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A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Over 26 Weeks in Postmenopausal Women

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Trial Profile

A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Over 26 Weeks in Postmenopausal Women

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Oct 2024

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At a glance

  • Drugs Elinzanetant (Primary)
  • Indications Hot flashes; Vasomotor symptoms
  • Focus Registrational; Therapeutic Use
  • Acronyms OASIS-1
  • Sponsors Bayer

    • Most Recent Events

    • 09 Oct 2024 According to a Bayer media release, the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for the investigational compound elinzanetant seeking approval for the treatment of moderate-to-severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause.
    • 22 Aug 2024 According to a Bayer media release, data from this study were published in the Journal of the American Medical Association (JAMA).
    • 22 Aug 2024 Results published in a Bayer Media Release.

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