Cosmo Pharmaceuticals Reports Positive 12-Month Safety Data for Clascoterone 5% in Male AGA

Cosmo Pharmaceuticals has reported positive 12-month phase 3 data for clascoterone 5% topical solution in male patients with mild to moderate androgenetic alopecia (AGA), highlighting sustained efficacy and favorable long-term safety.¹ The findings, derived from the SCALP 1 (NCT05910450) and SCALP 2 (NCT05914805) trials and their extension phase, reinforce the potential of clascoterone as a chronic-use therapy targeting the underlying biology of hair loss.

“These 12-month phase 3 results mark a defining moment for Clascoterone and for the treatment of male hair loss. We are now seeing the combination that matters most: positive long-term safety, statistically significant continued hair growth through one year, and clear evidence that ongoing treatment drives sustained benefit,” Giovanni Di Napoli, MBA, Chief Executive Officer of Cosmo, said in a statement. “In a disease that has seen limited innovation for decades, Clascoterone has the potential to emerge as a major new therapeutic option and a highly valuable growth platform for Cosmo. We are moving with urgency toward regulatory submissions and commercialization discussions.”¹

Primary Phase 3 Safety Findings

The phase 3 clinical program enrolled 1,465 male participants across 51 study centers in the United States and Europe, representing the largest late-stage clinical development effort to date for a topical treatment in AGA. The studies consisted of an initial 6-month randomized, double-blind, vehicle-controlled phase (Part 1), followed by a 6-month extension phase (Part 2) in which responders were re-randomized to either continue clascoterone or switch to vehicle. This design enabled evaluation of both the durability of response and the long-term safety over a full 12-month treatment period.

Safety outcomes were a central focus of the extension phase, given the lifelong nature of AGA and the need for sustained treatment. Across 12 months, clascoterone demonstrated a safety and tolerability profile comparable to vehicle, with no significant systemic hormonal adverse effects observed. These findings align with earlier studies and topline results indicating negligible systemic absorption and support the suitability of clascoterone for long-term, continuous use.2 The absence of systemic endocrine effects is particularly notable given the drug’s mechanism as an androgen receptor inhibitor, designed to reduce dihydrotestosterone signaling without meaningful systemic absorption.

“AGA requires long-term management, so safety matters enormously. These data are encouraging because they show a profile that supports chronic use over time,” Maria Hordinsky, MD, Professor of Dermatology at the University of Minnesota and clinical investigator in the phase 3 program, said.¹

Efficacy and Patient-Reported Outcomes

Efficacy results demonstrated continued improvement in hair growth among patients who remained on active treatment. Patients treated with clascoterone for the full year experienced ongoing increases in Target Area Hair Count (TAHC), with a statistically significant 2.39-fold greater improvement compared with patients who discontinued active therapy after 6 months and were switched to vehicle. The trajectory of response further supports clascoterone’s biological activity over time. Patients continuing therapy showed progressive gains from month 3 through month 12, suggesting ongoing modulation of follicular dynamics rather than a plateau effect.

Patient-reported outcomes were consistent with objective efficacy measures. Patients receiving 12 months of continuous treatment reported a statistically significant 24.5% relative improvement in treatment satisfaction compared with those who switched to vehicle. Additionally, participants reported favorable ease of use and acceptability at month 12.

Next Steps

The company is currently preparing regulatory submissions, including a New Drug Application to the US Food and Drug Administration and a Marketing Authorization Application in Europe, with a U.S. filing planned for early 2027. If approved, clascoterone 5% solution would become the first topical androgen receptor inhibitor indicated for AGA and the first novel mechanism of action introduced for male AGA in more than 30 years.

“Male pattern hair loss is far more than a cosmetic concern. It affects confidence, identity, emotional wellbeing, and quality of life for millions of men every day. Yet physicians have had very few truly new tools to offer patients for decades,” Michael H. Gold, MD, FAAD, founder of Gold Skin Care Center, said. “Seeing a potential new FDA-approved topical treatment with a differentiated mechanism, a favorable safety profile, and efficacy that continues through 12 months is highly meaningful. Clascoterone has the potential to redefine the treatment landscape in male AGA, unlock significant value in a large underserved market, and become the long-awaited new standard of care for patients seeking meaningful regrowth with strong tolerability.”¹

References

1. Phase III 12-Month Data for Clascoterone 5% Topical Solution Confirm Positive Safety for Chronic Use and Continued Hair Growth, both of which Are Statistically Significant. News release. Cosmo Pharmaceuticals. Published April 15, 2026. Accessed April 16, 2026. https://www.cosmohealthconfidence.com/news/98958067-clascoterone-12-month-safety-results-ende

2. Cosmo announces breakthrough phase III topline results from Scalp 1 and Scalp 2 for clascoterone 5% solution in male hair loss, showing up to 539% relative improvement in target-area hair count vs placebo; US and EU submissions are underway. News release. Cosmo Pharmaceuticals. Published December 3, 2025. Accessed April 16, 2026. https://www.cosmopharma.com/news/cosmo-announces-breakthrough-phase-iii-topline-results-from-scalp-1-and-scalp-2-for-clascoterone-5-solution-in-male-hair-loss-showing-up-to-539-relative-improvement-in-target-area-hair-count-vs-place