Cosmo Pharma said it plans to file for FDA approval of clascoterone 5% topical solution for androgenetic alopecia in early 2027 after positive 12-month Phase III results. The androgen receptor inhibitor demonstrated continued hair growth with a chronic-use safety profile comparable to vehicle. In the Phase III program, Cosmo reported statistically significant target area hair count improvement for patients maintained on continuous clascoterone treatment through 12 months versus a shorter dosing period followed by vehicle. The program enrolled 1,465 patients across SCALP 1 and SCALP 2 trials spanning the U.S. and Europe, with SCALP 2 also including Germany and Poland. The NDA timing will be closely watched by dermatology stakeholders because AGA remains a lifelong indication where long-term tolerability and adherence are central to treatment expansion.