Elinzanetant, approved in the UK in July 2025 and by the FDA in October 2025, is the first non-hormonal NK1 and NK3 receptor antagonist for moderate-to-severe menopausal vasomotor symptoms, demonstrated effective and safe in pivotal phase 2b/3 trials with added benefits on sleep and quality of life.
OASIS‑3 evaluated once‑daily oral elinzanetant 120 mg vs placebo for 52 weeks in postmenopausal women with moderate–severe vasomotor symptoms. At 12 weeks elinzanetant reduced daily moderate–severe VMS frequency by a least‑squares mean difference of −1.6 vs placebo (P < .001); numerical advantages persisted through 50–52 weeks with no signal for hepatotoxicity or endometrial hyperplasia.
Bayer's Lynkuet (elinzanetant), a first-in-class dual neurokinin 1 and 3 receptor antagonist, has received FDA approval for treatment of moderate to severe menopausal vasomotor symptoms, demonstrating sustained efficacy and favorable safety in phase 3 trials.
A comprehensive analysis reveals that menopause does not significantly alter the risk of disability progression in women with relapse-onset multiple sclerosis, underscoring the complexity of reproductive aging's role in disease trajectory.
This review synthesizes the Menopause Priority Setting Partnership findings, highlighting the top ten evidence-based research priorities addressing non-hormonal treatments, lifestyle interventions, cognitive and sleep changes, hormone therapy duration, global experiences, breast cancer management, dementia risk, and personalized hormone therapy safety.
The AMY Study highlights vasomotor symptoms, particularly hot flushes, as key indicators of perimenopause onset, challenging traditional cycle-based definitions and underscoring the need for tailored symptom management across diverse reproductive stages.
This review synthesizes evidence on mobile digital therapeutics targeting vasomotor and behavioral health symptoms in menopausal and midlife women, highlighting efficacy, engagement, and implications for scalable symptom management.
Large-scale UK data reveal a transient increase but sustained long-term reduction in fracture risk after discontinuing menopausal HRT, challenging prior assumptions and guiding future clinical decisions.
Leading experts call on the FDA to update boxed warnings on menopausal hormone therapies, arguing current labels are outdated and deter women from effective, safe treatments.
A new study reveals combining tirzepatide and hormone therapy significantly boosts weight loss in postmenopausal women, offering a promising approach to managing obesity-related health risks.
The FDA delays its review of Bayer's elinzanetant, a novel treatment for menopause-related vasomotor symptoms, by 90 days, citing the need for additional data assessment.