🇺🇸 Etrasimod in United States

FDA authorised Etrasimod on 12 October 2023

Marketing authorisation

FDA — authorised 12 October 2023

  • Application: NDA216956
  • Marketing authorisation holder: PFIZER
  • Indication: Type 1 - New Molecular Entity
  • Status: approved

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Etrasimod in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Immunology approved in United States

Frequently asked questions

Is Etrasimod approved in United States?

Yes. FDA authorised it on 12 October 2023.

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

PFIZER holds the US marketing authorisation.