Alopecia Areata Treatment Pipeline 2023
In this article we will cover the most prominent therapeutic candidates in the alopecia areata treatment industry in 2023.
Frontrunners To Market
In June 2022, Eli Lilly/Incyte received the FDA’s first ever approval for a systemic treatment for alopecia areata with their drug Olumiant. Alopecia areata, an auto-immune disorder which results in patchy and sometimes total hair loss, differs from “common” hair loss or pattern baldness which is driven by androgen sensitivity. Prior to this FDA approval designation, baricitinib was previously an FDA approved drug for other conditions and was prescribed off-label for AA.
Just days ago, Pfizer announced that its candidate for alopecia areata which has received “breakthrough” designation by the FDA, , ritlecitinib, met its endpoints in a phase 2b/3 study. Because of the breakthrough designation, Pfizer will be able to use data from the phase 2b/3 and from an ongoing long term study of ritlecitinib to file for FDA approval in the near future. Concert Pharmaceuticals has also reached a phase 3 trial for AA.
Alopecia Areata Pharmaceutical & Biotech Therapies In Development
AnaptysBio – Rosnilimab or ANB030 is a Anti-PD-1 agonist. It is currently being evaluated in a 45 patient phase 2 clinical trial in moderate to severe alopecia areata. Rosnilimab is administered through subcutaneous injection. The phase 2 “AZURE” trial is expected to produce clinical data in Q1 2023.
Arena Pharmaceuticals – Etrasimod is an oral selective S1P receptor modulator. It’s currently at the phase 2 stage for AA in Arena’s pipeline. It appears the company is looking for a commercial partner to initiate a trial with.
Bioniz Therapeutics – See Equillium.
Concert Pharmaceuticals – CTP-543 (deuterated ruxolitinib) is an oral inhibitor of JAK1/2. A phase 3 trial of CTP-543 was initiated in November 2020 and the company expects to report topline results in 2022.
Eli Lilly/Incyte – Baricitinib is an oral inhibitor of JAK1/2. It has completed two successful phase 3 trials and a new drug application is expected to be filed by the end of 2021. In June 2022, baricitinib became the first drug candidate to receive FDA approval for the treatment of severe AA.
Equillium – EQ101 is an IL-2/9/15 antagonist. In November 2022, Equillium announced the initiation of a phase 2 clinical trial of EQ101 in adults with moderate to severe alopecia areata.
HCW Biologics – HCW9302 is an IL-2-based immunotherapeutic being developed for AA. HCW’s pipeline page currently lists the program as currently working on IND-enabling studies for HCW9302. This means that when those studies are complete, HCW can bring this drug into FDA clinical trials.
Horizon Therapeutics / Q32 Bio – Bempikibart (formerly ADX-914), a partnered program between Q32 Bio and Horizon Therapeutics, is a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function by blocking signaling mediated by both IL-7 and TSLP. In September 2023, the companies announced the initiation of a phase 2 clinical trial for bempikibart in adults with severe AA. Horizon Therapeutics also has listed in its pipeline daxdilimab, which similarly is a fully human monoclonal antibody against ILT7 that depletes certain dendritic cells. Daxdilimab is currently undergoing a phase 2 clinical trial in adults with moderate to severe AA which is expected to complete in 2024.
Legacy Healthcare – LH-8 or Coacillium is a botanical compound intended to treat pediatric alopecia areata. The company has announced positive results from its phase 2/3 trial for children and adolescents with moderate to severe alopecia areata, on its website. Subsequently, Legacy has applied for marketing approval which is currently under evaluation by the CHMP in Europe.
Nepsone – A preclinical-stage pharmaceutical company developing a topical and novel treatment for AA.
Pfizer – Ritlecitinib, an oral JAK3/TEC inhibitor, is Pfizer’s lead candidate for AA. The candidate has successfully completed a phase 2b/3 trial in August 2021 and a new drug application may be filed by Q1 2022. Pfizer also has an oral TYK2/JAK1 inhibitor, brepocitinib, in its pipeline for AA. Brepocitinib is listed at phase 2 but not currently enrolling for a clinical trial.
