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FDA Medication Tracker

← All approvals · Women's & hormonal health · 2025

Lynkuet (elinzanetant)

The FDA approved Lynkuet (elinzanetant) on October 24, 2025 to treat moderate-to-severe vasomotor symptoms due to menopause.
Brand name
Lynkuet
Generic name
elinzanetant
FDA approval date
October 24, 2025
Approved use (FDA wording)
To treat moderate-to-severe vasomotor symptoms due to menopause
Company
Bayer Hlthcare
Application
NDA219469
Dosage form / route
CAPSULE · ORAL
Boxed warning on label
Not listed
Category on this site
Women's & hormonal health

Indications and usage, from the FDA label

LYNKUET is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. LYNKUET is a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause. ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.