Alopecia Clinical Trial Forecast For 2023
An overview of treatments for pattern baldness and alopecia which will be in the clinical trial stage during 2023.
Androgenetic Alopecia Reversal (Triple Hair)
Androgenetic Alopecia Trials
Chong Kun Dang Pharmaceutical – We begin the list with a newcomer, previously unannounced. CKD-843 is a new injectable drug being trialed in “alopecia” by the Chong Kun Dang (CKD) Pharmaceutical company of Seoul, South Korea. Interestingly, the CKD-843 candidate is not yet listed on CKD Pharmaceutical’s pipeline page, however, we can gather some information from CKD-843’s clinical trial listing. The phase 1 trial testing for safety, pharmacokinetics, etc. indicates that there is some new/novel substance involved. The disease condition is vaguely listed as alopecia, yet the inclusion criteria mentions “those diagnosed with androgenic alopecia”, and the exclusion criteria mentions “alopecia areata”; thus, we can be sure this is a treatment for pattern hair loss or AGA. Finally, the administration method is noted to be through injection. Could this indicate that CKD-843 is one of Inventage Lab’s long lasting nanoparticle injections? Interestingly, Inventage Lab and CKD Pharmaceutical just announced a joint collaboration for an injectable dementia therapy. Yet, the Inventage Lab pipeline shows that its finasteride injections are partnered with Daewoong and Withus Pharmaceutical, only. This may further point to CKD-843 being a new compound; and you know how we love new compounds. In any event, CKD-843 is an interesting development worth following. Update: It was shared in a Money Times article that CKD’s therapy is a long lasting form of dutasteride injection. So, the treatment turned out to be novel, but not quite new.
Kintor Pharmaceutical – Kintor Pharmaceutical boasts clinical trials for AGA for two drug compounds, in two geographies, in both males and females, for a total of 5 clinical programs. Phew. Below is a brief outline of what we can anticipate from Kintor in 2023:
- KX-826 China (male) – Ongoing enrollment in a phase 3 trial. Announcement of completed enrollment is very possible in 2023. If successful, 2024 is a reasonable estimate for market approval.
- KX-826 China (female) – Announced positive data from a phase 2 trial in Dec 2022. Phase 3 trial can be expected to begin in H1 2023.
- KX-826 USA (male) – Completed phase 2 trial enrollment in Aug 2022. Data readout expected in 2023.
- GT20029 China (both) – Announced positive safety data from a phase 1 trial in Nov 2022. Phase 2 trial expected in 2023.
- GT20029 USA (both) – Completed enrollment and dosing in a phase 1 trial in Oct 2022. Data readout expected in H1 2023.
Hope Medicine – One of the internet’s favorite candidate therapies at the moment is HMI-115 from Hope Medicine. An un-updated clinical trial listing for a phase 1 trial of HMI-115 in Australia estimates that the study may continue through all of 2023, yet we will only know if this is accurate once the listing becomes updated. After a press release in January 2022 indicated a phase 2 US trial was imminent, it remains possible that Hope Med could pursue that route in 2023, although, it’s perhaps unlikely now with the Australian trial in progress.
TechnoDerma Medicines – TDM-105795, a new small molecule therapy for AGA, was estimated to complete its phase 1b dose-escalating study in October 2022 in the US. The TechnoDerma Medicines pipeline shows a phase 2 trial expected to start in Q1 2023.
Cutia Therapeutics – CU-40101 is another new and slightly obscure molecule which has recently entered a phase 1 trial in China. The study is estimated to complete somewhere near mid 2023 and it’s likely we would get a safety readout by the end of this year.
Dermaliq Therapeutics – The first patient in a phase 1b/2a clinical trial for DLQ01, a topical F2a analogue, was dosed in December 2022. The trial is estimated to run through 2023, but it’s possible that with fast enrollment the study could be completed by year’s end.
Follicle Pharma – A phase 1 trial of FOL100 began in October 2022 and is expected to continue throughout the year. FOL100 is a topical anti-androgen nanoformulation (either finasteride or dutasteride) which is being studied against 1mg oral finasteride.
