Lynkuet (elinzanetant)

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General information based on published sources and the symptoms you searched for. This isn't medical or legal advice, a diagnosis or a treatment plan. Please consult a doctor about your own symptoms. If your symptoms are severe or sudden, seek urgent care.

Evidence:Strong evidence

On October 24, 2025, the U.S. Food and Drug Administration approved Lynkuet (elinzanetant) for the treatment of moderate-to-severe vasomotor symptoms (hot flashes and night sweats) due to menopause. It joins Veozah (fezolinetant) in the class of targeted non-hormonal prescription treatments that act directly on temperature-regulating pathways in the brain.

What the OASIS 1–3 trials evaluated

Unlike fezolinetant (which blocks only the NK3 receptor), elinzanetant is a dual neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist. Its FDA approval was supported by three Phase 3 randomized clinical trials:

  • OASIS 1 and OASIS 2 (efficacy): 12-week randomized trials in 796 menopausal women with moderate-to-severe hot flashes.
  • OASIS 1–3 (safety): Evaluated across 1,420 women in total, including 627 women followed for up to 52 weeks in the long-term OASIS 3 study.

Source transparency note: Our current registry entry for elinzanetant is verified against the October 24, 2025 approval announcement; always review the full FDA-approved prescribing label with your clinician for contraindications, drug interactions, and laboratory monitoring requirements.

Questions to ask your clinician

Prepare for your appointment with our treatment conversation builder and compare all options in the Does It Work? evidence directory:

  • How do Lynkuet (elinzanetant) and Veozah (fezolinetant) compare for someone with my medical history and current medications?
  • What baseline or follow-up blood tests and drug-interaction checks are required on the FDA label before starting elinzanetant?
  • Does my insurance formulary cover Lynkuet, or are prior authorizations required?

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Questions people ask

How is Lynkuet (elinzanetant) different from Veozah (fezolinetant)?

While Veozah blocks the neurokinin 3 (NK3) receptor alone, Lynkuet (elinzanetant) is a dual antagonist that blocks both NK1 and NK3 receptors on thermoregulatory neurons in the hypothalamus.

How many women were studied in the Lynkuet clinical trials?

Efficacy was evaluated over 12 weeks in 796 postmenopausal women in the Phase 3 OASIS 1 and OASIS 2 trials, and safety was evaluated in 1,420 women across OASIS 1–3, including 627 women followed for up to 52 weeks in OASIS 3.

References

  1. Bayer's Lynkuet (elinzanetant) approved in the U.S. for treatment of moderate to severe vasomotor symptoms due to menopause. Bayer, 2025. [Brand-funded] Funding: Manufacturer press release. Replace with the FDA label for efficacy and safety figures..
  2. Shufelt CL, Brown V, Carpenter JS et al.. The 2023 nonhormone therapy position statement of The North American Menopause Society. Menopause (The North American Menopause Society, now The Menopause Society), 2023.
  3. VEOZAH (fezolinetant) tablets, prescribing information. Astellas Pharma US, 2026. Funding: Manufacturer-issued label (FDA-approved text).
Change log
  • : Published clinical guide on Lynkuet (elinzanetant)