Clascoterone 5% Solution Achieves Hair Regrowth in Large AGA Study

Cosmo Pharmaceuticals N.V. has reported phase 3 results from its two pivotal trials—Scalp 1 (NCT05910450) and Scalp 2 (NCT05914805)—evaluating clascoterone 5% topical solution for male androgenetic alopecia (AGA). 

According to a press release from the manufactrurer, the two trials together form the largest phase 3 program eery conducted for a topical AGA therapy. Total enrollment included 1,465 men across the United States and Europe. Both studies met their primary endpoint of clinically significant improvements in Target-Area Hair Count (TAHC) compared with vehicle. Scalp 1 achieved a 539% relative improvement, while Scalp 2 showed a 168% relative improvement. Safety outcomes were favorable, with treatment-emergent adverse events comparable to placebo and generally unrelated to the study drug.

Clascoterone 5% solution works by blocking dihydrotestosterone (DHT) directly at the follicular androgen receptor without systemic absorption, according the manufacturer.

“These data reflect a significant milestone for patients with male pattern hair loss,” said Maria Hordinsky, MD, R.W. Goltz Professor of Dermatology at the University of Minnesota, in the press release. “For decades, available treatments have forced patients to choose between limited efficacy or systemic risks. These findings show the potential for clascoterone 5% solution to change that equation by delivering measurable regrowth with negligible systemic exposure.”

Cosmo expects to complete the required 12-month safety follow-up in spring 2026 and plans parallel U.S. and EU regulatory submissions upon completion.

Source: Cosmo Pharmacetuicals press release. December 3, 2025.