I have covered the novel androgen receptor antagonist Breezula® (clascoterone) for 11 years across numerous posts. The product was originally known as CB-03-01, and manufactured by a company named Cassiopea (Italy). The latter was acquired by Cosmo Pharmaceuticals (Ireland) in December 2021.
Update: January 21, 2026
Cosmo has a brand new upgraded website with a new domain name.
December 2, 2025
Cosmo Pharmaceuticals Announces Breakthrough Phase III Trial Results for Breezula (Clascoterone)
Earlier today, Cosmo Pharmaceuticals announced breakthrough Phase III trial 6-month topline results for Clascoterone 5% solution in treating male pattern hair loss (androgenetic alopecia). Subsequently, the company’s CMOPF stock price rose a significant 24%.
Interestingly, Cosmo did not use the word “Breezula” even once in the press release. It does not show up on the company’s pipeline page either. And the Breezula page on their site is not working at present. I really hope they do not change the name yet again. My blog post “categories” about this company and product are already too numerous.
Key notes from the press release:
- A massive 1,465 patients were randomized into the two identical clinical studies: Scalp 1 (NCT05910450) and Scalp 2 (NCT05914805). I covered these in detail here and here.
- Both studies reached statistically significant endpoints in Target-Area Hair Count (TAHC). The first reached 539% relative improvement compared to placebo; and the second reached 168% relative improvement to placebo.
- The safety profile across both studies for positive.
The way they present these numbers is a bit strange and may exaggerate the efficacy. And the large gap between 539% and 168% is very surprising. In the successful 6-month interim Phase 2 trial results that were presented in 2018, they chose to compare Breezula results with finasteride.
Cosmo will complete the required 12-month safety follow-up in spring 2026. Thereafter, Cosmo plans to promptly pursue parallel regulatory submissions in the United States and Europe.
“Clascoterone 5% topical solution is positioned to become the first topical androgen receptor inhibitor ever approved for AGA, subject to regulatory authorization.”
This development also bodes favorably for China-based Kintor Pharma’s androgen receptor antagonist KX-826 (Pyrilutamide). It is currently in Phase 3 trials. A number of other such products are currently in trials or have been released as weaker cosmeceuticals.
On a related note, Cosmo Pharma released Winlevi clascoterone 1% cream in 2020, and it has since become the number 1 most prescribed topical acne brand in the US. Some people were trying to use Winlevi off-label on their scalps in the past, but I suspect that the dose is too low. Moreover, scalp absorption of the cream might be totally different from scalp absorption of the solution.
Also of interest, an August 2025 study concluded that Breezula promotes dermal papilla inductivity and hair matrix keratinocyte proliferation to a similar extent as minoxidil. In addition, Breezula also reduces the secretion of hair growth inhibitor IL-6 in balding skin samples. Some of the scientists involved in this research are affiliated with Cosmo.
Years ago, I mentioned how a hair transplant surgeon raved to me about Breezula based on a presentation (with photos) that he witnessed at an ISHRS conference. Fingers crossed that we finally have a third FDA-approved hair loss treatment by the end of 2027 (30 years after finasteride was approved, and 39 years after minoxidil was approved)!
No new update on Clascoterone, but I am republishing this post to the home page. The reason being, I am currently bed ridden.
Edit: Looks like Cosmo has a new website, so there is a new update.
I ruptured my appendix a few days ago, which required surgical removal. Crazy pain for a couple of days.
Am slowly recovering, but still have a nuisance drain pipe coming out of my stomach. Will get it removed tomorrow if everything looks ok.
Get well soon.
Speedy recovery admin!!!
I wish you a speedy recovery
Sorry to hear that admin. Get well soon!
So sorry admin…wishing you a quick recovery.
Wishing you the best, Admin!
Sorry to hear that admin! Get well soon mate!
I wish you a speedy recovery.
Speedy recovery and best wishes Admin!
Another nice read …
https://www.hcplive.com/view/phase-3-scalp-study-clascoterone-androgenetic-alopecia-maria-hordinsky-md
Photos!
https://www.genengnews.com/topics/translational-medicine/stockwatch-cosmo-surges-40-on-baldness-candidates-phase-iii-data/
Did not feel like writing a new post on this story, although it was covered in many publications this week.
