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Dalosirvat (SM-04554)

Dalosirvat (SM-04554) is in Phase 2/3 for androgenetic alopecia, developed by Biosplice Therapeutics.

Phase 2/3TopicalWnt pathway

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Developed by
Biosplice Therapeutics
Current phase
Phase 2/3

A combined efficacy and confirmatory study.

Mechanism
Wnt pathway

Targets the Wnt signalling pathway, a master switch for follicle formation and regrowth.

Indications
Androgenetic alopecia
Also known as
SM04554, SM-04554
Last public activity
October 2026
Record confidence
Medium

A research record, not medical advice: being listed here says nothing about whether a treatment works or whether it is right for you. Talk to a dermatologist about your own case.

Development history

  1. Phase 2Phase 2/3

    First Phase 2/3 trial on record: NCT03742518 — A Study Evaluating the Efficacy and Safety of SM04554 Topical Solution in Male Subjects With Androgenetic Alopecia

    ClinicalTrials.gov ↗
  2. Phase 2

    First Phase 2 trial on record: NCT02275351 — A Study of the Safety, Tolerability, and Efficacy of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA)

    ClinicalTrials.gov ↗

Registered trials

Pulled automatically from ClinicalTrials.gov. Matching is by name and development code, so occasional gaps are possible — tell us if you spot one.

  • NCT03742518Phase 2/3Completed

    A Study Evaluating the Efficacy and Safety of SM04554 Topical Solution in Male Subjects With Androgenetic Alopecia

    Biosplice Therapeutics, Inc. · n=675 · November 2018

  • NCT02503137Phase 2Completed

    A Study of SM04554 Applied Topically to the Scalp of Male Subjects With Androgenetic Alopecia Analyzed by Biopsy of the Scalp Prior To and Post Dosing

    Biosplice Therapeutics, Inc. · n=49 · August 2015

  • NCT02275351Phase 2Completed

    A Study of the Safety, Tolerability, and Efficacy of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA)

    Biosplice Therapeutics, Inc. · n=302 · November 2014

Listing a trial is not a recommendation to join one. Eligibility, risks and costs vary enormously — discuss any trial with your own doctor first.

Sources

Cite this page

Hair Pipeline, "Dalosirvat (SM-04554) — development record", hairpipeline.com/pipeline/dalosirvat