Treats moderate to severe vasomotor symptoms (VMS) due to menopause. NDA 219469, held by Bayer Hlthcare. Elinzanetant.
As of Nov 13, 2026, NDA 219469 (Lynkuet), held by Bayer Hlthcare, was first approved by FDA on Oct 24, 2025, with 0 approved supplements and 0 published complete response letters.
LYNKUET is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 24, 2025 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lynkuet60MG · capsule;oral | Elinzanetant | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