Scientists from L’Oréal Research & Innovation and Queen Mary University (London) find that human hair grows through pulling rather than pushing:
https://www.qmul.ac.uk/media/news/2025/medicine-and-dentistry/fmd/human-hair-grows-through-pulling-not-push–study-.html
The only thing that makes sense is that the data is cut. They are most likely only picking the top responders when presenting or something similar. The delta between the two identical studies shouldn’t be so significant.
I work in tech and have seen this happen far too often. Managers/ leaders look for the “win” while ignoring entire sets of data that don’t support their narrative. My guess is that they are under pressure to produce results.
Isn’t what you’re describing securities fraud? Doesn’t seem like a viable long-term strategy.
Dear all, Dr. Munoz here shows some impressive before-after picture attributed to the effect of Breezula, what do you think?
https://www.youtube.com/watch?v=jsqiGIbt_80
Wow! …well that really looks like 500 percent more. Thanks for that Pellata! :-)
Isn’t it just a random AI picture? I believe so, since he also used AI in the image before when he showed the Breezula packaging.
Everyone, please refresh your browser and clear your cache if the site page load is slow. A few things have been causing a slowdown during the past few days. I think the issue is now solved.
Pellata that does look amazing. My concern is that it’s results from one patient. I just skipped to the visuals but I speak Spanish so I’ll do my best to watch it to see if this is a normal/ average/ median result.
Patients who have taken finasteride have seen results like this. They’re often referred to as super responders (or something like that). Unfortunately the vast majority of people will not see results like that so when taking finasteride. That’s my concern. Is this just one person or is this result repeated enough to make it the norm? This is called a scalability fallacy if it can’t be reproduced across a system or more commonly referred to as an outlier in the data set. Shifty people love to focus on them as sources of truth.
But again that approach won’t wash with the FDA and all statements from Cosmo now are in the context of regulatory approval for their investors so the product can be marketed.
People seem to think the company is being fraudulent in that respect, but if they are it won’t last long if their planning to file for approval next year… just doesn’t seem realistic to me
Plus, they have the #1 acne drug, would they risk their reputation on the hair loss version only to pump up the stock? Their #1 clinical target for both drugs is the same, Dermatologists.
Okay, just listened to it twice – once in Spanish and then once with the AI dubbed English. The guy has a thick accent from Spain so some of his vocab and words don’t translate well for me.
What I got from it.
1. The photo shown might just be a random photo. At no point (to my knowledge) does Munoz strictly call out that the photo is actually a patient from the trial. It might be marketing from Cosmo.
2. He suggests that the material released for Cosmo are for marketing purposes.
3. He doesn’t like how the data is presented and suggests multiple times that it is to get a response from investors/ targeting a bump to the stock market.
Has there been any official statement on the price of this drug after its official launch?
So many people mentioned price so I had to do a ctrl+F in my past Breezula posts.
$110 per month it seems. Not bad for a new product.
Yes,thank you!
I’m not here to say what does and doesn’t constitute a securities fraud but tech leaders exaggerating/omitting data is nothing new, they’ve been doing it for decades.
It’s what you get from morally bankrupt corporations and people who work at them. The amount of shit I’ve caused in my career by asking to see the actual data on low level projects is insane. The wool being pulled over your eyes gets worse with ever rung of the ladder you climb – the c suite is only shown crafted narratives and if you challenge something you’re often removed from the convo.
With that said, I’m not in finance so I can’t say how often they actually skew financial data, but I can tell you that on earnings report calls they tend to shift narrative to fit a positive outlook. For example: the company I work for is a publicly traded company and is slowly losing market share. But they are squeezing the customers by charging more so revenue is going up. During earnings they focus on the 15% increase in revenue, not the 5% reduction is market share which doesn’t get reported in the financial numbers. Ethical? Nope but it’s not mandatory to report market share as far as I know.
Thanks, interesting. I found this article interesting, apparently it’s one of the most common areas for SEC action and ex-US companies are increasingly having to exercise caution in this regard when reporting CT results:
https://www.taylorwessing.com/en/insights-and-events/insights/2024/10/reporting-clinical-trial-results-to-the-market
I also found this article which provides some account for the difference between the two trials’ results:
https://www.dermatologytimes.com/view/clascoterone-5-delivers-strong-phase-3-hair-growth-results
The company has only released topline results, no peer-reviewed data, no standardized photography documentation, and no independent confirmation of the images.
