A Long-Term Study of JNT-517 in Participants With Phenylketonuria
Recruiting now · Phase 3
Conditions studied: Phenylketonuria (PKU)
In brief
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.
Key facts
- Study ID
- NCT06628128
- Run by
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- People needed
- 240
- Starts
- 2025-08-11
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2026-05-01
Who can join
Age: 4 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Florida (UF) Health Shands Hospital — Gainesville, Florida, United States (enrolling)
- University of South Florida — Tampa, Florida, United States (enrolling)
- Oregon Health and Science University — Portland, Oregon, United States (enrolling)
- University of Pittsburgh Medical Center (UPMC) - Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
- Children's Medical Center Dallas — Dallas, Texas, United States (enrolling)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
- University of Texas Health (UTHealth) Science Center at Houston — Houston, Texas, United States (enrolling)
- Utah Health - The University of Utah Hospital — Salt Lake City, Utah, United States (enrolling)
- Children's Health Queensland - Queensland Children's Hospital — South Brisbane, Queensland, Australia (enrolling)
- Mater Health - Mater Hospital Brisbane — South Brisbane, Queensland, Australia (enrolling)
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (enrolling)
- Murdoch Children's Research Institute — Parkville, Victoria, Australia (enrolling)
Full record on ClinicalTrials.gov
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