Does Clascoterone (Winlevi) for hair loss work?

Read Off Label rates the evidence for Clascoterone (Winlevi) for hair loss as Moderate and the benefit magnitude as med, producing an overall grade of B+ (7.1/10). Cassiopea/Sun Pharma.

Is Clascoterone (Winlevi) for hair loss safe?

Clascoterone (Winlevi) for hair loss has a low risk profile in published human data. Legal status: Rx (approved 2020 for acne as Winlevi); AGA off-label / Phase 2-3. This is not medical advice — see the disclaimer.

Rankings / Hormones & Endocrine

Clascoterone (Winlevi) for hair loss

Hormones & Endocrine · Topical androgen receptor antagonist

Tier B+

Reviewed by Read Off Label · Last reviewed Jun 7, 2026 · How we grade

androgen-receptortopicalagaprescription

7.1 / 10

Tier B+

Ev 6 Bn 5 Sf 9

Bottom line

Read Off Label grades Clascoterone (Winlevi) for hair loss as B+ (7.1/10) based on moderate evidence, med benefit magnitude, and a low-risk safety profile.

Cassiopea/Sun Pharma.

Typical use: Topical cream/solution to scalp — Rx (approved 2020 for acne as Winlevi); AGA off-label / Phase 2-3.

What this is

Cassiopea/Sun Pharma. FDA-approved 2020 for acne (Winlevi); hair-growth Phase 2 data support an androgenetic-alopecia program, Phase 3 pending. A non-systemic topical anti-androgen, complementary/competitive with pyrilutamide and topical finasteride. Industry-sponsored.

Mechanism

Topical androgen-receptor antagonist (approved for acne) in development for androgenetic alopecia, with local anti-androgen action at the follicle without systemic anti-androgen exposure.

Dose & route

Topical cream/solution to scalp

Citations

https://clinicaltrials.gov/search?term=clascoterone%20androgenetic%20alopecia

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Common questions

Does Clascoterone (Winlevi) for hair loss work?: Read Off Label rates the evidence for Clascoterone (Winlevi) for hair loss as Moderate and the benefit magnitude as med, producing an overall grade of B+ (7.1/10). Cassiopea/Sun Pharma.
Is Clascoterone (Winlevi) for hair loss safe?: Clascoterone (Winlevi) for hair loss has a low risk profile in published human data. Legal status: Rx (approved 2020 for acne as Winlevi); AGA off-label / Phase 2-3. This is not medical advice — see the disclaimer.
What is the typical dose for Clascoterone (Winlevi) for hair loss?: Topical cream/solution to scalp
How does Clascoterone (Winlevi) for hair loss work?: Topical androgen-receptor antagonist (approved for acne) in development for androgenetic alopecia, with local anti-androgen action at the follicle without systemic anti-androgen exposure.

This is an independent synthesis of published research by a non-clinician. Scores are opinions supported by citations, not prescriptions. See the full disclaimer and methodology for how this score was produced and what it does and doesn't mean.