WAY-316606 for Hair Loss

Update: September 16,  2020 — WAY-316606 is a novel SFRP1 antagonist. It inhibits catagen phase progression in human hair follicles. This new study is co-authored by scientists affiliated with Monasterium Laboratory (Germany) and Giuliani S.p.A (Italy).

WAY-316606 Hair Loss Drug
WAY-316606 for Hair Loss. Source: PLOS.


May 8, 2018

Cyclosporine A to WAY-316606

A new hair related study from the UK’s University of Manchester has been making global news today as a potential cure for baldness. The paper is titled: “Identifying novel strategies for treating human hair loss disorders: Cyclosporine A suppresses the Wnt inhibitor, SFRP1, in the dermal papilla of human scalp hair follicles.” The paper was released in in the open access journal “PLOS Biology”.

Note that despite the title of the study, the main subject matter is not Cyclosporine A (CsA), but rather, an unrelated drug called WAY-316606. I will discuss the actual findings of this research in the next section. The lead author is Dr. Nathan Hawkshaw, and one of the co-authors is Dr. Ralf Paus (who I have covered a number of times on this blog in the past). A summary of this latest work can be read here.

Dr. Nathan Hawkshaw
Dr. Nathan Hawkshaw.

For regular readers of this blog, this is not a surprising development. I covered Cyclosporine and hair growth in detail in 2016. It should be noted, however, that past research has focused on Cyclosporine’s anti-inflammatory and autoimmune properties (as is the case with JAK inhibitors). However, this latest research found an alternative mechanism via which Cyclosporine A benefits hair growth.

The researchers, via gene expression analysis, discovered that CsA inhibits a protein called SFRP1, which in turn is responsible for blocking the Wnt pathway and hindering hair growth. Also note that this latest work was conducted on human hair follicles. Most past research has involved mice hair or other mammalian cell culture.

WAY-316606 for Hair Growth

More importantly, this latest research went one crucial step further. The researchers found that an already existing SFRP1 antagonist drug to treat osteoporosis (brittle bones) was several times more effective than CsA at growing hair in humans. This drug is called WAY-316606 and it is used to treat osteoporosis.

Moreover, while CsA has major potential side effects, the same is not true for WAY-316606. Note that while CsA is an immunosupresant, WAY-316606 is a non-immunosppressive, chemically unrelated agent.

Giuliani Pharma

Per the Guardian, Giuliani Pharma of Italy might take this research forward and conduct clinical trials.

According to the BBC:

Project leader Dr Nathan Hawkshaw said it could “make a real difference to people who suffer from hair loss”.

According to the more tabloidy SUN:

Dr. Hawkshaw said “I’m very optimistic it could work. In lab tests, the drug started promoting growth in hair follicles in just two days. We are looking at using it as a topical treatment, a gel or shampoo that could reach the follicle. There are no known side-effects of the bone drug“.

Update: The University of Manchester now has an article on it.

Wnt signaling has been covered at least briefly by me in what must be several dozen blog posts by now. A number of companies are working on curing hair loss by targeting the Wnt pathway, with the most famous of these being Samumed.

Now we have one more name to add to that list.

72 thoughts on “WAY-316606 for Hair Loss”

  1. Shown to be effective in only two days? Brilliant! Clinical trials, please make your way to the stage, thanks.

  2. Two more years and we will have our wonder cure;-) it can’t take longer than this, it just can’t.
    Lately I feel very optimistic about this, just intuition.

  3. So, like, is WAY-316606 already approved for use in humans, or is it yet another promising compound about to spend eternity in clinical trial hell?

    1. This reminds me of the drug OSH101 from 2006. It was an osteoporosis drug that made it phase 2 trials. It had great potential then just scrapped and shelved. Nobody knew why….. hopefully this doesn’t happen with this exciting treatment and hopefully it’s an already approved drug so it can be out in a few years. If it’s 10 years of trials then well…..you know the deal lol

  4. Here’s a Q for the science nerds, is it possible that this is one of the compounds that Follica have been trialing? Given that this drug has existed on the market for a long time now and given that the fact that Follica and their people have been talking about repurposing drugs already on the market for something else for hairloss?

