🇺🇸 DEFACTINIB in United States

FDA authorised DEFACTINIB on 8 May 2025

Marketing authorisation

FDA — authorised 8 May 2025

  • Application: NDA219616
  • Marketing authorisation holder: VERASTEM INC
  • Indication: Type 1 - New Molecular Entity
  • Status: approved

The FDA approved DEFACTINIB, a new molecular entity, for an unspecified indication. The marketing authorisation was granted to VERASTEM INC on 2025-05-08, following a standard expedited pathway. The application number for this approval is NDA219616.

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DEFACTINIB 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 DEFACTINIB approved in United States?

Yes. FDA authorised it on 8 May 2025.

Who is the marketing authorisation holder for DEFACTINIB in United States?

VERASTEM INC holds the US marketing authorisation.