Elinzanetant Reduced Menopausal VMS Frequency by ≥50% in 67% of Women at Week 12: TMS 2026

Nearly 67% of postmenopausal women receiving elinzanetant (Lynkuet; Bayer) experienced at least a 50% reduction in moderate to severe vasomotor symptom (VMS) frequency at 12 weeks, compared with 40.5% receiving placebo, according to a pooled analysis of the phase 3 OASIS-1 and OASIS-2 clinical trials presented at The Menopause Society 2026 Annual Meeting, held October 20-24 in San Diego, California.¹

Among 410 US participants, 66.9% of women receiving elinzanetant 120 mg daily achieved at least a 50% reduction in VMS frequency at week 12, while 46.5% achieved at least a 75% reduction and 29.1% experienced at least a 90% reduction. Corresponding response rates in the placebo group were 40.5%, 21.4%, and 11.6%, respectively.¹

The findings provide additional insight into the proportion of women achieving clinically meaningful symptom relief with elinzanetant, a dual neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist approved by the FDA in October 2025 for moderate to severe VMS associated with menopause.²

Investigators led by JoAnn V. Pinkerton, MD, professor of obstetrics and gynecology at the University of Virginia, conducted an exploratory post hoc analysis of US participants enrolled in the global OASIS-1 (NCT05042362) and OASIS-2 (NCT05099159) trials. Both studies previously demonstrated significant improvements in VMS frequency and severity, sleep disturbance, and menopause-related quality of life with elinzanetant compared with placebo.¹

The pooled analysis included 410 postmenopausal women aged 40 to 65 years who experienced at least 50 moderate to severe VMS episodes per week at baseline. Participants were randomized 1:1 to receive elinzanetant 120 mg (n=205) or placebo (n=205) for 12 weeks, followed by elinzanetant treatment in both groups for an additional 14 weeks.

VMS frequency was assessed using patient-reported Hot Flash Daily Diaries. Investigators evaluated the proportions achieving reductions of at least 50%, 75%, and 90% from baseline at weeks 4, 12, and 26, with the 50% threshold designated as a clinically meaningful response.¹

Clinically Meaningful VMS Reductions Observed by Week 4

At week 4, 57.9% of elinzanetant-treated participants had achieved at least a 50% reduction in moderate to severe VMS frequency, compared with 26.7% receiving placebo. Higher response thresholds also favored elinzanetant, with 31.6% versus 14.1% achieving at least a 75% reduction and 17.4% versus 5.2% achieving at least a 90% reduction.¹

Response rates continued to increase through week 12:

• ≥50% reduction in VMS frequency: 66.9% with elinzanetant vs 40.5% with placebo.
• ≥75% reduction: 46.5% vs 21.4%.
• ≥90% reduction: 29.1% vs 11.6%.

At week 26, when all participants were receiving elinzanetant, 75.2% of women initially randomized to elinzanetant achieved at least a 50% reduction in VMS frequency, compared with 84.1% of those who switched from placebo to active treatment at week 12.

Similarly, 62.4% and 40.4% of continuous elinzanetant users achieved reductions of at least 75% and 90%, respectively, compared with 59.3% and 39.8% among participants initially assigned to placebo.¹

The convergence in response rates after both groups received active treatment supports the sustained symptom reductions observed during the treatment period. However, because all participants were receiving elinzanetant after week 12, the week 26 findings cannot establish comparative efficacy against placebo.

Implications for Menopausal VMS Management

The findings offer clinically relevant information for physicians counseling postmenopausal women about the expected magnitude and timing of symptom improvement with nonhormonal VMS treatment.

Elinzanetant is administered orally at a recommended dose of 120 mg once daily at bedtime and represents a nonhormonal treatment option for women with moderate to severe menopausal VMS.²

For primary care physicians, the responder data may help establish treatment expectations, particularly for patients who want to understand the likelihood of achieving a substantial reduction in hot flash frequency rather than the average reduction reported across a clinical trial population.

Although more than half of elinzanetant-treated women achieved a clinically meaningful response by week 4, additional improvements were observed through weeks 12 and 26, suggesting that symptom relief may continue to increase beyond the initial weeks of treatment.

However, the analysis was exploratory and conducted post hoc in the US subset of 2 multinational trials. The abstract did not report statistical comparisons or confidence intervals for the responder thresholds, limiting conclusions about the precision of the observed differences.

The investigators concluded that elinzanetant was associated with clinically meaningful reductions in VMS frequency beginning as early as week 4, with more than 40% of women receiving continuous treatment achieving at least a 90% reduction by week 26. The US findings were consistent with results observed in the overall trial populations.¹

References

1. Pinkerton JV, Tough DeSapri K, Clark A, et al. Proportion of postmenopausal participants achieving ≥50% reduction in moderate-to-severe vasomotor symptom frequency with elinzanetant: pooled US population data from OASIS-1 and OASIS-2. Abstract S-5. Presented at: The Menopause Society 2026 Annual Meeting; October 20-24, 2026; San Diego, CA.
2. US Food and Drug Administration. Drug Trials Snapshots: LYNKUET. October 24, 2025. https://www.fda.gov/drugs/drug-trials-snapshots/drug-trials-snapshots-lynkuet
3. Lynkuet (elinzanetant). Prescribing information. Bayer HealthCare Pharmaceuticals Inc. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f42884ff-7dff-419c-8a0c-affe2ed73818