Clascoterone 5% timeline
Current statusThe hair-loss solution remains investigational in the U.S. Cosmo targets a U.S. application in Q1 2027 and a European application in Q2 2027. Winlevi's approved 1% acne cream is a different formulation and indication.
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Occurred15 Apr 2026sponsor-reported extension and safety data
Continued dosing preserves gains in responders
Cosmo reports continued hair-count improvement with ongoing treatment and declining gains after switching to vehicle. Reported tolerability is comparable to vehicle through 12 months.
The extension re-randomized initial responders, so its findings cannot estimate how many new users will respond. The sponsor safety report does not establish absence of systemic or rare long-term harms.
Step 3 of 6
Evidence limitations. The headline relative hair-count percentages do not describe percentage scalp regrowth. Patient-reported results were mixed across the two pivotal trials, and the 12-month extension selected initial responders. Full absolute effects and formulation-specific long-term safety remain important.
Dated events are ordered; spacing is schematic. Undated steps have no fixed timing. · Checked Sep 13, 2026. Read the topic research