Epibiotech – In December 2022, Epibiotech applied to the Korean Ministry of Food and Safety for an IND to begin a phase 1 trial for its cell therapy EPI-001. Epibiotech’s cell therapy culminates an array of research into dermal papilla cells and culturing techniques, and is one of the more interesting therapy candidates in the industry. Epibiotech expects to begin a phase 1 trial in H1 2023, if granted by the Korean authorities.
Moogene Medi – HUTERA is an advanced topical dutasteride therapy involving nanoparticles and an ultrasound/sonoporation delivery system. It is designed to increase the efficacy of the active drug and limit its frequency of application. In 2022, Prof. TJ Yoon, CEO of Moogene Medi, told Follicle Thought he expected to begin a clinical trial for HUTERA in H1 2023.
Shiseido/RCH-01 – Despite an ongoing dispute with the licensors of the RCH-01 cell therapy, Replicel, Shiseido appears to still be engaged in a pivotal multi-injection clinical trial of RCH-01 in men and women. The trial, which enrolled its first patient in December 2020, seeks to enroll 36 total participants. It’s quite possible the trial will conclude sometime in 2023, with data to follow.
Triple Hair – The TH07 combination includes topical finasteride, minoxidil, and latanoprost. After a few years of organization it seems likely that a phase 3 trial of TH07 in AGA will take place in 2023.
Eirion Therapeutics – In an October 2022 press release, Eirion mentioned that they planned to file an IND for their hair growth drug ET-02 in Q1 2023, with a goal of beginning a phase 1 trial shortly thereafter. It’s likely that a phase 1 trial for ET-02 will be initiated at some point in 2023.
OliX Pharmaceuticals – In late November 2022, OliX issued a press release which stated that the company “planned to submit a Human Research Ethics Application (HREA) for Phase 1 clinical trial” by the end of 2022. A phase 1 trial is likely to occur in 2023.
Alopecia Areata Case Study
Alopecia Areata Trials
Concert Pharmaceuticals – After the successful completion of its second phase 3 trial, THRIVE-AA2, Concert Pharmaceuticals intends to submit a new drug application (NDA) to the FDA in H1 2023.
Arcutis Biotherapeutics – In December 2022, the first patient was enrolled in a phase 1b trial of ARQ-255, a topical JAK1 inhibitor known as ivarmacitinib, for the treatment of adult alopecia areata.
Equillium – A phase 2 trial evaluating EQ101 in adults with alopecia areata in Australia is expected to complete around November 2023.
Zelgen Biopharmaceuticals – Zelgen is developing a proprietary JAK 1/2/3 inhibitor called Jaktinib. The company currently has two separate phase 3 trials for severe AA, and a phase 1/2 study of a topical version of Jaktinib in mild to moderate AA, ongoing in 2023.
Pfizer – Two drugs for AA are active in Pfizer’s pipeline, etrasimod and ritlecitinib. An estrasimod phase 2 trial is expected to complete in June 2023, with data likely to follow by the year’s end. A long term ritlecitinib phase 2 trial will be ongoing through 2023. Additionally, a phase 1 trial of low dose ritlecitinib in children 6 -12 years old will begin in January 2023.
Legacy Healthcare – A phase 2/3 pivotal trial of topical LH-8 in pediatric alopecia areata was completed in late 2022. In January 2023, Legacy announced positive trial results through a press release.
And as always, there are potentials for new drugs for both androgenic alopecia and alopecia areata to emerge directly into clinical trials in 2023. To stay on top of the latest pipeline updates for AGA and AA in the coming months, simply search for “hair regeneration” or “alopecia areata pipeline” in your browser’s URL to find Follicle Thought’s two dedicated articles on those subjects which will be updated throughout 2023.
Thank you for reading Follicle Thought, let’s hope to see significant progress in 2023!
Eirion said recently they are applying for IND start of this year and are hoping to start phase 1 clinical trials half way through 2023 for their et-02 product. Not sure if that is worth a mention or not but I personally am hoping they start to take off this year.
Good one Andy, will add! I hope they stick to their plans and file the IND soon.
FT, do you think Eirion will do the grey hair and baldness trial simultaneously since they’re using the same compound?
Manu, I believe they will only do one at a time, and probably hair growth to start. However, I imagine they will find a way to observe a pigmentation effect. And if it does work, the gray hair use is really not far behind because if the drug became approved anyone could get a prescription for hair loss and use it for pigmentation.
