JW Pharmaceutical to Begin Clinical Trials in 2024

Update: August 29, 2023

JW Pharmaceutical’s JW0061 Wnt-targeted hair loss treatment just got selected as the “first national new drug development project” in 2023 in South Korea. Additionally, the company signed a research and development agreement with the Korea Drug Development Fund (KDDF). As a results, JW Pharmaceutical will receive nonclinical research funding for JW0061 for the next two years from the KDDF.

July 22, 2023

JW Pharmaceutical’s JW0061 Hair Loss Treatment

I previously mentioned JW Pharmaceutical (South Korea) in my post on activating the Wnt signaling pathway for hair growth. The latter is also referred to as the Wnt/β-Catenin pathway.

JW Pharmaceutical’s JW0061 is a first-in-class drug candidate that promotes hair regeneration by activating the Wnt pathway in skin and hair follicle stem cells. However, the company is yet to begin Phase 1 clinical trials, so I delayed writing an entire post on them.

Previously, by far the most well known company that was working in this area of Wnt activation and hair loss was the much hyped Samumed (US). Unfortunately, it folded in 2022 despite completing Phase 3 clinical trials.

Also of note, another South Korean company named CK Regeon (previously CK Biotech) is working on a much anticipated peptide to restore Wnt/beta-catenin signaling and hair growth. This peptide is known as PTD-DDM or KY19382. It works by inhibiting the interaction between CXXC-type zinc finger protein 5 (CXXC5) and dishevelled (Dvl). Very different from JW Pharma’s mechanism of action (see further below).

JW Pharmaceutical Wnt Activator
JW Pharmaceutical Wnt Activator (JW0061) for Hair Growth.

JW Pharmaceutical to Begin Clinical Trials in 2024

Yesterday, a reader sent me a link to an update on JW Pharmaceutical’s patent application for its JW0061 Wnt activator product. Apparently, the company has applied for patents in over ten countries. They already got a patent approved in Russia in March 2023, and have now obtained a patent in Australia.

On JW Pharma’s website, the product is listed as being in pre-clinical phase on the pipeline page. However, in this latest article, there is an encouraging quote:

“JW Pharmaceutical is currently conducting toxicity evaluation according to Good Laboratory Practice (GLP) at global institutions with the goal of starting clinical trials of JW0061 in the first half of 2024.”

This is confirmation of an estimate JW Pharmaceutical also gave last year. According to a company representative, JW0061 will complement and replace existing hair loss treatments. JW plans to develop JW0061 as a topical drug.

Note that even as far back as 2017, JW Pharma partnered with U Penn and Dr. George Cotsarelis to develop this very treatment. It was at the time called CWL080061.

Activating the Wnt Pathway by Binding to the GFRA1 Protein

In November 2022, JW gave a detailed update on their website in regards to the mechanism behind JW0061 and its hair growth effect. This was based on a presentation given at the Wnt 2022 conference in Japan. See the enlarged image here.

It demonstrated preclinical efficacy for hair regeneration in mice. According to preclinical data, JW0061 activates the Wnt signaling pathway by directly binding to the GFRA1 protein in dermal papilla cells.

Wnt/β-catenin signaling is crucial for hair growth in any area of the human body. It is the most researched area in the hair loss world. I must have written at least 50 posts on this blog in which I at least briefly mention Wnt. Even wounding (such as from microneedling or fractional lasers) induced hair growth is connected to activation of the Wnt/Beta-Catenin pathway.

Some natural products such as methyl vanillate also activate the Wnt/β-Catenin signaling pathway and promote hair growth. Dr. John Cole’s company used to sell a Wnt Act spray on Amazon, but it is always out of stock these days.

32 thoughts on “JW Pharmaceutical to Begin Clinical Trials in 2024”

  1. Always good to see new potential treatments go into the pipeline, waiting for the day we see one come out of the pipeline. In the meantime we keep polishing the turd with the medical treatments that we have. In this sense, I’m considering changing my topical regime yet again. Does anyone have direct experience or informed feedback on either of these?

