Follicum Develops Direct-to-Scalp Formulation of FOL-005

I have covered Swedish company Follicum numerous times on this blog in the past, including twice already earlier this year. The company is developing a topical scalp hair stimulation product called FOL-005 that is based on the human protein osteopontin. Interestingly, a variation of this same drug will likely be developed by Follicum in order to reduce body hair. Side note: see my post on excessive body hair in men and its correlation with scalp hair loss.

Of the numerous companies in the world that are developing a treatment or cure for hair loss, Follicum is currently the most professional when it comes to its communications and its product development strategy. Their clinical trial time-frames for each stage have generally been accurate over the past few years, and they seem to be on schedule to continue to hit targets over the next year.

Follicum Milestone

Earlier today, I got an e-mail from Follicum notifying me of their achieving a major milestone. The company has now successfully developed a direct-to-scalp topical formulation for their FOL-005 hair stimulation drug. This will in the near future replace their current method of delivery (intradermal injections) of FOL-005.

This newly developed formulation has been shown to be stable when it comes to long-term storage. The company plans to optimize it for large-scale manufacturing.

According to CEO Jan Alenfall, Follicum’s extensive experience in developing peptide drugs has enabled them to develop a stable formulation that delivers FOL-005 directly to the hair follicle.

Follicum Advisory Board

While browsing through Follicum’s website today, I also noticed that their scientific advisory board page seems to have been updated recently. They now have a highly respectable and accomplished group of advisers, many of whom have been covered on this blog in the past. The most well known of these in the hair loss world are Dr. Gerd Lindner (Germany), Dr. Ralf Paus (UK/Germany), Dr Ulrike Blume-Peytavi (Germany) and Dr. Amos Golhar (Israel).

If all continues to go well in Phase II trials, it is not out of the question that Follicum’s hair growth product could be released around the end of 2020 (maybe I am too optimistic — h/t John Doe’s comment).

85 thoughts on “Follicum Develops Direct-to-Scalp Formulation of FOL-005”

    1. Whatever comes out and actually Works I’m first in line. BUT, JAK will be out first by a long shot.

      Nice vindication by Follicum that a a topical can permeate the scalp this news is a big plus that JAK trials might be going very well NOW. While Follicum plans phase II later.

  1. Great Company indeed! But for the schedule 2020 is not likely. They speak of results of Phase 2a end of 2018 and of Phase 2b end of 2019. Then I guess another 1,5 years for Phase 3 and finally FDA / Authorities approval which takes another year. Comes to 2022 release if all goes well. Seems like 2022 will be THE year because so many companies aim to have their product released then.

  2. I’m assuming this is the ‘velly attractid topicol foamalation on da scalp’ he was talking about. And hopefully like the injections, you only need to apply “free times weekly”.

    Note:
    1) CEO believes it will be prescription only for the first couple of years (with the exception of Japan, maybe).
    2a) The Phase II study ends August 30.
    2b) The Topical Formulation Phase 2 study is planned for January 2019 (study ends in Q3 2019)
    3) Phase 3 is already planned for early 2020

    And what’s after that—?

    1. The have talked about “hair stimulation” and “hair growth” on their site and in various press releases and publications over the years.

  3. Good news that they are moving along. I hope they can achieve amazing regrowth and not 15% increase. We need 30 to 50% at this day in age. The 8 to 20% increase are the Rogaine and Propecia years. Either way it’s nice to see them stay on course. ….

  4. Baldy, baldy over there. What’s it like to have no hair? Is it hot or is it cold? What’s it like to be bald?

    I tell you what it’s like, it’s like being castrated. This cruel syndrome must be cured!

    Brotzu, Follicum, Riken, Shisheido, Aclaris………anyone, please help us!!!

  5. bw. 75 % responded to the treatment. And to you folks out in the big world: When a company from the Nordic countries says something, in this case about the timeline, yo can trust them.
    The mentality here is different. We may be boring :) but you can trust us.

