Clascoterone: Male pattern baldness, or androgenic alopecia, is one of the most common forms of hair loss among men, often appearing in their late 20s or early 30s. The condition leads to permanent hair loss on the scalp, typically seen through thinning strands and a gradually receding hairline.
Clascoterone Shows Breakthrough Results In Phase III Trials
Clascoterone will be the first ever drug in 30 years to treat male pattern baldness by boosting hair growth by 500%. Despite years of research and a market full of treatments claiming to reverse baldness, no medication has produced consistently strong results, until now. On Wednesday, November 31, 2025, Ireland-based Cosmo Pharmaceuticals announced promising findings from two large phase III clinical trials of clascoterone.
The trials included 1,500 male participants divided into two groups: one received a placebo, while the other used clascoterone. The first study reported a remarkable 539% improvement, while the second showed a 168% improvement, signalling significant progress in treating androgenic alopecia.
Cosmo Pharmaceuticals stated that the drug demonstrated a favourable safety profile. “With strong efficacy across the two largest Phase III studies, and a favourable safety profile, clascoterone 5% topical solution opens the door to a fundamentally better treatment paradigm for patients,” said Giovanni Di Napoli, CEO of Cosmo.
Availability, Pricing & Next Steps
Not approved yet: The product will still need regulatory clearance from the US FDA and European Medicines Agency.
Timeline: Cosmo plans to submit approval applications in 2026, aiming for a possible commercial launch in the US and Europe by 2027.
Cost: Pricing details have not been released, but experts expect it to become a major option for individuals dealing with hair loss once it enters the market.
Could Become A Game-Changer
With further data review and regulatory filings scheduled for 2026, researchers believe clascoterone may become a breakthrough topical solution for androgenic alopecia, potentially changing long-standing treatment strategies for male pattern baldness.
