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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 52 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 52 Weeks in Postmenopausal Women

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Mar 2025

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At a glance

  • Drugs Elinzanetant (Primary)
  • Indications Hot flashes; Vasomotor symptoms
  • Focus Registrational; Therapeutic Use
  • Acronyms OASIS-3
  • 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.
  • 04 Sep 2024 According to a Bayer media release, Detailed results from the Phase III OASIS 3 study evaluating the efficacy and long-term safety of investigational compound elinzanetant will be presented for the first time at this year Annual Meeting of The Menopause Society (TMS) which takes place from September 10-14, in Chicago, IL, United States.
  • 01 Aug 2024 According to a Bayer media release, a New Drug Application (NDA) for the investigational compound elinzanetant has been submitted to the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause.

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