Drugs / Repotrectinib
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed NTRK fusion positive cancer 2 milestones | |||||
| Filed | China (NMPA) | — | NTRK fusion positive cancer | 2025-04-21 | “China’s National Medical Products Administration (NMPA) has accepted the supplemental New Drug Application (sNDA) for repotrectinib” zailaboratory.com ↗ |
| Filed | US (FDA) | Augtyro | NTRK fusion positive cancer | 2024-02-14 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Augtyro™ (repotrectinib)” bms.com ↗ “In May 2023, Zai Lab partner Bristol Myers Squibb (BMS) announced that the NDA for repotrectinib was accepted for priority review by the FDA” zailaboratory.com ↗ “the FDA has accepted its supplemental NDA (sNDA) for repotrectinib for the treatment of adult and pediatric patients” zailaboratory.com ↗ |
| Filed RET fusion positive cancer 1 milestone | |||||
| Filed | US (FDA) | — | RET fusion positive cancer | 2023-05-30 | “The U.S. FDA accepted the New Drug Application for repotrectinib for the treatment of patients with ROS1 -positive locally advanced or metastatic NSCLC.” bms.com ↗ “Based on results from the TRIDENT-1 trial, the U.S. Food and Drug Administration accepted the New Drug Application for repotrectinib” bms.com ↗ “today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for repotrectinib” bms.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Approved · conditional | EU (EMA) | Augtyro | — | 2025-01-13 | europa.eu ↗ |
| Label expansion | US (FDA) | AUGTYRO | — | 2024-06-13 | fda.gov ↗ |
| Filed | EU (EMA) | — | ROS1-positive non-small cell lung cancer, NTRK-positive solid tumors | 2024-01-02 | “today announced that the European Medicines Agency (EMA) has validated its marketing authorization application for the next-generation tyrosine kinase inhibitor (TKI) repotrectinib” bms.com ↗ |
| Approved | US (FDA) | AUGTYRO | — | 2023-11-15 | fda.gov ↗ |
Trials 14
| 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 Stop: Enrollment |
| 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 Stop: Enrollment |
| 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 overdue | central nervous system neoplasm, lymphoma, metastatic malignant 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 → Feb 2027 expected | non-small cell lung carcinoma | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT05926232 Background | — | — | Bristol-Myers Squibb | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2026-01-06 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces National Medical Products Administration (NMPA) Approval of AUGTYRO™ (repotrectinib) for Patients with NTRK-Positive Solid Tumors zailaboratory.com ↗
We are pleased with the NMPA ’s approval of AUGTYRO for patients with NTRK-positive solid tumors. |
| 2025-04-21 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Acceptance of Supplemental New Drug Application for Repotrectinib for Patients with NTRK-Positive Solid Tumors zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted the supplemental New Drug Application (sNDA) for repotrectinib for the treatment of adult patients with solid tumors that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. |
| 2024-11-27 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces the Inclusion of AUGTYRO® (repotrectinib) for ROS1+ NSCLC and Other Updates in China’s National Reimbursement Drug List zailaboratory.com ↗
AUGTYRO® (repotrectinib) is included in the NRDL for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC); |
| 2024-11-15 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives Positive CHMP Opinion for Repotrectinib for the Treatment of Advanced ROS1-Positive Non-Small Cell Lung Cancer and Advanced NTRK-Positive Solid Tumors bms.com ↗ |
| 2024-06-13 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves Augtyro™ (repotrectinib), a Next-Generation Tyrosine Kinase Inhibitor (TKI), for the Treatment of Patients with NTRK-Positive Locally Advanced or Metastatic Solid Tumors bms.com ↗
This accelerated approval marks the second indication for Augtyro in the U.S. |
| 2024-06-03 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents Multiple New Analyses at 2024 ASCO® Annual Meeting Highlighting Opdivo and Opdivo-based Combinations in Early and Advanced Stages of Non-Small Cell Lung Cancer bms.com ↗
Other presentations include an updated analysis of the Phase 1/2 TRIDENT-1 study which shows Augtyro™ (repotrectinib) continued to demonstrate durable responses in ROS1 -positive TKI-naive NSCLC patients at a follow-up of approximately three years. |
| 2024-05-12 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Approval of AUGTYRO™ (repotrectinib) for Patients with ROS1-positive NSCLC by China’s NMPA zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the National Medical Products Administration (NMPA) in China has approved the New Drug Application (NDA) for AUGTYRO™ (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC). |
| 2024-02-14 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Augtyro™ (repotrectinib) for the Treatment of Patients with NTRK-Positive Locally Advanced or Metastatic Solid Tumors bms.com ↗
