Elinzanetant

(Lynkuet®)

Elinzanetant

Drug updated on 11/7/2025

Dosage FormCapsule (oral; 60 mg)
Drug ClassNeurokinin 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
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  • 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 TitleYearSource
Lynkuet (elinzanetant) Prescribing Information2025Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines