling’…
I think those that received a placebo in the 2a trial are getting PP405 in the 2b trial. Thus the blind was removed after 2a, I think. Or I might be wrong here?
There are however often interim analyses in trial protocols to allow assessment of safety/efficacy at various points, but highly unlikely that data from these would become public, those who speak don’t know and those who know don’t speak…
There must have been interim analysis which showed promise to proceed to part 2 (I wouldn’t personally call it 2b because it’s still officially called a 2a trial – although I think it’s possible that they will skip an official 2b based on the outcomes of this part 2 study), otherwise they wouldn’t waste anyone’s time or money on it. There’s also the ethical consideration of applying a research chemical which doesn’t do anything needlessly, which again would suggest at least some positive signs.
However, I don’t think the big names (Bill Lowry, Christina Weng, etc) would have seen the unblinded data, assuming they’re the ones who will be performing the analysis on the data, there’s just too much risk of introducing bias. More likely some independent panel made a recommendation to proceed to part 2.
I think this is strengthened because Delta was told about the extension back in December last year, before the completion date for part 1. I don’t think the main researchers would have unblinded the data at this point.
I’m tired of these theories and AI conversations, I want some juicy updates :/
Check back next year then.
Anyone here with HF biology knowledge care to give an opinion on this thread – https://x.com/andrew_bakst/status/1931756709661327477
What can I say? I fully believe Papa Smurf on Twitter with his convincing logic and not PHDs Lowry, Christofk and Jung…
We just have to wait it out…later this year we will know.
Stop talking about pelage. It will be released in 2030.
This is just a very optimistic approach so forgive me lol. But what if in the meantime, of all these Pelage updates, we get serious developments on Yunce Medical and their clinical trials? Where we could wait out or even get the procedure done meaning we wouldn’t even need PP405?
Did Yunce Medical mention something about clinical trials?
You asked the exact same question under the “Yunce Medical” page?
Yes, sorry.
Pelage announced the results of the 2a trial .
Two quotes that caught my eye from my initial scan of the article:
Quote 1: “Particularly striking was the finding that unlike existing drugs that primarily slow hair loss or support hair growth from already-active follicles, PP405 induced new hair growth from follicles where no hair was previously present — offering early validation of its regenerative potential.”
Quote 2: Pelage expects to initiate Phase 3 studies in 2026 designed to further evaluate the safety and efficacy of PP405 in men and women
Looking at quote 2, and looking at the pace this has gone from phase 1 to phase 2. Is there a possibility that phase three will be completed at the end of 2026, or early 2027?
Boom.
Reference:
https://www.businesswire.com/news/home/20250617338859/en/Pelage-Pharmaceuticals-Announces-Positive-Phase-2a-Clinical-Trial-Results-for-PP405-in-Regenerative-Hair-Loss-Therapy
Good to see – thanks for sharing!
Thanks kp. I will thank you here rather than in the post!
But it’s not that good numbers though.
“31% of those treated with PP405 exhibited a greater than 20% increase in hair density”
Only 31% experienced increased hair density which was only 20% increase. How is that good?
Re-read this (copy paste)
PP405 induced new hair growth from follicles where no hair was previously present — offering early validation of its regenerative potential.”
Note that the trial participants just had 4 weeks of treatment.
After only 4 weeks of treatment, growing hair on slick bald spots to me is very good. lets see what happens after 6 months of use.
I just don’t want to get so excited because it might not work. We need to see more numbers such as over 6 months and pictures of before and after of hair would of have been good.
As far as I know the action of this drug is immediate and we talk about few weeks here. So what I understand from this is what regrowth they got from the first month, it might be all, to me it sounds that this drug is not like finasteride where it needs a year to see full effects, with this one you should see in that short amount of time and that’s it.
I hope I’m wrong. Also They started this phase lat year in Nov, why they only gave them this drug for one month only? They had so much time to try for at least 3 months or maybe more and I’m also curious about dosage if they played with the best concentration etc.
None of the published primary or secondary endpoints of the part 1 study were geared towards efficacy. They were focusing on safety – they probably rightfully had reservations about the safety of the drug given the mechanism of action and this was the main focus of the 2a study. Efficacy being what it was is likely seen as an added bonus – this is suggested by Pelage CEO’s comment on the linkedin announcement .
With the part 2 trial, they have increased the application period to 12 weeks. This is likely more geared towards efficacy, now that safety has been firmly established.
Within just one month, 31% of the test subjects experienced a hair growth increase of over 20%. Isn’t this result good enough? Are you asking if it’s possible to go from NW7 back to NW1 in a month? Oh my, if there’s such a drug, please let me know.
What about NW7 to NW1 after a year of using pp405. Do you think that’s possible?
No, but I think if the effect of PP405 can surpass finasteride, that would be a phased victory. You say this figure is not good, I wonder what your standard for “good” is. However, I think being cautious is fine. Everyone has different opinions, and I respect yours.
I was disappointed as well until I did some digging. Someone correct me if I’m wrong,
Original Merck trials for Phase 3 Finasteride show:
Baseline –> Year 1 (+11% hair count)
Baseline –> Year 2 (+16% hair count)
So 4 weeks of PP405 outclasses 104 weeks of 1mg Finasteride for about a third of the cohort.
Keep in mind hair needs time to cycle so Phase 2b results will be key to show efficacy for the remaining 69% that got <20% hair count improvement in Phase 2a.
I agree with your assessment, growing any amount of hair in only 8 weeks (with only half of that time being the treatment) is pretty remarkable. Even more so if it is growing back hair where there wasn’t any previously. I think this is the best results from a trial at this stage we have seen maybe ever? The only bad news is that we will still have to wait ~6 months as you said for Phase 2B results.
Why did they not post any pictures? Could hair density increase after the initial 4/8 weeks over time?
Stop thinking the FDA testing process has as a step to qualm the anxieties of those unwilling to wait.
That was so poetic Frank!
hmm…without pictures what is the point of this….we need visual evidence to judge regrowth.
So, are they still continuing with trial 2b? I say this because they’ve said they want to start phase 3 in 2026.
They are already in 2b, finishing in december this year.
Papasmurf thinks it’s a nothingburger:
https://x.com/hairypapasmurf/status/1935048213842772035
Not that BS again.
I cannot even put it in words how ridiculous it is to give this stupid anonymous account on that toxic platform just the tiniest bit of credibility by reposting its „analysis“.
No, thank you.
Do you have any other arguments besides ad hominems and appeals to authority?
Yea LJ I’m with Ben, Frank and JD on this, this obsession with papasmurf is getting weird now.
Fair enough, if admin says to stop cross-posting or stops approving such comments I’ll get the message. I was just trying to stimulate debate on the science of upcoming treatments with any knowledgeable people visiting the site (if you know of any similarly seemingly well-informed commentator(s) posting publicly I’d be interested to read their takes likewise), but maybe I misread the room…
Who the fu*k is Papa Smurf? A new hair loss celebrity on the scene?
Just for the record, the appeal to authority fallacy works against you in this instance. The only reason to trust this guy on X is because he ‘seems’ to have enough knowledge in the theory to say Pelage’s effort is not gonna work out. While Pelage has the actual scientific rigor and clinical trials to back up their evidence (even if right now we don’t have the entire data available to us). The guy’s bio even says “Not a doctor”. While pessimism is certainly warranted considering what the admin said about nothing really working since fin was released, that statement is always going to be true until it isn’t.
How am I trusting him? The appeal to authority I guess has gone far enough to credit him as being more than someone who knows nothing about the topic, but beyond that I’ve been explicitly asking if anyone here is knowledgeable enough to give a reasoned/technical rebuttal to his points as I’d be interested to learn, but no one can…
Right, I get what you are saying but I would bet that the people who do actually know enough about the science to either completely debunk him or agree with him, probably will not be on these forums/twitter spaces.
You’re probably right, but I was clutching at straws, how many monthly unique visitors does this site have? 75k? If even 0.1% of those have a biology background or keen amateur hair loss research hobby they may be able to offer some insight/rebuttals that will make this place more worthwhile than just endless “when is it coming out, how effective will it be” posts while we wait for the full results.
You use the „appeal to authority“ by quoting the CTO of Hairdao (who isn‘t an authority ironically).
And „ad hominem“ is not possible for an anonymous Twitter account – ad hominem requires, as the name says, a human. Papa Smurf is a comical figure.
Why am I even discussing it’s so stupid…
“Papasmurf thinks it’s a nothingburger.”
It looks like how it sounds. Insane.
Do you have any rebuttal to the points he makes in the thread?
Since the approval of Finasteride for hair loss in 1997, every new hair loss drug undergoing trials has turned out to be a nothingburger for an assortment of reasons.
The easy and safe answer is to always be pessimistic.
Very few of them have been like Pelage though I think it’s fair to say, apparently solid scientific grounding, strong VC funding and seamless progression through clinical phases so far….
