Winlevi® (clascoterone cream 1%) is now available for the topical treatment of acne vulgaris in patients 12 years and older.

Winlevi, a topical androgen receptor inhibitor, targets androgen receptors at the application site, inhibiting the local effects of dihydrotestosterone, a key driver of acne lesion development.

The approval of Winlevi was based on data from 2 double-blind, vehicle-controlled phase 3 trials in 1440 patients with facial acne vulgaris; among these trials, there were 641 pediatric patients aged 12 to 18 years. 

The most common adverse reactions reported with Winlevi include erythema/reddening, pruritus and scaling/dryness. Pediatric patients may be more susceptible to systemic toxicity (eg, hypothalamic-pituitary-adrenal axis suppression).


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Winlevi is supplied in a 60g tube. Each gram contains 10mg of clascoterone in a cream formulation.

Winlevi is applied twice daily (morning and evening) to the affected area. The cream should not be applied to damaged skin, eczematous areas, or sunburned skin. Concomitant use of other potentially irritating topical products should be avoided.

References

  1. Sun Pharma announces availability of Winlevi® (clascoterone) cream 1% in the US for topical treatment of acne vulgaris. News release. November 1, 2021. https://www.prnewswire.com/news-releases/sun-pharma-announces-availability-of-winlevi-clascoterone-cream-1-in-the-us-for-topical-treatment-of-acne-vulgaris-301412078.html.
  2. Winlevi. Package insert. Sun Pharma; 2021. Accessed November 1, 2021. https://www.winlevi.com/pdf/winlevi-prescribing-information.pdf.