🇺🇸 Sephience in United States

FDA authorised Sephience on 28 July 2025

Marketing authorisations

FDA — authorised 28 July 2025

  • Application: NDA219666
  • Marketing authorisation holder: PTC THERAP
  • Indication: Type 1 - New Molecular Entity
  • Status: approved

The FDA approved Sephience, a new molecular entity, on 28 July 2025. The marketing authorisation was granted to PTC THERAP under the standard expedited pathway. The approval was based on the application number NDA219666.

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FDA

  • Marketing authorisation holder: PTC THERAP
  • Status: approved

Sephience 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 Sephience approved in United States?

Yes. FDA authorised it on 28 July 2025; FDA has authorised it.

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

PTC THERAP holds the US marketing authorisation.