The critique here is a mechanistic one, I have a lot of hope riding on PP405, but don’t know enough of the science/stats to be able to determine whether I should adjust my expectations.
Fully agree with you. They completely dismiss him just because it’s an anonymous twitter account, they have no idea whether it’s valid criticism or not. Of course only the researchers at Pelage can understand hair biology.
You cannot call his analysis an easy and safe answer.
I did not. He seems bright and makes solid points.
Would have been great if the press release gave an average for all patients too.
I too thought you were implying it’s an easy position to take to be pessimistic about an investigational treatment, but he actually presents scientific reasons why that could be so, I don’t know enough to know if he’s talking sense or not.
It is an easy position to take for all of us based on the trends since 1997. Even if the press release passed all the smell tests, you should still remain cautious until at least Phase 3 trials results come out. Sometimes good final Phase 2 results have not even translated into Phase 3 trials… forget a product coming to market.
The publicity for this product has been off the charts, and Google’s funding makes it all the more publicity prone. To be honest, I also got a bit biased by learning about Google’s involvement.
Finasteride increases density by around 14-16%.
Pelage saying only 31% had increase 20% density because those were the ‘impressive’ numbers. and probably wanted to show it can be better than finasteride.
The rest were most likely very underwhelming otherwise they would of had no problems showing them off like they did with 31%. As always, hair loss cure will always be too good to be true.
Finasteride increases the density once, by 14-16%. And stays above base line, by about 14 to 16% (+- something) probably for life. Finasteride is not a hair loss cure, but the drug, like dutasteride does protect your remaining wakened dermal papilla from DHT knocking it unconscious, if you like. It keeps what you have. Sadly with finasteride the 14% does not compound every cycle.
Treatments like Amplifica and pp405 are hair growth kickers. They are treatment cycle compounders? They stimulate hair follicles to wake, and increase the hair count after every treatment cycle?
In the scenario whereby you are dealing with a treatment cycle compounder, It only takes something like a 1% increase each cycle for a cure?
In the 2b testing, after one treatment cycle lasting 4 weeks one group got a 20% increase in density with PP405. This is a massive result. Someone with 50000 hair on his head, could have 100000 hair in 4 treatment cycles? 50000 X (1.2^4) = 104000. And so on.
I hope you’re right kp. I just don’t wanna get my hopes up but we need to see 2b results and then hopefully phase 3 results too
The numbers are not exciting at all if you really think about it. 78 participants in phase 2a study.
Around half of them are in placebo which leaves 39 left. So if 31% of the 39 had 20% increased hair density then that’s only 12 people who had increased 20% hair density.
We want to hope this compounds per treatment cycle, if so, the percentages are not that important. It is about the compounding effect over treatment cycles.
So, if it compounds over treatment cycles, then, for example, it would only need 1% increase in density per treatment cycle for a potential cure?
So Google after due diligence invested in this company. And the research behind PP405 goes back a decade. Yet people are trusting anonymous accounts on X more lol.
There have been many well funded companies that ultimately failed. And regarding the research: that’s what the critique is based on.
A 20% increase in hair means where you had 10 hairs now you have 12. Yawn. This is disappointing, big surprise.
Christina Weng and Daniel Gil are attending BIO2025. Hopefully some more discussion about results there.
https://www.linkedin.com/feed/update/urn:li:activity:7339047730826137601/
As I understand, they are still tweaking the chemical formula and the dosage. If they find the optimal dosage, could these numbers be even better?
The numbers are not exciting at all if you really think about it. 78 participants in phase 2a study.
Around half of them are in placebo which leaves 39 left. So if 31% of the 39 had 20% increased hair density then that’s only 12 people who had increased 20% hair density…..
Less than 12, recall that the 31% covers men ‘with higher degree of hair loss’.
So that discounts any women and on top of that any men < 'high degree of hair loss' (meaning Norwood 3 vertex ).
So that group of 39 for the treatment group has now shrunk much more to the point where 31% of it could literally be 6 people, they obfuscate so much with their choice of words.
You’re both missing two important things.:
1) 31% had a 20% or GREATER increase in hair. So the level of gain was obviously higher in many people.
2) We don’t know how much hair growth the other 69% had but even if it was 10% in one month that’s a very good result.
Just to give you an idea. Say you had 50000 hairs on your head, 10% is potentially 5000 hairs.
Even if it was just 1% increase in hair count, per treatment cycle, it is more, or less, a cure? (a cure if you factor in, persistent application?)
