In 2021, I wrote a post on microRNA (miRNA) and hair growth. In there, I also discussed a new company working on messenger RNA (mRNA) based hair regeneration. And now we have RNA interference (RNAi) as a hair loss treatment, thanks to OliX Pharmaceuticals (South Korea) and its small interfering RNA (siRNA) based product.
Also not to forget, most recently, we have become excited by CosmeRNA, a SAMiRNA based hair loss treatment that targets the androgen receptor. SAMiRNA is a new type of siRNA nanoparticle that does not result in innate immune stimulation. The number of different acronyms containing “RNA” that are being developed for hair loss treatments is mind boggling.
Update: June 13, 2023
Olix Pharmaceuticals Begins Clinical Trials in Australia
OliX Pharmaceuticals just announced that it has commenced Phase 1 clinical trials for OLX72021. This investigational RNAi therapeutic suppresses the hormonal activity that causes androgenic alopecia by reducing the expression of the androgen receptor (AR). OLX72021 is topically injected into the scalps of men with male pattern hair loss.
It seems like OLX104C has been renamed to OLX72021, although the former name is still the one listed on the company’s pipeline page. It could also end up being two separate products, with one being a drug and the other a cosmeceutical. I infer this from the earlier CEO update with quotes (see further below).
The 30 trial participants will be split into 5 cohorts that will get one intradermal injection of various doses (or placebo) and come back for follow-up after 8 weeks. The injection will be spread across 6 areas of alopecia near the crown region of the patients’ scalps.
The Australia Phase 2 trial page for OLX72021 can be found here.
Update: March 10, 2023
OliX just got approval from Australia’s Human Research Ethics Committees (HREC) to begin a phase 1 clinical trial of OLX72021. This candidate “inhibits the activity of hormones that cause male hair loss”. The effect lasted for more than three weeks in animal tests.
Update: In a March 23 article on this same development, CEO Dong Ki Lee states the following:
“We are also planning to launch hair loss cosmeceuticals in due time for the safety of OLX72021 to be confirmed in this clinical trial.”
“The company will develop OLX72021 not only as an RNAi technology-based new drug, but also as a cosmeceutical, which offers consumers accessibility and convenience of use.”
So far, we have only heard about Olix’s RNAi based candidate for the treatment of male pattern hair called OLX104C. It reduces the expression of the androgen receptor via small interfering RNA (siRNA). Perhaps the new product is just the old one renamed. I will update this post when I find out.
Asymmetric siRNA Targeting of the Androgen Receptors
On November 22, 2022, OliX published preclinical research on its androgenetic alopecia treatment program, OLX104C. The results are very encouraging. Actual study is here and the researchers demonstrated:
“Efficacy of androgen receptor (AR) reduction, hair loss inhibition, and long duration of action in primary cultured human follicle dermal papilla cells (HFDPC) and rodent models of hair loss.”
They call this technology “cp-asiRNA targeting AR” and “AR-targeting asiRNA (cp-asiAR)”. The asiRNA stands for asymmetric small interfering RNA.
In May 2022, OliX raised $45 million and announce that its androgenetic alopecia product (OLX104C) will enter clinical trials later this year. Moreover, in August 2021, OliX obtained a Notice of Allowance from the US Patent and Trademark Office for OLX104C.
In June 2021, OliX signed an agreement with LGC Biosearch Technologies to accelerate production of asymmetric siRNA for the treatment of androgenic alopecia. Olix CEO Dong-ki Lee also presented at SMi’s 12th Annual RNA Therapeutics virtual conference.
February 10, 2021
OliX Pharma’s RNAi Hair Loss Product OLX104C
OliX Pharmaceuticals (South Korea) just made a major announcement. Their RNAi based hair loss product OLX104C successfully grew back hair in mice following just one single injection. The mice were suffering from androgenetic alopecia due to them being given excess dihydrotestosterone (DHT).
“We are advancing a novel and potentially durable approach to treating hair loss” — CEO Dong Ki Lee
In this preclinical study, OLX104C was administered topically to a mouse model via an injection. The before and after photos are amazing. Interestingly, they compare the results to the anti-androgen Flutamide.
