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: Recruiting Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT06628128 is a Phase 3 study that is actively recruiting participants, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 240 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Reported based on results of 12-lead electrocardiograms (ECGs), vital signs, clinical laboratory tests, and other medical assessments.
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 |
What NCT06628128 shows while recruiting
NCT06628128 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 1 intervention - of which JNT-517 is the first listed.
NCT06628128 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT06628128's enrollment target sits among peer trials
240 1273rd of 2000 higher than 710 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02855554 · 240 participants · NA
Quantitative Cardiac Parametric Mapping
- NCT03230565 · 240 participants · Phase 4
Continuous Infusions vs Scheduled Bolus Infusions
- NCT03399929 · 240 participants
Traumatic Brain Injury and Stroke Long Term Outcome
- NCT03583710 · 240 participants · Phase 3
Mitotane With or Without Cisplatin and Etoposide After Surgery in Treating Patients With Stage I-III Adrenocortical Cancer With High Risk of Recurrence
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI