The FDA has accepted for review the new drug application for clascoterone cream 1% and has set Aug. 27, 2020, as the Prescription Drug User Fee Act action date.
Clascoterone is a proposed first-in-class topical androgen receptor inhibitor under FDA review to treat acne and also in late-stage development to treat androgenetic alopecia in males, according to a press release from Cassiopea.
Clascoterone competes with androgens, specifically dihydrotestosterone, for binding to the androgen receptors within the sebaceous gland and hair follicles. The drug also inhibits lipid production from sebocytes and reduces proinflammatory cytokines, according to the release.
Last year, data were announced from two pivotal phase 3 clinical trials for clascoterone cream 1% showing statistically significant improvements for all primary endpoints.