  6. FYI Follica must be very close to initiating their phase 3 clinical trail as Puretech has again modified their pipleline page, this time adding “/pivotal” after the phase 3 time line description and adding an additional time line segment labeled “Filing”: http://puretechhealth.com/puretech-pipeline/our-pipeline/details/wound-induced-neogenesis-rain

    All good signs and very nice to see someone close enough to include a “filing” into their timeline. It looks more and more like we may finally have at least something by the end of 2020!

  7. Good advisors appointed, product altered to have longer shelf life, new delivery method devised, accurate timescales of milestones, etc.
    All sounds good, but what does this product actually promise? The last I heard, it would just be an alternative to finasteride. So why not just take finasteride?

    Too little too late. There will be at least 1 better treatment out by 2020.

    1. @Tomjones I believe it will be Shiseido. They bought the rights to finish off the Replicel product for a reason. They did not buy into Brotzu, Follicum, Aclaris, even though they could afford to buy out all the big players.

  8. So to give NASA some hope on Aclaris…I want to mention that I went 10 days without using Nizoral shampoo due to a mishap with the my pharmacy. After a week my scalp inflammation came back, dandruff and oiliness. Inflammation is a key factor in hair loss at least for me. I used niz this morning and my scalp after two hours feels cool and healthier. So if jak is working on an the inflammation angle then I believe it will have benefit for AGA. I didn’t think I needed Nizoral that much and that has been a key treatment for me all these years.

    1. Just a friendly suggestion, you should try doing an egg white mask once/twice a week and see if it helps with the oiliness. It worked wonders for me and I’ve tried it all.

    1. @Joel.. Thanks for sharing the find. Target engaged with topicals. Let’s hope it leads to a consistent treatment for 100% of AGA and AA cases.

    2. Good News. It shows that the Topical is able to permeate to the lower skin levels and activate hair follicle cells. It means AGA has a Fair Chance at working, and if it does now work I truly believe we are simply Cursed.

      This has to work for AGA if it does not work, well, I am going to stay very Positive and realistic. If it does not work then its waiting for Tszui (sp). But IF it works then we are DONE, back to Tray Goudi type of different hairstyles every few weeks.

      Well, we will know ANY day now if it does not or does works.

      1. nasa_rs, in one breath you are saying that if JAK’s don’t work we are cursed, then in the next saying you will still remain positive? Everyone is bored to tears with your waffling unfounded support of Aclaris and JAK’s. Yaaaawwwwn. Bore off will ya mush!

  9. China calling!
    TSG, apoptosis, p53, senescence

    Tetrahydroxystilbene Glucoside Effectively Prevents Apoptosis Induced Hair Loss

    https://www.ncbi.nlm.nih.gov/m/pubmed/29808162/?i=2&from=p53%20hair

    https://www.researchgate.net/publication/324200539_Tetrahydroxystilbene_Glucoside_Effectively_Prevents_Apoptosis_Induced_Hair_Loss/fulltext/5ac56f0da6fdcc051daf2607/324200539_Tetrahydroxystilbene_Glucoside_Effectively_Prevents_Apoptosis_Induced_Hair_Loss.pdf?origin=publication_detail

    Pharmacological studies have demonstrated that TSG have multiple biological functions in treating many diseases such as vascular and cardiac remodeling [30, 31], delaying the senescence effect [32], learning and memory disorders [33], and diabetic complication [34]. In this experiment, TSG showed great effects on hair growth. Treatment with TSG resulted in the emergence of new hair shafts and recoveries of the size and numbers of follicles. Few TUNEL+ cells were detected in the dorsal depilated skin treated with TSG. The next step of this experiment is going to find the dose-effect relationship of TSG in hair length and hair recovery ratio and figure out optimal drug concentration and delivery devices with the least side effects.

