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FDA Approves First Topical Androgen Receptor Inhibitor for Acne

The FDA recently approved clascoterone cream 1% for the treatment of acne in patients aged 12 years or older.1 This is the first FDA-approved treatment in 40 years to target a new mechanism of action for acne.

Clascoterone cream 1% is an androgen receptor inhibitor that is thought to compete with androgens, specifically dihydrotestosterone, for binding to the androgen receptors in sebaceous glands and hair follicles. Two phase 3 clinical trials showed clascoterone cream 1% achieved treatment success, reduced acne lesions, and had a favorable safety profile compared with vehicle.2

Clascoterine is intended for twice-daily application. The most commonly reported adverse effect was mild erythema.1 Other reported adverse effects included pruritus, burning, edema, and peeling. Hypothalamic-pituitary-adrenal axis suppression was observed in one adult participant and two adolescent participants. Elevated potassium was observed in 5% of participants, though this was also observed in 4% of participants in the vehicle group.


1. Cassiopea. Cassiopea receives FDA approval for Winlevi® (clascoterone cream 1%), first-in-class topical acne treatment targeting the androgen receptor. Press release. PR newswire; August 27, 2020. Accessed August 31, 2020.

2. Hebert A, Thiboutot D, Stein Gold L, et al. efficacy and safety of topical clascoterone cream, 1%, for treatment in patients with facial acne: two phase 3 randomized clinical trials. JAMA Dermatol. 2020;156(6):621-630. doi:10.1001/jamadermatol.2020.0465

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