Drugs / JNT-517
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-03-13 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results 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 ↗
Adolescents in a long-term, open-label extension study receiving a twice-daily low dose of repinatrabit achieved clinically meaningful reductions in blood Phe levels at month one of the open-label extension study, with all participants demonstrating clinical response |
| 2026-03-12 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results 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 ↗
Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced new open-label extension study data for repinatrabit (JNT-517), demonstrating early and clinically meaningful reductions in blood phenylalanine (Phe) levels (-67% mean change from baseline) in adolescents with phenylketonuria (PKU). |
All press releases naming this drug 5 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | JNT-517 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06628128 ↗ |
| Known as | Repinatrabit | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07713758 ↗ |
| Route | Oral | “oral JNT-517” NCT05781399 ↗ |