Lynkuet (elinzanetant)

New molecular entity

Region: 🇺🇸 US
Active substance: elinzanetant
Company: Bayer Hlthcare
Status: Approved
FDA approval: Fri 24 Oct 2025
Designations: New molecular entity
Application: NDA219469
Official record: www.accessdata.fda.gov

Regulatory milestones

Mon 17 Nov 2025🇪🇺 EU approval (EC decision)

Lynkuet (elinzanetant) approved in the EU

Marketing authorisation to Bayer AG; Additional monitoring · source

Fri 24 Oct 2025🇺🇸 FDA approval

FDA approves Lynkuet (elinzanetant), a new medicine

Bayer Hlthcare; NDA219469; New molecular entity; capsule · source

Same substance in other markets

🇪🇺 Lynkuet Authorised · Bayer AG

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.