FDA — authorised 28 July 2025
- Application: NDA219666
- Marketing authorisation holder: PTC THERAP
- Local brand name: SEPHIENCE
- Indication: POWDER — ORAL
- Status: approved
🇺🇸 PTC923 in United States
FDA authorised PTC923 on 28 July 2025
Marketing authorisation
PTC923 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 PTC923 approved in United States?
Yes. FDA authorised it on 28 July 2025.
Who is the marketing authorisation holder for PTC923 in United States?
PTC THERAP holds the US marketing authorisation.