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A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multi-Center Trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines (SAKURA-1)

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multi-Center Trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines (SAKURA-1)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Sep 2022

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At a glance

  • Drugs Daxibotulinumtoxin A (Primary)
  • Indications Glabellar lines
  • Focus Registrational; Therapeutic Use
  • Acronyms SAKURA-1
  • Sponsors Revance Therapeutics

    • Most Recent Events

    • 19 Sep 2022 Results published in Revance Therapeutics Media Release.
    • 19 Sep 2022 According to Revance Therapeutics media release, post-hoc analysis of patients in the Phase 2a forehead line (FHL) study and the SAKURA open-label safety (OLS) study as well as the efficacy and safety of DAXXIFY analyzed by age and race based on a subgroup analysis of the SAKURA glabellar lines clinical trials was published in Aesthetic Surgery Journal.
    • 08 Sep 2022 According to Revance Therapeutics media release, based on the Phase 3 SAKURA clinical program, the United States (USA) Food and Drug Administration (FDA) has approved DAXXIFY™ (DaxibotulinumtoxinA-lanm) for injection for the temporary improvement of moderate to severe frown lines (glabellar lines) in adults.

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