More importantly, OliX is the real deal. Their news page is very impressive with regular significant developments. This includes raising $37.2 million in December 2020. They also received US FDA Phase 2a approval in November, 2020 to treat hypertrophic scars.
siRNA
On OliX’s pipeline page, they state that small interfering RNA (siRNA) has limitations in terms of stability, delivery and toxicity. This is not a problem with RNAi therapeutics. Edit: Per the patent, they are using asymmetric siRNA to inhibit male pattern hair loss gene expression.
Hundreds of millions of people around the world took mRNA vaccines during the past few years. Even thought they did not go through rigorous clinical trials for five plus years. In effect, this will speed up scientific progress. Many people will no longer worry about long-term side effects for newer such RNA related drug candidates. Perhaps a mistake, but I will not complain too much if it speeds up the realization of a hair loss cure.
Another product we won’t get before 2030. Looking for samumed in 2022, our only hope in the short term.
Or you just wait for the Phase I results and then buy it on the grey market.
Admin if tsuji were to go to human trials what’s the approval timeframe like? You said it would be fast tracked but how many years would it actually take for them to release to us?
At this point, they cannot finish Phase 1 in 2021 even if they get the funding before summer. Best case would be 2022. Then you have to assume that the data from Phase 1 was positive in humans. And no safety issues.
Then they would need to raise funds again for Phase 2. In Japan, there is a good chance that no Phase 3 is not required for autologous hair regeneration. So perhaps absolute best case is 2024 if everything goes perfect?
In any case, all speculations this early are pointless as they will inevitable have delays. Who would have ever guessed that Organ Technologies would back out? Despite the successful outcome shown in the recent paper.
Accurate I think. The best thing about it is, that RIKEN said they are ready for human trials NOW. Meaning no R&D anymore.
And how long could that trial take them? I mean you extract follicles, cultivate and amplify the cells and transplant/inject the germ. Look at efficacy and safety and validate the results. For example Histogen didn’t need more than 4 months for their 2020 trial. I think it is realistic that the first trial doesn’t need more than 6 months. If everything goes well, a 2021 result is not impossible.
By the way, that OLIX, who nobody heard of before, looks like the real deal. Makes me wonder where Exicure stands, with a 25 million dollar funding they should be on to something. Last year I thought to myself after the OrganTech disappointment, who knows if gene-therapies are coming before cell-therapies. There’s 3 legit companies are working on it: Olix, Moogene, Exicure.
Here is a question for anyone who has a medical degree. So these mice are injected with high dht. Claimed to give them aga. Wouid high dht level give you AGA? I always thought it was the sensitivity to dht not the levels that matter. Several of my Greek and middle eastern friends have body hair thick beards etc. Super high dht but no balding in their family. So these mice developed real aga or are they just shaved to the skin, no miniaturization, loaded with dht to mimic aga? If this is the case then of course all these mice studies grow their hair back since it was just shaved and not miniaturized. If this is the case then this study is bogus and doesn’t count.
What is everyone’s thoughts?
I completely agree with this logic. My hope is that they would use genetically modified mice which have hair follicles which are sensitive to the effects of DHT. Not just pump them with so much of the stuff that it would make any living creature lose hair.
If the hair in the photo was only shaved, why would the control mouse still be bald? All mice would have grown their hair back at roughly the same rate regardless of stimulation.
I don’t see a lot of difference between overloading DHT and DHT-sensitivity. Either way, too much DHT miniaturized the follicle.
The bigger question for me is, since mouse lifespan is short, is the regrowth due to the follicle not enduring permanent damage prior to being stimulated to regrow the hair? IOW, would it still work on a man’s head who lost the hair 20 years ago?
Imo dht sensitivity is bs invented to fill a void of knowledge. The only thing studies show is dht is created locally and certain follicle synthesize more dht than other. Like frontal with occipital. Men with aga have frontal follicle with more 5ar than immune men. Besides that there is AR variants but imo that doesn’t explain everything. We need more studies comparing aga prone/non prone men scalp dht.
