New PKU drug JNT-517 moves to Long-Term safety trial

NCT ID NCT06628128

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 study is testing the long-term safety of an oral drug called JNT-517 in 240 children and adults with phenylketonuria (PKU). All participants will receive the drug twice daily, with doses based on age and weight. The goal is to see if JNT-517 is safe to use over time and how it affects blood phenylalanine levels.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

JNT-517 (oral drug taken twice daily)

What this could lead to

If successful, this could confirm JNT-517 as a safe long-term treatment to help control phenylalanine levels in people with PKU.

What could go wrong

This is an open-label study with no placebo, so results may be biased. Long-term safety and effectiveness are still being evaluated, and side effects are possible.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

phenylketonuria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Children's Health Queensland - Queensland Children's Hospital

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Children's Medical Center Dallas

    RECRUITING

    Dallas, Texas, 75235, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Mater Health - Mater Hospital Brisbane

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Murdoch Children's Research Institute

    RECRUITING

    Parkville, Victoria, 3052, Australia

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Royal Adelaide Hospital

    RECRUITING

    Adelaide, South Australia, 5000, Australia

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • University of Florida (UF) Health Shands Hospital

    RECRUITING

    Gainesville, Florida, 32608, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • University of Pittsburgh Medical Center (UPMC) - Children's Hospital of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33606, United States

    Contact Phone: •••-•••-•••• Email: •••••@•••••

    Contact

  • University of Texas Health (UTHealth) Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••

  • Utah Health - The University of Utah Hospital

    RECRUITING

    Salt Lake City, Utah, 84112, United States

    Contact

    Contact Phone: •••-•••-•••• Email: •••••@•••••