Sun Pharmaceutical / Winlevi
CLASCOTERONE CREAM 1%
The first topical androgen receptor inhibitor — the drug adult women with hormonal acne have been waiting for, with irritation rates no worse than its own vehicle. Then read the storage line: discard one month after opening, on a tube that costs five hundred dollars.
Worth buying for a specific person with a specific problem. Read who.
ASSESSED ON 75% OF THE MODEL. 2 CRITERIA LEFT UNSCORED — SEE SCORING FOR WHY.
We earn nothing on this link. Ask two questions before filling it: what does it cost you covered, and how much of a 60 g tube will you actually use before the one-month discard date.
The verdict
Clascoterone is the genuinely new thing here. It is an androgen receptor inhibitor applied to skin, which means it competes with dihydrotestosterone at the sebaceous gland without the systemic anti-androgen load that oral spironolactone brings. For the group this site is written for — women in their thirties and forties with jawline acne that arrived or returned after twenty-five — that is the mechanism they have been asking their prescribers about for years.
The tolerability data are remarkable and worth stating precisely: local skin reactions occurred at essentially the same rate on drug as on vehicle. Erythema was reported by 12.2% on Winlevi and 15.4% on vehicle. Scaling and dryness 10.5% against 10.4%. Pruritus 7.7% against 8.2%. Skin atrophy 1.6% against 2.6%. In a category where every other option is a controlled burn, a drug that irritates no more than its own base is a real clinical asset.
The efficacy is modest and honestly framed. Investigator global assessment success at twelve weeks was 18.8% and 20.9% against 8.7% and 6.6% on vehicle — treatment differences of 10.1 and 14.3 points, both with confidence intervals excluding zero. Non-inflammatory lesions fell about 30% against 16% to 22%. The label also states, in the mechanism section, that the mechanism of action of Winlevi for acne is unknown. That is unusually candid for a drug whose entire marketing rests on its mechanism.
Two things pull this down to conditional. First, systemic activity is real: HPA axis suppression was seen in 5% of adults and 9% of adolescents after two weeks of twice-daily use, reversing within four weeks of stopping, and potassium shifted upward in 5% of treated subjects. Second, the economics are close to absurd. A 60 g tube costs around $509 with a discount card, needs refrigeration before dispensing, and must be discarded one month after first opening — which for most users means throwing away a substantial fraction of a five-hundred-dollar tube on the label's own instruction.
- First-in-class topical androgen receptor inhibitor — a genuinely new mechanism in acne.
- Local reaction rates no worse than vehicle across eight measured reaction types.
- Erythema and skin atrophy were both lower on drug than on vehicle.
- Two identically designed trials with consistent results and published confidence intervals.
- HPA axis suppression rates published by age group, with the recovery interval.
- Potassium shifts published against vehicle: 5% against 4%.
- Systemic exposure quantified — mean peak plasma concentration 4.5 ng/mL after two weeks.
- States plainly that the mechanism of action for acne is unknown.
- No contraindications listed.
- Offers an alternative to systemic anti-androgens for people who cannot take them.
- Around $509 to $754 for a single 60 g tube.
- Must be discarded one month after first opening, or 180 days after dispensing — whichever comes first.
- Requires refrigerated storage before dispensing, which limits where it can be filled.
- HPA axis suppression in 5% of adults and 9% of adolescents after only two weeks.
- Twice-daily application, which is harder to sustain than once nightly.
- Trial mean age 19.7 and 91% Caucasian — neither matches the adult women it is marketed toward.
- No trial against spironolactone, the systemic option it is positioned to replace.
- Effect size modest: roughly one subject in five reached the success endpoint.
- Pediatric patients may be more susceptible to systemic toxicity, per the label.
Every active, assessed
- Clascoterone1%
Androgen receptor inhibitor — competes with dihydrotestosterone at the sebaceous gland androgen receptor
- BENCHMARK
- 1% is the only approved topical concentration; there is no comparator product
- ASSESSMENT
- A first-in-class topical anti-androgen, and the only way to act on the androgen pathway in skin without a systemic anti-androgen. Correctly dosed in the sense that 1% is what was trialled and approved. The caveat is on the label itself: 'The mechanism of action of WINLEVI cream for the topical treatment of acne vulgaris is unknown.' The receptor biology is established; the causal chain to lesion counts is inference.
| ACTIVE | CONC. | BENCHMARK | ASSESSMENT |
|---|---|---|---|
| ClascoteroneAndrogen receptor inhibitor — competes with dihydrotestosterone at the sebaceous gland androgen receptor | 1% | 1% is the only approved topical concentration; there is no comparator product | A first-in-class topical anti-androgen, and the only way to act on the androgen pathway in skin without a systemic anti-androgen. Correctly dosed in the sense that 1% is what was trialled and approved. The caveat is on the label itself: 'The mechanism of action of WINLEVI cream for the topical treatment of acne vulgaris is unknown.' The receptor biology is established; the causal chain to lesion counts is inference. |
Scoring
- EVIDENCE FOR THE ACTIVEWEIGHT 30%72/100
Two identically designed vehicle-controlled trials, 1,421 subjects, 12 weeks, with confidence intervals on every difference and a consistent result across both. Marked down because the effect size is modest, because the mean trial age was 19.7 while the product's practical constituency is adult women, and because the label concedes the mechanism of action for acne is unknown.
- FORMULATION INTEGRITYWEIGHT 20%78/100
A well-behaved cream that irritates no more than its own vehicle across eight measured reaction types, which is the hardest thing to achieve in this category. Full excipient list, stated 60 g fill, pharmaceutical manufacture. Marked down for cold-chain storage before dispensing and a one-month in-use discard limit that wastes a large share of an expensive tube.
- DISCLOSUREWEIGHT 15%90/100
Publishes the vehicle arm reaction rates alongside the drug — including the ones where vehicle was worse. Publishes HPA axis suppression rates by age group and the recovery interval. Publishes the potassium shift. Publishes systemic exposure. States the mechanism is unknown. Gives the trial demographics that undercut its own marketing. Held back only because the discard rule and its cost consequence are stated as a pharmacy instruction rather than to the patient paying.
- TOLERANCE IN USEWEIGHT 15%NOT ASSESSED
Not assessed by us, and the label's own figures are strong: eight local reaction types measured, none meaningfully worse than vehicle. A panel would confirm whether that holds in adult skin over a full course, since the trial population was almost a decade younger.
- TEXTURE & WEARWEIGHT 10%NOT ASSESSED
Not assessed. Twice-daily application including mornings makes wear under sunscreen and make-up a real question that the trials did not address.
- COST PER APPLICATIONWEIGHT 10%30/100
Around $509 discounted and $754 retail for 60 g, applied twice daily, with the label instructing disposal one month after opening. The fill weight is published so the arithmetic is available, and it is punishing: most users will discard product they paid for because the in-use limit expires before the tube does. Copay assistance can change this entirely, which is itself a reason the sticker price is meaningless without checking.
What it is
Clascoterone 1% in a cream, applied twice daily, approved for acne vulgaris in patients twelve and older. It is the first topical drug approved to act on the androgen receptor, and the first new mechanism in topical acne treatment in decades. A 60 g tube, around $509 with a discount card.
Why this molecule matters at thirty-five
Adult acne in women is disproportionately androgen-driven. The standard systemic answer is spironolactone, which works well and brings a set of consequences with it — potassium monitoring in some groups, menstrual irregularity, breast tenderness, and an absolute incompatibility with pregnancy. This register has already looked at what happens when spironolactone is fused into a compounded pill with two other drugs at undisclosed doses, at R-09.
Clascoterone offers the same target at the skin rather than the whole body. It binds the androgen receptor in the sebaceous gland and the hair follicle, competing with dihydrotestosterone locally. In principle that gives you the anti-androgen effect where the acne is and nowhere else.
HPA axis suppression — a post-stimulation cortisol of 18 mcg/dL or less — was observed in 1 of 20 adults and 2 of 22 adolescents after fourteen days of twice-daily use. All returned to normal function four weeks after stopping. Potassium shifted from normal to elevated in 5% of treated subjects against 4% on vehicle. So 'topical, therefore local' is not quite right: clascoterone gets in, reaches a mean peak plasma concentration of 4.5 ng/mL, and does measurable things at a distance. The effects were reversible and small. They are also the reason this is a prescription and not a serum.
The tolerability result is the headline
Winlevi N=674, vehicle N=656. Every reaction type measured, with the vehicle rate beside it. On three of the five most common reactions, the vehicle arm reported more than the drug arm. This is the profile no retinoid, no benzoyl peroxide and no compounded acne formula in this register can claim.
There is a lesson buried in the vehicle column that applies far beyond this product. Between 8% and 15% of people applying a plain cream to acne-prone facial skin for twelve weeks reported redness, flaking or itching. Much of what people attribute to an active is the ordinary consequence of putting anything on inflamed skin twice a day — which is precisely why a vehicle arm is not a formality.
The efficacy, and the population it was measured in
Success required a two-point IGA reduction and a score of clear or almost clear. Trial 1: N=342 against 350, difference 10.1% (95% CI 4.1 to 16.0). Trial 2: N=367 against 362, difference 14.3% (95% CI 8.9 to 19.7).
Now the demographics. Mean age 19.7. Forty-five per cent of subjects were between twelve and seventeen. Ninety-one per cent were Caucasian. Sixty-two per cent female.
