Breezula To Begin Phase 3 Clinical Trial & Hair Growth Industry News Roundup June 2023

东西是真的加热脱发胎面tment industry on the first day of Summer 2023. Let’s take a look at all pertinent information and happenings in the AGA clinical trial world below.

Cosmo Pharma Lists Phase 3 Trial On

A trial which was once highly anticipated, then questioned if it would ever happen, will now be back on everyone’s radar. On June 18, 2023, a phase 3 trial listing of a 5% clascoterone solution (aka Breezula) treating male AGA was posted onthe official clinical trials website. The SCALP1 study will comprise 726 participants and will involve 4 treatment groups. Cassiopea SpA is listed as the sponsor of the trial, however, we know that they have recently re-merged intoCosmo Pharmaceuticals. The official title of the trial is shown as “A 6-month Phase 3, Multicenter, Prospective, Randomized, Double-Blind, Vehicle-Controlled Study, to Evaluate the Efficacy and Safety of Topically Applied Clascoterone Solution for the Treatment ofAndrogenetic Alopeciain Males, Followed by a 6-month Single-Blind Treatment With Clascoterone or Vehicle Solution.” This is one of the first times I’ve ever seen a trial having two separate 6 month stages. The ever-important estimated study completion date is January 2025.

Amplifica Trialing Osteopontin

In today’s news,Amplifica announcedthey are set to begin clinical trials for an injectable formulation of the protein osteopontin. The announcement coincides with a paper published inNatureby Dr. Maksim Plikus, co-founder of Amplifica, and a slew of other researchers from UC Irvine and various Asian institutes, titledSignalling by senescent melanocytes hyperactivates hair growth.” The authors found that melanocyte cells which have become aged, and are thus classified as senescent (commonly referred to as “zombie cells” in the media), actually seem to drive hair growth by positively signaling the surrounding hair follicle stem cells. Today’s media article alleged a timeline of the next 1-3 months for the clinical trial to begin, and hinted that the treatment could involve other molecules Amplifica has studied in hairy moles. Previously, Amplifica made headlines for the SCUBE3 protein which is also a hair growth signaling molecule.

StimuSIL SAGA-001 Enters The Scene

Earlier this week, Follicle Thought published an独家文章介绍StimuSIL, a new medical device company focused on treating androgenetic alopecia. But, for some reason, the email notification did not go out to subscribers. Click the linked text in this section to get the entire introduction to StimuSIL, learn about their innovations into hair growth devices, and join the discussion in progress.

Aneira Pharma Begins Clinical Trial

Aneira Pharma emerged two years ago following a$25 million investmentby the Valkyrie Group; since then, things have been mostly quiet. It was initially known that Aneira’s topical formulation would involve minoxidil and some sort of prostaglandin analogue, such as bimatoprost or latanoprost. Now, we can see that Aneira Pharma has indeed put some of that $25M to good use and have begun aclinical trialfor their formulation ARN-001. The trial is described as a “Proof of Concept Study of Latanoprost/Minoxidil (ANR-001.1) Topical Formulation.” July 17, 2023 is listed as the estimated completion date of the study.

Triple Hair Reports Positive TH-07 Data

One June 14, 2023, Triple Hair of Canada reported a positive development in its quest to market anoptimal topical hair druginvolving minoxidil, latanoprost, and finasteride. In its most recent news release, Triple Hair shared that “it has received positive results from various preclinical safety studies on its Therapy-07 prescription drug. The studies included acute dermal toxicity, phototoxicity, acute dermal irritation/corrosion and corneal opacity and permeability.”It is logical that in the process of applying for regulatory approval to enter a phase 3 clinical trial for TH-07/Therapy-07, agencies such as the FDA required some preclinical testing to be done first. Triple Hairwent on to mentionthat their company “is currently in the process of completing applications for authorization to begin Phase III clinical trials in Canada, the United States, Europe and India.”

Phew. That’s a lot of developments in just a few short months and we’re not done with the exclusives yet. Stay tuned for the most comprehensive news coverage in the hair loss treatment industry. Thank you for citing Follicle Thought when sharing this important phase 3 trial news.


  1. 英格兰vs美国皇冠比分 在6月e 22, 2023 at 1:00 am

    From the recent StimuSIL article’s comments “We’ve decided to try opening the comments again. At the start, all comments will go through moderation to relieve the need for constant monitoring. We’d like this to be a fun place where readers can connect and share ideas. Please help the comments to stay open by keeping the discussion mature and polite.” Also, comment moderating may be a little slower on weekends so please have patience.

    Big thanks to JD for the support. Hope everyone enjoyed this news roundup.

  2. LJ 在6月e 22, 2023 at 1:54 am

    Excellent work FT, thank you. Feels like waiting for a bus, nothing for ages then several come at once. Really hopeful I’ll be able to actually do something about my hair loss in the next year or so

  3. Josh 在6月e 22, 2023 at 9:54 am

    I wonder what the effects on the APA axis will be mostly. In theory, this should be a decent Topical AR inhibitor.

