Cosmo Reports Significant Phase III Topline Results for Clascoterone 5% Solution in Male Hair Loss, Demonstrating Up to 539% Improvement in Hair Count Compared to Placebo; Submissions in the US and EU Are in Progress

Clinical Trial Results: Cosmo Pharmaceuticals announced significant results from two Phase III trials of clascoterone 5% topical solution for male androgenetic alopecia, showing a 539% and 168% relative improvement in hair count compared to placebo.

Safety Profile: Both studies demonstrated a positive safety profile, with treatment-emergent adverse events similar to those of the placebo, indicating good tolerability for the new treatment.

Innovative Mechanism: Clascoterone is the first topical androgen receptor inhibitor targeting the biological cause of male-pattern hair loss, representing a major therapeutic breakthrough in over 30 years.

Regulatory Plans: Cosmo is preparing for parallel regulatory submissions in the U.S. and Europe, with expectations to redefine treatment paradigms for androgenetic alopecia upon approval.