Clascoterone (Winlevi)
Clascoterone (Winlevi) is prescription-only
We review what you can buy over the counter, so nothing carrying it appears here. This page is the reference — what it does, what the evidence supports, and what to raise with a prescriber.
The full clascoterone (winlevi) guide
Hormonal acne treatment has always meant swallowing something — spironolactone, a combined pill, isotretinoin — because androgens circulate and topicals traditionally could not touch them.
Clascoterone broke that rule in August 2020 by blocking the androgen receptor inside the sebaceous gland and then falling apart into an inactive metabolite before it can do anything systemically. It was the first genuinely new topical acne mechanism approved in roughly four decades, and notably it works the same way regardless of the user's sex.
Where the evidence stands, by concern
Evidence for an ingredient is not one grade — it differs concern by concern. Each row below was researched separately against regulatory approvals, clinical guidelines, and trials our team opened and verified; the band and dots rank how central clascoterone (winlevi) is to treating that concern, from first-line therapy down to supportive care, at treatment-level doses and vehicles. A product's own grade weighs its actual formula.
How it's regulated in the US
FDA does not classify ingredients — it classifies products, by what they are sold to do. The same molecule can be a drug active in one product and a cosmetic ingredient in the next, and only the claim on the label decides which. What follows is a statement about that legal standing, not about whether it works — the evidence question is answered separately above.
Approved drug Clascoterone is the first genuinely new mechanism approved for acne in decades — a topical androgen receptor blocker — and it is prescription-only. Nothing sold as a cosmetic works this way.
- acne FDA-approved 1 percent cream
Approved by FDA under a New Drug Application
Permitted label wording “For the topical treatment of acne vulgaris”
NDA213433.
Two identically designed phase 3 vehicle-controlled trials, published in JAMA Dermatology in 2020, enrolled patients aged 9 and up with moderate-to-severe facial acne and met every co-primary endpoint at week 12. Treatment success on the Investigator's Global Assessment reached 18.4% versus 9.0% for vehicle in one trial and 20.3% versus 6.5% in the other; inflammatory and non-inflammatory lesion counts both fell further on drug than on vehicle. Those absolute success rates look small until you notice they are the normal scale for acne trials, where the IGA bar is clear or almost-clear skin. The 2024 American Academy of Dermatology acne guideline includes clascoterone with a conditional recommendation supported by high-certainty evidence — an honest reading being that the effect is real and reliably demonstrated, while its size relative to established topicals is still being worked out.
How it works
Sebaceous glands are hormone-responsive tissue. Sebocytes take circulating precursors and convert them locally into dihydrotestosterone, which binds an androgen receptor in the cytoplasm; the pair then dimerizes, moves into the nucleus and switches on genes that drive sebum output and inflammatory cytokine production. That local hormonal signalling is why acne clusters where the glands are largest and why it flares with hormonal shifts even when blood androgen levels read as normal. Clascoterone is a steroid shaped closely enough to DHT to occupy the same receptor without activating it. Sitting in the pocket, it competitively blocks DHT from binding, so the transcriptional programme downstream never starts — less sebum, fewer inflammatory signals, and a follicle less likely to become a lesion. The clever part is what happens next. Once absorbed into skin, the propionate ester is cleaved and clascoterone becomes cortexolone, a metabolite with no meaningful antiandrogen activity. The drug is therefore spent by the time it reaches the bloodstream, which is why the phase 3 trials recorded no systemic antiandrogen effects and why men can use it without the feminizing effects that rule out oral antiandrogens for them. That local-inactivation trick is the entire design, not a happy accident — and it is also why the cream has to be applied twice daily to keep receptor occupancy up.
Key benefits
- Blocks androgen signalling in the skin without systemic hormonal effects
- Works for men and women alike, unlike oral antiandrogens
- Reduces sebum production and inflammatory cytokines at the source
- Attacks a pathway no other topical acne active addresses
- Layerable with retinoids and benzoyl peroxide for different mechanisms
- Approved down to age 12, with trial data in younger patients
Concentration & usage
One strength exists and it is prescription-only: 1% cream, a thin layer roughly a gram in total, applied to the whole affected area twice daily, morning and evening. There is no over-the-counter version and no lower-strength cosmetic analogue — a product claiming to be a topical antiandrogen without a drug label is not this molecule. Trials ran twelve weeks before assessing response, which is the timeframe to plan for; expecting a verdict at four weeks will make a working drug look like a failure. A higher-strength solution of the same molecule is under study for androgenetic alopecia, but that indication is not approved and nothing on the acne label extends to it.
