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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: 17 Oct 2025

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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

  • 14 Oct 2025 According to an Astellas Pharma media release, data from this trial will be presented at Menopause Society 2025 Annual Meeting in Orlando, Florida, October 21-25.
  • 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.

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