Clascoterone

What clascoterone is and how it works

Clascoterone (Winlevi) is a prescription cream for acne vulgaris. It is the first widely available topical androgen receptor inhibitor -- it blocks androgen (male-hormone) activity directly in the skin's oil (sebaceous) glands, which is thought to reduce the excess oil production and inflammation that drive acne, without the systemic anti-androgen effects of oral acne medicines. (1) (2) (3)

Clascoterone is applied directly to acne-affected skin twice a day. It can cause hormone-axis changes (HPA-axis suppression) that are usually temporary and reverse after stopping treatment, and can irritate the skin, especially early in treatment. In the European Union specifically, it also carries a formal pregnancy-prevention programme with patient education cards, because of what has been observed in animal reproduction studies.

Mechanism of action: how clascoterone works

Clascoterone is a topical androgen receptor inhibitor. It competes with dihydrotestosterone (DHT) for binding to androgen receptors in the sebaceous gland and hair follicle, reducing androgen-driven sebum production and inflammatory signalling implicated in acne, while systemic exposure after cutaneous application is reported as negligible. (2) (1)

What clascoterone is used for

Before taking clascoterone

Do not take / not appropriate for

• Do not use clascoterone if you have a known hypersensitivity reaction to clascoterone or to any of the cream's other ingredients. (United Kingdom, European Union) (2)
• Do not apply clascoterone to broken skin, cuts, sunburned skin, or skin already irritated by other products, without your clinician's specific guidance. (all countries) (1)

Tell your clinician about

• If you are pregnant, planning a pregnancy, or breastfeeding -- this affects how clascoterone can be used, and in the European Union triggers a specific pregnancy-prevention discussion.
• Any history of adrenal or pituitary gland problems, given the observed effect on the HPA (hypothalamic-pituitary-adrenal) hormone axis.
• Any other topical products you are using on the same skin, especially other irritating or drying acne treatments.
• Whether you are under 12 years of age -- safety and effectiveness have not been established in children under 12 in the sources reviewed.

How to take clascoterone

• Cleanse and dry the affected skin before applying.
• Apply a thin, uniform layer (about 1 gram, roughly two fingertip units) to the affected area twice daily, in the morning and evening.
• For topical use only -- avoid the eyes, mouth, lips, and other mucous membranes.
• Your clinician will typically re-evaluate your response around 12 weeks of use.

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

If you miss an application, simply resume your normal twice-daily routine at the next scheduled time. Contact your clinician or pharmacist if you are unsure how to proceed, rather than doubling up the amount applied.

Overdose

Clascoterone cream is for external use on the skin only. If it is accidentally swallowed, or if a large amount is applied and you notice signs such as unusual dizziness, weakness, or other new symptoms, contact your clinician, pharmacist, or a poison-information service promptly. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Serious warnings

Interactions

• Systemic absorption of clascoterone through the skin is negligible, so interactions with medicines taken by mouth or injection are not expected in the sources reviewed. (2)
• Caution is advised when combining clascoterone with other medicines known to suppress the HPA (hormone) axis. (2)
• Avoid combining with other irritating or drying topical acne products on the same skin without your clinician's guidance, since combined irritation has not been separately studied. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Monitoring

Before starting

• Assessment of the acne-affected area and overall skin condition
• Discussion of pregnancy status/plans and contraception where the EU pregnancy-prevention programme applies

During treatment

• Clinical review of treatment response, typically around 12 weeks.
• Watching for signs of significant local irritation or HPA-axis effects, particularly in adolescents (where suppression was more frequent in the UK data reviewed).

Storage

Store at room temperature (68-77°F / 20-25°C); do not freeze. Discard 180 days after the pharmacy dispenses it, or 1 month after first opening the tube, whichever comes first.

Frequently asked questions

References

1. WINLEVI (clascoterone) cream, for topical use -- full prescribing informationU.S. Food and Drug Administration / DailyMed · United States · dated 2022-07 · accessed 2026-07-30 · source 1
2. Winlevi 10 mg/g cream -- Summary of Product Characteristicselectronic Medicines Compendium (UK) · United Kingdom · accessed 2026-07-30 · source 2
3. Winlevi -- European Public Assessment Report (EPAR) overviewEuropean Medicines Agency · European Union · dated 2025-10-17 · accessed 2026-07-30 · source 3
4. WINLEVI (clascoterone) -- Product MonographHealth Canada · Canada · dated 2023-06-15 · accessed 2026-07-30 · source 4
5. WINLEVI clascoterone 1% w/w cream tube -- ARTG 403948Therapeutic Goods Administration · Australia · dated 2024-03-12 · accessed 2026-07-30 · source 5
6. Winlevi (clascoterone 1% cream) -- New Zealand Data Sheet and Consumer Medicine InformationMedsafe (New Zealand Medicines and Medical Devices Safety Authority) · New Zealand · accessed 2026-07-30 · source 6

Brand names by country

Single-ingredient clascoterone names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries