Cosmo Pharmaceuticals Announces Landmark Results in Phase III Trial of Hair-Loss Drug
Geneva,Switzerland - December 3,2025 – Cosmo Pharmaceuticals (CMOPF) today announced overwhelmingly positive topline results from two Phase III clinical trials evaluating clascoterone 5% topical solution for the treatment of male pattern hair loss (androgenetic alopecia). The studies, involving a total of 1,465 patients, demonstrated important improvements in target hair count (TAHC) compared too a placebo, with gains of 539% and 168% respectively.
These findings represent a potential breakthrough in the treatment of male pattern hair loss, a condition affecting over 50 million men in the United States alone. Cosmo estimates the U.S. market opportunity for a new treatment exceeds $20 billion. The company plans to submit applications for regulatory approval to both the U.S. Food and Drug Management (FDA) and the European Medicines Agency (EMA) following completion of 12-month safety follow-up, anticipated in spring 2026.
Clascoterone 5% distinguishes itself from existing treatments as a topical androgen receptor inhibitor, directly targeting dihydrotestosterone (DHT) in hair follicles while exhibiting negligible systemic absorption. This localized action is designed to minimize potential systemic side effects. Trial data reported positive safety and tolerability profiles, with treatment-emergent adverse events (TEAEs) comparable to placebo and largely unrelated to the study drug.
Cosmo has secured patent protection for clascoterone 5% extending through 2036. The company’s research indicates a significant unmet need for novel, effective, and well-tolerated therapies for male pattern hair loss, positioning clascoterone 5% as a potentially transformative option for patients.