    As Admin pointed out, this isn’t exactly new (although the method would appear to be) but what if someone (ie Follica) were already on board this train?

  5. Follica, replicel, histogen and so on have become very suspicious through the years… as I’ve already said our wonder cure will NOT come from these wise guys.

  6. No worries @admin, I am sure I will be popular again once my “after hair system” comes out this weekend.
    Manchester University is one of our parkour group’s training spots.

      1. @admin the thought had occurred to me as well :-) Very spooky when I saw this today. You did say 2018 would be interesting! The irony that when the eventual cure would come out I would be willing to fly to Kobe in Japan, or some place in the USA or China, but in the end all I might have to do is get on a bus :-)

        But now I am going for the hair system, nothing less than a complete cure will bring me back to the table. If this ends up being one of those treatments with results only visible under a microscope (PRP, ACell, Laser Cap) then I will stay away even if it is on my doorstep. Still, this is very spooky!

    1. Pics in study lazy useless smartass. How can time frame be released if trials not started yet..??Drug already in the market if you want to try. You are egg head and egg brain.

      1. I haven’t seen any “pics” unless you talking about the scientific charts showing DP cell growth and statistical bar charts. All that stuff is cool not hating JAK is already on the market and it’s still 4 years away according to Aclaris. Just because a drug is already out there and approved apparently doesn’t mean ..jak.

        when I had a fro my screen name used to be a joke when I first start lurking this blog years ago but yes i have fufilled my own prophecy now the jokes real i’m about 1 year from being slick bald.

  7. It has been a month since JAK trials started. They might know by now if it works. I hope it works. We will probably find out in a month or two. Word will leak out.

  8. Does anyone know if WAY-316606 is FDA approved for other uses? Has it passed safety checks already? How do they know it has no side effects?

    1. I have seen links to a few such sources since yesterday, but we have no idea about topical scalp delivery methods, doses and safety as yet.

      1. Admin, I agree that no one should proceed without knowing safe dosage and application method, but I just think it’s great that the drug is already for sale with minor red tape.

        I’d hope the safety portion of clinical trials would be expedited. Also, it’s interesting to read up on specifics about the drug.

  9. 2 days for hair growth is what I am taking about. Do we know if this was tested on hair attacked by mpb or just on a normal person’s scalp with no issues. If the latter then we shouldn’t get too excited. Either way it’s a good step forward. Maybe follica is already using this in their mystery approved compound topical?

    1. Mjones, from what i understand they tested it on harvested follicles from transplant patients. So you have to assume the harvested follicles were healthy back of the head follicles. Not shrinking or dying follicles.
      If they wanted to really test this for regrowth potential then they should have taken some dying follicles and tried to regenerate them. But they didnt.
      This looks to only accelerate growth of healthy hair. I could be wrong but that’s how I read it

      1. Champy you are probably right. Still a good discovery but not really worth caring about unless they show it really grow back hair on a mpg miniaturized follicle but even then you are looking at trials etc years down the road. Waiting game continues……

      2. What the study indicated is that the controlled HF’s remained the same size, while the HF’ treated with WAY-316606, grew larger. Additionally. under closer analysis, the cell walls actually became excited, and started moving/communicating. Mind you these hairs where sitting ina solution meant to keep the hairs alive not ‘feed,’ like would be the case to our own hair. So its a great discovery because the hair essentially grew in a petri dish… What i think is even more facinating is that it reaffirms my belief, life is in EVERYTHING. #cellswakingup


    AGA-201 Topical – an ongoing Phase 2 open-label clinical trial of ATI-502 for the topical treatment of androgenetic alopecia (AGA), also known as male/female pattern hair loss. This trial will evaluate the effect of ATI-502 on the regrowth of hair in up to 24 patients with AGA and data are expected in first half of 2019.

    one year?? is good or bad news????

  11. Why is it that stories like this take off in major media, but most of the general public still has no idea about say JAKs, Follica, Tsuji, or Shiseido/Replicel? Is it simply the hook that this was a ‘mistake’ that they found out it works for hair? Whereas the others are just ongoing trials and therby ‘less exciting?’