Reistone Biopharma – SHR0302 is an oral JAK1 inhibitor with high selectivity, according to the company’s website. A phase 2 trial with 94 participants was recently completed in July 2021.
Serpin Pharma – SP16 is a novel peptide therapeutic aimed at resolving inflammation. Serpin’s AA program is listed at proof of concept.
siRNAgen Therapeutics – A silencing-RNA therapeutic company with alopecia areata listed as a target in its pipeline. (note the pipeline listings have changed since this was written, however AA is still likely a target for this early stage company.)
Soterios Pharma – STS-01 is a non-steroidal topical treatment for mild to moderate alopecia areata. A phase 2 trial for patchy AA completed enrollment in November 2023. The company’s website indicates that STS-01 does not involve JAK inhibitors.
TagCyx Biotechnologies – Developing a nucleic-acid based therapy for AA which is currently listed at the preclinical stage. A highly interesting additional tidbit, Cage Bio Inc. is listed as a partner for the AA program in TagCyx’s pipeline. Cage Bio is a startup developing a novel technology which limits the systemic exposure of liquid formulations. This could be highly useful in the androgenic alopecia industry as well, for example, even in conjunction with established drugs like finasteride.
TIGO GmbH – A biotech company developing IFN-y receptor antagonists with AA as a highlighted indication target. The company is seeking strategic partnerships for their programs.
Zelgen Biopharmaceutical – Zelgen’s pipeline lists an oral JAK inhibitor for severe AA and a cream JAK inhibitor for mild to moderate AA.
It’s good to see so many new potential players working to find cures for alopecia areata, particularly a few outside the realm of JAK inhibitors. Please share this information and hope with those who you think would benefit from it.
Please share your feedback about the pipeline.
What’d you guys think of Cage Bio?
Have you heard anything in regards to thronebio?
I have not, but thanks for pointing them out.
Any of this interesting for mpb?
Adrian, not so much. Please check the Ultimate Guide to Hair Regeneration article for pattern AGA treatments.
Hi. I also have been following this site for over 8 years, and despite all the so called new technology being employed in the hope of treating male pattern baldness, it still seems in reality that no pharma company is even close to producing a treatment showing any efficacy in human beings. Disappointing to say the least. The only real option available for some is SMP.
You’re a legend for following this site for over 8 years.
It’s only existed 6 years.
Condolences to your disappointment, but if you have been following along like you say you’ve noticed we are on a journey. There have been letdowns for sure, and also there have been many, many new players trying to cure MPB from different angles. In response to your statement about pharma companies and efficacy, that’s an exaggeration and inaccurate. Breezula has efficacy and Follica has efficacy, even if not game changing. IMO what’s more promising is the ever-expanding list of new treatments based on stronger science.
The 6 year legend comment is pure gold!
Thanks Keith!
Follicle thought, cant understand why u got so offended from J.Kirk.
i guess he’s following hair loss news for a long time, and he has been following your site the most. (and in my opinion this is the best site for hair loss news) and that’s why he got confused. and well I can relate, all hair loss sufferers are following hair loss sites forever.
I do agree with him that the bottom line is, in 2021, there s nothing but minoxi and propecia (and SMP)
i have been following hair loss news since 2009, today i am 30 years old, and all the promising drugs i have been waiting for (the 5 years spell) never came out.
and as u can see, 2021 is about to end, with no drug about to be released, Only empty promises.
Updated response: It’s not always about the content of the message, fiveyeardrug, it has to do with context as well. Main issue is there was another comment before his which was very negative from a guy who just randomly chimes in his misery and kirk thought it was worthwhile to jump on the bandwagon of negativity. I understand that Kirk’s frustration and complaining wasn’t necessarily directed at me, however, it comes across as disrespectful (at times) when members want to jump right in with a rant/vent and make no mention of appreciation to the work that goes into tracking the news. My response was intended for both Kirk and the previous troll, and thus may have sounded harsh since the troll’s post needed to be removed.
