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A Randomized, Placebo-Controlled, Double-Blind Phase 3 Clinical Study to Investigate the Long-Term Safety of Fezolinetant in Women Suffering From Vasomotor Symptoms (Hot Flashes) Associated With Menopause

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Trial Profile

A Randomized, Placebo-Controlled, Double-Blind Phase 3 Clinical Study to Investigate the Long-Term Safety of Fezolinetant in Women Suffering From 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 Adverse reactions; Registrational
  • Acronyms Skylight 4
  • 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.
  • 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
  • 13 Oct 2023 According to an Astellas Pharma media release, the positive opinion will now be reviewed by the EC, which has the authority to approve medicines for European Union member states, as well as Iceland, Norway, Liechtenstein and Northern Ireland.

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