Drug · Small Molecule
Repotrectinib
CI-DRUG-00000514Explore in graph →NCIt C133821 CHEMBL4298138 CIViC Approved
Regulatory
Approvals (6)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- Health Canada — Drug Product Database (DPD)
- Dataset
- Health Canada DPD
- Version
- dpd-2026-09-11
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- Open Government Licence – Canada (https://open.canada.ca/en/open-government-licence-canada)
- Run
- ING-HEALTHCANADADPD-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| CA Health Canada | — | Marketed in Canada as AUGTYRO (DIN 02557444) under ATC L01EX28 REPOTRECTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Pre Marketsince Oct 17, 2025 | — | health-canada-dpd |
| CA Health Canada | — | Marketed in Canada as AUGTYRO (DIN 02557452) under ATC L01EX28 REPOTRECTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | withdrawnsource: Cancelled Pre Marketsince Oct 17, 2025 | — | health-canada-dpd |
| EU EMA | Tumor-agnosticLung Non-Small Cell Carcinoma | Augtyro as monotherapy is indicated for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC). Augtyro as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with advanced solid tumours expressing a NTRK gene fusion, and who have received a prior NTRK inhibitor, or have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1) |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 18 hours agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 3 | 6 | 5 | 1 | 12 | 6 | CA, EU, US | Nov 15, 2023 | Mar 7, 2017 |
| Malignant Lung Neoplasm | Approved | Phase 3 | 3 | 2 | 1 | 4 | 2 | EU, US | Nov 15, 2023 | Feb 11, 2022 |
| Malignant Breast Neoplasm | Phase2 | Phase 2 | 0 | 0 | 0 | 1 | 0 | — | — | Aug 8, 2024 |
Curated evidence
Clinical evidence (8)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 34625502
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| NTRK3 Fusion + NTRK3 G623R1 | ||||||||
| Repotrectinib | Lung Non-Small Cell Carcinoma | |||||||
Clinical trials
Trials with this intervention (14)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT04094610 | A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations | recruiting | Phase 1 / Phase 2 | 75 | Turning Point Therapeutics, Inc.INDUSTRY | 11 | Sep 25, 2026 | clinicaltrials |
| NCT06140836 | A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3) |