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Clascoterone Cream Now Available in US


Sun Pharma has announced that their Winlevi 1% cream is now available in the US to treat acne vulgaris in patients 12 years and older.

Clascoterone (Winlevi, Sun Pharma) 1% cream, after being FDA approved in August of 2020 for the topical treatment of acne vulgaris in patients 12 years and older, is now available in the United States (US).1

It is the first FDA-approved treatment for acne with a first-in-class mechanism of action in neatly 40 years, according to the press release. Clascoterone cream 1%, a first-in-class androgen receptor inhibitor, restricts sebum production and inflammation caused by androgen hormones.

“The US launch of Winlevi enhances Sun Pharma’s specialty product portfolio and reflects our commitment to meeting patients’ needs by providing innovative dermatology medicines,” said Abhay Gandhi, CEO, North America of Sun Pharma, Princeton, New Jersey. “With its safety and tolerability profile, combined with its demonstrated efficacy in clinical trials, Winlevi has the potential to be an important topical treatment option for the millions of Americans affected by acne vulgaris.”

The most common adverse events [AEs] were erythema, pruritus, and scaling/dryness (occurring in 7%-12% of treated patients). Other AEs were edema, stinging, and burning, but a similar percentage of patients in both the vehicle and clascoterone arms experienced this.

“Androgen receptor inhibition has long been the missing link in the topical management of acne vulgaris,” noted Julie Harper, MD, founding director and past president of the American Acne and Rosacea Society, Birmingham, Alabama. “Androgens are the most important hormone in regulating sebum production – which is a major cause of acne in both males and females – yet Winlevi is the first FDA-approved topical therapy to address this and does so without inducing the systemic side effects associated with oral androgen receptor inhibitors. The availability of Winlevi is thus a welcome acne treatment option.”


1. Acne vulgaris treatment Winlevi now available. Medical Bag. Published November 1, 2021. Accessed November 1, 2021. https://www.medicalbag.com/home/news/acne-vulgaris-treatment-winlevi-now-available/

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