Thanks!
Dermaliq therapeutics also started a phase 1b/2 trial recently
Thanks! There’s so many companies in trials these days.
I want more info on moogene medi
Ryan, please see link in Moogene description to Follicle Thought article, it contains an interview with two company officials.
High effort post, thank you so much for your work, so many irons in the fire, shame they’re mostly early phase though…
Thank you for noticing LJ.
Amazing post. Appreciate all the time it takes you to thoroughly research and consolidate the information in bite size chunks for the unscientifically minded plebes like myself. Fingers crossed for a breakthrough sooner than expected 😉
Prince Harry took a jab at Williams hair loss. If hairloss is such a concern why don’t you help find a cure or bring more awareness to the issue instead of low blows
I happen to know prince Harry very well and will be sure to pass your disparaging remarks along to him.
What do we think has the best chance of coming out in 2023?
For clinical therapies, nothing new for AGA will be out in 2023. The closest is KX-826 in China, it may be nearing approval towards late 2023.
Thank you for the write up admin. I like these overview posts as I keep losing track of which initiatives are out there.
Great summary Admin, cool to see all the treatments that are currently in process.
What I wanted to mention, is that the Hope Medicine trial is supposed to end in April 2023, at least according to participants.
It was also mentioned by the guy sharing his expiriences on reddit, that the US phase 2 trial is waiting for the conclusion of the Australian trail before starting, but I, of course, can’t confirm if that is true, but still some interesting info maybe
What about CosmeRNA? Any news? Do you think HUTERA could be available in 2023?
HUTERA could be available in 2023, but it’s probably a coin flip, not guaranteed. I will have an article about CosmeRNA in the next few months, still awaiting for the company to be ready.
Hello, administrator, as a patient in the early stage of hair loss, I am very much looking forward to the marketing of CosmeRNA, because I think it is possible to use CosmeRNA to keep my hair after using finasteride and minoxidil to grow it. Although CosmeRNA has not shown excellent results in growing my hair, it is really great in terms of its mechanism of action. I hope it can keep my hair for a long time. Also, I’m also looking forward to the listing of KX-826. Although it may have systemic side effects and drug resistance, after all, there are too few choices for us in the field of AGA, and no new drugs have been listed for more than 20 years. However, as far as I know, the phase III clinical trial of KX-826 has not been registered, and recently kintor seems to be in trouble. Because too much money has been spent on the development of COVID-19’s specific medicine, and COVID-19’s specific medicine seems to have encountered difficulties in approving it, kintor’s funds are a little tight at present. It has already carried out two stock placements within half a year, and the stock price has been falling, and the trading volume has been decreasing, which seems to be neglected. In addition, in these two stock placements, the senior executives have repeatedly reduced their holdings of kintor’s shares, which leads to investors’ great disapproval of them. I think they are a dishonest enterprise, so it seems that kintor has encountered difficulties at present. I hope they can persist and successfully develop KX-826 and GT20029.By the way, I wonder if you have the latest news of CosmeRNA to update. When will it be available?
Hi, yes I mentioned in another comment I will be covering CosmeRNA as soon as I can. Sometimes a company’s estimate of release is delayed a few months; it will be coming.
Great work admin, this is a Herculean post packed with top quality info. This is without a doubt the number 1 website to keep up to date with everything in the hair loss world. Let’s hope we receive some fantastic news this year💪
Thanks for that acknowledgment BearlyEagle, I appreciate it.
Happy new year FT and thanks for all the updates. Its great to actually be able to come back to this article and see the current research that’s going on.
Have you heard any updates on that SULT1A1 minoxidil booster that is on the way? Last I remember they said Q1 of 2023. I understand there is a Daniel Alain version available but requires you buy his minoxidil with it.
Big Kahuna, Happy New Year. Yes, there was an update that the minoxidil booster will be licensed by companies in Asia, so Daniel Alain is probably the best bet. Please scroll down the Updates page to September.
What happened to Follica? People are having great success following their patent protocol, even though it’s not possible to replicate it perfectly. It’s absolutely ridiculous that after two decades of research and multiple phase completions (what was their last one? II-C? II-D? I’ve never heard a trail with so many phase two chapters) that it hasn’t progressed. It should have come to market last year.
