The US Food and Drug Administration has approved elinzanetant (Lynkuet, Bayer), a dual neurokinin 1 and neurokinin 3 receptor antagonist, for the treatment of moderate to severe vasomotor symptoms associated with menopause. Lynkuet is the first nonhormonal therapy to target both neurokinin 1 and neurokinin 3 receptor pathways by modulating thermoregulatory dysfunction through inhibition of Substance P and Neurokinin B signaling on kisspeptin/neurokinin B/dynorphin neurons. The medication is administered as a 60-mg soft gel capsule taken once daily at bedtime, with or without food.

Approval was supported by data from three phase 3 randomized, double-blind, placebo-controlled trials (OASIS 1, OASIS 2, and OASIS 3) involving 1,420 postmenopausal women. In OASIS 1 and OASIS 2 (n = 796), elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms at weeks 4 and 12 compared with placebo. OASIS 3 evaluated long-term safety and tolerability in 627 participants treated for up to 52 weeks.

Common adverse events included headache, fatigue, dizziness, somnolence, abdominal pain, rash, diarrhea, and muscle spasms. Serious risks included elevated hepatic transaminases, central nervous system effects, pregnancy loss, and seizure risk in patients with a history of seizures. The drug is contraindicated during pregnancy, and clinicians are advised to monitor hepatic function at baseline and again after 3 months of therapy.

Lynkuet is expected to be available in the US in November 2025. Bayer will offer patient access and support through the Lynkuet Access Savings & Support program.

Source: Bayer