NDATOPICALCREAM
Approved
Aug 2020
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
5
Data completeness
6/8 — Strong
WINLEVI (clascoterone) by Fosun Pharma is androgen receptor antagonists [moa]. Approved for acne vulgaris. First approved in 2020.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
WINLEVI (clascoterone) is a topical androgen receptor antagonist cream approved for acne vulgaris and androgenetic alopecia. It works by blocking androgen signaling at the skin level, addressing the hormonal drivers of acne and hair loss without systemic effects. This is the first and only topical antiandrogen approved in the U.S.
$0.88MPart D
Peak4.2 years to LOEProduct is at peak lifecycle stage with modest Part D uptake, suggesting stable commercial operations but limited growth trajectory for larger team expansion.
Mechanism of Action
Androgen Receptor Antagonists
Pharmacologic Class:
Androgen Receptor Inhibitor
Indications (1)
Clinical Trials (5)
1% Clascoterone Cream for the Treatment Acne Vulgaris
Started May 2026
692 enrolled
Acne Vulgaris
Pharmacokinetics, Safety and Tolerability of Clascoterone Cream 1% in Healthy Chinese Adult Subjects
Started Aug 2024
12 enrolled
Acne Vulgaris
Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris
Started May 2024
692 enrolled
Acne Vulgaris
A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP2)
Started Aug 2023
762 enrolled
Alopecia, Androgenetic
A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss
Started Jun 2023
703 enrolled
Alopecia, Androgenetic
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.