    Musley, more the woman’s as same as men’s with the addition of Spirolactone, both are very fairly priced, easy to access.

    https://www.musely.com/hair

    On the more expensive front, Powers Hair Solution, has some interesting, exotic ingredients, pretty costly though.

    https://get.agelessrx.com/powers-hair-solution/

    Can buy Powers direct from Ageless’ pharmacy (Superior) at lower price for 100ml, unfortunately they don’t ship to my state yet.

    https://www.superiorcompounding.com/health-news/hair-regrowth/hair-regrowth-serum-guide/

    I was leaning towards Powers, however four times the cost and unproven. Either way I think Musley is a good choice for many readers, it’s priced fairly, includes proven medications at decent percentages. Constructive feedback is welcomed!

    1. And this is a good thing, otherwise no resources would be allocated to stop it.
      You gotta love the profit motive.

  2. Every addition is great, that’s for certain.

    Won‘t follow JW though, the timeline is uninteresting to me. Almost 10 years of pre-clinical work (not talking about basic research) is neither convincing nor trustworthy to me.

    The same applies to CK Regeon. Nothing from that famous Professor for years and years except announcements.

    Also a reminder: Epibiotech soon enters their 9th (!) year of operation. Not a trial in sight. But a shitload of press releases and collaborations. I really hope they step up soon.

    Korea is very disappointing so far.

  3. Everything sucks since 1997 when propecia came out. That was the legit treatment that works. Everything else since then has been lies and false promises. I like amplifica since they are moving forward a bit quicker, usa based company and talked about on major news channels. I give this 25% chance of being the next drug to hit the market. Probably 2027 if it works. Those who know me on here know I am very pessimistic on hair loss drugs. 25% success is high on my terms since I think most of these hair loss companies are just startups looking for a quick buck.

      1. The most reasonable year is never. I’m not getting my hopes up. Any treatment that seems to have nothing to do with androgens or the AR receptors I am automatically skeptical on.

        Odds are this will be a dud like Replicel.

        1. What are you talking about lol? There are multiple potential ways to tackle hair loss, not just solely androgens and AR receptors lol. Do you not understand what ostepontin is potentially capable of? It’s a signalling protein that can reawaken the dormant follicles and like Plikus said, “You’ll have hair like you remember when you were 18” Are you sure you know enough to be commenting on this site or are you a troll? Genuine question. Breezula and Pyrilutamide won’t nearly have the effect that ostepontin could have, and GT20029 is only good for those who are just starting to notice hair loss as it’s a AR degrader but can’t reverse hair loss.

            1. Well it would depends on what you mean by dead follicles. Bald people have their follicles intact it’s just that the hair follicles aren’t getting enough/no signals which is promoting them to grow like they once did. However, if someone has suffered from chemical burns, burns, chemo than those hair follicles can be destroyed.

  4. Why don’t people just take Dutasteride and use minoxidil if you are nw 4 or 5 and under and go to some of the best surgeons in the world you can have a perfect hairline and appear to have a full head of hair as opposed to waiting for a cure. I think the problem is people go to cheap clinics and it gives a bad reputation for hair transplants with bad results. Some of the top surgeons are unbelievable for bringing hair back that looks like you never lost it.

      1. Who didn’t see that coming? Might have sexual side effects , not on everyone genius. Have been on them for over 25 years, guess my dick didn’t get the memo.

  5. The very best surgeons in the world a) won’t likely be in the country the person lives so will require travel and b) will likely be the most expensive (and many need more then one surgery to get the job done). People can barely afford groceries but you want them to spend 25-50k on travel and hair loss surgery lol. For most, that’s not an option. Obviously.

    Certainly one can find a good surgeon close by, but I can tell you from experience whatever price their website says is not the price (go in and get a quote and you’ll see) and prices are skyrocketing (demand). If you really want a good surgeon, you’re going to cough up quite a bit. And even then it’s not the cure all everyone thinks it is.

