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Investigational topical small-molecule modulator of Wnt signalling

SM04554 — 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

1 record in this file

  • CLINICAL TRIAL1

Research areas. Investigational hair-follicle research.

Publication span. 2019.

What we know

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

    What remains uncertain

      Regulatory notes

      Investigational

      • No approved product in Drugs@FDA as of this review.
      • Registered Phase 2 study NCT03742518 evaluated 0.15% and 0.25% topical solution against vehicle in men with androgenetic alopecia.
      • The development programme's later status is not established by the registry records reviewed here. Absence of an active registration is not evidence of discontinuation.
      • Wnt pathway modulation is the proposed mechanism, and the trial protocol itself flags theoretical pathway-related risks. That is a mechanistic concern, not an observed human safety finding.

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

      Studies and documents

      1. CLINICAL TRIAL2019Phase 2 randomised, double-blind, vehicle-controlled trial (protocol record)

        Topical SM04554 0.15% and 0.25% in male androgenetic alopecia (Phase 2 protocol)

        Samumed, LLCClinicalTrials.gov

        Population
        Adult men with androgenetic alopecia
        Objective
        To characterise the efficacy, safety and tolerability of two topical SM04554 concentrations in men with androgenetic alopecia.
        Endpoint investigated
        Absolute non-vellus hair count in a target area at week 48

        Study design

        Registry
        NCT03742518

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

        The protocol record describes a multicentre, randomised, double-blind, vehicle-controlled study of 0.15% and 0.25% topical SM04554, with non-vellus hair count at week 48 as the primary endpoint. It also records theoretical Wnt-pathway-related risks as part of the risk assessment.

        Limitations. Protocol record, not a results paper. The protocol's risk discussion is mechanistic, not an observed human safety finding, and Therapept has not indexed a peer-reviewed pivotal report.

        ClinicalTrials.gov — NCT03742518Reviewed 13 November 2026

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