Drug updated on 11/7/2025
| Dosage Form | Capsule (oral; 60 mg) |
| Drug Class | Neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
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Summary
- This summary is based on the review of five systematic reviews/meta-analyses. [1-5]
- Lynkuet (elinzanetant) is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
- Reduction in Vasomotor Symptoms (VMS) Frequency: Synthetic conjugated estrogens (SCE) 1.25 mg showed the greatest reduction in VMS frequency (MD −5.69; 95% CrI −7.93 to −3.38). Elinzanetant demonstrated a significant reduction (MD −3.09; 95% CI −4.18 to −2.01; I² = 0%) and achieved ≥50% reduction in VMS frequency at doses >100 mg. Fezolinetant ≤45 mg achieved ≥50% reductions (MD −1.38).
- Reduction in VMS Severity: Drospirenone 0.5 mg + estradiol 0.5 mg produced the greatest severity reduction (MD −1.06; 95% CrI −1.39 to −0.72). Elinzanetant reduced severity (MD −0.32; 95% CI −0.43 to −0.21; I² = 39%) with significant improvement at 120 mg (MD 0.36; 95% CI 0.26–0.46; I² = 0%), while fezolinetant 30 mg and 45 mg reduced severity (MD 0.20 and 0.24; I² = 0%).
- Quality of Life and Sleep Quality: Elinzanetant improved menopause-specific quality of life and significantly enhanced sleep quality (MD −4.65; 95% CI −5.56 to −3.73; I² = 0%). Fezolinetant also improved menopause-specific quality of life and sleep quality scores.
- Most treatments had safety profiles similar to placebo; elinzanetant demonstrated a more favorable side-effect profile than fezolinetant.
- Estradiol 0.5 mg + Dydrogesterone 2.5 mg was associated with more adverse events (RR 1.56; 95% CrI 1.16 to 2.24); elinzanetant showed increased adverse effects at higher doses, with common events including COVID-19, headache, somnolence, and gastrointestinal issues; no significant differences in serious adverse events were observed across treatments.
- All studies enrolled postmenopausal women with vasomotor symptoms (mean age 53.4–55.6 years); BMI data were extracted but not analyzed. Elinzanetant and fezolinetant demonstrated effectiveness in reducing VMS and improving quality of life and sleep quality with comparable safety profiles, and no subgroup-specific safety concerns were reported.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Lynkuet (elinzanetant) Prescribing Information | 2025 | Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Pharmacological treatments for menopausal vasomotor symptoms: A systematic review and bayesian network meta-analysis of efficacy and safety | 2025 | European Journal of Obstetrics, Gynecology, and Reproductive Biology |
| Efficacy and safety of fezolinetant and elinzanetant for vasomotor symptoms in postmenopausal women: A systematic review and meta-analysis | 2025 | Maturitas |
| Efficacy and safety of elinzanetant in vasomotor symptoms associated with menopause: A meta-analysis of randomized controlled trials | 2025 | European Journal of Obstetrics, Gynecology, and Reproductive Biology |
| Fezolinetant and elinzanetant therapy for menopausal women experiencing vasomotor symptoms: A systematic review and meta-analysis | 2025 | Obstetrics & Gynecology |
| Systematic review of neurokinin-3 receptor antagonists for the management of vasomotor symptoms of menopause | 2024 | Menopause |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| European Society of Endocrinology clinical practice guideline for evaluation and management of menopause and the perimenopause | 2025 | European Journal of Endocrinology |
| British Gynaecological Cancer Society and British Menopause Society guidelines: Management of menopausal symptoms following treatment of gynaecological cancer | 2024 | Post Reproductive Health |
| NAMS Position Statement: The 2023 nonhormone therapy position statement of The North American Menopause Society | 2023 | Menopause: The Journal of The North American Menopause Society |

