New Data Show Elinzanetant Is a Safe, Well-Tolerated Non-Hormonal Therapy for Menopausal Vasomotor Symptoms

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At The Menopause Society (TMS) 2025 meeting in Orlando, Florida, James Simon, MD, CCD, MSCP, IF, FACOG, Professor of Obstetrics and Gynecology at The George Washington University School of Medicine, discusses pooled safety data showing that elinzanetant is highly tolerable, with very few side effects or treatment-emergent adverse events observed across diverse patient populations. He explains that these findings support elinzanetant’s potential as a safe and effective non-hormonal option for managing vasomotor symptoms associated with menopause, positioning it as an important emerging therapy in clinical practice.

Pharmacy Times: What does the pooled safety data reveal about elinzanetant’s tolerability profile in treating vasomotor symptoms across diverse patient populations?

James Simon, MD, CCD, MSCP, IF, FACOG: This shows that it’s highly tolerable, with very few side effects or treatment-emergent adverse events.

Pharmacy Times: How do these findings shape its potential role in clinical practice as a non-hormonal option for menopause symptom management?

Simon: Okay, so we’re talking a little out of school here because we don’t have the final label, but the data that I’ll present suggests that the restrictive liver testing the FDA has applied to fezolinetant is unnecessary in this setting, because adverse events of liver dysfunction were simply not seen in the U.S.-based population.