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A Phase 3 Study of PTC923 in Subjects With Phenylketonuria

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Trial Profile

A Phase 3 Study of PTC923 in Subjects With Phenylketonuria

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Jun 2025

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At a glance

  • Drugs Sepiapterin (Primary)
  • Indications Phenylketonuria
  • Focus Registrational; Therapeutic Use
  • Acronyms APHENITY
  • Sponsors PTC Therapeutics

Most Recent Events

  • 26 Jun 2025 According to a PTC Therapeutics media release, The Sephience European launch will be initiated in Germany in the first half of July.
  • 23 Jun 2025 According to a PTC Therapeutics media release, Sephience (sepiapterin) was granted marketing authorization by the European Commission for the treatment of children and adults living with phenylketonuria (PKU). The authorization includes a broad label inclusive of all ages and disease severities.
  • 25 Apr 2025 According to a PTC Therapeutics media release, the New Drug Application (NDA) for sepiapterin is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of July 29, 2025.

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