Though gutted that there is no mention of stemson therapeutics , I find comfort in knowing that hope medicine is finally going to cure prolactinogenic alopecia
Follica wasn’t mentioned in Puretech’s 2022 activity report, I saw someone query this with them on twitter but they didn’t respond…
Hey Admin, noticed no mention of Cosmo’s Breezula here. Any idea what happened to their Phase III trial scheduled for H2 22′?
Thanks for the write up!
DueDiligence, thank you. I don’t know what the status of Breezula is, have not seen activity lately. I expect we’ll find out this year.
Any update for Sirnagen admin?
Isn’t their product launching this quarter in europe?
Hi Peterson, I gave some feedback on Sirnagen/CosmeRNA in two comments in the thread, please see.
Does anyone know anything about when Mane biotech are planning on unavailing their device?
From their website it’s closing the early bird sign-up offer on the 14th of January.
Maybe close to then they’re planning on showing it off?
There was a little report of a study participant of Mane on a german hairloss forum a few days ago & aside from sharing a bit about the expirience, he claimed the offical launch should be around April. Of course, nobody can tell if that’s true or not or if they will start even earlier (the study itself has been over for quite a while so there is no way the guy knows thier current plans)
New study admin!
https://www.leicestermercury.co.uk/news/health/baldness-could-soon-cured-after-8008513
Thanks Peterson, I saw this but somehow I feel it’s a fake article. The gene study they seem to be referring to is very mysterious and not listed in the article.
Update: Not a spam article actually! Here is the link to the actual study they are referencing https://elifesciences.org/articles/76911
Wow thanks for the answer Cygnus.
Do you have a link to the forum? Would be a nice read.
The link was posted in the previous article’s comment section (HairDAO) to a Reddit thread, Skye.
Must have missed it. Thanks Admin
Hi Admin, thanks for providing this useful update as we head into 2023.
When you mentioned Kintor Pharma’s Pyrilutamide, for their Phase 3 drug, you said that they’re currently enrolling for this clinical trial. Kintor mentioned that enrollment would be completed by June 2022, in their press release once this clinical trial was initiated.
https://en.kintor.com.cn/news/202.html
Based on that, it seems that this trial will be complete before end of Q1 2023. What are your thoughts on that?
Keep up the good work!
Thanks Chatbot. In this case I believe I was correct. The estimate Kintor released last January is no longer accurate. In Kintor’s most recent press release they mention they were still enrolling for the phase 3 at time of release.
Found this comment about Cosmerna.
“Here’s some updated news – I have a friend in China and I’ve seen online that investors have said kintor is delaying phase 3 and phase 2 usa for late 2024 due to the covid outbreak effecting China once again. I’ve also emailed cosmerna June park and she told me they are planning to release cosmerna in 2025 as a pharmaceutical as they once again didn’t get approval by EU government.”
Have you heard anything about those admin or are these just random comments?
The CosmeRNA comment is complete nonsense, so I would not be surprised if the other part was, too.
Thanks for the clarification Admin. Has a feeling the Cosmerna one sounded wrong. Interviews with June made it seem like the EU have already given approval.
Wouldn’t have been a great start to 2023 that the first release and potential clinical release would get delayed.
In fact, I am from China, and we are not seriously affected by COVID-19. Moreover, the website of siRNAgen shows that CosmeRNA will be commercialized in 2023.https://www.sirnagen.com/program
Thanks Hope.
Really should have learned not to trust anywhere but here.
The admin really does some great work to keep everything accurate.
Hi everyone, until further notice I’m asking everyone to refrain from posting links or discussing Mane/NioS on the site. At this time it is my preference and request, that’s all that will be shared on the subject. There are no current plans to cover this topic on Follicle Thought. Thank you for your cooperation.
You guys think Stemson is a bust? Odd how no news has come out, not even an update. You would think if great progress was being made they would have an official statement?
