Winlevi
Winlevi 60GM of 1%
What is Winlevi?
Winlevi (clascoterone cream 1%) is a novel topical medication approved by the FDA for the treatment of acne in patients aged 12 years and older. It functions as an androgen receptor inhibitor, specifically targeting the hormonal causes of acne without the systemic side effects associated with other hormonal treatments. This medication provides a targeted approach by reducing sebum production and inflammation directly at the skin level.Side Effects
- Color changes on the skin, dark freckles, easy bruising, muscle weakness, round, puffy face
- Blisters, swelling, rash, or red, scaly, crusty skin
- Severe skin itching, burning, redness, peeling, or pain
Warnings
- Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
- This medicine may cause the following problems:Skin reactionsAdrenal or pituitary gland problems
- Tell your doctor if you are pregnant or breastfeeding, or if you have eczema, other skin problems, or sunburn.
- Call your doctor if your symptoms do not improve or if they get worse.
- Keep all medicine out of the reach of children. Never share your medicine with anyone.
Prescription savings · · · ·
What is Winlevi ?
Winlevi (clascoterone cream 1%) is a novel topical medication approved by the FDA for the treatment of acne in patients aged 12 years and older. It functions as an androgen receptor inhibitor, specifically targeting the hormonal causes of acne without the systemic side effects associated with other hormonal treatments. This medication provides a targeted approach by reducing sebum production and inflammation directly at the skin level.- Color changes on the skin, dark freckles, easy bruising, muscle weakness, round, puffy face
- Blisters, swelling, rash, or red, scaly, crusty skin
- Severe skin itching, burning, redness, peeling, or pain
- Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
- Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
- This medicine may cause the following problems:Skin reactionsAdrenal or pituitary gland problems
- Tell your doctor if you are pregnant or breastfeeding, or if you have eczema, other skin problems, or sunburn.
- Call your doctor if your symptoms do not improve or if they get worse.
- Keep all medicine out of the reach of children. Never share your medicine with anyone.
- Topical application routeDo not use this medicine to treat a skin problem your doctor has not examined.
Winlevi Coupons & Prices
Winlevi 60GM of 1%
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Looking for a Winlevi coupon? Winlevi (clascoterone) is a brand-only prescription cream for acne, and there is no generic version, so what you pay can swing widely from pharmacy to pharmacy. Rx.com gives you a free cash-price discount coupon you can use at most major U.S. pharmacies, whether you are uninsured, on Medicare, or your plan will not cover this cream. Enter your ZIP code above to see today's price near you, then show the coupon at the pharmacy counter. There is nothing to sign up for and no membership required.
What is Winlevi (clascoterone) and how does it work?
Winlevi is a topical cream approved by the FDA for treating acne vulgaris in people 12 years of age and older. The active ingredient, clascoterone, is an androgen receptor inhibitor. Importantly, the FDA label is explicit that the mechanism of action of Winlevi cream for the topical treatment of acne is unknown. Researchers believe it works by competing with androgens such as DHT at receptors in the skin's oil glands and hair follicles, which is thought to reduce sebum production and the inflammatory signals involved in acne, but that explanation is a working theory rather than an established fact. When it was approved in August 2020, it was the first genuinely new mechanism for treating acne to reach the market in roughly 40 years.
The label instructions are to apply a thin layer (approximately one gram) to the affected areas twice a day, morning and evening. It is for use on the skin only, and not for ophthalmic, oral, or vaginal use. Because clascoterone is applied to the skin and is believed to act locally rather than throughout the body, it is prescribed for both women and men, which is different from oral spironolactone. Pharmacies keep Winlevi refrigerated until it is dispensed; once you take it home, you store it at room temperature. The label also tells you to discard any unused cream 180 days after the date it was dispensed, or 1 month after you first open the tube, whichever comes first.
Winlevi cost: manufacturer savings card vs. the Rx.com cash coupon
Two very different kinds of savings exist for Winlevi, and it helps to know which one applies to you. The manufacturer, Sun Dermatology, runs an official copay savings program that is described on the brand's own website (winlevi.com). Like most brand copay cards, it is generally limited to people with commercial (employer or marketplace) insurance, and it typically excludes anyone with Medicare, Medicaid, TRICARE, or other government coverage. Eligibility rules, expiration dates, and how much it takes off vary, so read the manufacturer's current terms before you count on it. Ask your dermatologist's office or the manufacturer directly whether any patient assistance is available if you cannot afford the medicine.
The Rx.com coupon works differently. It is a cash-price discount, not insurance, so it is the option to reach for when:
- You have no prescription coverage at all.
