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# Cassiopea NDA Filed for New Acne Cream
- URL: https://www.fdaweb.com/cassiopea-nda-filed-for-new-acne-cream/
- Published: 2019-11-08T12:00:00.000Z
- Updated: 2026-09-14T15:52:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145464

FDA has accepted for review a Cassiopea NDA for clascoterone cream 1% for treating acne. The agency has set a user fee review action target of 8/27\. Clascoterone is a new chemical entity and first-in-class topical androgen receptor inhibitor, which is also under development for treating under androgenetic alopecia (in a higher strength solution) in males.

“Although clascoterone’s exact mechanism of action is unknown, laboratory studies suggest clascoterone competes with androgens, specifically dihydrotestosterone (DHT), for binding to the androgen receptors within the sebaceous gland and hair follicles,” the company says. “Because of clascoterone's likely local effect at the site of application, the risk of off-target, or systemic side effects, is minimized.”