    Or is this really that big of a breakthrough?

    1. I think it has to do with….when you never suffered from hairloss, were you starring at people’s heads? Probably not. Would you even consider typing in, “Hair Loss”, in a search engine? Probably not. It’s only until it effects the person until do we look. Which is a little sad, do to the fact gene testing is already available. So basically most don’t prevent hairloss and only treat until after it happens….almost like every disease in Health Care, which isn’t healthcare..it’s,” Symptom….or, Treatment Management.” Those two happen to be the best customer, a returning one. Oh, and in a field were these doctors are not held accountable by insurance companies, because everyone pays in cash( for the most part ), so less staff( overhead ) for medical billers and coders to take on insurance companies and reimbursements.

      A great example on how insurance can hold doctors and nurses to a higher standard….If you came in and needed a catheter, but a nurse who inserted a catheter didn’t use sterile technique( busy day, tired, wasn’t thinking, or properly trained ) and the patient…..I mean client( another word for customer ), gets an infection. Under medicare, the hospital gets how much? $0. The hospital not only has to eat the pay for the patient’s stay, but treat the infection.

      In hairloss, since you take insurance out of it, it allows more scandal to happen, because less regulated when it comes to reimbursements. So, say a doctor bills $150 for a visit….do you think he gets that through insurance? Insurance might say, they will only cover 80% of that. So all in all, the doctor makes $120. Then we can debate cost of healthcare vs insurance. However, in my opinion it allows the bad docs and, “Technicians”, to practice with a much greater sesne of recklessness, besides being nervous about bad reviews, in which I would think the Doctor would try to settle because these,” Reviews”, are their really regulation obstacle.

  12. Sad thing is news like these come once in a while and then they go totally quite… Luckily jak is making good progress lets hope some thing comes out soon

  13. admin one question:
    Which is the difference between hair follicle stem cells and human derived cells? tsuji solved the first, when solved the second will start trials in 2019 and probably hair cloning will be a reality .

  14. another question:
    the hair growth in mice (tsuji pictures) was human hair right?
    perfect, why the hair was no rejected?
    is not mice hair is human hair…

    1. yup, that is human skin with human follicles grafted it is not murine hair. it’s as close as they got years ago. They have control over the breadth and length too which is an excellent side note. and they are starting this year with projected release in 2020.

      Shiseido has some steep competition because they are using a derivative of replicel’s technology which resulted in statistical significance but it was determined to be a game changer in the way tsuji’s work shows.

      Shiseido will win the race if their product has somehow expanded the efficacy of Replicels work to something comparable .


        Graft versus host disease ( GVHD ), a complication of hematopoietic stem cell transplantation
        On May 8, Hokkaido University discovered that Lgr 5 + hair follicle stem cells were damaged and decreased in skin GVHD, a complication of hematopoietic stem cell transplantation, and found out a topical medicine for JAK 1/2 inhibitor ” Luxoritinib ” When it was applied, it announced that it has revealed worldwide for the first time that skin homeostasis is maintained by improving hair regeneration and wound healing by protection of skin stem cells. This research is based on a research group of Professor Toyoshima of the same graduate school medical institute. The research results are published in “Blood”.
        In graft-versus-host disease (GVHD), a complication of hematopoietic stem cell transplantation performed for the treatment of hematological malignancies such as leukemia, various organs such as intestinal tract, skin, and liver are targeted. In recent years, Professor Toyoshima et al. ‘S research group found that tissue stem cells are damaged in the intestinal tract GVHD and exacerbate the disease condition.
        Therefore, in this study, we investigated the injury of tissue stem cells in the skin, which is a typical target organ of GVHD, and investigated the influence of tissue stem cell injury on skin tissue. In addition, he tried to develop a new treatment method that can protect stem cells and maintain skin homeostasis, he says.
        Steroid external preparation is toxic to Lgr 5 + hair follicle stem cells
        In the study, skin stem cells were evaluated using mice in which genes were recombined so that Lgr 5 + hair follicle stem cells could be distinguished by fluorescent proteins. Bone marrow transplantation was performed on this mouse and the presence or absence of injury to the stem cells after transplantation was evaluated by immunostaining of the back skin of the mouse. As a study of the treatment, externally applied drugs were daily administered to the back skin of the mouse after transplantation and examined in the same way. In addition, as a functional evaluation of skin stem cells, analysis on hair regrowth and wound healing after transplantation was performed.

