Clascoterone 5% topical solution for male androgenetic alopecia (AGA) showed up to 539% relative improvement in Target-Area Hair Count vs. placebo, according to top-line results from two Phase 3 trials, Cosmo Pharmaceuticals reports.
By blocking dihydrotestosterone (DHT) directly at the hair-follicle receptor without systemic absorption, clascoterone 5% topical solution—the same active ingredient used in the acne medication Winlevi—is the first topical androgen receptor inhibitor designed to target the biological root cause of male pattern hair loss without the risks associated with oral therapies.
Cosmo is on track to complete the required 12-month safety follow-up in spring 2026. Upon completion of the full data set, the Company plans to pursue parallel regulatory submissions in the United States and Europe.
Top-line Data From Scalp 1 and Scalp 2
Across 1,465 patients enrolled in two identically designed Phase 3 studies conducted in the United States and Europe, clascoterone 5% solution delivered robust, statistically significant, and clinically meaningful improvements with a safety and tolerability profile comparable to the placebo vehicle. One study demonstrated a 5.39x (539%) relative improvement in Target-Area Hair Count (TAHC) vs. vehicle, while the second study showed a 1.68x (168%) relative improvement. Treatment Emergent Adverse Events (TEAEs) were similar across both studies, and similar to vehicle, with most TEAEs not related to the study drug.
One patient-reported outcomes (PRO) endpoint reached statistical significance and the other study PRO showed a positive trend, while the combined analysis across both studies was statistically significant and fully consistent with the objective TAHC measures.
Unlike existing therapies, clascoterone 5% solution was developed specifically for AGA.
“These data reflect a significant milestone for patients with male pattern hair loss,” says Maria Hordinsky, MD, the R.W. Goltz Professor of Dermatology at the University of Minnesota in Minneapolis, MN. “For decades, patients have had to choose between available treatment options with limited efficacy or safety issues due to systemic hormonal exposure, often resulting in patients not treating their hair loss at all. These findings show the potential for clascoterone 5% topical solution to change that equation by delivering real, measurable regrowth with negligible systemic exposure. These data have the potential to redefine how dermatologists treat androgenetic alopecia worldwide.”
Giovanni Di Napoli, CEO of Cosmo, adds: “This is a pivotal moment for Cosmo and for billions of men worldwide who struggle every day with the emotional and social impact of hair loss. Androgenetic alopecia is far more than a cosmetic issue—it affects confidence, identity, and emotional well-being. For the first time in more than 30 years, we have a completely new mechanism with the potential to truly change that reality. With strong efficacy across the two largest Phase 3 studies, and a favorable safety profile, clascoterone 5% topical solution opens the door to a fundamentally better treatment paradigm for patients.