There will undoubtedly be a ceiling as hair loss is a multi factor problem, but people do seem a bit pessimistic, which is understandable given the record for hair loss treatments over the decades. But another very encouraging point is the 31% was in the worst cases. The best cases are likely much better. I share people’s discouragement with the wording of this press release but Google Ventures is a highly sophisticated group with access to DeepMind and the very best biological AI systems. I think we’ll get a new treatment out of this one.
OK, Phase 3 in 2026 … Nice!
https://www.businesswire.com/news/home/20250617338859/en/Pelage-Pharmaceuticals-Announces-Positive-Phase-2a-Clinical-Trial-Results-for-PP405-in-Regenerative-Hair-Loss-Therapy
One can assume that phase 2b started weeks ago, rumors were March. It’s entirely possible that the first patients already finished their protocoll and entered the observation period.
The board of Pelage has already much better data available and hence plans phase 3.
I think it is very hard to draw any solid conclusions from what Pelage released but I would break it down like this. On the one hand, you could speculate from a pessimistic perspective that the 31% and 20% figures are puff (which we are conditioned to expect) ……designed to make PP405 look, on the surface, better by comparison than existing treatments. But as pointed out, the 20% increase in density is meaningless without actual numbers or pictures. And if it only works on 31% of the users, I would say that is also a discouragingly low level of consistency. Looking at this from a positive perspective, and assuming the press release is not the typical hype we see : 1) PP405 induced new hair growth from follicles where no hair was previously present…… a scientific breakthru although it remains to be seen whether it is a cosmetic breakthru; 2) the percentages were from an evaluation at the 8 week mark…….really early in the cycle; 3) The treatment was applied for only 28 days. Let’s hope those numbers jump significantly at the 4 month mark after tripling the length of administration.
I can never eem to find the FDA post about their slow pace for approval but here is another quick article about efforts to improve turn time:
https://seekingalpha.com/news/4458991-fda-to-launch-national-vouchers-to-cut-drug-review-time
These numbers do not look promising at all to and just indicate another maintenance solution for young who caught first hair loss indicators very early, most definitely not something that could be called a cure or at very least reverse you back 3-4 stages (eg norwood 6-7 to norwood 2-3).
If results were something like of all participants who received pp405, all of them got regrowth but in various extend – then this would look like it is actually working and they are on to something. But of all participants only 30% got 20% increase (i assume that is the most regrowth that happened) then it is hit or miss with most likely being a miss for vast majority of people, just like fin and min.
They probably will just pack it as another fin and min alternative with most marketing potentially focusing that has way less side effects – but minimal results if at all.
Hope i am wrong though, we will see i guess at some point soon.
It was only applied for 4 weeks.
If you check the clinical trial, they are only accepting “AGA modified Norwood-Hamilton Classification score of Type III vertex, Type IV or Type V.” This is people with hair still on their head, not slick bald.
They say the 20% increase was in the highest Aga males, so Norwood vertex 5, aka this level https://imgur.com/twAhlxo
(from this: https://www.reddit.com/r/tressless/comments/eqv945/psa_these_are_the_actual_norwood_scale_definitions/)
Considering a 20% increase after 4 weeks in a Vertex level 5, I would say that is quite impressive.
You can find the trial criteria here: https://clinicaltrials.gov/study/NCT06393452?intr=pp405&rank=1
If you’re a Norwood vertex 5 (the top responder according to this data). The “10 hairs now you have 12” anecdote does not really apply.
I do think these are intentionally misleading statistics and are mainly there for investors and funding; we can’t make any assumptions either way. This was a Phase 2a with some early efficacy built in to help investment backing. Phase 2b will give us a far better idea.
But why are they only testing upto norwood 5 and not upto norwood 7 especially when they claim they can wake up dormant follicles?
Part 2: Baseline-OLE to Day 84-OLE
Why was this not in the press release?
The truth is that when I read the results, I was excited, but thinking about it carefully and knowing what this industry is like, I have very little confidence in the way the results are read. Why not talk about hair counts per square centimeter? Why not talk about the rest of the participants? Anyway, if this is just the same old thing again… very disappointed. PP405 has always been underestimated because Google has invested 30 million, Kintor invested 130 in pyrylutamide.
Because the primary endpoint was to evaluate safety and preliminary efficacy.
They were checking for markers of growth occuring, not measuring for cosmetic growth, hence why it was only 4 weeks.
They’re gonna release overall measurements in the 2B trial.
But I thought it was 3 months the 2a trial and pelage decided to release data on just 4 weeks?
I think the data generation is based on one month of usage, and the following two months are for safety follow-up checks.
The negativity is insane. Pelage stated
“ We’re doing 3 different measures of hair growth. First, we’re assessing what’s visible with the naked eye. Second, we’re using high-resolution photography to quantify hair growth at the single hair level. This allows us to identify changes in density in a very objective way. Third, we’re collecting tissue, and we’re able to assess markers of hair growth at the macroscopic level. ”
From my understanding this study was very brief and checking more scientific markers vs cosmetic hair/cm2
People need to relax and wait for the actual cosmetic studies to launch. Again this is a NEW drug and fine tuning the science behind it is expected.
Thanks again admin for the updates.
Will the results of 2b have more information?
Yes, that one has hair growth measurement as actual endpoint
https://www.linkedin.com/posts/mathew-avram-308bb217_pelage-announced-preliminary-data-from-its-activity-7341283220790923264-a-vh
Seems to be just rehashing the press release but emphasizing the working on ‘dormant’ follicles part. Mathew Avram is on the clinical advisory board for Pelage.
So is that a good thing or not?
Good find! I particularly like the comment: “Importantly, PP405 not only enhanced hair density from active follicles but also appeared to stimulate new hair growth from previously inactive follicles”. My understanding is that an “active” follicle would include a follicle producing both a terminal and a vellus hair. There is much to be learned in the year ahead but if PP405 can not only strengthen weaker hairs but also turn vellus hairs into terminal hairs, I would think that also would have the potential to produce a noticeable amount of cosmetic hair in many people.
What quote I think is telling here is this, “with more ‘advanced hair loss’ experienced at least a 20% increase in hair density’
To point out the obvious, ‘advanced hair loss’ implies more visible scalp tissue and less hair.
Could it be the others with more hair and less visible scalp, lost some of the solution in their hair? And thus, a percentage of the solution was not in direct contact with the scalp?
I think the 20% is in the baldest people because it is easy to reach that number in someone with 20 hairs per cm2 since it would be adding 4 hairs. In those who had more hair, (about 100 per cm2) it will have been very far from 20%, if 4 hairs per cm2 also appeared we would be talking about a 4% increase. I saw it as risky to include people with severe alopecia because the data in the study would seem less powerful, but it is turned around by presenting this data, sorry for my English, it is not my first language.
Best of luck to the PP405 program but unless they get solid double-digit improvement over minoxidil, I cant see funds for phase III working out. I’m not saying the sky is falling but…
Having said that, I encourage all to check in with your chatgpts and compare PP405, HMI-115 and Eirion ET-02…they’re are all similar in that they work differently than minox and finasteride but they each still differ. I’m intrigued my ET-02 much and if they have a solid phase Ii could come to market before PP405. This competition is good.
Pelage confirmed phase 3 in their last press release and there was a snippet of Dr. Lowry stating phase 3 starts in 2026. I guess they move on quickly unless they have major setbacks in their current trial.
I don’t know how Eirion could be faster to market than Pelage when they didn’t even start phase 2 (if ever!) whilst Pelage is close to finishing it.
Everybody has his own logic I guess…
I have been re-asking ChatGPT lately and they have been consistent in its response:
“ Advanced stage – ET‑02 is entering later-stage Phase 2 focusing on actual hair growth, while PP405 is still in early Phase 2 without growth results.
Rapid and strong initial results – ET‑02 showed major hair increases quickly, enabling confidence for progression; PP405 has shown mechanistic safety but limited growth data.
Earlier start and smoother progress – ET‑02 moved from Phase 1 to Phase 2 seamlessly in early 2025; PP405’s P2a is only expected to complete by late 2025.”
But in short ET-02 has had more data regarding better responses.
That’s all just wrong wtf.
Eirion DID NOT start their (planned) phase 2 yet.
Stop believing everything your chatbot is churning out, ffs!
This is ridiculous.
Yeah that’s wrong. Are you using a reasoning model? If not, I presume it didn’t do a web search.
Frank,
Different versions of ChatGPT have varying cutoff dates for their core training data:
GPT-3.5 has a knowledge cutoff of January 2022.
GPT-4 has a knowledge cutoff of April 2023.
GPT-4o initially had an October 2023 cutoff, which was later extended to June 2024.
New developments in the hair loss world are probably not accurately depicted by RLMs and LLMs.
I asked my version about cutoff dates and it told me that since I use the paid version ($20 a month) I have up to date data. It says ET-02 is currently in the planning stages for a Phase 2 trial, expected to launch in 2025. This study will involve approximately 150 participants over a six-month treatment period. It came back with correct data for Pelage but nothing more than we already know.