    Taken together, these findings suggested that TSG could inhibit p53, Fas, and Bax induced apoptotic signaling pathway and help to prevent follicles from entering into catagen phase of the hair cycle. TSG may be an alternative medicine for treating hair loss such as alopecia and telogen effluvium.

        1. I was surprised to find an article from China. It could be that something comes out of nowhere.

          The questions is whether (all) AGA is apoptosis induced hair loss… I can imagine that there are several types of AGA, as some sufferers benefit from MIN alone, others from FIN alone, and some keep losing it no matter what they do.

          Some feel pain, others don’t, some have dermatitis, others don’t, some lose certain fat layers, others don’t …

          1. Netshed. Interesting points. I’ll probably be in the category of bald no matter what I do!.. grrr. But thanks for the info.

      1. i am chinese but i hear few studies about hairloss in china,but it is obvious that hairloss issuse attract more attention among youngh people nowadays and young
        people have more svevre hairloss problem compared with
        last generation.

    1. It’s interesting they mention telogen effluvium, I lost most of my hair with a telogen effluvium after a crash diet and it didn’t grow back.

    1. I just follow the stock briefly, but there is a new issue @2.20 kr with last call now at 3rd july and there could be people manipulating the stock downwards (illegaly) so they can buy the new issue rights from other people at a low price and in that way getting stocks without pumping the actual stock price.

  10. Hi Admin, my Foxo4-DRI news probably went to spamfolder, it had 3 internet-links in it. They initiated 2 start ups at 2 different Dutch universities.

  11. Anyone hear if JAK is working for Aclaris Trials? The company should mention it during their telecom first week in August. I guess a lot of ears will be listening very, Very Intently.

    1. Dear Lord…
      Hush already!
      And be patient!
      You spam every single post with your crying about news from Aclaris.
      Hush!

  12. anyone knows did AA trial start with aga trail at the same time? if it is, its wired that aclaris do not mention aga trail

    1. If they don’t mention anything by end of august it’s because either it works to well and someone is blocking it from production or it doesn’t work at all. The makers of Rogaine make HUGE money worldwide from it and I bet your ass they will fight to the end to block better treatments. Every guy I know that went bald tried Rogaine or still use. Everyone knows Rogaine and they set a brand for themselves. You might think I’m dumb for thinking it but it makes sense. I know deep down one of these treatments the past 2 decades worked for AGA, osh101, intercytex, aderans, etc….

    2. I am pretty sure that the AA trials started 3-6 months BEFORE AGA trials. Let’s just hope we get the same results.

      I think there is an investors conference call in the first week in August we might get a note on how the trials are doing for AGA.
      All is my opinion.

  13. From the downward movement of the stock price, I think the product efficacy should be far from exciting. It may have some very light effect, less effective than propecia, but they may have some market space for people not willing to take propecia. This is why they probably chose a direct to scalp formulation, more acceptable for a product with limited efficacy.

    This is my opinion from just looking at the stock price movement over three years. The reality can be different, but I doubt a big step forward is coming from Follicum.

    1. Follicum’s results are similar to Minoxidil, but where they believe they have a market advantage is that it only has to be applied three times weekly as opposed to twice daily. So this is for Minoxidil non-responders and people who don’t want the hassle of a twice daily regimen. It would be interesting to see the results when combined with both Fin / Min.

  14. Interesting reading comments about China. The reason you don’t hear much of out China is due to its censorship of the Internet :-) Facebook is blocked, YouTube is blocked. They have their own limited equivalents but of course this won’t then get read much by foreigners. Thankfully when I was in mainland China this site was still accessible and, besides a cure itself, nothing is more important :-)

    It would be no surprise if the cure did come out of China; the “other” world superpower. It’s patent applications has already surpassed the USA and its R&D expenditure is coming close.

    1. Good find John doe! That looks very interesting. I am assuming that will be an injection done by ht docs or derms. I remember seeing am adipose fat cell treatment in a Korean journal and the results were excellent. Very good regrowth. Hopefully this isn’t a snake oil….