The FDA granted the application Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 15, 2024. |
| 2024-01-10 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab Announces The New England Journal of Medicine Publication Demonstrating Durable Clinical Activity of Repotrectinib in Patients with Advanced ROS1 Fusion-Positive NSCLC zailaboratory.com ↗
In the TRIDENT-1 study, repotrectinib demonstrated high response rates and durable activity in patients with ROS1+ NSCLC, including patients with TKI-naïve and TKI-pretreated tumors, ROS1 G2032R resistance mutations and brain metastases. |
| 2024-01-02 | Bristol-Myers Squibb | Regulatory European Medicines Agency Validates Bristol Myers Squibb’s Application for Repotrectinib for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer and NTRK-Positive Solid Tumors bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated its marketing authorization application for the next-generation tyrosine kinase inhibitor (TKI) repotrectinib as a treatment for ROS1 TKI-naïve and -pretreated adult patients with ROS1 -positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and TKI-naïve and -pretreated adult and pediatric patients 12 years and older with NTRK -positive locally advanced or metastatic solid tumors. |
| 2023-11-15 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves Augtyro™ (repotrectinib), a Next-Generation Tyrosine Kinase Inhibitor (TKI), for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer (NSCLC) bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Augtyro ™ (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC). |
| 2023-08-30 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Breakthrough Therapy Designation Granted for Repotrectinib for Treatment of Patients with NTRK-positive TKI-pretreated advanced solid tumors in China zailaboratory.com ↗
Zai Lab Announces Breakthrough Therapy Designation Granted for Repotrectinib for Treatment of Patients with NTRK-positive TKI-pretreated advanced solid tumors in China |
| 2023-08-16 | Bristol-Myers Squibb | Results Updated Data from TRIDENT-1 Trial Show Durable Efficacy Benefits with Repotrectinib for Patients with Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer bms.com ↗
Repotrectinib continued to demonstrate high response rates and durable responses, including robust intracranial responses, in patients with ROS1 -positive locally advanced or metastatic non-small cell lung cancer who were TKI-naïve or previously treated with one TKI and no chemotherapy |
| 2023-06-28 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces NDA Acceptance of Repotrectinib for Patients with ROS1-positive NSCLC by China’s NMPA zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the National Medical Products Administration (NMPA) in China has accepted the New Drug Application (NDA) for repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC). |
| 2023-05-30 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Repotrectinib for the Treatment of Patients with Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for repotrectinib, a next-generation tyrosine kinase inhibitor (TKI), for the treatment of patients with ROS1 -positive locally advanced or metastatic non-small cell lung cancer (NSCLC), based on results from the TRIDENT-1 trial. |
| 2023-05-18 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces That Repotrectinib Granted Priority Review by China’s NMPA zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted priority review to repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC). |
| 2023-05-11 | Bristol-Myers Squibb | Results Bristol Myers Squibb to Highlight Diversified Approaches and Commitment to Improving Outcomes for Patients with Cancer and Serious Blood Disorders at ASCO, EHA and ICML 2023 bms.com ↗
New TRIDENT-1 data reinforce potential of precision medicine repotrectinib in patients with locally advanced or metastatic ROS1 fusion-positive non-small cell lung cancer (NSCLC), including those with central nervous system metastases |
| 2022-06-10 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Breakthrough Therapy Designations Granted for Repotrectinib in China zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted two Breakthrough Therapy Designations for investigational repotrectinib |
| 2022-02-17 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Breakthrough Therapy Designation Granted for Repotrectinib in China zailaboratory.com ↗
Zai Lab Announces Breakthrough Therapy Designation Granted for Repotrectinib in China |
| 2021-10-04 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Partner Turning Point Therapeutics Granted Breakthrough Therapy Designation for Repotrectinib Treatment in Patients With NTRK-Positive, TKI-Pretreated Advanced Solid Tumors zailaboratory.com ↗
today announced the U.S. Food and Drug Administration (FDA) granted a seventh regulatory designation to lead drug candidate, repotrectinib. |
All press releases naming this drug 23 releases
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 NCT03093116 ↗ |
| 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 |