FDA — authorised 24 October 2025
- Application: NDA219469
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: LYNKUET
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 ELINZANETANT in United States
FDA authorised ELINZANETANT on 24 October 2025
Marketing authorisations
FDA
- Status: approved
ELINZANETANT in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is ELINZANETANT approved in United States?
Yes. FDA authorised it on 24 October 2025; FDA has authorised it.
Who is the marketing authorisation holder for ELINZANETANT in United States?
BAYER HLTHCARE holds the US marketing authorisation.