If those photos are real and the source truly had inside access, then the trial most likely required participants to use only the study drug. If that is the case, the results look very impressive considering they were not stacked with Dut, Fin, or Minox. Since Breezula works through a different mechanism and naturally complements the traditional treatments, combining them could lead to results that are even stronger than what we are seeing now. I am excited.
I agree with Slick on this. The results (from the two sets of photos) are very underwhelming…especially given the possible cost that was mentioned in the presentation earlier this year. My plan remains the same – to use this as a bridge to Pelage (assuming that gets approved later) and as a replacement for finasteride. I will continue to use Minox 5% along with it. If all goes as planned, my usage of clascoterone will be very short – probably <2 years as I would drop it once Pelage is approved. Lots of assumptions – Pelage is better and will get approved. Counting down the months until I get off this finasteride garbage.
Most sensible post in the thread, £100pm for a couple of years is not such a bad prospect given the apparent safety/efficacy profile.
This is a huge huge thing if it even crosses the finish line even if it worked as well as finasteride. Propecia has a lot of side effects, and a large group of guys can’t even use it because of sides. So just something with less sides that works is a huge win. The down side I expect this to be VERY expensive.
We can gauge the cost from whatever they are charging for Winlevi for acne. Including savings programs and discounts such as the below.
https://www.goodrx.com/winlevi/how-much-is-winlevi-without-insurance
https://www.winlevi.com/savings
I just saw these before / after pictures … I dont know but I cannot see 500 percent better
https://www.genengnews.com/topics/translational-medicine/stockwatch-cosmo-surges-40-on-baldness-candidates-phase-iii-data/
They are pretty decent though, sadly as a slick bald NW6 can’t see it doing much for me.
There’s a visible improvement, but the question is of course what the baseline was. If it’s comparable to Minoxidil/Finasteride without side effects I might even try it.
But this does not look like THE cure yet.
Not bad! Maybe hair growth will improve in upcoming months.
This is a very nice result tho. Not 500% probably, but for some of us – like me – this will be enough.
The photos show a 10% improvement, tops (and possibly none depending on lighting). This is not 500% or even 100%. Thank you for sharing.
Pretty decent. Cannot expect more from this method of action.
I could not find these before and after images on Cosmo’s site. Any other source?
Yes, where‘s that coming from? Never seen before…there‘s no reference in the pictures.
But the stock exploded from ~ 70 to ~110 in a week. That‘s remarkable. Press releases obviously work well.
Questions:
1 – How good this is compared to finasteride?
2 – No serious side effects?
Could be a good replacement for finasteride imo.
How is this combined with PP405 not fin + min 2.0?
Tbh I do hope they change the name. “Breezula” is a terrible name, always has been. But then maybe the product will also be terrible so it’s fitting, who knows.
Who gives a crap what they call it as long as it makes it to market? SMH
Always appreciate the positive news… I just wish it didn’t have to be so obviously sketchy with the way they reported results using meaningless numbers and no photos. The % results need to be defined with variables to have meaning, so why purposely avoid reporting real information if the results were considered good?
This is exactly correct. When something actually works, photos will be everywhere.
100% agree with you. I think Breezula is completely useless. They are just ‘messing’ around with the numbers so it looks like it’s impressive. But 539% increase vs placebo could just mean 1 hair /cm2 or lower, which is cosmetically unnoticeable.
If the results are really that good, they will talk about different numbers. Not against placebo. And they will share pictures.
if it’s useless, they won’t submit it to the FDA, so at least it has some use.
In the interim Phase 2 results post that I linked to, they said that when it comes to target area hair count: 7.5% Clascoterone solution twice per day gave similar results after 6 months as oral Propecia did after 12 months.
It obviously does do something.
Plus the news added millions of value to the company in terms of stock price so there is optimism in the markets about the treatment.
Market optimism isn’t equivalent to efficacy, though.
Anyone have an update or can ask Dr. Rassman about the hairy nevus treatment please?
