Elinzanetant: First Approval

<p dir="ltr"><b>Declarations</b></p><p dir="ltr"><b>Funding</b> The preparation of this review was not supported by any external funding.</p><p dir="ltr"><b>Authorship and Conflict of interest</b> Arnold Lee is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.</p><p><br></p><p dir="ltr"><b>Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability</b> not applicable</p><p><br></p><p dir="ltr">Additional information about this Adis Drug Review can be found <a href="https://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews" target="_blank">here</a></p><p><br></p><p dir="ltr"><b>Abstract</b></p><p dir="ltr">Elinzanetant (Lynkuet™) is a non-hormonal, small-molecule neurokinin 1 (NK1) and 3 (NK3) antagonist being developed by Bayer for the treatment of vasomotor symptoms (VMS), which received its first approval in the UK in July 2025. As a neurokinin-targeted therapy, elinzanetant moderates the activity of hyperactive kisspeptin/neurokinin B/dynorphin neurones to reduce the frequency and severity of VMS, which was demonstrated during the OASIS clinical trials. This article summarizes the milestones in the development of elinzanetant leading to this first approval for the treatment of moderate to severe VMS associated with menopause.</p><p><br></p><p dir="ltr">© Springer Nature Switzerland AG 2025</p>