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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: 11 Sep 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

  • 10 Jul 2025 According to a Bayer media release, Based on the positive results from the Phase III clinical development program, submissions for marketing authorizations for elinzanetant are also ongoing in the US, the EU and other markets around the world.
  • 10 Jul 2025 According to a Bayer media release, company announced that the Medicines and Healthcare products Regulatory Agency (MHRA, regulatory authority in the UK) has authorized the use of elinzanetant, t under the brand name Lynkuet for the treatment of moderate to severe vasomotor symptoms. The approval worldwide and based on positive results from the OASIS-1, -2 and -3 Phase III studies.
  • 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.

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