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Elinzanetant reduces vasomotor symptom frequency and sleep disturbance in menopausal women across diverse populations

In the OASIS clinical trial program (OASIS-1-4), elinzanetant significantly reduced vasomotor symptom frequency vs placebo from as early as week 1 in OASIS-1 and -2, and by week 12 in all studies, with benefits maintained up to 50 weeks. Sleep disturbance, measured by PROMIS Sleep Disturbance Short Form 8b, improved across all trials as early as week 1, with significant reductions vs placebo at week 12 in OASIS-1, -2, and -4.

Last updated: Aug 4, 2026•1 RCTs•📖 Read as article →

Evidence Score

Evidence Score44/100
Human RCT★★☆☆☆
Meta-analysis☆☆☆☆☆
Mechanism★★★★★
Safety★★★★☆
Confidencelow

Study Evidence

Study 1. Consistency of efficacy and safety of elinzanetant for vasomotor symptoms and sleep disturbance associated with menopause across different populations: a review of the OASIS clinical trial program.

observational

Pinkerton JV, Simon JA, Panay N, Nappi RE, Brennan DJ, Donders G, Soares CN, Maki P, Caetano C, Haberland C, Laapas K, Zuurman L, Cardoso F · Maturitas (2026)

Participants: N/A
Duration: Up to 50 weeks
Intervention: Elinzanetant (dual neurokinin-1/-3 receptor antagonist) at the approved dose for moderate-to-severe vasomotor symptoms
Outcome: Vasomotor symptom frequency and severity, sleep disturbance (PROMIS Sleep Disturbance Short Form 8b total T-score), menopause-related quality of life (MENQOL total score)
Effect Size: N/A (specific effect sizes not reported in abstract)
Population: Diverse populations of women with vasomotor symptoms associated with natural or surgical menopause (OASIS-1, -2, -3) and caused by endocrine therapy for breast cancer (OASIS-4)

Result:

PubMed: 42537360DOI: 10.1016/j.maturitas.2026.109075

Mechanism Graph

Elinzanetant antagonizes neurokinin-1 and neurokinin-3 receptors
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Modulation of hypothalamic pathways involved in thermoregulation and sleep
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Reduction in vasomotor symptom frequency and severity
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Improvement in sleep disturbance and quality of life

Limitations

  • ⚠Abstract does not report specific effect sizes or confidence intervals
  • ⚠OASIS-3 and OASIS-4 analyses for some endpoints were descriptive only, not inferential
  • ⚠Long-term efficacy beyond 50 weeks not addressed

Frequently Asked Questions

How quickly does elinzanetant reduce vasomotor symptoms?▼

Significant reductions vs placebo appeared as early as week 1 in OASIS-1 and -2, and by week 12 in all studies.

Does elinzanetant improve sleep disturbance?▼

Yes, sleep disturbance improved across all four trials as early as week 1, with significant reductions vs placebo at week 12 in OASIS-1, -2, and -4.

Is elinzanetant effective in women with breast cancer-related vasomotor symptoms?▼

Yes, OASIS-4 included women with vasomotor symptoms caused by endocrine therapy for breast cancer, and results were consistent with other trials.

How long do the benefits of elinzanetant last?▼

Benefits were maintained for up to 50 weeks across the trials.

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References

  1. 1.Pinkerton JV, Simon JA, Panay N, Nappi RE, Brennan DJ, Donders G, Soares CN, Maki P, Caetano C, Haberland C, Laapas K, Zuurman L, Cardoso F. "Consistency of efficacy and safety of elinzanetant for vasomotor symptoms and sleep disturbance associated with menopause across different populations: a review of the OASIS clinical trial program.." Maturitas, 2026. PMID: 42537360 DOI: 10.1016/j.maturitas.2026.109075
Disclaimer: This content is for educational purposes only and is not medical advice. Evidence scores reflect the quality and quantity of available research, not clinical recommendations. Always consult a healthcare professional before starting any supplement or intervention.