Clascoterone
Winlevi · ATC code D10AX06
Also known as: Clascoteron, Klaskoteron, Clascotérone, Clascoterona
- 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 on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
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.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Winlevi – EPAR, Product Information. 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.