FDA-approved Winlevi® is the first novel topical mechanism for acne in nearly 40 years
Winlevi® (clascoterone) cream 1% is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years of age and older.
Our first-in-class topical androgen receptor inhibitor, Winlevi® tackles the androgen hormone component of acne in both males and females. Androgen receptor inhibitors act by limiting the effects of these hormones on increasing sebum production and inflammation.
In the pivotal phase 3 clinical program, comprising two identical-in-design, randomized, double-blind, placebo-controlled phase 3 studies, Winlevi® demonstrated a significantly higher treatment success and reduction in acne lesion count (inflammatory and non-inflammatory lesions) as compared to placebo, and was well tolerated when used twice a day1. The most frequently observed local skin reaction was mild erythema.
A pooled analysis of efficacy of the 2 pivotal studies in the target intended population (i.e., subjects 12 years of age or older) was very recently published in Journal of Drugs in Dermatology2.
Approved by FDA, Health Canada and Australia (TGA)
In August 2020, Winlevi® (clascoterone cream 1%) received FDA approval for the topical treatment of acne vulgaris in patients 12 years of age and older.
In June 2023, our partner Sun Pharmaceutical Industries Limited (“Sun Pharma”) received marketing authorization (“Notice of Compliance”) from Health Canada for Winlevi® (clascoterone cream 1%). For more information visit www.sunpharma.com/canada
In March 2024, our partner Sun Pharmaceutical Industries Limited (“Sun Pharma”) received regulatory approval from the Australian Therapeutic Goods Administration (TGA) for Winlevi® (clascoterone cream 1%).
Winlevi® will be available in Australia as of June 2024. For more information, visit https://sunpharma.com/australia.
Submitted Marketing Authorisation to European Medicine Agency (EMA)
In October 2023, Cosmo officially submitted the Marketing Authorisation Application (MAA) for its innovative acne treatment clascoterone 1% cream (Winlevi®) to the European Medicine Agency (EMA) through the centralized procedure, aimed at obtaining a single Marketing Authorization for the product in the European Union.
The company is exploring commercial partnerships for Winlevi® for other remaining territories.
For more information on Winlevi®, please visit https://www.winlevi.com
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1 Herbert et al. JAMA Dermatol. 2020. 156(6):621-630
2Herbert et al. J Drugs Dermatol. 2023. 22(2):174-181
