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clascoterone

Winlevi · ATC code D10AX06

Also known as: Clascoteron

Key facts
Active substance
clascoterone
ATC code
D10AX06
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Winlevi 10 mg/g cream
Marketing authorisation holder
Cassiopea S.p.A.
Information as of
2026-10-27

Key facts

Clascoterone is a topical androgen receptor inhibitor cream used to treat acne vulgaris in adults and adolescents.

What it is used for

  • Adults: acne vulgaris (face, chest and/or back)
  • Adolescents from 12 to <18 years: facial acne vulgaris

Dosing

  • Thin layer twice a day, morning and evening, at least eight hours apart.
  • Adults: no more than ten fingertip units per day (approximately 5 g of cream).
  • Adolescents: no more than four fingertip units per day (approximately 2 g), face only, no more than 60 g a month.
  • Treatment for three months recommended, then regular physician assessment every three months.
  • Not recommended from 65 years; do not apply to broken, eczematous or sunburned skin or under occlusion.

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Pregnancy

Important warnings

  • Hypothalamic-pituitary-adrenal axis suppression (laboratory-based, resolved after discontinuation)
  • Avoid use over large surfaces, prolonged use and occlusive dressings
  • Symptoms such as fatigue, weight loss, low blood pressure or hypoglycaemia should be reported to the physician
  • Earlier evaluation may be needed in adolescents

Side effects

  • Local skin reactions: erythema (11.5%), scaling/dryness (10.0%)
  • Pruritus (7.4%), stinging/burning (4.0%)
  • These reactions were usually self-limiting

Interactions

  • No interaction studies; use with other cutaneous products not evaluated
  • Caution with concomitant glucocorticoids
  • An interaction with hormonal contraception cannot be excluded

Pregnancy and breastfeeding

  • Contraindicated in pregnancy; verify pregnancy status before starting.
  • Women of childbearing potential: effective contraception during treatment and for at least 10 days after the last dose.

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • WinleviCassiopea S.p.A. · EMEA/H/C/006138

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Winlevi
Liechtenstein
Winlevi
Norway
Winlevi

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Winlevi – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/winlevi-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.