Androgen Receptor InhibitorPrescription OnlyPregnancy Cat. Not classifiedFDA Yes

Winlevi

CLASCOTERONE

1 INDICATIONS AND USAGE WINLEVI (clascoterone) cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. WINLEVI (clascoterone) cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. ( 1 )

Medically reviewed by MedCentralHub Medical Review Board, Licensed Pharmacists & Physicians · May 2026

Brand names:Winlevi

Rx Only

WinleviMedication

Quick Reference

Medicine ClassAndrogen Receptor Inhibitor

FDA ApprovedYes

PregnancyCategory Not classified

Check Interactions Dosage Details

Quick Facts

Active ingredient: CLASCOTERONE
Medicine class: Androgen Receptor Inhibitor
Brand names: Winlevi
Availability: Prescription only (Rx)
Pregnancy category: Not classified
FDA approved: Yes

Winlevi (CLASCOTERONE) medication overview

What Is Winlevi?

Winlevi (CLASCOTERONE) belongs to the Androgen Receptor Inhibitor class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.

Key Safety Information

•Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
•Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
•Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
•Avoid or limit alcohol while taking Winlevi. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
•Take Winlevi with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
•Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.

This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.

Uses & Indications

Winlevi is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.

1 INDICATIONS AND USAGE WINLEVI (clascoterone) cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

WINLEVI (clascoterone) cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Dosage Guide

The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.

Adult Dosage

2 DOSAGE AND ADMINISTRATION 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. ( 2 ) Not for ophthalmic, oral or vaginal use. ( 2 )

Available Forms

Available Strengths

View Complete Dosage Guide

Side Effects

Common

6 ADVERSE REACTIONS 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.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc.
1-800-818-4555 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In two identical multicenter, randomized, double-blind, vehicle-controlled trials, 1421 subjects 12 years and older with facial acne vulgaris applied WINLEVI cream or vehicle twice daily for 12 weeks.
Overall, 62% of the subjects were female, and 38% were male, 91% of the patients were Caucasian, and the mean age was 19.7 years.

Serious

5 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.
( 5.1 ) Hypothalamic-pituitary-adrenal (HPA) axis suppression may occur during or after treatment with clascoterone.
( 5.2 ) Attempt to withdraw use if HPA axis suppression develops.
( 5.2 ) Pediatric patients may be more susceptible to systemic toxicity.

Rare

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Medicine Interactions

Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.

MajorModerateMinor

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Warnings & Contraindications

5 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. ( 5.1 ) Hypothalamic-pituitary-adrenal (HPA) axis suppression may occur during or after treatment with clascoterone. ( 5.2 ) Attempt to withdraw use if HPA axis suppression develop

How Winlevi Works

12.1 Mechanism of Action Clascoterone is an androgen receptor inhibitor. The mechanism of action of WINLEVI cream for the topical treatment of acne vulgaris is unknown.

Pharmacokinetics

Absorption

Absorption Following topical treatment of WINLEVI cream for 2 weeks with a mean dose of approximately 6 grams applied twice daily to adult subjects with moderate to severe acne vulgaris (n=20), systemic concentrations of clascoterone were at steady state by Day 5

Metabolism

Metabolism Following topical treatment with WINLEVI cream, the plasma concentrations of cortexolone, a possible primary metabolite of clascoterone, were detectable and generally below or near the lowe

Excretion

Excretion Excretion of clascoterone has not been fully characterized in humans

Pregnancy & Breastfeeding Safety

Not classified

FDA Pregnancy Category Not classified

Consult your healthcare provider.

Full Pregnancy Information

Breastfeeding

Many medications pass into breast milk in varying amounts. Before using Winleviwhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.

Storage & Handling

Prior to Dispensing: Store the product in a refrigerator between 36°F and 46°F (2°C and 8°C). Do not freeze.

Frequently Asked Questions

Sources & References

• FDA Prescribing Information — Official labeling and package insert for Winlevi
• U.S. National Library of Medicine — MedlinePlus drug information
• American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
• PubMed / MEDLINE — View clinical studies

Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy

Medical Disclaimer

The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.