Who it's for & who should be cautious
Who it's for
It suits people whose acne has a clearly hormonal pattern — jawline and lower-face lesions, cyclical flares, oiliness that never lets up — and who either cannot take an oral antiandrogen or would rather not. Men with hormonally driven acne are the group with the least prior option here, since spironolactone is rarely appropriate for them. It also fits alongside a retinoid or benzoyl peroxide in a routine that has stalled, because it is doing something neither of those does.
Who should be cautious
The label carries real warnings rather than boilerplate. Elevated potassium turned up in some trial participants, and reversible suppression of the hypothalamic-pituitary-adrenal axis was seen in a phase 2 study without any clinical signs of adrenal insufficiency — so people with adrenal or kidney disease, or on potassium-raising medication, should have this decision made with a clinician rather than around one. Animal reproductive studies showed malformations at high multiples of the human dose and there are no human pregnancy data, so it is not a pregnancy-safe default. Children are more susceptible to systemic absorption relative to body size. Layering it with several other irritating actives at once is the fastest route to the redness and peeling that show up as its common side effects.
Pairs with & conflicts
Pairs well with: Benzoyl Peroxide, Adapalene, Azelaic Acid, Niacinamide (Vitamin B3), Ceramides
Myths & facts
Myth: It is basically topical spironolactone.
Reality: They land on the same receptor from opposite directions. Spironolactone is taken orally, blocks androgen receptors throughout the body, and carries systemic consequences that make it unsuitable for most men. Clascoterone is designed to be destroyed into an inactive metabolite in the skin, so its antiandrogen action stays where it was applied. Same target, entirely different exposure.
Myth: An IGA success rate around 20% means it barely works.
Reality: That endpoint counts only people who reached clear or almost-clear skin plus a two-grade improvement in twelve weeks — a demanding bar that most approved acne topicals clear at similar-looking rates. The more informative numbers are the lesion counts, which fell substantially further on drug than on vehicle. Judging acne drugs by IGA percentages without knowing the scale makes every one of them look weak.
Myth: Men shouldn't use an antiandrogen on their face.
Reality: The concern is legitimate for oral antiandrogens, which act body-wide. Clascoterone was specifically engineered around it: the propionate ester is hydrolysed in skin to cortexolone, which lacks antiandrogen activity, and the phase 3 programme recorded no systemic antiandrogen effects in either sex. Men were included in the pivotal trials and are part of the approved population.
Frequently asked questions
How long before clascoterone cream shows results on acne?
The pivotal trials measured their primary endpoint at twelve weeks, and improvement accumulated across that window rather than arriving early. Some people see oiliness drop within a few weeks, but judging whether it is working before the eight-week mark is premature. Consistent twice-daily use is what the evidence rests on.
Can clascoterone be used together with a retinoid or benzoyl peroxide?
It targets a pathway neither of those touches, so combining is mechanistically sensible and commonly done — typically clascoterone twice daily with a retinoid at night. The limit is tolerance, not chemistry: the label warns against stacking it with other irritating products, so add one thing at a time and back off if the skin turns red and flaky.
Does clascoterone affect testosterone levels or fertility?
No systemic antiandrogen effects were seen in the phase 3 trials, because the drug is converted in skin to an inactive metabolite before meaningful systemic exposure occurs. That is a different question from pregnancy safety, where human data are absent and animal studies showed harm at high doses — it is not a product to continue casually while trying to conceive.
Is clascoterone available over the counter?
No. It is a prescription cream in the United States, sold as Winlevi, with no over-the-counter or cosmetic equivalent. Anything marketed online as a topical androgen blocker without a drug label is not this molecule and has no comparable evidence behind it.
Why does the label mention potassium and adrenal suppression?
Clascoterone is structurally a steroid, and trials picked up elevated potassium in some participants plus reversible HPA-axis suppression in a phase 2 study, with no clinical adrenal insufficiency. For most healthy users this is monitoring language rather than a practical problem, but it is a real reason for anyone with kidney or adrenal disease to have the conversation before starting.