Clascoterone

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

• 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.ICD-10: L70.0

• None.contraindicated

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 )

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. ( 5.2 , 8.4 ) Hyperkalemia: Elevated potassium levels were observed in some subjects during the clinical trials. ( 12.2 ) 5.1 Local Skin Reactions WINLEVI cream may induce local irritation (erythema/redness, pruritus, scaling/ dryness). Concomitant use with other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect and products with high concentrations of alcohol, astringents, spices or lime) should be limited. The product should not be applied to cuts, abrasions, eczematous or sunburned skin. 5.2 Hypothalamic-pituitary-adrenal (HPA) Axis Suppression Hypothalamic-pituitary-adrenal (HPA) axis suppression was observed and may occur during or after treatment with clascoterone. In the PK trial, all subjects returned to normal HPA axis function at follow-up 4 weeks after stopping treatment [see Clinical Pharmacology (12.2) ]. Conditions which augment systemic absorption include use over large surface areas, prolonged use, and the use of occlusive dressings. If HPA axis suppression develops, an attempt should be made to withdraw the drug.

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. Local skin reactions (edema, erythema/redness, pruritus, scaling/dryness, skin atrophy, stinging/burning, striae rubrea, telangiectasia) were observed during the 12-week treatment and occurred in a similar percentage of subjects treated with vehicle. Local skin reactions reported by ≥ 1% of subjects treated with WINLEVI cream are shown in the following table. Table 1.

8.1 Pregnancy Risk Summary There are no available data on WINLEVI cream use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneous administration of clascoterone to pregnant rats and rabbits during organogenesis at doses 8 or 39 times the maximum recommended human dose (MRHD), respectively, increased malformations in rats and post-implantation loss and resorptions in rabbits (see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryofetal development study, clascoterone was administered subcutaneously to pregnant rats at doses of 1, 5, or 25 mg/kg/day during the period of organogenesis. No clascoterone-related maternal toxicity or effects on uterine parameters were noted at doses up to 25 mg/kg/day (336 times the MRHD based on AUC comparison). Clascoterone-related malformations were noted at all dose levels, without a dose relationship. Omphalocele was noted in a single fetus at each dose level.

Metabolism

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. On Day 14, the mean ± SD maximum plasma concentration (C max ) was 4.5 ± 2.9 ng/mL, the mean ± SD area under the plasma concentration-time over the dosing interval (AUC ꞇ ) was 37.1 ± 22.3 h*ng/mL and the mean ± SD average plasma concentration (C avg ) was 3.1 ± 1.9 ng/mL.

• Aug 26, 2020NDANDA213433Sun Pharm

1. 1Product Storage Error33324%
2. 2Product Physical Consistency Issue32923%
3. 3Product Use Complaint28620%
4. 4Product Dose Omission Issue18313%
5. 5Product Use Issue15211%
6. 6Drug Ineffective14510%
7. 7Therapy Cessation866.1%
8. 8Poor Quality Product Administered846.0%
9. 9Product Physical Issue785.5%
10. 10Condition Aggravated755.3%
11. 11Product Quality Issue674.8%
12. 12Acne463.3%
13. 13Off Label Use382.7%
14. 14Erythema292.1%
15. 15Liquid Product Physical Issue251.8%

The 10 most recently updated of 21 ClinicalTrials.gov registrations naming Clascoterone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss
  Completed · Phase 3 · Interventional · 703 enrolled · Cassiopea SpA
  NCT05910450updated 2026-06-08
• Clascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 18 enrolled · Stanford University
  NCT05891795updated 2026-04-30
• 1% Clascoterone Cream for the Treatment Acne Vulgaris
  Not yet recruiting · Phase 3 · Interventional · 692 enrolled · Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.
  NCT07457294updated 2026-03-09
• Topical Anti-Androgens in Pilonidal Sinus Disease
  Recruiting · Phase 2 · Interventional · 75 enrolled · University of Pennsylvania
  NCT06286397updated 2026-02-27
• A Study to Assess Sebaceous Gland Changes and Constituents of Sebum (Skin Oil) Induced by Clascoterone 1% Cream in Acne Patients
  Active not recruiting · Phase 4 · Interventional · 10 enrolled · Sun Pharmaceutical Industries Limited
  NCT06425900updated 2026-01-21
• A Study Evaluating the Efficacy and Safety of Clascoterone Cream 1% in Skin of Color Patients With Acne
  Completed · Phase 4 · Interventional · 10 enrolled · Sun Pharmaceutical Industries Limited
  NCT06415305updated 2026-01-16
• A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP2)
  Completed · Phase 3 · Interventional · 762 enrolled · Cassiopea SpA
  NCT05914805updated 2025-12-22
• A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne
  Completed · Phase 4 · Interventional · 20 enrolled · Sun Pharmaceutical Industries Limited
  NCT06336603updated 2025-10-09
• A Study Assessing the Efficacy and Safety of Combined Use of Clascoterone 1% Cream and Duac Gel (Benzoyl Peroxide/Clindamycin) for the Treatment of Acne
  Completed · Phase 4 · Interventional · 10 enrolled · Sun Pharmaceutical Industries Limited
  NCT06336629updated 2025-07-17
• Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris
  Recruiting · Phase 3 · Interventional · 692 enrolled · Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.
  NCT06403501updated 2025-07-09

Frequently asked questions

How does Clascoterone work?

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

What is Clascoterone used for?

According to FDA labeling, Clascoterone carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Clascoterone?

Clascoterone is classified as Other anti-acne preparations for topical use, Androgen Receptor Inhibitor, Androgen Receptor Antagonists.

What are the brand names for Clascoterone?

Clascoterone is marketed under brand names including Winlevi.

What are the contraindications for Clascoterone?

Clascoterone labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.