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# Cassiopea First-in-Class Acne Drug Approved
- URL: https://www.fdaweb.com/cassiopea-first-in-class-acne-drug-approved/
- Published: 2020-08-27T12:00:00.000Z
- Updated: 2026-09-14T16:26:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147527

FDA has approved a Cassiopea NDA for Winlevi (clascoterone cream 1%) for treating acne in patients 12 years and older. The approval represents the first new mechanism of action for an acne drug in almost 40 years, the company says. The drug targets the androgen receptors directly in the skin to curb excess oil production. Approval was based on clinical trial data that demonstrated reductions in acne lesions, and according to Cassiopea the drug was well tolerated when used twice a day. The most frequently observed local skin reaction was mild erythema, it says. Complete prescribing information is available on [www.winlevi.com](https://www.winlevi.com/?ref=fdaweb.com).