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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: 20 Nov 2025

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At a glance

  • Drugs Elinzanetant (Primary)
  • Indications Hot flashes; Vasomotor symptoms
  • Focus Registrational; Therapeutic Use
  • Acronyms OASIS-2
  • Sponsors Bayer

Most Recent Events

  • 24 Oct 2025 According to Bayer media release, Bayers Lynkuet (elinzanetant) approved in the U.S. for treatment of moderate to severe vasomotor symptoms due to menopause. The approval is supported by data from three Phase III clinical trials of OASIS program (OASIS 1, OASIS 2 and OASIS 3).
  • 24 Oct 2025 According to Bayer media release, company announced that the US FDA approved elinzanetant (Lynkuet) 60mg capsules for the treatment of moderate to severe hot flashes due to menopause. The approval is supported by data from three Phase III clinical trials of OASIS program (OASIS 1, OASIS 2 and OASIS 3).
  • 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.

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