Hairlosscure2020 can you use your influence to spread awareness of the funding/donation threshold Tsujis team has requested? I’m sure a lot of us would be willing to make a donation but we don’t know how and the logistics regarding it
I already e-mailed Tsuji and Riken and notified them that Allergan invested in 4 hair loss companies since 2018. Worth contacting them in case they want to add one more.
Was debating on adding some kind of notification on the blog, but not yet sure. I will ask the Tsuji team if they have an easy way to collect donations. I would definitely not want to be involved in any collection of funds.
Edit: I also asked them to start a GoFundMe if it made sense.
This is positive news. That said… Last week, I helped a mouse to regrow hair by feeding it Cheetos. This may have implications for humans, and it could be available in 5 years. Please invest your money.
Good news, and I won’t be a smartass this time! I really hope it shows results in people.
I am pretty sure Cheetos are banned in some countries. ;)
They’re banned in those countries because it works. The secret council of hair transplant doctors have got together to thwart Cheetos because it threatens their very existence.
Olix was always one of my favorites – no shiny appearance, but solid finances and and constant R&D.
The results from the mouse study were extraordinary, but we‘ve seen many hairy mouses thus far.
One treatment (injection) is enough for durable results? That would be simply miraculous…
What baffles me: the timelines. The patent application was in February 2018, more than 4 years ago. Means research started probably years before 2018. Their product development was finished then in let’s say 2017, a year before the patent application. So they needed ~ 5 years (!) from the end (!) of the development to their first clinical trial.
The process from basic research to commercialization is almost impossible to be done in under 10 years.
This is cool, but it looks like they are knocking down expression of an androgen receptor
(if that’s what they mean by AR).
They claim that their therapeutic is rapidly degraded in the blood so as not to have systemic effects, but I’d be interested to see if they have any direct proof that androgen receptors elsewhere are not affected .
If not, it could be a fancy treatment that still has the systemic side effects so many of us struggle with when using Fin or Dut.
Let’s face it, it is 2022 and still no cure for baldness. The last hair loss cure protect was in 1998 and was finasteride. If Klaus Schwab head of the world economic forum who has tons of money and is still bald as a buzzard cannot be cured. What gives anyone the idea baldness will be cured by 2030 or sooner. Again there has not been a baldness drug since 1998 and it’s 2022.
that magical drug or whatever … will never be found in our life time, it is what it is.
Then why do you keep coming here? Lol
I’m a depressed bald man, I need cheap entertainment from time to time … Lol
They literally just found a drug (CTP-543) by Concert Pharmaceuticals that reverse balding in AA. Not sure if it works for AGA, but still.
Can’t give up on science.
Indeed you are correct. The Schwabometer is a highly reliable indicator for progress on AGA treatment progress.
Checking in in response to our boy @Mjones.
It’s been 4 years (28M now) since I noticed one day after a haircut that I was developing a more pronounced widow’s peak in addition to my formerly black as night thick gorilla hair turning slowly brown and thinner (mixed mesoamerican and northern euro genes).
I banked on a cure for these years, developed body dysmorphobia during this time which was pretty severe, also probably something many of us here suffer from. My hair anxiety was so bad I even developed telogen effluvium, I sh*t you not. Since then, I’ve had fluctuating periods of thinning and stabilizing hair, but not all too different in appearance to when I first made the realization of genetic hair thinning 4 years ago. Things that have reduced shedding and increased shininess = ketoconazole shampoo, anywhere from 1-14 times per week. I tried minoxidil for some time which did improve hair thickness and count but changed hair texture, induced new shedding and I feared might result in side effects, so I stopped (only for a new round of shedding). I tried fin more than once and within days developed very unpleasant side effects (hot flashes, neuro symptoms).
4 years in and somehow, my anxiety towards the issue is very much reduced. I don’t worry anymore about what I will look like in 5, 10, 20 years. I am probably very fortunate in that at 28 I am still close to NW1/1.5 albeit with thinner hair and a slightly receded hairline compared to age 22-23. I am guessing I have a very long time until I am bald. Do I expect a cure by then? Nope. But I have come to terms more generally with the fact that I am aging and will no longer be attractive to young women sooner rather than later, no matter how much broccoli I eat and how often I go to the gym. It is life, it is our genes.
