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# FDA Extends Review of Bayer Menopause Drug
- URL: https://www.fdaweb.com/fda-extends-review-of-bayer-menopause-drug/
- Published: 2025-07-25T12:00:00.000Z
- Updated: 2026-09-14T15:17:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159572

FDA has extended by three months its review of a Bayer NDA for elinzanetant, a neurokinin 1 and neurokinin 3 receptor antagonist for treating moderate to severe vasomotor symptoms (hot flashes) due to menopause. The agency told the company that additional time is needed for a full review of the NDA, including information provided to support the application, the company says, noting that it did not raise any concern regarding the general approvability of submission.

The NDA is based on data from the Phase 3 studies OASIS 1, 2 and 3 evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo. The company says that elinzanetant was recently approved under the brand name Lynkuet in the United Kingdom and Canada.