NCT06971731View on ClinicalTrials.gov

A Study to Evaluate the Safety and Efficacy of JNT-517 in Participants With Phenylketonuria (PKU)

PHASE3Not yet recruitingINTERVENTIONAL

Enrollment

120

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

November 30, 2026

Study Completion Date

October 31, 2027

Conditions

Phenylketonuria

Interventions

DRUG

JNT-517 Tablet

JNT-517: 75 mg BID

DRUG

JNT-517 Tablet

JNT-517: 150 mg BID

DRUG

Placebo Tablet: BID

Placebo Tablet: BID

All Listed Sponsors

lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY