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First-in-Class Topical Treatment Clascoterone Launches in US to Treat Acne Vulgaris


The first FDA-approved acne drug with a first-in-class mechanism of action in nearly 40 years launched in the United States in November 2021 after being approved in August 2020.

The first-in-class topical treatment for acne vulgaris, clascoterone (Winlevi, Sun Pharmaceuticals) cream 1%, has officially launched in the United States. The topical androgen receptor inhibitor was first approved by the FDA in August 2020 to treat patients 12 years and older who have acne vulgaris. The cream launched in November 2021 in the United States.

The therapy represents the first FDA-approved acne drug with a first-in-class mechanism of action in nearly 40 years. It works by inhibiting the effects of androgen receptors. Androgens largely drive sebum (oil) production and inflammation.

“Androgen receptor inhibition has long been the missing link in the topical management of acne vulgaris,” Julie Harper, MD, founding director and past president of the American Acne and Rosacea Society, said in a statement. "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.”

Acne affects up to 50 million Americans annually and is the most prevalent skin condition in the United States. Previous conventional topical approaches focused on addressing follicular hyperkeratinization, reducing inflammation, or exerting antibacterial effects.

Clascoterone was approved based on data from 2 double-blind, vehicle-controlled phase 3 trials in a total of 1440 patients.1 The trials randomized patients to receive clascoterone (n = 722) or vehicle cream (n = 718) and apply approximately 1 g to the whole face twice daily for 12 weeks.

At the end of 12 weeks, one trial had a success rate of 18.4% for clascoterone vs 9.0% for the vehicle cream and the other trial had success rates of 20.3% vs 6.5%, respectively. Clascoterone significantly reduced absolute noninflammatory lesions from baseline to –19.4 in both trials compared with the vehicle cream (–13.0 and –10.8). There was also a significant reduction in inflammatory lesions from baseline to ­−19.3 and –20.0 compared with vehicle cream (–15.5 and –12.6).

Adverse event (AE) rates were low and mostly mild. The most common AEs occurring in 7% to 12% of patients receiving closcoterone were erythema, pruritus, and scaling/dryness. Edema, stinging, and burning occurred in at least 3% of patients and in a similar percentage of patients receiving the vehicle cream. Pediatric patients may be more susceptible to systemic toxicity.

"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," said Abhay Gandhi, CEO, North America of Sun Pharma.

Clascoterone should be applied twice daily—once in the morning and once in the evening—to clean and dry skin.


1. 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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