Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06628128 · ClinicalTrials.gov registry record · Phase 3
A Long-Term Study of JNT-517 in Participants With Phenylketonuria
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 240
- Enrollment target
NCT06628128 is a Phase 3 study that is actively recruiting participants, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 240 participants.
The verdict
NCT06628128, a Phase 3 study, is actively recruiting participants, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 240 participants
- Enrollment target
Study 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.
Interventions
- DRUG JNT-517
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2025-08-11 |
| Est. Completion | 2028-02-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06628128
The ClinicalTrials.gov registry entry for NCT06628128 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which JNT-517 is the first listed.
NCT06628128 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06628128 about?
NCT06628128 is a clinical study titled "A Long-Term Study of JNT-517 in Participants With Phenylketonuria". 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 ...
What is the current status of trial NCT06628128?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2025-08-11. Estimated completion is 2028-02-01.
What interventions are being tested in trial NCT06628128?
The interventions under investigation include: JNT-517 (DRUG).
Who is sponsoring clinical trial NCT06628128?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.