I completely understand people’s disappointments in getting hopes up and then treatments not panning out, I get it. My advice to people who feel frustrated would be, either bear down and stay the path or perhaps decide it’s best to get away from hair industry news and get a buzz cut, etc. Finally, this article was about Areata, so the feedback really didn’t belong in first place. There is a lot of new research and companies TRYING, more than ever before.
In conclusion, I understand why you can’t understand, it’s because you don’t always get the whole picture, for example the comment from the troll which was deleted above his.
Well, if you looked at his name you’d realize that the Captain of the USS Enterprise can freely travel through time.
Oh wow very exciting stuff – we’re going to be a bunch of very hairy men soon!
but they bring out a Covid con vaccine poof just like that
Im still waiting for the day , that i would see
“Stemson lunching there hair cloning treatment the cure for hair loss is here”
The war is over…
This is like my dream hairloss effected my life mentally and phiscly so much .
That’s a good image to hold.
And yes, to clarify for others wondering about their comments, if you have no hope for these things, you should probably move on from hair related sites. The promotion of pessimism is not part of the mission statement here.
I’ve often wondered if my hair loss (general, patchy thinning) is alopecia areata. When I saw a private dermatologist, they suggested that it might be. With this in mind:
How would I go about trying baricitinib? Would it be worth it?
Are there any potential side effects that you guys know about? I know if I Google it, I’ll see loads of terrible side effects, but are there any genuine things to worry about?
@FollicleThought https://www.asiaone.com/business/hope-medicine-completed-us56-million-series-b-financing-strengthening-capabilities-global
It’s great news, looking forward to that phase 2 kicking off for sure!
Alopecia Areata is many aspects worse than AGA. I remember this kid who went to my primary (elementary) school who pretty much went bald over night. It’d be good news if they find a effective treatment/cure for AA sufferers.
@Follicle thought This is a very comprehensive article, good job admin.
Thanks Shayak. The AA crowd needs love too for sure.
I loved the tidbit about Cage Bio as well.
Hi everyone, does anyone know something about alm12845? They passed 3 phase and said that they will sell it in EU in 2021, but now is look like everything stopped.
https://blog.naver.com/hanbio_official/222440697553
interview with han bio. Studies will probably start soon, supposedly it could well be a cure. Please focus on it.
I’ll look into it Focus, thanks.
Admin,
I’m really curious about your opinion on the link Focus provided. I’m trying to temper my expectations for hair cloning but according to the article from the link, this company plans on trialing it soon (second half of this year according to article). If that is true, wouldn’t that make them closer to hair cloning than any company we’ve been hearing about until this point? If the article is legit I would think this would be big news.
Ok, so first off I would say there is a slight ambiguity on whether they are really working on “hair cloning” or they are doing some sort of cell injection similar to Shiseido or HairClone in UK. I do like their company, they seem to be closest to trial based on their projected timeline, so I hope the timeline holds up. I am trying to get more info from them now, hopefully I can.
Interesting.
But we’re all waiting for Biosplice’s (samumed) results
?
If Follica is re-evaluating their go-to-market strategy due to limited innovation, what do you think that could look like in the real world? Could they open up their own clinics and just try to beat out future competitors? Clearly they haven’t given up since they brought in an executive chairman and another board member in January. I’m really hoping they can somehow go to market in 2022 someway somehow.
It’s unfortunate that people are negative on the Follica results. I’ve been impressed. Nothing is a miracle, but it looks like this could definitely help some people who just need a tiny bit more coverage.
I’d love them to come to market as well. I’m just wondering what they’re waiting for, it seems like they could have started their trial by now.
This can work With AGA too?
@admin do you have any news about exicure?
Not at the moment..
Ok, thank you.
