There’s a reason this idea won’t die: the biology makes sense. And recently, late-stage trial programs of clascoterone formulated for the scalp have reported promising topline results in androgenetic alopecia. STAT+2Fierce Pharma+2
But here’s the key clinical reality:
Winlevi is FDA-approved for acne, not hair loss. That means we do not yet have FDA-reviewed evidence that Winlevi regrows hair, and we don’t have standardized guidance on dosing, scalp formulation, long-term outcomes, or insurance coverage for alopecia treatment using this medication. FDA Access Data+1
Let’s break down what we know, what we don’t, and how some clinicians are handling the “patients want to try it now” moment.
What Winlevi is (and why it’s interesting for hair)
Winlevi (clascoterone) cream 1% is a topical androgen receptor inhibitor approved by the FDA for the treatment of acne vulgaris in patients ≥12 years old. FDA Access Data+1
Androgenetic alopecia is driven largely by androgen signaling at the hair follicle, especially in genetically susceptible scalp follicles. The theory is straightforward: block androgen signaling locally at the scalp → slow miniaturization → preserve (and possibly improve) hair density.
This is conceptually different from:
Finasteride/dutasteride (systemic DHT suppression)
Minoxidil (follicle stimulation via non-androgen pathways)
A topical “local anti-androgen” could be appealing—especially for patients who want to avoid systemic hormonal effects.
The important nuance: acne Winlevi ≠ the hair-loss formulation being studied
A major source of confusion online is that people say “Winlevi for hair loss” when the trials people are excited about are typically clascoterone formulated specifically for the scalp—often described as a 5% topical solution in late-stage development programs for male androgenetic alopecia. STAT+2HCPLive+2
Meanwhile, Winlevi is a 1% cream designed for facial/truncal acne—not optimized for scalp delivery, spreadability through hair, or large-surface-area use. FDA Access Data+1
So even if clascoterone proves effective for hair loss in a scalp-specific product, it does not automatically mean the acne product (Winlevi 1% cream) will perform the same way.
What clinical data exists for hair loss so far?
Early clinical trial activity (proof-of-concept era)
Clascoterone (also known historically as CB-03-01/cortexolone 17α-propionate) has been studied in androgenetic alopecia for years in various formulations. Trials are registered for male pattern hair loss outcomes (efficacy and safety endpoints). ClinicalTrials.gov+2ClinicalTrials.gov+2
More recent: Phase 3 “topline” results in male androgenetic alopecia
In late 2025, multiple reputable outlets reported topline findings from two Phase 3 studies (often referenced as SCALP 1 and SCALP 2) suggesting statistically significant improvements in target-area hair count compared with placebo/vehicle, with a generally favorable safety profile in topline reporting. STAT+2Fierce Pharma+2
What we still need: peer-reviewed publication details (methods, effect sizes in absolute terms, subgroups, durability, adverse event specifics, and longer follow-up). Topline results are encouraging, but FDA approval and labeling depend on the full data package.
Can clinicians prescribe Winlevi for hair loss today?
Yes—off-label prescribing is legally permissible in the U.S. when a clinician believes it is medically appropriate for a patient, after informed consent and documentation.
But: off-label does not mean proven, and it does not guarantee coverage.
Winlevi’s FDA indication is acne. FDA Access Data+1
So if it’s being used for hair loss, that should be clearly discussed as:
Experimental/early adoption
Not FDA-approved for alopecia
Not guaranteed to work
Potentially expensive
Dosing: what’s approved for acne, and how that differs from hair-loss trials
FDA-labeled acne dosing (Winlevi 1% cream)
The label dosing is: apply a thin uniform layer twice daily (morning and evening) to the affected area. FDA Access Data+1
Hair-loss trials (clascoterone scalp formulations)
Clinical programs for androgenetic alopecia have typically evaluated a scalp-appropriate formulation and often a higher concentration (e.g., 5% solution) applied to the scalp region(s) of thinning. The Derm Digest+2HCPLive+2
Practical implication
If a patient uses Winlevi 1% cream on the scalp:
the concentration is lower
the vehicle is different (cream vs scalp solution)
scalp coverage often involves a much larger surface area than acne treatment areas
And that matters for both effectiveness and systemic exposure risk.
Safety considerations patients should understand before trying it off-label
Winlevi is generally considered a topical medication with most adverse events being local skin reactions (redness, itching, dryness/scaling). FDA Access Data+1
However, the FDA label also includes more serious considerations:
1) Potential HPA-axis suppression (rare, but real)
The label notes that hypothalamic-pituitary-adrenal (HPA) axis suppression was observed and may occur, and that systemic absorption is more likely with use over large surface areas, prolonged use, or occlusion. FDA Access Data+1
Why this matters for scalp use: hair-loss application can involve large surface areas and long durations.
2) Hyperkalemia signal
The prescribing information lists hyperkalemia among identified adverse reactions/concerns. FDA Access Data+1
That doesn’t mean most patients will get high potassium, but it does mean clinicians should keep an eye on risk context (kidney disease, meds that increase potassium, etc.) when using it broadly or long-term.
3) Pregnancy considerations
The label notes limited human pregnancy data and includes animal data suggesting fetal risk at exposures above human dosing. FDA Access Data+1
For patients who can become pregnant, this should be a serious part of counseling (even though my practice focus is largely adult men).
Coverage and cost: the most common real-world barrier
Because Winlevi is approved for acne, insurers may:
deny coverage if coded/justified primarily as hair loss
require prior authorization
cover only for acne diagnosis
apply high copays depending on plan
Some patients choose to pay cash; others prefer to spend that money on treatments with clearer evidence (finasteride/minoxidil) and revisit clascoterone when/if FDA approval for alopecia arrives.
How I counsel patients who “want to try it anyway”
If you’re considering Winlevi off-label for androgenetic alopecia, my usual approach is:
Start with evidence-based basics (and make sure expectations are realistic)
hair loss is slow; improvement is measured in months
Review what we know vs. what we’re guessing
Discuss that the “headline” clascoterone hair-loss data is based on scalp formulations and often higher concentrations than acne Winlevi STAT+1
Talk cost/coverage frankly
Agree on a time-limited trial (e.g., 4–6 months) with a clear “continue/stop” plan
Track outcomes objectively (photos, consistent lighting/angle; sometimes dermoscopy if available)
Bottom line
Clascoterone is one of the more biologically compelling “new mechanism” candidates in hair loss we’ve seen in a long time, and late-stage topline reports in male androgenetic alopecia are genuinely encouraging. STAT+2HCPLive+2
But Winlevi (clascoterone 1% cream) is not FDA-approved for hair loss, and it is not the same formulation/concentration as those scalp-focused hair-loss trials. FDA Access Data+1
Patients can absolutely ask about it—and clinicians can prescribe it off-label—but everyone should go into that decision with eyes open about uncertain efficacy, formulation differences, potential risks when used over large surface areas, and cost/coverage hurdles. FDA Access Data+1 I do prescribe this for patients who want to try it and are willing to pay out of pocket for the medication while understanding the risks.
Medical disclaimer: This article is for education only and is not medical advice. Decisions about prescription therapy should be individualized and made with a licensed clinician who can evaluate your medical history, medications, and goals.
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