Uses
WINLEVI (clascoterone) cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Source: US FDA prescribing information
- Presentations
- 1
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Clascoterone is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. It is available as cream for topical use. MedsAcross supplies Clascoterone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Androgen Receptor Inhibitor, Androgen Receptor Antagonists
- ATC classification
- D10AX06 Clascoterone · Acne treatments, subgroup D10A, subgroup D10AX
- US FDA first approval
- 26 August 2020
- EU status
- Authorised
- Orphan designation
- No
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Topical
- Dosage forms
- Cream
- Identifiers
- UNII XN7MM8XG2MCAS 19608-29-8DrugBank DB12499Q27293917
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
Clascoterone is an androgen receptor inhibitor. The mechanism of action of WINLEVI cream for the topical treatment of acne vulgaris is unknown.
Source: US FDA prescribing information
Dosing overview
Cleanse the affected area gently. After the skin is dry, apply a thin uniform layer of WINLEVI cream twice per day, in the morning and the evening, to the affected area. Avoid accidental transfer of WINLEVI cream into eyes, mouth or other mucous membranes. If contact with mucous membranes occurs, rinse thoroughly with water. WINLEVI cream is for topical use only. WINLEVI cream is not for ophthalmic, oral or vaginal use. Apply a thin layer (approximately 1 gram) to affected area twice daily (morning and evening). Avoid contact with eyes, mouth, and mucous membranes. Not for ophthalmic, oral or vaginal use.
Source: US FDA prescribing information
Contraindications
None. None
Source: US FDA prescribing information
Warnings and precautions
Local Irritation: Pruritus, burning, skin redness or peeling may be experienced with WINLEVI cream. If these effects occur, discontinue or reduce the frequency of application of WINLEVI cream. Hypothalamic-pituitary-adrenal (HPA) axis suppression may occur during or after treatment with clascoterone. Attempt to withdraw use if HPA axis suppression develops. Pediatric patients may be more susceptible to systemic toxicity. Hyperkalemia: Elevated potassium levels were observed in some subjects during the clinical trials.
Source: US FDA prescribing information
Side effects
Most common adverse reactions occurring in 7 to 12% of patients are erythema/reddening, pruritus and scaling/dryness. Additionally, edema, stinging, and burning occurred in >3% of patients and were reported in a similar percentage of subjects treated with vehicle. or http://www.fda.gov/medwatch.
Source: US FDA prescribing information
Storage
Store the product in a refrigerator between 36°F and 46°F (2°C and 8°C). Do not freeze. Dispensing Instructions for the Pharmacist: Direct the patient to store the product while in use at room temperature, between 68°F and 77°F (20°C to 25°C). Do not freeze.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
1 presentations of Clascoterone, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Winlevi 1% creamTopical Cold chain | Sun Pharmaceutical IndustriesIndia | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Indian manufacturers are highlighted.
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Questions and answers
Is Clascoterone available for export from India?
Yes, on request. MedsAcross lists 1 presentations of Clascoterone and sources them for licensed hospitals, importers and physicians against valid import documents. Indian manufacturers include Sun Pharmaceutical Industries.
What brand names does Clascoterone have?
The catalogue lists 1 brand names for Clascoterone, including Winlevi.
Is Clascoterone approved by the US FDA?
Yes. The US FDA first approved Clascoterone on 26 August 2020, according to Drugs@FDA.
Is Clascoterone authorised in the European Union?
Yes. Clascoterone has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
Does Clascoterone need cold chain shipping?
At least one listed presentation of Clascoterone must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Which ATC class is Clascoterone in?
Clascoterone is classified under ATC code D10AX06 (Clascoterone).
References
- Winlevi prescribing information (Sun Pharmaceutical Industries). U.S. National Library of Medicine, DailyMed. Retrieved 2 January 2025
- Winlevi: European public assessment report (EPAR). European Medicines Agency. Retrieved 10 November 2026
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