> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Bayer Files NDA for Menopause Drug
- URL: https://www.fdaweb.com/bayer-files-nda-for-menopause-drug/
- Published: 2024-10-09T12:00:00.000Z
- Updated: 2026-09-14T14:43:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157949

FDA has accepted a Bayer NDA for elinzanetant, a non-hormonal investigational compound for treating moderate-to-severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause. The submission is based on the positive results from the OASIS Phase 3 studies evaluating elinzanetant versus placebo. Bayer says the findings showed a significant reduction in VMS for those taking elinzanetant compared to placebo. “In addition, improvements were seen in measures of sleep disturbances and menopause-related quality of life with elinzanetant use over 52 weeks,” according to the company.

Elinzanetant is described as the first dual neurokinin-1 and 3 receptor antagonist that works by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons). When the neurons experience a decrease in estrogen,they “become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS, Bayer says.