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.
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Elinzanetant reduces vasomotor symptom frequency and sleep disturbance in menopausal women across diverse populations The current body of evidence comprises 1 study, including 1 randomized controlled trial. EvidenceHub rates the overall confidence at 44/100 (low).
The Claim
Elinzanetant reduces vasomotor symptom frequency and sleep disturbance in menopausal women across diverse populations
This conclusion is most relevant to: 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).
What the Research Shows
The conclusion draws on 1 linked study. Highlights from the cited literature:
- ▸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) —
How It Works
The proposed biological pathway:
- ▸Elinzanetant antagonizes neurokinin-1 and neurokinin-3 receptors
- ▸Modulation of hypothalamic pathways involved in thermoregulation and sleep
- ▸Reduction in vasomotor symptom frequency and severity
- ▸Improvement in sleep disturbance and quality of life
Who Might Benefit
Evidence fit by 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)
Recommended Dose
N/A (specific dose not mentioned in abstract)
Limitations & Caveats
Important context when interpreting this evidence:
- ▸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.
References
- 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