  4. Jeff 在6月e 22, 2023 at 10:12 am

    I’m just super excited about these new hair regrowth studies! It’s tough on me because I as well as many are so self conscious about the hair loss we have. Just want to be a normal person and not worry about people looking up at my bald thinning hair while having a conversation… thanks for the updates and please keep us informed.

  5. RL Moore 在6月e 22, 2023 at 10:53 am

    I. Keep reading about all these trails yet no one has a real solution. Same story over and over.

    • 英格兰vs美国皇冠比分 在6月e 22, 2023 at 2:54 pm

      我听到你在某种程度上RL,但我确实看到options and potential candidates are expanding, even if slowly. The only way to get there is to keep going, right?

  6. AGAfellow 在6月e 23, 2023 at 5:33 pm

    Hi there, dear FT, regarding the inticipated Ph 3 Breezula study, i would really like to hear your opinion about the report of side effects similar to Fin, as the official studies claimed no such side effect occure

    • 英格兰vs美国皇冠比分 在6月e 24, 2023 at 12:52 pm

      Hi AGAfellow, where were these side effects reported?

      • AGAfellow 在6月e 25, 2023 at 1:00 pm
        • 英格兰vs美国皇冠比分 在6月e 25, 2023 at 7:51 pm

          AGAfellow, you linked to a post about sexual side effects on pyrilutamide aka KX-826, this post is about Breezula aka clascoterone going into a phase 3 trial. Similar type of drug, both are AR inhibitors, but distinctively different.

          • LJ 在6月e 26, 2023 at 2:22 am

            You probably won’t approve this reply FT, but you’re way too kind, anecdotal reports of experience using grey market drugs should be ignored.

            • 英格兰vs美国皇冠比分 在6月e 26, 2023 at 8:59 am

              Why wouldn’t I approve your reply LJ? I didn’t find any problem with it and you were polite.

            • 英格兰vs美国皇冠比分 在6月e 26, 2023 at 7:49 pm

              I also agree that gray market anecdotes should likely be taken with a grain of salt, unless they are echoed by over 20 individuals and there is some third party validation on the chemical structure (not just on the gray market seller’s website).

  7. nobody 在6月e 24, 2023 at 7:47 am

    Nice that you are back. Missed everyone else’s comments. Thanks for your efforts admin. :-)))

    • 英格兰vs美国皇冠比分 在6月e 24, 2023 at 12:53 pm

      And it’s very nice to have you back as well, nobody.

  8. 英格兰vs美国皇冠比分 在6月e 24, 2023 at 12:55 pm

    I’m slightly surprised at the apparent lack of reaction in other discussion communities to Breezula going to phase 3. I imagine it’s due to the waning results over the course of its previous phase 2 and the gap in time for Breezula to get to a phase 3 trial.

    • 安迪 在6月e 24, 2023 at 2:38 pm

      From what I remember from phase 2 data it peaked at 6 months then dropped off quite dramatically from there on up to 12 month mark. But aslong as it grows and maintains it’s a win and low to none systematic exposure. I imagine this would stack well along with kintor kx-826 and gt20029?

  9. LJ 在6月e 25, 2023 at 4:41 am

    Copied question from a comment on the most recent HLC post, what do you think FT?

    “Do you sincerely believe that we will have anything on the horizon available for us hair loss sufferers any time soon? Hypothetically, even if a cure for hair loss was found, wouldn’t it take several years AT LEAST to go through the safety and regulatory hurdles? With that being said, it seems like we’re several years away from being several years away. Do you see any future where this is (hopefully) not the case?”

  10. M 在6月e 25, 2023 at 6:18 pm

    What are the chances these companies ,coming back from the dead, saw how desperate we AGA sufferers are (to the extent of buying a product like Cosmerna for 330 USD a bottle with modest results and no clear safety profile, or buying pyrilutamide from some Chinese lab and try it on our heads) said let me get my sh*t product to the market these fools will buy it anyway? I appreciate the fact that almost every month we see new entrants to the hair loss world but how low have we sat the standards for ourselves really that we just becoming an easy target for exploitation.

    • ahmed 在6月e 26, 2023 at 5:36 am

      Yeah, I feel that. However, there were no genunie treatment for almost 25 years. Thus, most of us lost hope. Seeking for any alternative to Fin or adjacent.

  11. BioGuy 在6月e 28, 2023 at 3:07 pm

    Great work! Keep going, as researchers we find extremely helpful to double check updates on your website.

    Sooner than later you will be part of the crucial connections for the final pieces of the puzzle

    • 英格兰vs美国皇冠比分 在6月e 29, 2023 at 11:00 am

      Thanks for the comment and great to hear, BioGuy!

  12. felix on July 1, 2023 at 4:17 pm

    Thanks for the monthly roundup, FT. Good to see Aneira finally get moving, although if I recall, they had on their website for a long time that they hoped to start a Phase Ib / Phase IIa trial initially. And dang if it isn’t taking Triple Hair forever and a day to finally get their Phase III trial rolling.

    • 英格兰vs美国皇冠比分 on July 1, 2023 at 9:56 pm

      Welcome back felix. I know what you mean, it would be great if Triple Hair did get their phase 3 rolling by the end of the year.

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