Drugs / Repotrectinib
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved · conditional | EU (EMA) | Augtyro | — | 2025-01-13 | europa.eu ↗ |
| Label expansion | US (FDA) | AUGTYRO | — | 2024-06-13 | fda.gov ↗ |
| Approved | US (FDA) | AUGTYRO | — | 2023-11-15 | fda.gov ↗ |
Trials 14 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT07223671 | Dec 2025 → Feb 2026 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT05828303 | Nov 2024 → Jul 2025 | metastatic neoplasm, neoplasm | Turning Point Therapeutics, Inc. | Withdrawn | No outcome recorded |
| Phase 1 | NCT06493409 | Aug → Dec 2024 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT06352528 | Apr 2024 → Sep 2025 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT05828277 | Jul 2022 → Aug 2025 | metastatic neoplasm | Turning Point Therapeutics, Inc. | Withdrawn | No outcome recorded |
| Phase 1 | NCT04772235 | Feb 2022 → Apr 2026 | non-small cell lung carcinoma | Instituto Oncológico Dr Rosell | Unknown | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT05071183 | Sep 2021 → Mar 2023 | metastatic neoplasm | Turning Point Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT05004116 | Aug 2021 → Aug 2028 expected | metastatic neoplasm | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04094610 | Mar 2020 → Sep 2026 expected | lymphoma, metastatic neoplasm, primary brain neoplasm | Turning Point Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03093116 | Mar 2017 → Feb 2028 expected | metastatic neoplasm | Turning Point Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06315010 | Jun 2025 → Mar 2027 expected | metastatic malignant neoplasm in the brain, non-small cell lung carcinoma | MedSIR | Recruiting | No outcome recorded |
| Phase 2 | NCT06552234 | Oct 2024 → Sep 2031 expected | non-small cell lung carcinoma | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer | Recruiting | No outcome recorded |
| Phase 2 | NCT06408168 | Aug 2024 → Dec 2025 | hormone receptor-positive breast cancer, invasive lobular breast carcinoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06140836 | Dec 2023 → Mar 2026 overdue | non-small cell lung carcinoma | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| — | NCT05926232 Background | — | — | Bristol-Myers Squibb | Available | No outcome recorded |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Repotrectinib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06315010 ↗ |
| Known as | Augtyro | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298138 ↗ |
| Known as | BMS-986472 | “A Phase I, Two-part, Single-center, Open-label, Drug-drug Interaction Study to Assess the Effect of Voriconazole (Part 1) and Quinidine (Part 2) on the Pharmacokinetics of a...” NCT06493409 ↗ |
| Known as | TPX-0005 | “Oral repotrectinib (TPX-0005) capsules.” NCT03093116 ↗ |
| Known as | TRX-0005 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298138 ↗ |
| Action | Inhibit | “Repotrectinib potently inhibited in vitro and in vivo tumor growth and ROS1 downstream signal” PMID 32269053 ↗ Apr 20203“Neurotrophic tyrosine kinase receptor type 2 inhibitor” CHEMBL4298138 ↗ “Nerve growth factor receptor Trk-A inhibitor” CHEMBL4298138 ↗ “NT-3 growth factor receptor inhibitor” CHEMBL4298138 ↗ |
| Modality | Small molecule | “Repotrectinib (TPX-0005) is a rationally designed, low-molecular-weight, macrocyclic TKI” PMID 30093503 ↗ Aug 2018 |
| Route | Oral | “Oral repotrectinib (TPX-0005) capsules.” NCT03093116 ↗ |
| Target | ALK | “Repotrectinib (TPX-0005) is a rationally designed, low-molecular-weight, macrocyclic TKI that is selective and highly potent against ROS1, TRKA-C, and ALK.” PMID 30093503 ↗ Aug 2018 |
| Target | NTRK1 | “Nerve growth factor receptor Trk-A inhibitor” CHEMBL4298138 ↗ |
| Target | NTRK2 | “Neurotrophic tyrosine kinase receptor type 2 inhibitor” CHEMBL4298138 ↗ |
| Target | NTRK3 | “NT-3 growth factor receptor inhibitor” CHEMBL4298138 ↗ |
| Target | ROS1 | “Repotrectinib (TPX-0005) is a rationally designed, low-molecular-weight, macrocyclic TKI that is selective and highly potent against ROS1, TRKA-C, and ALK.” PMID 30093503 ↗ Aug 2018 |