Happy to hear other’s thoughts on George’s question as well, but my perspective is that they are working on a very ambitious project and it feels normal to me to only get an update from them around once per year until something big happens. Their goal is similar to climbing Mt. Everest, it’s not necessarily a project which gets an update every quarter and boom they are done in 2 years. Still, I always leave room for good possibilities. By the way, Geoff Hamilton just gave an interview in October 2022 where he was quoted to say “We’re trying to get our first product into clinic, which is an autologous cell therapy-based approach to bioengineering hair follicles….it’s probably going to be at least a couple of more years before we feel we’re really ready.” https://www.scienceboard.net/index.aspx?sec=cgt&sub=def&pag=dis&itemId=4909
George they can’t supply us with new data every other month, what they’re working on is complicated. They probably don’t feel the need to give updates until they deem something major enough to share with the public. But to share this, there’s clearly positive developments… https://www.linkedin.com/posts/allan-dovigi-aa962389_i-continue-to-provide-surgical-pathology-activity-7013899232692637696-ahU_?utm_source=share&utm_medium=member_desktop
Thanks yo-yo I always look to your comments regarding stemson. The odd thing is this is big news so why not share it officially? Maybe get some investors excited.
I never heard of any company growing these types of smaller hair structures before.
I really want every company to do well, but I’m thinking stemson might be ways away? Really hoping by 2030 they have something for market but with such little news doesn’t seem so
No worries George. In my opinion it all depends on where they do the clinical trials, FT did an interview with Geoff and he expressed how he is interested in doing clinical trials outside of the States. If it’s done in Australia, Japan, South Korea the process can be moved along much faster compared to the FDA. And if they start Clinical trials this year or the next who knows how fast the process can move along.
But if you look at the history of news from Stemson page they usually release 2 updates on the company per year
I read on the Internet the work of some scientists who say that the consumption of energy drinks and sugary coffee and tea, artificial juices, cause hair loss by 40%
Article was updated with one new morsel of information: Chong Kun Dang’s injection will be a long lasting dutasteride injection. It was revealed in an article which compares it to Daewoong’s long lasting finasteride nanoparticle injection. https://news.mt.co.kr/mtview.php?no=2021041914040549945 Thanks to Tigris.
Seems like a waiting year. Frustrating, but it genuinely seems like we’ll have something big by 24 or 25. Thanks for your hard work FT.
Thank you C.
https://www.cell.com/trends/biotechnology/fulltext/S0167-7799(22)00348-1 Very cool read for those interested.
Interesting study indeed! thanks Yoyo. What are the odds that some of that info is from Follicle Thought?
Update: Nevermind, just saw that FT is cited in the Resources section of the article! That’s a first for me. Thanks very much to the authors of that study.
Lol as you should for all the work you put in!
Thank you, thank you.
By the way, a new image of CosmeRNA was just posted to the Updates page.
Great to hear! Even if it’s just a maintenance product it’s good to see a new release that is based on sound science is so close.
Hi new update by moeman on reditt
Hi ft
There is an update in epibiotech section. They are developing an antibody. Looking forward for an update from you as it is not much comprehended.
Hi Gurvinder, thanks for asking. Previously, it was stated by Epibiotech that they were developing an antibody treatment for alopecia areata around March 2022, however, this recent news update points to the fact that they are also researching antibodies for pattern hair loss. So, it seems the two companies will be using AI to find new antibodies to treat hair loss with. There will be time involved, but it seems like a good development, especially with all the talk about Hope Med’s antibody.
Thanks YoYo for the article, I swear beside FT I look for your comments about good news lol
I appreciate the kind words George but I don’t do anything special it’s all FT lol
I appreciate the credit YoYo, and I will say that your positive and valuable contributions in the comments are greatly appreciated.
Thanks FT 👍🏼, btw they’ve added yet another on the Stemson team, (and she’s a nerd lol) looks like they’re moving in a positive direction thus far.
Hi. And what about Amplifica? They were saying that scube3 is couple years away from clinical trials but at the same time they have some other molecules that will enter human trials in 2023.
Hi Bogdan, yes it’s possible they can make it to a trial, but they’re still pre-IND I’m pretty sure, so they didn’t quite make the list. Eirion just barely made the list, for example. Aneira Pharma (another one most people will say “oh yeah what about them”) is another company which could make it to a trial this year, but they’ll need to prove it.
Also, good timing Bogdan. There is a new Amplifica update on the Updates page.
