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Therapept

Topical androgen-receptor inhibitor (cortexolone 17α-propionate), supplied as a 1% cream

Clascoterone — evidence

What has been published, classified by the kind of document it is. This is not a protocol, not a score, and not a recommendation for use.

Evidence overview

2 records in this file

  • CLINICAL TRIAL1
  • REGULATORY1

Research areas. Approved dermatological treatment; Investigational hair-follicle research.

Publication span. 2022–2026.

What we know

    Editorial reading of the records below, labelled as Therapept analysis. How records are built

    What remains uncertain

      Regulatory notes

      FDA-approved drug substance

      • WINLEVI 1% cream, NDA 213433, approved 26 August 2020 for acne vulgaris in patients 12 years and older.
      • The approved indication is acne, not hair loss. Regulatory approval for one skin condition does not transfer to another.
      • Phase 3 trial NCT05910450 in men with androgenetic alopecia is registered as completed, with a six-month blinded phase and a six-month single-blind extension.
      • Therapept has not indexed a peer-reviewed publication of the androgenetic alopecia results. Registry completion is not a result and is not an approval.

      Regulatory status describes how a substance is classified. It is not a safety assessment of any particular material.

      Studies and documents

      1. CLINICAL TRIAL2026Phase 3 randomised, double-blind, vehicle-controlled trial with a single-blind extension (registry record)

        Topical clascoterone solution for androgenetic alopecia in males (Phase 3)

        Cassiopea SpAClinicalTrials.gov

        Population
        Adult men with androgenetic alopecia
        Objective
        To evaluate the efficacy and safety of topically applied clascoterone solution for androgenetic alopecia in men.
        Endpoint investigated
        Hair-growth endpoints over a six-month blinded phase, followed by a six-month single-blind extension

        Study design

        Registry
        NCT05910450

        This describes the published study design. It is not a usage or dosing recommendation.

        The registry record describes a multicentre, randomised, double-blind, vehicle-controlled Phase 3 study with a six-month blinded phase and a six-month single-blind extension. The record's overall status is listed as completed, with a primary completion date in January 2026.

        Limitations. Registry record only. No peer-reviewed efficacy or safety results were indexed at this review, and completion is neither a positive result nor an approval for hair loss.

        ClinicalTrials.gov — NCT05910450Reviewed 13 November 2026

      2. REGULATORY2022Approved product labelling

        WINLEVI (clascoterone) cream — prescribing information

        U.S. Food and Drug AdministrationFDA approved labelling

        Objective
        To record the approved indication and population for clascoterone cream.
        Endpoint investigated
        Approved indication and labelling

        The label indicates clascoterone 1% cream as an androgen-receptor inhibitor for the topical treatment of acne vulgaris in patients 12 years and older. It does not include an indication for androgenetic alopecia.

        Limitations. A regulatory document for acne, not a hair-loss trial. It cannot be used to infer scalp efficacy, and it is not a complete safety review.

        FDA — WINLEVI prescribing information (2022)Reviewed 13 November 2026

      Last reviewed 13 November 2026 · Compiled by Therapept Editorial · How these records are built