Male pattern baldness: After decades of limited new options for male-pattern hair loss, Cosmo Pharmaceuticals has reported positive topline results from two pivotal Phase III trials of clascoterone 5% topical solution, suggesting a potential new treatment approach with a fresh mechanism of action.
The two identically designed studies enrolled 1,465 men across the US and Europe. Cosmo said both trials showed statistically significant and clinically meaningful improvements in Target-Area Hair Count (TAHC) compared with placebo vehicle. One study recorded a 539% relative improvement, while the second reported a 168% relative improvement.
Also Read | Androgenetic alopecia: Early signs of pattern baldness you shouldn’t ignore
The company said treatment-emergent adverse events were similar to placebo, with most not considered related to the study drug. Patient-reported outcomes also supported the objective findings: one study met statistical significance, the other showed a positive trend, and a combined analysis across both trials reached significance.
Clascoterone is designed to block dihydrotestosterone (DHT) directly at the hair follicle receptor with minimal systemic absorption, making it a topical androgen receptor inhibitor specifically developed for androgenetic alopecia. Cosmo said this localised approach could address concerns about systemic hormonal exposure seen with some existing oral options.
The company is expected to complete a 12-month safety follow-up in spring 2026 and plans to pursue parallel regulatory submissions in the United States and Europe after the full dataset is finalised. If approved, clascoterone could become the first topical androgen receptor inhibitor authorised for male-pattern hair loss.
