← Eichor
Study identifier: NCT06628128 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Phenylketonuria (PKU)  ·  Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

PhasePhase 3
Planned participants240
Who can joinAll sexes, 4 Years to no upper limit
Healthy volunteersNo

About this study

The goal of this Phase 3, open-label study is to evaluate the long-term safety of JNT-517 in pediatric and adult participants with Phenylketonuria (PKU) after completion of either Study JNT517-101 (NCT05781399) or JNT517-201 (NCT06637514) as well as participants who have not participated in a prior JNT-517 study. In this trial, all participants will receive JNT-517 using age- and weight-banded dosing as outlined in the protocol, regardless of any dose received in a previous study.

This description comes directly from the study's public registry record.

Talk to the study team

Otsuka Call Center  ·  844-687-8522  ·  otsuka-professionalservices@otsuka-us.com

Always discuss trial participation with your own doctor first.

Locations (12)

University of Florida (UF) Health Shands HospitalGainesville, Florida, United StatesRecruiting
University of South FloridaTampa, Florida, United StatesRecruiting
Oregon Health and Science UniversityPortland, Oregon, United StatesRecruiting
University of Pittsburgh Medical Center (UPMC) - Children's Hospital of PittsburghPittsburgh, Pennsylvania, United StatesRecruiting
Children's Medical Center DallasDallas, Texas, United StatesRecruiting
University of Texas Southwestern Medical CenterDallas, Texas, United StatesRecruiting
University of Texas Health (UTHealth) Science Center at HoustonHouston, Texas, United StatesRecruiting
Utah Health - The University of Utah HospitalSalt Lake City, Utah, United StatesRecruiting
Children's Health Queensland - Queensland Children's HospitalSouth Brisbane, Queensland, AustraliaRecruiting
Mater Health - Mater Hospital BrisbaneSouth Brisbane, Queensland, AustraliaRecruiting
Royal Adelaide HospitalAdelaide, South Australia, AustraliaRecruiting
Murdoch Children's Research InstituteParkville, Victoria, AustraliaRecruiting

Follow this study

Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.

We email about this public record only. Unsubscribe anytime with one click. Never medical advice.

Is this your study? This page was generated automatically from the public registry record. Sponsors can claim it — free — to add branding and verified contact routing. Claim this page →

This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.

Source record: clinicaltrials.gov/study/NCT06628128