Elinzanetant demonstrates favorable safety profile in menopausal women, with James A. Simon, MD

At The Menopause Society Annual Meeting, James A. Simon, MD, CCD, MSCP, IF, FACOG, clinical professor of Obstetrics and Gynecology at George Washington University in Washington, DC, discussed findings on the safety of elinzanetant in menopausal women experiencing vasomotor symptoms (VMS).^1,2

Safety findings across one year of treatment

According to Simon, data from a pooled US safety analysis demonstrated that elinzanetant was well tolerated over an average of one year of treatment in menopausal women with vasomotor symptoms. “It shows that elinzanetant is incredibly safe with very few adverse events or treatment-emergent adverse effects,” he said. “That’s amazing and very good news for women and for the people of all presentations—hormone doctors, internists, primary care docs, gynecologists, pharmacists, etc. All of us as a care team should be reassured that there were no serious adverse events of consequence and that there were no new unexplainable adverse effects in this safety database.”

No liver safety signal observed

Simon noted that no adverse signal related to liver function was detected in the elinzanetant clinical trial data—an important distinction from earlier regulatory experiences with similar agents. “There was no signal for a treatment adverse effect on the liver, which the FDA has heightened our concern about based on the fezolinetant label and its several incarnations, with increasingly stringent monitoring,” he said. “Those types of effects on liver function tests were just simply not seen in the elinzanetant clinical trial data.”

Most common side effects were mild

The most common treatment-emergent events were mild and unrelated to the study drug. “The side effect of most interest, I think, is that there was an increase in headache, which is a pretty common symptom,” Simon said. “The second most common side effect, which had nothing to do with the drug, was COVID. So if that’s the second most common side effect, it really speaks to how clean this therapy is in terms of side effect profile.”

Broader implications for women’s health

Simon emphasized the significant impact of treating VMS on quality of life and overall health. “Menopausal vasomotor symptoms have pretty dramatic, both direct and indirect effects on a postmenopausal woman’s quality of life,” he said. “Hot flashes and night sweats disturb sleep, disturb work productivity, disturb energy, well-being, etc.” He added that poor sleep can contribute to cognitive and mood problems, appetite changes, and weight gain, all of which increase cardiovascular risk. “Just intervening on the issue of hot flashes and night sweats is not just about hot flashes and night sweats,” he said. “There are lots of downstream benefits to a given woman by just helping her get a good night’s sleep that’s free of night sweats, and helping her not to sweat through her business meeting when she’s trying to close the deal.”

Simon reports no relevant disclosures.

*Editor's note: This interview was conducted prior to the October 24, 2025, approval of elinzanetant.

References

1. Simon JA. Pooled Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause Across the US Population From 4 Placebo-Controlled Studies. Presented at: The Menopause Society’s 2025 Annual Meeting. October 21–25, 2025. Orlando, Florida.
2. Panay N, Joffe H, Maki PM, et al. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: A Phase 3 Randomized Clinical Trial. JAMA Intern Med. Published online September 8, 2025. doi:10.1001/jamainternmed.2025.4421