Always hope for new treatments but realistically I think anything truly side-effect free is non-congruent with the designs of nature. We are men, we lose our hair.
I feel like we have had the knowledge and ability to cure MPB for a long time like stopping it from happening.
The MRNA vaccines why can you simply encode mrna to build the protein that binds with the hair ARs just like covid. Poof MPB is history. There is no way hair ARs are identical receptors to elsewhere in the body.
You’re talking about an antibody response to an antigen. AR receptors aren’t foreign proteins, you won’t mount a response. If you did it likely would not be results you’d be happy with since any positive cells would be killed off. You’d have a very bad day once antibodies starting attacking AR positive cells in your brain and testes (and hair follicles, but at that point what would it matter).
Admin, stop taking sides and accept all comments on here. people who write over and over that “there will never be a cure”, that they are “screwed up” etc. for years should just stop coming and complaining as I wrote in my previous post (that got deleted by you), that’s the simple truth.
You’re not neutral and that’s a very bad thing for the site, censorship has never solved anything. everyone should be free to express themselves on here, as long as it remains polite. act as a moderator and not as a bully.
I do not recall deleting any comment recently. If you include unusual links or spammy words in a comment, the plugin often automatically sends to spam.
I would suggest that Admin is the very model of a good administrator. Prepared to give all a good hearing, consistent in his dealings, but prepared to be firm when required. Oh, and it’s his blog.
https://www.thedailystar.net/life-living/news/drug-cure-bald-hair-here-scientists-claim-3034421
Thanks for good news Lorence,
But the medicine is not for androgenetic alopecia,
That is for AA. On the other hand, the questionnaire is, that will be a milestone drug for androgenetic alopecia in future?
I don’t think it is a milestone for Aga as the causes aren’t the same at all….
It’s not for androgenic alopecia. Just for alopecia aerata, alopecia aerata is not a definitive hairloss like ours….forget about it
From the lack of comments on this blog we can see how people are slowly giving up on a cure for baldness
Medical science moves at snails pace. It’s infuriating, and not just for hair loss. We’re still using medicine for some diseases/illnesses that we were forever ago (example: we started using chemo in the 1940s, beta blockers for heart issues about 64 years ago and they’re still widely used etc.). I had a friend pass away from cancer last year. They gave him chemo and some new “test” medicine (they wouldn’t even give the medicine a name it was so experimental). He died six months earlier than predicted. What a joke.
We’re not actually curing anything – or very little. It’s always right around the corner. We’re always super close. While tech makes leaps and bounds (look at what tech accomplished since the 1940s vs what medical science has). I’ll have a self driving car (that can probably fly too) and a robot to play scrabble with and they’ll still be trying to figure out how to cure hair loss.
Agreed, and the most frustrating part is hamilton figured out androgens cause MPB in like 1960s or something. Then we got proscar/propecia, and since then we had about 20 something topicals either in trials or claiming to do what propecia does.
Here we are 30+ something years later and we dont have 1 topical to even mimic a 30 year old drug and do it safer.
Its honestly amazing how bad medical science is, and how slow it is. Maybe its a money thing? IDK
It’s a money thing. At least partially. While tech pushes new advances because the new advances make money, advances in the medical field are driven by the pharm industry, to some extent. Why cure someone when they can have them all on meds? There’s no money in curing anything. I know people that are in their mid 40s taking 8 different meds for medical issues. Daily. We don’t cure anything, we treat the symptoms. It’s embarrassing, really, that medical science is so slow and so bad. With almost any major illness, it’s a pill or some sort of medication. Even for the illnesses that have been around for a hundred years or more.
Okay, I’m done. My rant went on long enough.
@James1 – Great post. I’ve told others the same thing for years now. When it comes to advancement, fields such as computer technology, space, defense, etc., have run laps around the field of medicine in the past few decades. Amazing they still can’t cure hair loss, solve the reversal of grey hair, tan the skin with a topical, etc. I know several people that, even with all the medical imaging now, doctors have no idea what is wrong with their bodies.
