Drugs / JNT-517
last change Jul 2026 re-read 2 minutes ago

JNT-517

also known as Repinatrabit
Developed for
phenylketonuria
Investigated by
Otsuka Pharmaceutical Development & Commercialization, Inc.

Trials 7 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT07713758 Jul 2026 → Feb 2027 expected phenylketonuria Otsuka Pharmaceutical Development & Commercialization, Inc. Not yet recruiting No outcome recorded
Phase 1 NCT07446400 Mar → Jun 2026 overdue Otsuka Pharmaceutical Development & Commercialization, Inc. Recruiting No outcome recorded
Phase 1 NCT07573449 Jan 2024 → Jan 2025 Otsuka Pharmaceutical Development & Commercialization, Inc. Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT05781399 Oct 2022 → Jul 2025 phenylketonuria Otsuka Pharmaceutical Development & Commercialization, Inc. Completed No outcome recorded
Phase 21 trial
Phase 2 NCT06637514 Jul 2025 → May 2026 phenylketonuria Otsuka Pharmaceutical Development & Commercialization, Inc. Completed No outcome recorded
Phase 32 trials
Phase 3 NCT06971731 Oct 2025 → Mar 2028 expected phenylketonuria Otsuka Pharmaceutical Development & Commercialization, Inc. Recruiting No outcome recorded
Phase 3 NCT06628128 Aug 2025 → Nov 2027 expected phenylketonuria Otsuka Pharmaceutical Development & Commercialization, Inc. Recruiting No outcome recorded

Press releases naming this drug 5 releases

DateIssuerRelease
2026-03-13 Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka Unveils New Repinatrabit Open-Label Extension Data in Phenylketonuria (PKU) Signaling Efficacy in Adolescents at the 2026 American College of Medical Genetics and Genomics (ACMG) Meeting otsuka.co.jp
2026-03-12 Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka Unveils New Repinatrabit Open-Label Extension Data in Phenylketonuria (PKU) Signaling Efficacy in Adolescents at the 2026 American College of Medical Genetics and Genomics (ACMG) Meeting otsuka-us.com
2025-12-19 Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka Initiates Global Phase 3 Clinical Trial Evaluating Repinatrabit for the Treatment of Phenylketonuria (PKU) otsuka.co.jp
2025-12-19 Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka Initiates Global Phase 3 Clinical Trial Evaluating Repinatrabit for the Treatment of Phenylketonuria (PKU) otsuka-us.com
2024-08-01 Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka Pharmaceutical to Acquire Jnana Therapeutics Inc.- Transaction Includes JNT-517, a Potential First-In-Class Oral Treatment for Phenylketonuria (PKU) - - Expands Specialty and Autoimmune Portfolios and Drug Discovery Technologies - otsuka.co.jp

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 7 sources stand behind the page.

FieldValueCited text
Known as JNT-517 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05781399
4

NCT07573449

NCT06637514

NCT06628128

NCT06971731

Known as Repinatrabit ClinicalTrials.gov intervention name — accepted as the source's own label NCT07446400
1

NCT07713758

Route Oral oral JNT-517” NCT05781399