The drug is marketed, reasonably, on hormonal adult acne. It was trialled overwhelmingly in adolescents and very young adults, in whom acne is common and androgen-driven for different reasons. Nothing here suggests it will not work in a thirty-eight-year-old woman — the receptor is the same receptor. But the evidence for that specific use is extrapolation, and the label's demographic table says so more plainly than any marketing page will.
The tube you are told to throw away
Discard the unused product 180 days after the date of dispensing or 1 month after first opening, whichever is sooner.
FDA-approved labelling, How Supplied / Storage and Handling
Applied twice daily to a face, a 60 g tube lasts most people considerably longer than a month. The label says to discard it anyway. At around $509 for that tube, the instruction converts directly into money thrown away — and unlike almost every disclosure failure in this register, this one is a disclosure success being punished by an economics failure. The information is there. It just makes the product look terrible.
This is where copay assistance and coverage stop being a footnote. With a manufacturer card or a covering plan, Winlevi becomes an ordinary monthly prescription and the discard rule is irrelevant. Paying cash, it is one of the worst value propositions in this register. The same tube, the same drug, and a tenfold difference in what it costs you — which is a fact about the American prescription market rather than about clascoterone.
If you are considering it
- Establish the covered price before the pharmacy fills it, and ask about manufacturer copay assistance in the same conversation.
- Ask honestly how much of a 60 g tube you will use in a month, and factor the discard rule into the real cost.
- Twice daily, morning and evening, on clean dry skin.
- Give it twelve weeks. Both trials read out at week 12 and neither showed much before week 4.
- It can be combined with a retinoid or benzoyl peroxide — different mechanisms, and this one contributes almost no irritation of its own.
- If you are already on spironolactone and doing well, there is no trial telling you to switch.
- Tell your prescriber if you have adrenal, renal or potassium issues — the HPA and potassium findings are small but real.
- Confirm the pharmacy has stored it refrigerated before dispensing.
Where we stand
At 72 this is a good drug held down by its price and by an evidence base assembled in the wrong age group. The pharmacology is the most interesting in the register, the tolerability result is the best we have recorded against a vehicle arm, and the label is candid to the point of telling you its own mechanism in acne is unknown.
For an adult woman with androgen-driven acne who cannot take spironolactone, this is a real option that did not exist a few years ago, and the reason to hesitate is financial rather than clinical. For everyone else, the honest position is that a five-hundred-dollar tube with a one-month discard limit needs to be doing something the cheaper options cannot — and for a meaningful number of people, it is.
What happens when the anti-androgen is systemic, compounded, and undosed.
The compounded acne comparator, prescription-gated but not FDA approved.
The retinoid this is most often combined with.
Who this is for
- An adult with hormonal or androgen-driven acne who cannot take, or does not want, oral spironolactone.
- Someone whose skin cannot tolerate retinoids or benzoyl peroxide, where a non-irritating mechanism is worth a great deal.
- Someone with good coverage or access to copay assistance, which is what makes the price survivable.
- Someone who will use enough of a 60 g tube within a month to make the discard rule irrelevant.
- Someone who wants to act on the androgen pathway without systemic anti-androgen effects.
- You are paying full cash and have not exhausted cheaper options.
- You will not get through much of a 60 g tube in a month, because the label tells you to bin the rest.
- You need a once-daily regimen to keep to it.
- You want evidence in your own age group — the trials were run in teenagers and very young adults.
- You are pregnant or breastfeeding and want a clear position; the label offers limited data.
- You want a head-to-head against spironolactone before choosing. It does not exist.
We earn nothing on this link. Ask two questions before filling it: what does it cost you covered, and how much of a 60 g tube will you actually use before the one-month discard date.
This is an editorial assessment of published information about a prescription product. It is not a diagnosis, not a prescription and not a substitute for your own prescriber. Hydroquinone and tretinoin are drugs. Decisions about them belong with a clinician who has seen your skin.
Sources
- S-01FDA-approved labelling — WINLEVI (clascoterone) cream, 1%, Sun Pharmaceutical Industries, Inc. The 1% strength stated as 10 mg per gram; twice-daily dosing; the two 12-week trials (NCT02608450, NCT02608476) with IGA success of 18.8% against 8.7% and 20.9% against 6.6% and confidence intervals on both differences; the local skin reaction table including erythema 12.2% against 15.4% and skin atrophy 1.6% against 2.6%; HPA axis suppression in 1 of 20 adults and 2 of 22 adolescents at day 14 with recovery by four weeks; the potassium shift of 5% against 4%; peak plasma concentration of 4.5 ng/mL; the statement that the mechanism of action for acne is unknown; the trial demographics of mean age 19.7 and 91% Caucasian; and the 60 g tube with refrigerated pre-dispensing storage and the one-month in-use discard limit. Read 2 August 2026.
- S-02GoodRx — Winlevi pricing Cash pricing from around $508.55 against an average retail price near $753.78. Retrieved 2 August 2026.