The Annals of pharmacotherapy · 2026
Elinzanetant: A Novel Approach to Management of Vasomotor Menopausal Symptoms.
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Rowe Jordan M, Coffman Ian, Barnes Kylie N
Аннотация
OBJECTIVE: To review the efficacy and safety of elinzanetant for the management of vasomotor symptoms (VMS) associated with menopause.
DATA SOURCES: Literature was identified using PubMed (1966 to January 2026), EMBASE (1973 to January 2026), and clinicaltrials.gov. Search terms included elinzanetant, VMS, and menopause, limiting trials to those published in English.
STUDY SELECTION AND DATA EXTRACTION: Articles selected for inclusion included trials evaluating elinzanetant for the treatment of VMS.
DATA SYNTHESIS: Elinzanetant was evaluated for reduction in frequency and severity of moderate-to-severe VMS associated with menopause in 3 phase 3 trials (OASIS 1, 2, and 3) and 1 phase 3 trial in patients receiving endocrine therapy for breast cancer (OASIS 4). All studies showed significant improvements in symptom frequency at week 12 compared to placebo (P < .001). Improvement in sleep disturbances and quality of life was also significant in OASIS 1, 2, and 4. Elinzanetant was well-tolerated, with headache, fatigue, dizziness, somnolence, abdominal pain, and rash reported as the most frequent drug-associated adverse effects.Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:Elinzanetant is the first dual neurokinin-1 and neurokinin-3 receptor antagonist approved for moderate-to-severe VMS associated with menopause. Elinzanetant offers a nonhormonal treatment option with favorable tolerability, representing a promising alternative for patients who cannot or prefer not to use hormonal therapy.
CONCLUSION: The U.S. Food and Drug Administration approval of elinzanetant provides an additional nonhormonal option for managing moderate-to-severe VMS of menopause in patients for whom hormonal therapy is contraindicated or undesired.
DATA SOURCES: Literature was identified using PubMed (1966 to January 2026), EMBASE (1973 to January 2026), and clinicaltrials.gov. Search terms included elinzanetant, VMS, and menopause, limiting trials to those published in English.
STUDY SELECTION AND DATA EXTRACTION: Articles selected for inclusion included trials evaluating elinzanetant for the treatment of VMS.
DATA SYNTHESIS: Elinzanetant was evaluated for reduction in frequency and severity of moderate-to-severe VMS associated with menopause in 3 phase 3 trials (OASIS 1, 2, and 3) and 1 phase 3 trial in patients receiving endocrine therapy for breast cancer (OASIS 4). All studies showed significant improvements in symptom frequency at week 12 compared to placebo (P < .001). Improvement in sleep disturbances and quality of life was also significant in OASIS 1, 2, and 4. Elinzanetant was well-tolerated, with headache, fatigue, dizziness, somnolence, abdominal pain, and rash reported as the most frequent drug-associated adverse effects.Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:Elinzanetant is the first dual neurokinin-1 and neurokinin-3 receptor antagonist approved for moderate-to-severe VMS associated with menopause. Elinzanetant offers a nonhormonal treatment option with favorable tolerability, representing a promising alternative for patients who cannot or prefer not to use hormonal therapy.
CONCLUSION: The U.S. Food and Drug Administration approval of elinzanetant provides an additional nonhormonal option for managing moderate-to-severe VMS of menopause in patients for whom hormonal therapy is contraindicated or undesired.