  15. Have been struggling with baldness all my life. I am almost 40 years old. I found something that actually worked for me it is 2 things shaving my head and trading crypto. Trading crypto prevents me from constantly searching google for a cure and it brings a profit. I highly recommend it. If a cure comes cool, but honestly I could care less every since I started trading crypto currency. I hop JAK works out, but guess time will tell.

  16. If I have it right, it was reported that Topical JAK works for AA hair loss on June 28, 2018. But I have no idea when they started does anyone know?

    That started topical JAK for AGA hairloss on April 23, 2018. And if we know how long it took until they reported positive results for AA then we should know when they should report results for AGA hair loss.

    Fingers still crossed and if it does not work guess how many fingers I will be holding up.

  17. I tossed out my theories 2 years ago on how I thought JAK would work for AGA hair loss on another website I’ll just call it the Bald Lie hair website. Where they only care about HT. They all proclaimed how I was completely wrong.

    Only the ADMIN on this website believed me and thought it was 50/50. Now, we are on the verge of knowing and having our hair problem solved. They just announced positive results for AA Topical with JAK. It means it is Possible that it will work for AGA. Waiting for sometype of word from the company my guess within 3 months.

    The world will change for me if it works. I’ll say it now, thanks ADMIN for letting us know there is a brighter future if not JAK then Tszui if not that then something else. We will win.

  18. nasa_rs I hope it works out too. I mean the person from Aclaris said it worked in the initial presentation that was hosted on this site. One thing to kind of take note of though is they are probably looking out for their investors. A cure for AGA is huge, so if that got leaked there may not be enough shares to go around. They are probably looking out for their best interest. I think the possibility of something with their trials on AGA leaking out is slim to none. If it happened there would be lawsuits… good or bad results.

    1. I understand that they would not want to show early results in that the hair would not be filled in. Better to show the 5 month result where the person has a full head of hair. But no way do they wait until mid 2019 to show results. I would expect an announcement within months IF it works. Otherwise they could announce any day now that it did not work and that they stopped the trials obviously for safety reasons. The longer we do not hear anything then the better that should be at least for the next month or two.

      I just posted a link from cnn where they wrote about a drug that could solve hair loss. How it stops a specific gene from turning off the hair cycle. It sounds a lot like what JAK does. cnn also mentions how there are two drugs that do this but one does it better and thus grows more hair. That could be a similar case for JAK. It could work but maybe this newer drug will work even better. I am just hoping jak works very well and I can wait for a safer drug down the road with a full set of hair.

      Let’s hope.

      1. Nasa,

        Aways keep in mind that Aclaris has another type of Jak inhibitors willing to test for Aga.

        Maybe this trial is meant to see whether there’s no need for the newer type of jak’s for Aga, or otherwise, if a result occurs with the current trial, they will proceed to trial the new type earlier if it might produce a better full head of hair.

  19. Replicel is to my knowledge the only company approaching a real “cure” in that unlike Tsuji who combats the forest fire by planting more trees, Replicel puts out the fire and lays a bed of nourishing soil for renewal — at least in theory. The way Rolf Hoffmann (Chief Medical Officer at Replicel) spoke of RCH-01, it sounded as though it would be a one-stop, one-treatment, lifetime restoration. I mean, that’s the dream!

    Speaking of dreams, I had a vivid one a few weeks ago in which I went into a salon to get a haircut—I had long shaggy hair and only wanted the ends to be cut. After, on the receipt, was written: “you’ve found yourself in chaos, now find yourself in company” (???) And then the dream went off elsewhere. I woke up, must have been the first time I realized that I have forgotten what it’s like to have hair! I have avoided the horseshoe-look by shaving for the last decade and I really can’t recall running my hand through my own hair or feeling it toss about. All the little things lost; makes me sad.