One thing’s still unclear to me: is it a cosmetic or a drug? And the price? If pp405 turns out to be the best remedy, everyone else goes home.
It is a drug. I doubt it will be cheap either.
Breezula + Kintor combo in 2028 might regrow a whole Norwood.
And they said No without an explanation!
They now say that at this time their pharmacy doesn’t offer clascaterone for custom compounding although that could change.
I have asked Happy Head if they can add clascaterone to their Pro Blend. Since it is already FDA approved for acne, we don’t necessarily need to wait until 2028. That doesn’t mean I am not leary of the cosmetic vs statistical benefits but I doubt it can hurt anything other than my pocketbook.
Did they make it? Would you mind share the price?
Added an update in the second last paragraph in relation a recent study on Breezula that I had not covered previously.
I think it’s great we have HMI, GT, PP405, and now CB all potentially coming out. Different method of actions. Stackable probably. Fingers crossed.
Stackable for hundreds a month though. But I’m indeed optimistic. So much work has been done in the last 4-5 years.
I’ve seen CB powder on grey market sites. No idea how to make the product from that though. I’d be willing to try if there were clear easy instructions.
This seems underwhelming, even if both TAHC endpoints met statistical significance, the fact that one of the patient reported observations didn’t (“positive trends”) would suggest the actual visual improvement wasn’t particularly impressive.
Plus why would they be reporting in such a weird way if not to try and obfuscate the most important metric – significant cosmetic improvement.
Absolutely. The numbers reported are meaningless without defining the variables behind the %. Information is absolutely withheld on purpose.
More media coverage now:
https://www.bloomberg.com/news/articles/2025-12-03/cosmo-shares-soar-most-in-17-years-on-hair-loss-treatment-data?srnd=homepage-europe
https://www.investing.com/news/stock-market-news/cosmo-shares-surge-over-20-after-breezula-phase-iii-trials-hit-key-goals-4387715
Check out comments here:
https://x.com/HLcure2020/status/1996311255007768868
And on Reddit:
https://www.reddit.com/r/tressless/comments/1pcx8g0/breezula_6_month_topline_phase_iii_results/
This is great news. Cosmo has to realize that two additional treatments could be approved soon after this, nipping their heels. So I’m sure they are motivated to get this out as soon as they can.
Good news..but 12 months! Can’t they expedite it?
You mean it will be released in 12 months?
I’ve been waiting for over 30 years. 12 months is like 12 minutes to me. LOL.
I know, but I have been waiting over 20, and I don’t want to wait any longer.
Admin said end of 2027 in article, almost 2 years away? I remember reading similar positive reviews on a different hair site many years ago about Breezula based on the presentation (with photos) at the ISHRS conference, by an attendee that the site sponsored to attend.
They already got approval for Winlevi, and I suspect that approval for higher-dose Clascoterone will be fast.
Most likely, it will be early 2027. I just added some leeway based on past experiences. They will file for approval after the Spring 2026 12-month safety data per the press release. They already have Winlevi approved, so the higher-dose Clascoterone will not cause any issues with the FDA assuming safety remains solid.
The surgeon who raved to me about Breezula is a totally honest and legit person I respect.
I am glad he saw the photos before we got AI images and deepfakes becoming so good. Soon, we will be in a world full of suspicion :-(
It’s always been that way, “believe half of what you see and none of what you hear”.
I already believe less that that percentage when it comes to trusting any online text content being from real humans. By 2027, it will be almost impossible to decipher most images and videos from being real vs AI generated.
In some countries, this may cause a lot of violence. I already saw several videos this week of star newscasters making crazy claims that turned out to be fakes that were very difficult to detect.
I just had a chat with my tax advisor and showed him the latest pictures of Nano Banana. He said „we‘re absolutely screwed“ and couldn‘t believe the sheer perfection.
It also happened so quickly, like in 1 year it went from ‚nice but something is obviously off’ to ‚indistinguishable from reality‘.
I used to be very pro AI in every aspect, but we are heading into dark times. AI-generated pictures and videos can and likely will start huge turmoil if not wars.
Where can I see these photos Yoda?
Report of one who saw the photos like Admin’s doctor who attended, not actual photos.