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A Phase 3, Randomized, Placebo-controlled, 12-week Double-blind Study, Followed by a Non-Controlled Extension Treatment Period, to Assess the Efficacy and Safety of Fezolinetant in Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause

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Trial Profile

A Phase 3, Randomized, Placebo-controlled, 12-week Double-blind Study, Followed by a Non-Controlled Extension Treatment Period, to Assess the Efficacy and Safety of Fezolinetant in Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Dec 2024

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At a glance

  • Drugs Fezolinetant (Primary)
  • Indications Hot flashes; Vasomotor symptoms
  • Focus Registrational; Therapeutic Use
  • Acronyms Skylight 2
  • Sponsors Astellas Pharma Global Development

    • Most Recent Events

    • 03 Dec 2024 According to an Astellas Pharma media release, based upon BRIGHT SKY program, the Health Canada approved VEOZAH (fezolinetant film-coated tablets) for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.
    • 10 Oct 2024 According to Astellas Pharma media release, data from the study will be presented during the International Menopause Society (IMS) 19th World Congress on Menopause in Melbourne, Australia, October 19-22.
    • 07 Dec 2023 According to an Astellas Pharma media release, based upon BRIGHT SKY program, the European Commission (EC)approved VEOZATM (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, The EC marketing authorization for fezolinetant is applicable in the European Union (EU) Member States, as well as Iceland, Norway and Liechtenstein. Fezolinetant was also approved in Switzerland on December 4, 2023

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