Bayer reveals promising results for hot flash drug elinzanetant ahead of FDA decision
- Bayer released results showing the safety and efficacy of elinzanetant for treating hot flashes.
- The study confirms earlier positive findings, with anticipation for FDA approval delayed until late October.
- Experts believe elinzanetant may offer a much-needed alternative for women seeking non-hormonal treatment.
In St. Paul, Minnesota, on September 10, 2025, Bayer, the German pharmaceutical company, announced full results from a significant clinical study examining its hot flash treatment, elinzanetant. The study highlighted the drug's long-term safety and effectiveness for women suffering from vasomotor symptoms (VMS) related to menopause. As Bayer awaits a delayed decision from the U.S. Food and Drug Administration (FDA), the firm continues to emphasize the drug’s potential as a non-hormonal alternative for managing hot flashes, which affect over 85% of women during menopause. The OASIS 3 clinical trial, which followed previous studies (OASIS 1 and 2), confirmed Bayer's earlier claims of elinzanetant's positive results. According to Richard Anderson, co-author of the study and a professor at the University of Edinburgh, the findings represent a significant advancement for women seeking treatment options without hormonal therapy. This alternative could fill a critical gap in treatment as traditional hormone therapy is not suitable for everyone, particularly women with specific health concerns like a history of breast cancer or heart disease. Experts, including Dr. Stephanie Trentacoste McNally from Long Island Jewish Medical Center, support this innovation because VMS can substantially impact a woman's quality of life for several years after menopause. The clinical trial results suggested that elinzanetant could deliver swift relief from debilitating symptoms, which is a considerable improvement over existing non-hormonal treatments. The drug's action mechanism, targeting neurokinin-1 and neurokinin-3 receptors, may also provide additional health benefits and safety, particularly compared to previously used alternatives like fezolinetant. With some concerns regarding liver toxicity associated with fezolinetant, experts believe that adding elinzanetant to the market will foster greater competition while also expanding the treatment landscape for menopausal symptoms. As Bayer anticipates FDA approval, the market dynamics for such treatments could shift significantly, potentially positioning elinzanetant as a blockbuster drug in the U.S.