Clascoterone shows positive Phase 3 results for male pattern hair loss

Cosmo Pharmaceuticals has reported positive 12-month data from two Phase 3 clinical trials for clascoterone 5%, a topical solution designed to treat androgenetic alopecia, commonly known as male pattern hair loss. The SCALP 1 and SCALP 2 studies involved 1,465 men across 51 centers in the United States and Europe.

Clascoterone acts as an androgen receptor inhibitor to reduce signaling from dihydrotestosterone (DHT). The trial results indicated that men using the treatment for a full year saw hair counts increase significantly, showing a 2.39-fold greater improvement compared to those who discontinued use after six months. The treatment also reported a 24.5 percent relative improvement in patient satisfaction.

Dr. Joshua Zeichner of Mount Sinai Hospital noted that male pattern hair loss is driven by genetic susceptibility and hormone sensitivity, often carrying a significant psychosocial burden. He emphasized the importance of early dermatological evaluation. The clascoterone trials showed safety and tolerability levels comparable to a vehicle solution, with no significant systemic hormonal side effects. Cosmo Pharmaceuticals plans to file for FDA approval in early 2027.