Winlevi

Opinion

EMA has issued an opinion on this medicine

clascoterone

Overview

On 25 August 2025, the Committee for Medicinal Products for Human Use (CHMP), following a re-examination procedure, adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Winlevi, intended for the treatment of facial acne vulgaris in adolescents and acne vulgaris in adults.

The applicant for this medicinal product is Cassiopea S.p.A.

Winlevi contains the active substance clascoterone for topical use and will be available as 10 mg/g cream (ATC code: D10AX06). Clascoterone is an androgen receptor inhibitor that showed to antagonize the effects of androgens in primary human sebocytes in vitro. This reduces sebum production and the accumulation of inflammatory mediators, which are known drivers of acne pathogenesis.

The benefits of Winlevi were shown in two pivotal Phase 3 studies in adults and adolescents. After 3 months of twice daily application on the face, a greater proportion of patients responded to treatment with Winlevi than to vehicle. Response was defined as an investigator’s global assessment (IGA) score of 0 (clear skin) or 1 (almost clear skin) on a 5-point scale and an IGA reduction of at least 2-points compared to baseline. Across the two studies, the proportion of responders was 19.5% with Winlevi, compared with 7.7% with vehicle. In patients with a baseline IGA of 3 (moderate acne), the success rate was 18.9% with Winlevi and 6.6% with vehicle, and in those with baseline IGA of 4 (severe acne), it was 10.4% and 1.8% respectively.

The most common side effects are local skin reactions such as erythema, scaling/dryness, pruritus and stinging/burning.

The full indication is:

Adults

Winlevi is indicated for the treatment of acne vulgaris.

Adolescents (from 12 to < 18 years of age)

Winlevi is indicated for the treatment of facial acne vulgaris.

Treatment with Winlevi should be initiated and supervised by a physician experienced in the diagnosis and treatment of acne vulgaris.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Winlevi

Adopted Reference Number: EMA/CHMP/244647/2025

Product details

• Name of medicine:
  Winlevi
• Active substance:
  clascoterone
• International non-proprietary name (INN) or common name:
  clascoterone
• Therapeutic area (MeSH):
  Acne Vulgaris
• Anatomical therapeutic chemical (ATC) code:
  D10AX06
• EMA product number:
  EMEA/H/C/006138
• Marketing authorisation applicant:
  Cassiopea S.p.A.
• Opinion adopted:
  25/08/2025
• Opinion status:
  Positive