Admin or somebody knows Some thing about Th16? Now its avaiable for sale,, I received email from them
https://www.sciencedaily.com/releases/2021/08/210811162844.htm
New study which was published yesterday. These microneedle patches continue to be discussed as therapies for AGA. I don’t see this particular molecule having a great potential for humans, but I think overall approach definitely does.
The last part of the study disappointed me – when it says it has similiar efficacy of the leading topical for hair loss ( must be minoxidil ). It’s funny how they tried to tackle and solve balding from every possible angle and still there’s so little we can do about it.
Thank you admin for your work and for keeping things positive in here, we are already fighting this battle, there’s no need to fight each other
Yes, it’s true Shia, thanks. The next step would be how can be further the efforts to get things done? There are wealthy people who come here frequently, there are numerous people who come here frequently, but what are people willing to do to help progress come faster?
If it’s not broken don’t fix it. I don’t think there’s anything to do since you are doing a superb job as a moderator.
In the end it is our interest to be part of a community of people that comfort, help and share thoughts on what’s already here and what’s to come. It really does help me and my mental sanity to know that I’m not alone in this “tragedy” and that there are things being done to find a cure while I spend my days devoured by the fear of balding; and I think this applies for many ( if not all people here ).
So coming here and being able to comment in a positive and not toxic environment is pure gold.
Thank you a lot Admin, what you are doing is so precious you mignt not even fully realize it
I appreciate that insightful comment Shia. I’ve said before, generally speaking, people do not know how much they are valued unless they hear it/see it once in a while.
“An eye for an eye only ends up making the whole world blind”.
Mahatma Ghandi
Good point FT about this group needing to get more involved. Anyone here have experience running a nonprofit? Wouldn’t it be incredible if someone would start an AGA Association dedicated to raising money toward finding a cure? It’s kind of shocking that such an advocacy group doesn’t already exist. Or does it?
It would be incredible, yes.
There is no such functioning group for AGA at the moment, there is a group for areata http://www.naaf.org
To be successful I believe a group for AGA would need a founding businessperson with a good track record and a good strategy. There may also be an opportunity to create something for-profit, but either ideas are worth pursuing in my opinion. Who would be a good candidate to do it?
Random question to everyone….anyone here using brand name propecia? If so, where you buying it and how much for 1 month supply?
I use brand name Propecia, I got it prescribed by my dermatologist and I pay a little over 100$ per month with GoodRx.
Hey CT thanks. I pay the same 115. Are you having issues getting a refill? I went today and supposedly pharmacies in the philly area have it on back order from the manufacturer Merk. I went to cvs and Walgreens. Supposedly Merks sister company Organo is supplying it now. Did you have issues getting your latest monthly refill? Is your propecia from Merk or Organo?
Sorry Merk sister company is called Organon.
Hi admin,
Thanks for the update.
Would you know anything about kerastem advance therapy? It completed phase 2, but no news about phase 3.
https://www.prweb.com/releases/kerastem_publishes_successful_us_phase_2_hair_growth_clinical_trial_results/prweb17051434.htm
I don’t know much, it’s an adipose derived stem cell treatment which does not attract a lot of interest.
Oh I see. Thanks.
Lets just hope there are many positive updates soon.
hi , FT
Any update from hairclone . are they still in position to offer cell expansion service end of 2021?.
They are not, unfortunately.
AD kerastem is already available in europe and it also doesn’t work lol. Dont get your Hope’s up for it. It’s the past anyway. Be lucky we got hair clone, stemson to really bring us a treatment soon.
Just wondering is anyone going to give the TH-16 RIZN a try?? I didn’t know it was available already.
Yes, would any readers who are trying RIZN like a discussion page to share your progress and photos on?
LOL – if it ever arrives!
Pretty sure it’s already launched.
Who here is using RIZN?
They delayed shipping it. Been 3 weeks.
I see, thanks for the headsup I did not know. Please keep us updated.
Ohh I see. Thanks for the update! Yeah I hope they all succeed.
I’ve been reading articles and came across the following one.
https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(21)00258-3/fulltext
The company is called arbor life. Any relevance??
Thanks for sharing AD. I have seen this company and while I respect them and it looks interesting, I am not convinced this is a winner here. I don’t see the blatant photos which indicate above average efficacy, though I admit their numbers look great.
No problem admin. I was wondering if its possible for you to get in touch with the founder of arbor life again in order to know its further plans.
I will try again soon AD.
Sorry thats the link to the study they conducted.
https://www.arborlifelabs.com/contact
This is the company’s website.
^Arborlifelabs look extremely legitimate in my opinion, at least relative to many other companies we see creep up on HL forums. Their product apparently follows a “non-drug regulatory pathway” and their HL treatment has good results in the study mentioned. Currently says “available for licensing” which I take means an external company would need to take over the product. I think it would be worth contacting them to find out more on this.
I had a convo going with their founder which has gone quiet now, waiting for a response. But, like I said before I’ve yet to see an indication of something “above ordinary”, while I do remain open-minded.
PS, admin, I think we can expect an update from Biosplice closer towards the end of the year. An interview suggests that they expect approval late this year or early next year. There is a tweet that states that they will release their Phase 3 results following presentation at a medical congress. Their last presentation was at the American Academy of Dermatology which is concluding its presentations in October this year.
Thanks Anthony!
Where is this interview?
They actually have already concluded their summer presentations. You can view the online Vods until October.
Of all the previous conferences Biosplice have been at:
The AAD have a conference in March 2022, as does the International Dermatology and Cosmetology Congress.
The Society for Investigative Dermatology has their annual meeting in May 2022.
The World Congress for Hair Research has their meeting in April 2022.
Unless there are more congresses they can present at this year it seems all the previous ones they’ve been at indicate they won’t be showing the results until 2022.
However they must release the results of the clinical trial within 4 months according to the FDAAA tracker, or they get a fine.
So being pessimistic and reading between the lines, the results probably aren’t positive and they’re trying to find a good moment to release the mediocre results and hoping the Osteoarthritis drug has good enough results to overshadow.
If they make progress with FDA prior and there is another congress that’ll be great, but I’m not sure they will.
Hi Admin,
You covered yuva biosciences in 2019.
Seems like they are conducting human trials for a cosmetic product.
Results to be announced by the end of the year.
https://www.longevity.technology/targeting-mitochondria-to-beat-hair-loss-and-skin-wrinkles/
Thanks AD, I will follow up with them!
Okay great! Thank you
PureTech half-year report. ( thanks to glammetal over on HLT)
Follica plans to initiate a Phase 3 registration program in male androgenetic alopecia in 2022. (For us)
https://news.puretechhealth.com/node/9786/pdf probably won’t work, just go to their website and open it .
Also, Puretech was having a live conference and webcast today, maybe they will touch on follica. They mention the live cast will be loaded onto their website later.
https://finance.yahoo.com/news/kintor-pharma-report-2021-interim-090400673.html
After a day sitting in a box on a hot UPS truck and then sitting on my near 100-degree porch, RIZN has arrived. Day 1 for me starts manana. Very low expectations….
One of the companies in this article, Reistone, happened to issue a press release about their phase 2 results today https://www.prnewswire.com/news-releases/reistone-announces-positive-topline-phase-2-results-for-shr0302-a-selective-jak1-inhibitor-for-treatment-of-patients-with-alopecia-areata-301360967.html
Anybody here having difficulty finding brand name propecia from their pharmacy? My pharmacy says it’s on special order and it’s been two weeks. Keep telling me they are waiting from the warehouse. Cvs by the way. I called up Merk and propecia is manufactured by their sister company Organon. So organon told me they still make it. Not sure why no pharmacy carries it all of a sudden.
Try Walmart. That is where I get it from.
Hey FT. Any chance of doing an article on Triple Hair’s “Therapy-16”? Just seen it was recently released in North America. Would like to hear you opinion it.
I will consider doing one in the near future Big Kahuna, thank you for the request that helps me know you guys want an article on it specifically. I’d potentially like to hear some good indicators from users before giving them the spotlight, but we’ll see.
