FDA — authorised 13 November 2025
- Application: NDA220305
- Marketing authorisation holder: KURA
- Local brand name: KOMZIFTI
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Komzifti in United States
FDA authorised Komzifti on 13 November 2025
Marketing authorisations
FDA
- Marketing authorisation holder: KURA
- Status: approved
Komzifti in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Komzifti approved in United States?
Yes. FDA authorised it on 13 November 2025; FDA has authorised it.
Who is the marketing authorisation holder for Komzifti in United States?
KURA holds the US marketing authorisation.