Thanks Pinotq.
It is still a bit crazy as to how many people are now relying on free version AI for so many answers, and many never even second guess the responses.
I read a funny story last week about people getting angry that some teachers are now using AI to grade papers…getting back at students who are constantly using AI to write papers.
I posted what I found which did not mean I believed it verbatim but worth considering; and you fellas start quibbling over who’s version of chatGPT is superior. As if this topic is your particular expertise. Which it is not.
This forum has become quite the knitting circle – certainly keep posting and fantasizing about Pyrilutamide though.
I’ve said before finasteride raises estrogen, so is it any wonder there’s cattiness on MPB forums?
lol great observation.
It also raises testosterone, so I would want to argue with any of you in real life.
Not to mention the constant discussion about cosmetics now that I think about it lol
The type of AI doesn’t change that ET-02 may release before PP405.
While that is a factual statement, it is indeed possible that ET-02 releases before PP405, the rest of what you’ve said is verifiably false. ET-02 has only reported phase 1 results, and is expected to begin phase 2 later this year. You can find this from a quick search, and hear it from Eirion CEO’s own mouth.
There has also been no significant information released about ET-02’s efficacy, the same as PP405. Please stop believing everything AI says. It will say things that are 100% wrong with 100% confidence.
Based on the data that is unlikely.
Paid versions do not have access to better info than the free versions, rather the paid versions offer more expedient services (media editing) and higher usage limits.
Paid versions are more intelligent and better at searching the web, and validating information.
All of the reasoning models and GPT-4o now search the web when required. Though this sometimes doesn’t happen, you can then click the web search button anyway. Many people do not seem to be aware of that.
Here is another one based on the same press release, nothing new:
https://www.dermatologytimes.com/view/pelage-s-pp405-demonstrates-efficacy-in-phase-2a-trial-for-androgenetic-alopecia
I would however take this chance to make a remark. Please, let us not hurt ourselves elaborating too much on pp405: this is the best academic research can do for a disease, science behind it is rock solid and the methodologies implemented to get to this point are rigorous and validated by the scientific community, and, frankly, results so far are exceptional. A 20% regrow after 4 weeks is beyond anything we could have imagined, knowing the time it takes to grow hairs from healthy follicles. Still, we should not celebrate till this product makes it to the market and Phase 3 is over!
The most constructive we can do in meantime is try to get as many info as we can from reliable sources, but this is more to keep up and help us going through the months/years ahead.
Admin, being one of the most respected influencer (for a lack of a better term) in the hair loss community, you could try to get in touch directly with Pelage and have some first hand info. Other than that, I suggest we all keep our fingers crossed! Also for the other products in the same league of PP405.
8 weeks, not 4 weeks. But in general I agree
Well, it depends on when you start the count, since the last dosing day is indeed 4 weeks. Either way it is exceptional!
Admin, wasn’t sure where to add this, and I know it’ll get the “hairy mice” eye roll from subscribers, but wondering what you think about:
https://nypost.com/2025/06/19/health/breakthrough-cure-for-baldness-100-of-male-mice-regrew-fur/
Seems like new research?
I covered it here three weeks ago:
https://www.hairlosscure2020.com/mesenchymal-stem-cells-and-hair-growth/
Funnily enough, three people emailed me about it in the past two weeks…I think I should have made a new post about it and titled it more appropriately.
https://www.youtube.com/watch?v=Irkfb7vHz0g
Some more info instead of theories.
Actually there‘s zero new information.
Influencers are taking advantage of Pelage for their views, nothing new.
The only worthwile news come from Pelage directly.
Right on the money Ben.
New linkedin post from Christina Weng https://www.linkedin.com/posts/christinawengqy_hair-loss-isnt-just-a-mans-problem-4-ways-activity-7345571445202161664-QEjb?utm_source=share&utm_medium=member_desktop&rcm=ACoAADUULqoBfbpQbv8Atgmh-VZiqV9SfTBemJo
Interesting is confirmation that phase 2 is primarily evaluating safety of a new chemical entity, and that “this is one of the few therapies under development where we understand the mechanism and biological pathways of how it works”, and also “The preliminary data so far supports its #regenerative potential, where we see new terminal hair growth in previously empty follicles. “
Hi one question would PP405 also work for beard growth??
Anyone who tells you anything but “we don’t know” is speculating.
We have no information about the results for women?
I think ItsAlwaysAI linked to a post by Weng which touches on the subject.