    1. Toccata – the JAK’s work by stopping a protein from shutting off the hair growing cycle. Its like this. If you are at work and you use a specific room for conferences when you go in their and turn the light on when you use the room and turn off the light when you leave that is like your normal hair cycle. But if someone always walked in their and only turned off the light even if you are using the room that is like what the specific protein does to the normal hair cycle it turns it off. What JAK does is to look out of the building the guy who is always turning off the light in the conference room. Then the room can be used normally again.

      1. Assuming it works, you’re still stuck taking it for life. So while it IS a cure (in as much as running downhill IS keeping balanced, until you stop and fall down) it is not quite the one-treatment-never-think-about-hairloss-again type cure. (Until then, I’m on that Aclaris hope with you bro)

  20. Let’s not get greedy here. One step after another. I’d happily pay for and pop a pill with no side effects once a day or have an affordable monthly treatment.

    1. As long as the treatment is affordable and will restore a full head of hair, I won’t mind daily topical applications.

      It’s like hitting the gym, once you get the results, you can’t stop exercising, otherwise all muscle gain will be lost.

  21. I really think the JAK by Aclaris is working. It has been long enough that they would have stopped the trials if it was not working.

  22. nasa_rs – I would highly recommend taking into account that JAK will not work as good as you think. You have seen the pictures of people with AA and AGA and some of the people still had the horse shoe pattern. I do hope it works as well, but I’m not going to let it ruin my life if it doesn’t work out.

  23. Jak should technically work if it’s aiming at kick starting follicle regrowth from a different angle than min and fin. From my understanding it kicks starts a signal deep in the hair growth pathway. So hypothetical it’s not blocking dht or increasing bloodflow to kick start hair growth it’s doing it from cellular level….or something like that haha. The issue is those hairs that regrow will not be immune to dht but as long as you keep taking jak it shouldn’t mstter. Best case is to use jak once a year. Use it for 3 to 6 months to get full growth then not use it for another 6 months. I just don’t think it will be good to use jak long term.

  24. MJones you are right. The JAKs work differently than any of the current products on the market. That’s why they are (hopefully) going to Completely Work. Thought it’s a Huge Plus that the Topical works for AA. It means we have a very Fair Chance.

    If it does Work we are really going to have a different type of discussion after these years. Its going to be one When Do I Get It, And Safety.

  25. The idea of JAK inhibitors seem strange to me. On one hand RepliCel tells us the dermal cups of follicles in people with AA are damaged and need to revitalised, hence RCH-01. On the other hand current anti-androgen meds tells us hair is susceptible to DHT, and stimulating meds like Min tells us better circulation can be very beneficial. Using JAK inhibitors to force those hairs to grow sounds like the equivelant of forcing a plant to grow with crap soil with a broken plant pot – is that sustainable? AA the processes involved in it still aren’t completely understood; bruteforcing the growth of hair cells without addressing any underlying issues seems brash. Inducing abnormal growth by manipulating proteins also sounds like it could lead to some serious health implications; personally I would rather use cell cloning or follicle cloning instead of manipulating genes and proteins. Should JAK inhibitors for AA come out I’d probably wait a while before using just to hear about people’s reports using them.

  26. now that tsuji said that the hair cloning technology can make one follica cell into 100 or 1000 cell, i think even dupa can be treated unless you lose all your hair by dht which is never happen.the only matter is how much money it takes

  27. i hope that the ultimate cure is some kind of pill or lotion .it is horrible that millions of rich baldies take flight to japen

  28. NASA do you understand that if it works, they would not want to release the news immediately? No other company is doing this research to the best of our knowledge, so Aclaris is in no hurry. Releasing this news will attract a lot of investors, and Aclaris needs to have a strong plan on getting a product to market if they want to keep these new investors satisfied.

    What I’m saying is, if it works, there will probably be a few months of planning before they release the news.

  29. I heard and read about people using Voltaren in their regime, is there anyone who can tell me something more about it?

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