Overview
- Two identically designed Phase III studies (SCALP 1 and SCALP 2) in about 1,465 men showed statistically significant gains in target-area hair count versus vehicle, with one trial numerically stronger than the other.
- Patient-reported outcomes supported the objective findings, including a statistically significant improvement when data from both studies were pooled.
- Clascoterone 5% is a topical androgen receptor blocker that targets DHT at the scalp, positioning it as a potential first-in-class topical option for androgenetic alopecia if approved.
- Short-term safety appeared encouraging, with adverse events comparable to vehicle and no meaningful signs of systemic hormonal effects reported to date.
- Cosmo’s shares jumped roughly 40% after the topline release, and the company plans to complete 12-month safety follow-up in 2026 before seeking US and European approvals and considering partnerships.