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Winlevi FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 3, 2020.

FDA Approved: Yes (First approved August 26, 2020)
Brand name: Winlevi
Generic name: clascoterone
Dosage form: Cream
Company: Cassiopea SpA
Treatment for: Acne

Winlevi (clascoterone) cream is a first-in-class topical androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

  • Although the exact mechanism of action of clascoterone is unknown, laboratory studies suggest that it competes with androgens, specifically dihydrotestosterone (DHT), for binding to the androgen receptors within the sebaceous gland and hair follicles.
  • Winlevi is administered by applying a thin layer (approximately 1 gram) to the affected area twice daily (morning and evening).
  • Common adverse reactions occurring in 7 to 12% of patients include erythema/reddening, pruritus and scaling/dryness. Additionally, edema, stinging, and burning occurred in >3% of patients and were reported in a similar percentage of subjects treated with vehicle.

Development Timeline for Winlevi

DateArticle
Aug 27, 2020Approval  FDA Approves Winlevi (clascoterone) Cream for the Treatment of Acne
Nov  8, 2019Cassiopea Announces FDA Acceptance of its New Drug Application for Clascoterone Cream 1%
Aug 20, 2019Cassiopea Announces FDA Submission of New Drug Application for Clascoterone Cream 1%

Further information

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