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Cosmo’s Topical Hair-Loss Drug Posts Phase III Success, Shares Surge Nearly 40%

The company next targets a 12-month safety readout in 2026 ahead of planned US and European filings.

Overview

  • Two identically designed late-stage studies in 1,465 men met primary goals, showing statistically significant gains in target-area hair count versus vehicle.
  • Patient-reported outcomes aligned with objective measures, with one trial meeting the endpoint outright and the other showing a positive trend that was significant in pooled analysis.
  • Clascoterone 5% is a topical androgen receptor blocker that targets DHT at the scalp, offering a locally acting alternative to systemic oral therapies and differing from minoxidil’s mechanism.
  • Reported side effects were mostly mild and local with rates comparable to vehicle, though clinicians note long-term safety data are still limited and benefits wane after stopping treatment.
  • Dermatologists describe the drug as most useful for stabilising early-to-moderate thinning with modest density gains, and Cosmo is open to commercial partnerships after its safety follow-up.