Day one of Triple Hair’s RIZN for me. Spray application was easy. I’m using it about 1 hour after minoxidil (5%), and I’m using it with finasteride. Been on both since the Stone Age.
^Would welcome the creation of a RIZN/TH-16 progress page with before/after photos posted monthly.
I mentioned the spray application of Triple Hair’s RIZN was easy. Of course, results are what really matters to me, but so far, I give it high marks for ease of application. Not at all greasy. You could spray this on your dry noggin’, massage it in, and feel comfortable heading right out the door to work afterwards. I haven’t noticed any smell either.
I expected using RIZN an hour or two after applying Minoxidil foam would create a greasy mess. But using both of them on day 1 has worked well for me. The texture of my hair is the same. That’s a relief. Now, on to the more important thing in 90 days…results. If I have more hair on Thankgsiving, I’m going to steal all your broads!
Admin
ALRV5XR
Thank you for inquiry.
ALRV5XR is very effective for male patterned baldness. A clinical trial in men will be published within the next month. In the clinical trial no men lost hair on ALRV5XR. There was a 100% response rate in men and responders separated into 2 distinct groups; a low response group and a very high response group. It is suggested to use the product for at least 3-6 months to see an effect and then to continue the product for as long as you want to increase regrowth. The products are all vegan and alcohol free.
I contacted the company and this was their response to He says that it is 100% effective in men’s baldness.
Please advise and share from forum members before buying
Will get back to them soon.
I have other news in the works including from Kang-Yell Choi of CK Regeon. Always working on relevant content for you guys ?
@FollicleThought good, its so barren right now
https://www.patreon.com/FollicleThought
Thanks FT, I really do appreciate the time and effort you put into the articles on here. Thanks Felix too for the info on your actual use of the product. Would be nice to see you check back in comments every once in a while to give us an update. I’m in Europe, so I can’t get my hands on it ?
Very many people have it with hair loss and very few companies trying to make a cure are obviously not aware of the wealth they would gain by selling their medicine.
only Kintor is aware of the wealth he will gain by selling his hair loss remedy.
It is a simple economy of the pharmaceutical industry, in a short time get a quality drug, easy to use, mass production and affordable price.
Companies that need 20 years have not started the third phase of testing – losers
Companies that raise money for their healing-losing theories
Scientists with healing theories-losers
The biggest losers are the companies that talk about hair cloning because it is a very demanding process of getting hair and I think that no company is even remotely ready for cloning.
It reminds me of a marathon race
Many embarked on a marathon race
And lost
Hey,
FT a question for you. Which are your top companies? The companies in which you have faith and would bet on them. Some people around me really invest heavily in different industries in order to hedge their portfolios. Maybe I could sell some which our community interests in.
Can we get your opinion on TH-16, admin? Noticed there are no updates on update page
Ok, so looking at it as a natural product (which means I don’t expect a miracle, just looking for consistent efficacy) it’s a reasonable formula and melatonin has been linked to hair growth in studies previously. The company has some photos which look believable. If I was set on finding an all-natural product, I would absolutely try it. If you’re already on the big drugs there’s probably no reason to add it to a regimen.
https://www.asiaone.com/business/hope-medicine-inc-announced-dr-henri-nico-doods-chief-executive-officer
Hope medicine will start his hmi-115 trial in q4 (USA)
But not for Alopecia…
Very sad to hear
Thanks admin for everything you do.
^Wouldn’t cite this article as definitive that Phase-2 won’t happen for alopecia, but in the worst case trials for one molecule with multiple applications including alopecia isn’t the worst news either.
I have diffuse alopecia areata and it also caused grey hair. Do u think Baricitinib will be safe.
How can I get it and when it is going to be available?
[…] recent FDA-approved treatments for alopecia areata are baricitinib and ritlecitinib. These differ from REZPEG in that they are Janus kinase (JAK) inhibitors. While […]