We literally can make mRNA vaccines now in record time. That tech didn’t just appear overnight, was decades in the making. We literally have had a small group of patients effectively cured, or at least greatly helped, by knocking out ATTR with a CRISPR drug called NTLA-2001. We can grow fish tissue that looks like the real thing in a lab. The list goes on. If there was a hair loss drug tomorrow there would be another fraction of the population complaining their eyesight isn’t perfect or they need more height. In the last 50+ years we’ve learned a lot of biology resulting in journal libraries overflowing with data. But biology is complicated and there are new pathways discovered every year.
Most important thing is to get in the right mindset.
The thing is, the more this blog gets hits the more it appeals to advertisers. No problem there, everyone has to make a living. But if you wanted to fix your car would you lay out the options side by side or string together 200 pages of as much info as you can throw out there on every little thing with the word “hair” in it? The hair loss field could probably be boiled down to a spreadsheet and status updates but that doesn’t keep people engaged, and less visits to site = less advertising $s. Best investment is focus on things you CAN change – for example exercise/staying in shape, learning (free to check out books at the library), developing a skill and so on. If a therapy comes along that’s great but Alec Baldwin has a full head of hair and he shot a Ukranian. It’s not all about a head of hair.
I guess they want to keep it the way … After all, why change things, They have an endless source of money, people will keep on paying and paying for better health and looks. By the way I’ve never seen so many ads about hair transplants like today, they are everywhere, trains, busesn, billboards and so on … Now they even offer it with monthly payments.
https://www.genengnews.com/on-your-radar/hair-loss-treatment-uses-stem-cells-to-generate-healthy-new-follicles/
Thanks Jan for the news its better than the main article. Thus were looking at 2035 for a market release of stemson therapeutics hair cloning technology.
Biology is complicated. So is space travel yet we got a rover on mars we can maneuver with a joystick from someone’s basement while watching stranger things on a flatscreen tv. We’re working on star trek-like spaceships that can carry us 10xs faster and farther than we ever traveled before. We’re creating temporary/mini black holes. We’re doing all kinds of things with tech and space that even 20 years ago we’d have said was totally impossible.
The only reason we haven’t cured many illnesses is money. Money rules everything. The best scientists are grabbed by private sector companies trying to find ways to make money/profit. I don’t believe with billions put forth towards a diabetes cure we can’t cure it in a hundred years (tons of time and tons of money should equal a cure). And don’t tell me there is a cure – one guy was cured with that lastest trial. One. That’s it. And they won’t advance it further without finding a way to ensure everyone, even once “cured”, is on daily meds for the rest of their life. That’s the goal. Milk everyone. They make so much money off of diabetes supplies and meds they don’t want to cure it (they meaning private sector companies making tons off of these meds and supplies) unless they can be sure they continue to make money somehow. Any cure (for anything) will have an added lifelong cost, you can bet on it. We should have cured things like diabetes a LONG time ago. But there wasn’t any money in it.
Bottom line is, in the last 80 years, they haven’t cured much of anything. If the human body is still such a mystery at this point, we’re in pretty sad shape.
Thank you james1. Finally someone is adequately pointing out the bs, that is the hair loss industry.
The head of the National Cancer Institute wrote about this in the late 90s. The whole “why can’t we cure cancer if we can put a man on the moon.” Many of the basic principles that govern how a cell functions are still not known whereas we have a sufficient understanding of physics and material science to send someone to the moon. Biology is experiential, that’s the reason you can’t have a group of brilliant physicists step into the picture, push aside biologists and draw out equations that spell it all out.
We only discovered DNA in the 1950s, got to working with recombinant DNA in the 70s and PCR wasn’t even a thing until the 1980s. Now we have gene synthesis, CRISPR, NGS, the list goes on. The field isn’t going fast enough for you? Biotechs pop up all the time, people give it their all to come up with cures for devastating diseases (some of which are in their families) and fail. Doesn’t matter if you’re a billionaire, if we don’t have a solution yet, we don’t have a solution yet. They key is to realize life isn’t fair and make improvements in other parts of your life. Or just complain but that won’t move the needle.
