Clinical Trial

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

Recruiting Phase 3
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Summary
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.
Protocol Amendment History 2 changes
notable Enrollment increased: 45 -> 240 participants 2026-05-02
minor Trial arms changed: 4 -> 1 2026-05-02
Trial Details
NCT Number NCT06628128
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions Phenylketonuria (PKU)
Enrollment 240 participants
Start Date 2025-08-11
Primary Completion 2027-11-01 (estimated)
Study Completion 2028-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-01