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A Phase 3, Double-Blind, Randomized, Two-Period, Multicenter, Placebo-Controlled, Efficacy and Safety Study of JNT-517 for the Treatment of Participants With Phenylketonuria

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Trial Profile

A Phase 3, Double-Blind, Randomized, Two-Period, Multicenter, Placebo-Controlled, Efficacy and Safety Study of JNT-517 for the Treatment of Participants With Phenylketonuria

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 26 May 2026

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At a glance

  • Drugs Repinatrabit (Primary)
  • Indications Phenylketonuria
  • Focus Registrational; Therapeutic Use
  • Acronyms PheORD
  • Sponsors Jnana Therapeutics; Otsuka Pharmaceutical Development & Commercialization

Most Recent Events

  • 02 Apr 2026 Planned End Date changed from 15 Dec 2027 to 1 Apr 2028.
  • 02 Apr 2026 Planned primary completion date changed from 15 Nov 2027 to 1 Mar 2028.
  • 13 Mar 2026 According to an Otsuka Pharmaceutical media release, data from this study were presented at the 2026 American College of Medical Genetics and Genomics (ACMG) meeting.

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