Long-Term Study of JNT-517 for Phenylketonuria (PKU)

This study is looking at the long-term safety of a medicine called JNT-517 for people with Phenylketonuria (PKU). PKU is a genetic condition where the body can't break down a substance called phenylalanine. You might be able to join if you are 4 years old or older and have PKU. This study is for people who have already been in a JNT-517 study, as well as those who haven't. All participants will receive JNT-517 by mouth twice a day, with the dose adjusted for your age and weight. The main goal is to see how many people experience side effects from JNT-517. The study plans to enroll 240 participants, but its current status is unclear.

Study design
This is a Phase 3, open-label study, meaning everyone knows they are receiving JNT-517. It aims to enroll 240 participants.
What's involved
You would take JNT-517 by mouth twice daily. The specific number of visits or procedures is not detailed in this record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from the start of the study until two weeks after your last dose of JNT-517.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06628128

A Long-Term Study of JNT-517 in Participants With Phenylketonuria

Recruiting
PHASE3Ages 4+InterventionalTreatment
Otsuka Pharmaceutical Development & Commercialization, Inc.
~240 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:JNT-517

At a glance

Recruiting sites
12 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured over Screening to +2 weeks from last dose
Phenylketonuria (PKU)
12 sites across 8 states
Texas3
Florida2
Queensland2
Oregon1
Pennsylvania1
Utah1
South Australia1
Victoria1

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  • Number of Participants with Treatment-emergent Adverse Events (TEAEs)Screening to +2 weeks from last dose

    Reported based on results of 12-lead electrocardiograms (ECGs), vital signs, clinical laboratory tests, and other medical assessments.