• TRADE NAME: Winlevi (Cassiopea)
  • INDICATIONS: Topical treatment of acne vulgaris
  • SYNONYM: Cortexolone 17α-propionate
  • CLASS: Androgen receptor inhibitor
  • HALF-LIFE: Excretion of clascoterone has not been fully characterised in humans.
  • FDA APPROVAL DATE: 08/26/2020
  • CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:
    No clinical studies evaluating the drug interaction potential of clascoterone (cream) have been conducted.
  • PREGNANCY: No available data to assess drug-associated risk of clascoterone in pregnant women.

Formulated as a cream with cetyl alcohol and other excipients. Local skin reactions (edema, erythema/redness, skin atrophy, stinging/burning, striae rubrea, telangiectasia) were observed during a treatment period with clascoterone cream, and occurred in a similar percentage of subjects treated with the vehicle cream.

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Page last updated 07/31/2023

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Incidence

<1% 1‑5% 5‑10% 10‑15% 15‑20% 20‑30% >30%

Seriousness

Hospitalization possible
Life threatening
Fatal

Warnings in other populations

BreastfeedingBreast feeding

GeriatricGeriatric

PediatricPediatric