🇺🇸 Redemplo in United States

FDA authorised Redemplo on 18 November 2025

Marketing authorisations

FDA — authorised 18 November 2025

  • Application: NDA219947
  • Marketing authorisation holder: ARROWHEAD
  • Local brand name: REDEMPLO
  • Indication: SOLUTION — SUBCUTANEOUS
  • Status: approved

The FDA approved Redemplo, a new molecular entity, on 18 November 2025. The marketing authorisation was granted to ARROWHEAD under the standard expedited pathway. The approval was based on the NDA219947 application.

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FDA

  • Marketing authorisation holder: ARROWHEAD
  • Status: approved

Redemplo 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 Redemplo approved in United States?

Yes. FDA authorised it on 18 November 2025; FDA has authorised it.

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

ARROWHEAD holds the US marketing authorisation.