    1. 25 to 50k is a cheap price to pay to get your hair back if it bothers you. I’m going to a top surgeon in the world and it is between those numbers you quoted and I didn’t even blink an eye. I am not saying that with arrogance… I am simply saying to me it’s worth every penny of that to change my quality of life and get back my self confidence. In my opinion using medication coupled with hair transplant with the best surgeons we should be thankful that you can get your hair back. Would I like to take a pill or have a topical and be cured and never worry about hair loss again? Absolutely, but I think in the near future 5-10 years there will be maintenance solutions that help you hold on to what you have but the only way to bring your hairline back for the near future is surgery. And for the comment on making your dick go limp…. No problems here and I have been on 2.5mg oral Dutasteride daily and 5mg oral minoxidil for 12 years…not one issue

      1. I went to one of the top surgeons in the country (not the world but the US). And he was great. A good surgeon will be realistic and up front with you. If I remember correctly, he told me he believed I could get 5500 grafts out of my sides (don’t quote me on that). I had three other consultations and they all said something similar so I believed it. I did 3500 then a year later did another 1k. I didn’t do the full 5500 because I felt like my sides were getting too thin (I didn’t want to take more than that from the sides).

        Did it work? Of course. Gave me more hair, better coverage. Did it give me a full head of thick hair? Of course not. He never promised it would. Keep in mind the average person (who is not bald or balding) has 100k+ hairs on their head. People that thinks 3-6k grafts are going to make them go from totally bald to living the life isn’t thinking clearly (that’s not to you, just people in general).

        It did help and I’m definitely glad I did it but you’re right in that the struggle isn’t over. You’re still fighting genetics. And you can still continue to lose hair. They claim you can’t lose the transplanted hair because it’s from your sides, but that’s a lie. I’ve known several people that have lost some or even all of the implanted coverage over time.

        So yes, it can be great. Really great if you’re only somewhat balding. But if someone is in an advanced stage, they’re going to need WAY more grafts than they think. Several surgeries. They don’t go as far as people think they do (not all even survive).

        So I guess it all depends on your situation. My last point is that what you’re seeing from the surgeon and his website is the best case scenarios. Many have so so results but you’re not going to see those (not from your surgeon, that’s for sure). And again, we’re the lucky ones but the average person doesn’t likely have 50k for hair surgery. It is worth it, like you’d said – if you have it to spend.

        Good luck – sincerely.

        1. I agree with everything you said there…. If you are NW 5 or 6 you have to be realistic but can still get a solid hairline to frame your face. Nw 3 and 4 can get a huge benefit coupled with maintenance medication. I think the key is finding a surgeon that can do more with less grafts so you can keep grafts in the bank. In my opinion there isn’t a better surgeon in the world than Dr Konior. He can make 2,500 grafts go further than most using 4000 grafts. I have buddies that have had work done from him and it looks like they haven’t lost a hair on their head with perfect hairlines. Now again these guys were NW3-4. Most solid surgeons will give you solid density and great hairline in front that transitions to the look of a thinning back but still good coverage which is very age appropriate for guys in their 40s. That coupled with maintenance medications is really what I’m personally after until something new comes out.

        1. Only have progressed to nw 2.5 to 3 strong frontal forelock still and solid crown. I’m 35 and my dad is NW 6 and my brother is 38 and is nw4. It has definitely kept things at bay.

  6. I’ve only been on oral minoxidil for 1 year but finasteride for 10 years and Dutasteride for 2 years. Oral minoxidil definitely thickened up my hair on my head and makes it grow faster. I have had an increase in body hair but that doesn’t bother me. In my opinion Dutasteride coupled with oral minoxidil is the strongest stack out there. I have extensive hair loss nw 6 and 7 in my family but with this stack I’ve only advanced to NW 3 with no crown loss and am 35 years old and started thinning at 22.

          1. Better start poppin that dut everyday boys, or at least add topical dut to that stack. Just my opinion, depends whet you’re trying to achieve. Everyone has to do what they’re comfortable with.

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