- You are on Medicare or another government plan and the manufacturer card is not allowed.
- Your insurance denies Winlevi, or the pharmacy tells you the copay card was declined.
- Your plan's price is higher than the cash price.
You cannot combine a cash coupon with insurance on the same fill, so ask the pharmacist to run both and use whichever is lower. Prices vary from pharmacy to pharmacy, so it is worth comparing before you fill. Enter your ZIP code above to see today's Winlevi price at pharmacies near you. Note that there is no FDA-approved generic clascoterone cream on the market, so the usual "switch to the generic" savings lever is not available for this one yet.
Winlevi alternatives and how it compares
Winlevi is often added to an acne routine rather than replacing it, and in real-world practice it is frequently used alongside a retinoid or benzoyl peroxide, though those combinations were not formally studied in the pivotal trials. Other commonly prescribed acne treatments, all of which are available as generics, include:
- Tretinoin and adapalene — topical retinoids that unclog pores and speed skin turnover.
- Clindamycin — a topical antibiotic for inflammatory acne, usually paired with benzoyl peroxide.
- Doxycycline — an oral antibiotic used for moderate to severe inflammatory acne.
- Spironolactone — an oral anti-androgen used off-label for hormonal acne, most often in women; it is rarely used for acne in men because of antiandrogen side effects, though it is sometimes prescribed for men and for transgender patients on feminizing hormone therapy.
- Isotretinoin — an oral retinoid reserved for severe or scarring acne, with strict monitoring requirements.
Winlevi's appeal is that it is applied to the skin and is thought to act on the androgen pathway locally rather than throughout the body, which is why it is prescribed for male patients as well as female patients. Which combination is right for you is a conversation for your dermatologist or prescriber, not something to decide from a price list.
Winlevi safety, side effects, and warnings
Winlevi does not carry a boxed warning. In the 12-week clinical trials, the most commonly reported local skin reactions in Winlevi-treated patients were redness or erythema (12.2%), scaling or dryness (10.5%), and itching or pruritus (7.7%). An important piece of context: the vehicle (inactive cream) arm of the same trials reported these reactions at comparable or even higher rates — erythema 15.4%, scaling/dryness 10.4%, and pruritus 8.2% — so much of this irritation appears to come from acne itself or from the cream base rather than from clascoterone. Even so, if irritation becomes severe, your prescriber may tell you to use it less often or stop. The FDA label also notes two effects to be aware of: suppression of the body's HPA (hypothalamic-pituitary-adrenal) axis was seen in a pharmacokinetic study, including in adolescents, with the risk higher when large areas are treated, when the skin is covered or occluded, and in younger patients because they have more skin surface relative to body size; in that study, HPA function returned to normal within four weeks of stopping. A shift from normal to elevated potassium was also seen in about 5% of clascoterone-treated subjects compared with about 4% of vehicle-treated subjects. The label does not require routine potassium monitoring; whether any lab checks make sense for you is a judgment call for your prescriber, especially if you have kidney problems or take other medicines that raise potassium.
Winlevi is for use on the skin only. Keep it away from your eyes, mouth, lips, and other mucous membranes, and do not apply it to cut, damaged, or sunburned skin. Pregnancy and breastfeeding: there are no data on Winlevi use in pregnant or breastfeeding women. In animal studies, clascoterone given by injection to pregnant rats and rabbits during organogenesis at doses roughly 8 and 39 times the maximum recommended human dose increased malformations in rats and increased post-implantation loss and resorptions in rabbits. It is not known whether clascoterone passes into human milk. If you are pregnant, planning a pregnancy, or breastfeeding, talk to your prescriber before using Winlevi. This page is educational information, not medical advice. Talk with your doctor or pharmacist about your full medical history and every medicine you take before starting or stopping Winlevi.
This Winlevi information was written and reviewed against authoritative U.S. medical sources — MedlinePlus (U.S. National Library of Medicine), DailyMed, and FDA prescribing information — and checked for accuracy. It is provided for education and is not a substitute for professional medical advice.
Verify the official label: Winlevi on DailyMed (FDA)
Reviewed against FDA labeling · Last reviewed July 2026
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Medical disclaimer: This information is provided for general educational purposes only and is not medical advice. It is not a substitute for professional diagnosis or treatment. Always consult a licensed physician, pharmacist, or other qualified healthcare provider before starting, stopping, or changing any medication or treatment. Never disregard professional medical advice or delay seeking it because of something you read here. If you think you may have a medical emergency, call your doctor or 911 immediately.