EU: The European Medicines Agency (EMA) issued a positive recommendation for the approval of clascoterone in August 2025. The final decision of the EU Commission is expected shortly.

USA: Winlevi® Cream was approved in the USA in 2020.

Clascoterone, sold as Winlevi® Cream 1%, is a prescription topical acne medication. It represents a new class of drugs that specifically treats the hormonal causes of acne.

Mechanism of Action

Clascoterone is the first topical androgen receptor inhibitor. It works by blocking androgen receptors in the sebaceous glands, thereby inhibiting the action of hormones such as dihydrotestosterone (DHT). This results in:

Reduction of sebum production: Less sebum in the pores helps deprive blackheads and acne-causing bacteria of their livelihood.

Reduction of inflammation: Interrupting hormonal signals helps reduce inflammatory responses.

Minimal systemic effect: Topical application results in minimal absorption of the active ingredient into the bloodstream, thus avoiding systemic hormonal effects.

A detailed description can be found here: Clascoterone