FT when will we see an oral drug that regrows a nw7? Back to nw1? Will you be be posting anything on hair cloning soon or veterporfin? Thank you FT
Woofy, an oral drug that turns nw7 to 1 is a fantastic concept, but I don’t know when that would come. Maybe around 30 years from now? I will post anything on hair cloning or verteporfin as the news comes in, but nothing planned at the moment.
Something like that Woofy sounds like something in the very far future, that does sound ideal however lol
Sounds good FT. You know I get ahead of myself hahaha that would be amazing. Yeah yoyo far future 🙁
Serious and I don’t mean to be kill the vibe but By the time stemson releases there hair cloning im not going to cry happy tears. I’m going to cry tears because of how much time they took to come to market. By the time the cure comes I’ll be too old. And I’ll never find anyone because of this hairloss. I have no confidence and I didn’t go through with the hair system as I had a panic attack. Maybe I’ll try again soon but right now I don’t know what to do. I can’t get a transplant nothing. I want to get on lexipro SSRI to help with my anxiety and negative thoughts but I was on Prozac in 2012 or 2013 I don’t remember having any hair problems but when I hit 17 in 2014 I had a receding hairline after that it got worse from 2015 was alright until November 2015 in late 2016 i noticed really scary thinning and shedding after showers I got off Prozac completely. Shedding and hair loss continue through middle of 2017. That’s when I saw Dr Bauman and I got on finasteride.None of my family when bald at 17 or 20s. They went bald 30s or 40s idk. It doesn’t make any sense! I have lots of regrets its incredibly difficult to think about. If I just got on it sooner I would have a better quality of life. I’m having a hard time determining if Prozac was the trigger or purely genetic. All of my family members want me to get help but I can’t help my mental health because I don’t want lexipro to cause hair loss. I don’t want anymore hair loss 🙁
The hardest part I’m dealing with is that I can’t determine if Prozac triggered telogen affluvium which then trigger premature AGA. Maybe if I didn’t go on Prozac I wouldn’t be bald yet that’s just my thought but I don’t know for sure. I know lexipro would be beneficial for me and probably life changing but I’m fucking afraid to get on it. The reason didn’t do the hair system is because I know live like 8 hours away from that hair system place and it would be practical to go back and forth to get maintenance done and also I was worried about him shaving down the sides of my head and also the color matching was a concern
I would say to try and get help Woofy, it won’t do you any good if you don’t try to help yourself. But what I will say is that I wouldn’t be too down on the future, especially in the next year I feel like we’ll get some good news from Stemson regarding future clinical trials. Don’t believe the pessimists who say nothing will come out within the next 10/15 years, it’s mostly from individuals who have lived through the 90’s and 2000’s and refuse to believe that the future is advancing both in terms of science + technology. I whole heartedly believe that within this decade we’ll have something revolutionary. There’s also Yokahama, Epibiotech, dNOVO (though this one is still very early). Have faith that things will turn out for the positive.
First, you need to know that there are many people who lose their hair early in their teenage years. am one of those and I went and probably still going through the same. Am not saying to lose hope but life can be hard and sometimes you need to face your fears and say f**k balding am going to live anyway and am going to live happily.
1. You will find someone – not all partners care about looks, some care about personality, mindset , morals, intelligence … , bcz that’s what actually matters eventually .. love your own company and enjoy living independently it will just make you stronger- and then if someone come along the way then perfect if not then f**k it! you have YOU – your best friend
2. No one said you cant look handsome bald.. having hair helps but you can still be a badass balding male by wearing nice clothes , doing weightlifting, or even martial arts like jiu jitsu which all can build up your confidence
3. By all means don’t make a tradeoff between your hair and your mental health – if you think you need help you should seek it by a trained physician. I have regrets about not acting on my hair loss earlier but there is no way we can go back in time so just forget the past, it happened . Hope is your best defense against regret. I suggest you listen to Andrew Huberman channel on youtube (he gives actual tips on how to deal with stress and all mental issues and others in a practical way- he proposes supplements that can act like antidepressants ..) but no youtube channel will help if you don’t change your mindset. I hope you feel better and good luck 👍🏽
[…] Thought has mentioned TDM-105795 in its previous alopecia research pipeline summaries, here and here. It’s always encouraging to see the advancement of a novel therapeutic candidate for AGA. […]