        Image released from release
        As a result, Lgr 5 + hair follicle stem cells were found to be injured by skin GVHD after transplantation. It was found that the decrease of Lgr 5 + hair follicle stem cells inhibited hair regrowth after transplantation and was also related to the delay of wound healing. Although steroid topical preparations had strong immunosuppressive effect, they showed toxicity to Lgr 5 + hair follicle stem cells after transplantation and could not maintain skin homeostasis, while the JAK 1/2 inhibitor luxolitinib gave skin GVHD In contrast, it is said that skin stem cells can be protected, and hair regeneration and wound healing can also be improved.
        From the results of this research, it is possible that some of these side effects may be related to injury of skin stem cells. The research group says, “As a topical immunosuppressive drug that can maintain skin homeostasis for luxo rethinib external preparation, it is considered that clinical application in not only skin GVHD but also various inflammatory skin diseases is possible”. ( Oda Masayo )

  15. All roads lead back to KAK.

    Aclaris researchers Right Now probably know IF it’s working OR not going to work. Bits been ~1 month.

    1. It takes 6 months to know if any other treatment is working…why would Alcaris be any different? Do JAK Inhibitors work that fast?

  16. I’ve prescribed cyclosporine for numerous patients (never related to hair loss) and have never noticed much in terms of increased hair growth. Sometimes patients will get some peach fuzz on their face, but I’ve never seen anything on the scalp. But perhaps this “related” compound will be helpful.

    1. Also realize that it takes 15 years for a drug to develop from an idea to something you can be prescribed.

      1. @ Anon Giant it can take 15 years, thats correct! Sometimes even longer. … But that involves Discovery and Research and Animal testing before getting into human Trials. We now offen have finished data from this preclinical stage and move into Phase 1 and 2 Trials. And furthermore we more and more find existing drugs which are already aproved for other Treatments. This and the delivery via topicals makes this whole reasearch quicker. Lets say only few years and not 15 years.

    2. @ Anon Giant I guess you did not prescribe topicals right? I think its the same issue what we see with JAK Inhibitors. Systemic versus topical with different delivery mechanism.

  17. Looks like the screws are getting turned on a better treatment for hair loss. These company’s know one of them are close and missing out on a huge pile of cash would be devastating to their future.

    1. They need to test this on balding dht stricken damaged hair follicles. If it revives those in 48 hrs then we got a huge game changer if not then I place it with the rest that are in trials and we will need to wait and see. I am pretty sure one of these drugs already in trials will bring us something good. As for this new wonder drug I’m not going to get excited until they say it reverses miniaturization on mpb men. I’ve seen to many breakthroughs only to get disappointed.

  18. I hope something comes from this soon. Id like just to see pictures, and data from this existing drug on male osteoporosis patients. The WNT pathway might be a big player in MPB, and if it works in 2 days who knows what results you would see 6 months or 12 months later.
    This could be big, and id like to see more research into why this works.

  19. I think at some point in the future MPB will broken down into different types. I think people with the itch are different than people without it. It might be a couple different causes of MPB where certain drugs work better on certain types

  20. If you think JAK is going to work buy Jan 2019 $25 options now for $1.70. We should know by then if it’s the real deal.

  21. Way 316606 already seems to be available to buy on the web. It’s pretty expensive but I wonder if it could be dissolved in k&b solution and the applied topically like ru58841. Someone please try this. Maybe I will.

    1. You have to be careful about mixing your own products. I have training and I would be cautious and desirous. If DMSO is the only solvent then this drug goes systemic and increase in side effects is possible. Do people know the concentration to make? Likely no.

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