I agree. We don’t have the solution yet. My argument is that we should. For at least some of these illnesses (we have cures for almost nothing). You keep saying how hard it is. Sure, no doubt about it. But the general feeling/question of just about everyone worldwide with a chromic illness is why after decades and decades are we still no closer and using meds from the 1940s. It’s a valid complaint esp if you look at cancer (talk to some cancer patients and see how they feel). If you’re telling me after hundreds of years (literally) dissecting and analyzing the human body, we can’t cure anything, I’m saying we suck. As a species. We should know more by now. But if you’re saying money isn’t keeping us from some cures, no offense but you’re naive (I own a business and yeah, money/profit has an impact on literally every aspect of life). Companies are making a bundle off NOT curing these illnesses. I know an ER doctor. There are secret hospital price lists and yes people pay 40 dollars for a 1 dollar bag of saline solution. It’s all about money. Even if/when you’re dying.
I lead a great life. I’ll be in the amalfi coast next week sipping a nice drink. I made all the necessary changes in my life I need to. I’m happy. But this is a blog about a hair loss cure and we’re nowhere close to having one so yeah so people will complain. And we/they have a right to.
But this time I’ll truly end my rant. Time to move on. I have a trip to pack for ;)
I just saw today they may have a breakthrough for cancer – some new drug that worked amazingly in trials. It’ll be a while before they know for sure (and longer before it’s used wildly), but this is great news, if true and will surely renew faith in medical science. A huge step. Maybe that leap we need is coming.
Of course I’ll complain. Im the victim of a botched hair transplant in Turkey. I have FUE scars and even though I got SMP to hide them, I still feel unconfident about going out without a hat. My quality of life has decreased a lot because of that. Wigs are out of question because they feel like expensive rags glued on your head. I want a real cure. Not expensive medications that don’t fully regrow lost follicles. And I will complain until we get a REAL cure.
Hello Brian, to complain about slow progress in medical development is understandable.
But definetly not your HT in Turkey.
Sadly there are many trolls promoting HT’s in this country. Presumably paid for by the butchers.
Have you ever had a look at Bernstein in New York? It shows what is realistically possible.
When I see manipulated ‘Before’ and ‘After’ pictures it makes me cringe. This BS is beyond imagination.
Alone the advertising that you are picked up by a luxury car at the airport.. OMG.
Guilty until proven innocent as far as I am concerned.
Botched HT’s can destroy lifes…
Fingers crossed that Kintor, ManeBiotech etc can deliver as promised.
I have the cure. It’s costly, somewhat labor intensive, and may include questions of medical ethics. But it is a cure.
We can easily grow thousands of human hair follicles on a mice. The problem is that we can’t control the growth of certain cells which lead to cancer. That has been the main limitation with viable cloning methods- controlling cell growth factors.
The solution in its most basic form:
Harvest cells from human. Grow in dish and implant in immunosuppressed mice. Harvest hair from mice and transplant to human.
You arent wrong, but men with hair would probably much prefer the androgen route or AR (androgen receptor) to prevent/stop MPB and simply keep their hair.
What you describe will cost a literaly fortune like 50G+ which most people arent going to be willing to do.
I am not a biology expert, but we have a covid vaccine that took about 1 year to finish using MRNA instructions to build a protein.
Why cant we do the same thing, and bind to all the ARs, and basically prevent/stop MPB from happening? Are all hair receptors same as the receptors elsewhere in the body because it seems they would all be unique.
I cant see why MRNA stuff cant be used to solve MPB.
Olix has an update.
Clinical trial candidate for hair has been approved.
Thanks, updated post after finding link. Strange that they give the product a different name. Need to find out if same product or renamed.
I searched this forum but didn’t find anything related to QR678. Supposedly had a US patent and is being administered in India. The results look pretty compelling. Any insight from admin or the readers on when clinics in the US May start administering this treatment?
I was in contact with the inventor a while back, but did not see a reason to write an entire post at the time. May recheck if any trials etc.
QR is a sham, I am from India.
Have they made any mention as to whether or not they think this treatment will allow for hair regrowth or if it’s just that it could prevent hair loss from occurring?