SkinActive ingredient
Clascoterone
Androgen receptor inhibitor1 FDA label read
Clascoterone is sold as Winlevi and stands alone in this category by mechanism: it is a topical androgen receptor inhibitor, approved for acne in patients 12 years of age and older. Every other acne medication on these pages works through retinoid receptors, bacteria or keratin - this one addresses androgen signaling in the skin.
Highlights of the labels
- Winlevi
- Acne in patients 12 and oldercovers skin
- Supply
- Prescription only
- Generic
- None approved
- Boxed warning
- None in these labels
Brands and what each one is approved for
One active ingredient can hold several separate FDA approvals. They are different documents with different approved uses, and mixing them up is the most common mistake made about these medications.
| Brand | What its label approves | Supply | Label version |
|---|---|---|---|
| WinleviSun Pharmaceutical Industries, Inc. | What its label approvesAcne in patients 12 and olderCovers skin | SupplyPrescription | Label version2 January 2025 |
How it works
Clascoterone inhibits the androgen receptor. Its label is unusually candid about the limits of that statement: the mechanism of action of the cream for the topical treatment of acne is unknown. It is applied as a thin layer twice a day to cleansed skin.
Mechanism of action, Winlevi label
Clascoterone is an androgen receptor inhibitor. The mechanism of action of WINLEVI cream for the topical treatment of acne vulgaris is unknown.
What the FDA approved it for
The approved uses, as worded in the label.
WINLEVI (clascoterone) cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Forms and strengths
The presentations and strengths listed in the label.
- 3 DOSAGE FORM AND STRENGTHS Cream 1%.
- Each gram of WINLEVI cream contains 10 mg of clascoterone in a white to almost white cream.
How the label says it is taken
What the label states about administration. It is not a dosing instruction for any individual.
- 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.
Most common adverse reactions
The adverse reactions the label reports as most common.
Most common adverse reactions occurring in 7 to 12% of patients are erythema/reddening, pruritus and scaling/dryness.
Warnings and precautions
The warnings and precautions section of the label.
- 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.
Contraindications
Situations in which the label states the medication must not be used.
None. The label states that there are no contraindications.
Pregnancy and breastfeeding
The opening of the pregnancy section of the label. The full section is longer and is in the source document.
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...
Generic or brand
There is no FDA-approved generic clascoterone: the register lists the brand application only.
The FDA label database lists no approved generic application for this ingredient.
What affects the cost
Winlevi is brand-only, and the acquisition cost below is a brand price. What a person pays depends on insurance coverage. This site sells nothing and links to no sellers.
What pharmacies pay for it
These are acquisition costs: what pharmacies in the United States pay on average to buy the medication, published weekly by the Centers for Medicare and Medicaid Services. They are not retail prices and not what a person pays at the counter, which depends on insurance, pharmacy and discount programs. They are useful as an objective floor and for seeing how far a brand sits above its generic.
| Measured | Brand |
|---|---|
| per gram | Brand$9.99 (range $9.79 to $10.00, 34 listings) |
Median of 34 listings. Effective dates 2025-12-17 to 2026-08-19, file dated 2026-08-26.
Compared with other medications
What the labels do not do is compare one medication against another. These pages put two of them side by side.
Common questions
- Is Winlevi a hormone treatment?
- Its label calls it an androgen receptor inhibitor applied to the skin, and separately warns that suppression of the hypothalamic-pituitary-adrenal axis may occur during or after treatment, with an instruction to attempt withdrawal if it develops. What that means for a particular person is a question for a clinician.
- How does Winlevi differ from spironolactone for acne?
- Winlevi is approved for acne; spironolactone is not. The spironolactone label covers heart failure, hypertension, edema and primary hyperaldosteronism, and acne appears nowhere in it. The comparison page sets the two documents side by side.
- From what age is Winlevi approved?
- The label covers patients 12 years of age and older.
Other medications under skin
Whether each one carries an FDA approval for this use is marked on its page and in this list.
Sources
Every fact above comes from one of these documents. The date is the effective date of the label version this page was built from.
FDA prescribing information for Winlevi
Sun Pharmaceutical Industries, Inc.. Label version 8, effective 2 January 2025.
Each stripe is one section of the label, each division in a stripe one entry in that section.
Page last updated 29 August 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.