🇺🇸 Imcivree in United States

FDA authorised Imcivree on 25 November 2020

Marketing authorisation

FDA — authorised 25 November 2020

  • Application: NDA213793
  • Marketing authorisation holder: RHYTHM
  • Local brand name: IMCIVREE
  • Indication: SOLUTION — SUBCUTANEOUS
  • Status: approved

The FDA approved Imcivree, a drug developed by RHYTHM, for its approved indication on 21 August 2025. The application number for this approval is NDA213793. Imcivree was granted marketing authorisation through a standard expedited pathway.

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Imcivree in other countries

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

Other Metabolic approved in United States

Frequently asked questions

Is Imcivree approved in United States?

Yes. FDA authorised it on 25 November 2020.

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

RHYTHM holds the US marketing authorisation.