Cosmo Pharmaceuticals Announces Landmark โขResults in Phase III Trial of Hair-Loss Drug
Geneva,Switzerland -โฃ December 3,2025 – Cosmo Pharmaceuticals (CMOPF) โtoday announced overwhelmingly positive topline results from two Phase III clinical trials โคevaluating clascoterone 5% topical solution for the treatment of male pattern hair lossโค (androgenetic alopecia). The studies, involving a total of 1,465โฃ patients, demonstrated important improvements in target โhairโข count โข(TAHC) compared too a placebo, withโ gains of 539% โand 168% respectively.
These findings represent a potential breakthrough in the treatment of male pattern hair loss, a condition affecting over โฃ50 million men in โคthe United States โalone. Cosmo estimates the U.S. market opportunityโ for a new treatment exceeds $20 billion. โคTheโฃ company plans to submit applications for regulatory approval to both the U.S. Food and Drug Management โฃ(FDA) and the European โMedicines Agency (EMA) following completion of 12-month โขsafety follow-up, anticipated in spring 2026.
Clascoterone 5% distinguishes itself from existingโ treatments as a topical androgen receptor inhibitor, directlyโ targeting dihydrotestosterone (DHT) in hair โคfollicles while exhibiting negligible systemic absorption. This localized action is designed to minimize potential systemic side effects. Trial data reported โpositive safety and tolerability profiles,โค with treatment-emergent adverse events (TEAEs) comparable to placebo and largely unrelated to the study drug. โ
Cosmo has secured patent protection for clascoterone 5% extending through 2036. The company’s research indicates a significant unmet need for โnovel, effective, and well-tolerated therapies โขfor male pattern hair loss, positioning clascoterone 5% as a โคpotentially transformative option for patients.