Elinzanetant Safe, Effective for Moderate-to-Severe Vasomotor Symptoms

TUESDAY, Sept. 30, 2025 (HealthDay News) — Elinzanetant, a dual neurokinin-targeted therapy, is effective for treating menopause-associated moderate-to-severe vasomotor symptoms (VMS), according to a study published online Sept. 8 in JAMA Internal Medicine.

Nick Panay, M.B.B.S., from Imperial College London, and colleagues evaluated the 52-week efficacy and safety of elinzanetant for treating moderate-to-severe VMS associated with menopause. The analysis included 628 postmenopausal women aged 40 to 65 years who were seeking treatment for moderate-to-severe VMS and were randomly assigned to receive oral elinzanetant 120 mg once daily (313 women) or placebo (315 women).

The researchers found that at week 12, the mean change from baseline in daily moderate-to-severe VMS frequency was −5.4 for elinzanetant and −3.5 for placebo (least-squares mean difference for elinzanetant versus placebo, −1.6). Descriptive analyses showed numerical advantages for elinzanetant versus placebo for improving VMS frequency and severity over 50 weeks and sleep disturbances and menopause-related quality of life over 52 weeks. Elinzanetant was not associated with hepatotoxic effects, endometrial hyperplasia, or meaningful changes in bone density or bone turnover markers. Treatment-related adverse events were more common with elinzanetant than placebo (30.4 versus 14.6 percent), including somnolence, fatigue, and headache.

“Outcomes from this 52-week study were consistent with those observed in the 26-week OASIS-1 and OASIS-2 trials, contributing to the robustness of the findings and indicating the sustained benefit and safety of elinzanetant in a broad population with VMS over a prolonged duration of use,” the authors write.

Several authors disclosed ties to relevant organizations.

Abstract/Full Text