Cosmo has Announced Phase III Topline Results for Clascoterone 5% Solution in the Treatment of Androgenic Alopecia
Cosmo Pharmaceuticals has announced impressive topline results from its two pivotal Phase 3 trials evaluating clascoterone 5% topical solution for male androgenic alopecia (AGA).
These data mark what may be the first major therapeutic breakthrough for male-pattern hair loss in over 30 years.
What is Clascoterone?
Clascoterone is a topical androgen receptor inhibitor designed to block dihydrotestosterone (DHT) directly at the hair-follicle level. Unlike oral anti-androgens, clascoterone acts locally in the skin and is formulated to avoid systemic hormonal exposure. The same active ingredient is used in Winlevi®, an FDA- and EMA-approved topical acne medication with an established dermatologic safety profile.
Clascoterone 5% solution is the first therapy specifically developed to target the biological root cause of AGA with a novel mechanism of action.
The Trials
The program consisted of two identically designed, randomized, double-blind, placebo-controlled Phase 3 studies: Scalp 1 (NCT05910450) and Scalp 2 (NCT05914805).
Across the two studies:
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1,465 men with AGA were randomized, making this the largest Phase 3 program ever conducted for a topical male AGA treatment.
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The primary endpoint was the change in Target-Area Hair Count (TAHC).
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Treatment duration included efficacy assessments and ongoing safety follow-up.
Both trials achieved statistically significant improvements in TAHC.
Topline Results
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Scalp 1: 539% relative improvement in TAHC vs. placebo (5.39×).
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Scalp 2: 168% relative improvement in TAHC vs. placebo (1.68×).
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Safety: Treatment-emergent adverse events were similar to vehicle in frequency and severity, with most not considered related to the study drug.
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Patient-Reported Outcomes: One study achieved statistical significance; the other showed a positive trend. Combined analysis across both studies was statistically significant and aligned with objective hair-count improvements.
Reflections
The magnitude of improvement reported in TAHC, particularly the 539% relative difference in one study, is unprecedented for a topical AGA treatment. We would be keen to see the full data release, long-term safety results, and real-world outcomes as the therapy progresses towards potential approval.
This data also suggests a good safety profile, which addresses a major barrier for patients hesitant to use hormonal treatments for hair loss.
Cosmo expects to complete the required 12-month safety follow-up in spring 2026 and plans parallel FDA and EMA submissions thereafter. If approved, clascoterone 5% solution could become the first topical androgen receptor inhibitor available for male AGA.
What are your thoughts on clascoterone’s Phase 3 results? Share in the comments!
Posted in Cosmo Pharmaceuticals
Isn’t this the same mechanism as pyralutimide?
My thoughts are we’ve heard all of this “promising” results before. We’ve also heard their proposed dates slip to years away.
What are your expectations regarding monthly costs? Assuming you need to use the product on the entire scalp and not localized areas. (Norwood 7)
Promising. Do we know any differences between the two studies that might explain the differences in efficacy?
From an article about the clinical trial results in Dermatology Times:
“Both trials demonstrated statistically significant improvements in hair growth compared with vehicle. In one study, clascoterone produced a 5.39-fold (539%) relative improvement in TAHC, while the second trial showed a 1.68-fold (168%) relative improvement. The magnitude of difference between the 2 studies is not unusual for hair-growth research, which often shows variability based on baseline disease severity, regional demographics, or site-level differences in assessment technique.”
Any thoughts as to the difference in magnitude of positive treatment effect (increase TAHC) between scalp 1 study and scalp 2 study? Quite a variation there?
Wow, exciting stuff. Is this the final trial, and if so, is there an estimated timeframe for going to market?
has..it..finally.. happened? a cure?
Is this only for male AGA? Thanks
I think it’s strange that they have zero photo release just data. Is the TAHC better or same or worse as finasteride?
May God make this to be a success for all the hairloss sufferers.
Unfortunately from reading other articles on this drug it appears hair has to be present for it to work.The studies were done on men with mild to moderate hair loss.
Does transplanted hair count too? I was a NW7 and went back to NW4 due to hairtransplant.
Placebo grows 1 hair (which really should be 0). CB grows 5 hairs. Wow, 500% increase
Exciting… and considering they were able to bring WinLevi to market, for once the timeline seems realistic.
https://www.genengnews.com/topics/translational-medicine/stockwatch-cosmo-surges-40-on-baldness-candidates-phase-iii-data/
Cosmo investor relations confirmed to me these are the photos from the stage 3 trials
I see clascoterone is available on Cambridge bioscince. Is this the same drug but in a lower dose?
https://www.bioscience.co.uk/product~920446
I see that clascoterone is available at Cambridge bioscince. Is this the same drug but in a lower dose?https://www.bioscience.co.uk/product~920446
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