Elinzanetant Demonstrates Clinically Meaningful Reductions in Menopausal Vasomotor Symptoms, Meta-analysis Shows

Elinzanetant significantly decreases both the frequency and intensity of vasomotor symptoms (VMS) while improving sleep and overall quality of life in menopausal patients, according to a meta-analysis presented at the American College of Obstetricians and Gynecologists (ACOG) 2025 Annual Clinical and Scientific Meeting in Minneapolis.1

What the analysis found

The study authors, led by Paula Rocha, MD, a family physician with the University of Miami, performed a systematic review and meta-analysis of three randomized controlled trials encompassing 995 participants, with 551 women receiving elinzanetant and 444 receiving placebo. The mean age of the participants in the trails ranged from 54.4 to 55.6 years.1

The pooled data revealed that elinzanetant reduced daily hot-flash frequency compared with placebo and lowered VMS intensity scores. Health-related quality-of-life benefits paralleled symptom relief. Scores on the Menopause-Specific Quality of Life Questionnaire declined, and sleep-disturbance scores on the PROMIS Sleep Disturbnace Short Form 8b improved versus placebo. Importantly, the incidence of treatment-emergent adverse events did not differ significantly between elinzanetant and placebo groups.1

“Findings from our study suggest that elizanetant offers clinically important efficacy across a range of menopause-related symptoms with a favorable benefit/risk profile,” the authors wrote. “In patients with VMS associated with menopause, elinzanetant reduced VMS frequency and intensity. Furthermore, the drug promotes improvements in measures of sleep and quality of life."1

The findings position elinzanetant as the second nonhormonal neurokinin pathway agent —following fezolinetant — to show robust efficacy for moderate-to-severe VMS without added safety burden. Unlike hormone therapy, which can be contraindicated in women with cardiovascular disease, breast cancer risk, or advanced age, neurokinin antagonists target central thermoregulatory circuits and avoid estrogenic effects.

The OASIS trials

The phase 3 OASIS trials have demonstrated the efficacy of elinzanetant in reducing VMS frequency and severity and also in improving sleep disturbances associated with menopause. Results from the OASIS 1 and 2 trials were published in JAMA2 in August 2024. The OASIS 3 study, presented at The Menopause Society’s annual meeting in September 2024, provided additional long-term efficacy and safety data over 52 weeks.2

The OASIS 4 trial, assessing the efficacy of elinzanetant in managing VMS caused by adjuvant endocrine therapy for breast cancer, has also reported positive topline results, including treatment effect as early as week 1 that were sustained over the 52-week study period. Further details expected at upcoming conferences, according to Bayer.2

In 2024, Patient Care sat down with the lead investigator on the OASIS program, JoAnn Pinkerton, MD, who is professor of obstetrics and gynecology and division director of Midlife Health at the University of Virginia Health System in Charlottesville, Virginia. Pinkerton discussed the OASIS program, and the need for more individualized treatment.

“Even though all women go through menopause, less than 15% get effective, individualized treatment,” Pinkerton told Patient Care.

Watch the video to learn more about the elinzanetant and the OASIS trials.

The road to approval

The US Food and Drug Administration is currently reviewing the new drug application (NDA) for elinzanetant, submitted by Bayer in October 2024. The NDA was submitted based on positive data from the OASIS trials. The Prescription Drug User Fee Act date was set for July 26, 2025.2

Bayer said they are prepping their launch plan as they await word from regulatory authorities.2

“With regulatory submissions under review around the world, Bayer anticipates a potential launch this year, aiming for fast market penetration building on Bayer's strength in women's healthcare,” the news release reads. “Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist with potential to transform the management of menopause, broadening treatment choices, and addressing major unmet needs in women’s health.”3

References

1. Sobral MVS, Rocha P, Rodrigues LK, et al. Efficacy and safety of elinzanetant in vasomotor symptoms associated with menopause: a meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2025;286:45-53. doi:10.1016/j.ejogrb.2025.01.050. Poster to be presented at the ACOG Annual Clinical and Scientific Meeting; May 16-18, 2025; Minneapolis, MN.
2. Elinzanetant data to feature prominently at Congress of the European Society of Gynecology: Bayer update. Patient Care Online. Accessed May 16, 2025. https://www.patientcareonline.com/view/elinzanetant-data-to-feature-prominently-at-congress-of-the-european-society-of-gynecology-bayer-update
3. Elinzanetant VMS update: as positive results pile up, Bayer readies for menopause treatment’s future. Patient Care Online. Accessed May 16, 2025. https://www.patientcareonline.com/view/elinzanetant-vms-update-as-positive-results-pile-up-bayer-readies-for-menopause-treatment-s-future