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.

health-canada-dpdRegulatory2 approval records · authority, jurisdiction and indication text as published.

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

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 19 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

Computedclinicaltrials

Curated evidence

Clinical evidence (8)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–8 of 8 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

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.

clinicaltrialsPublishedShowing 1–14 of 14 studies · status and phase as posted by the registrant; each row links to the study record.

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)

Molecule

Record

Kind: Small Molecule
Mechanism: Nerve growth factor receptor Trk-A inhibitor; Neurotrophic tyrosine kinase receptor type 2 inhibitor; Proto-oncogene tyrosine-protein kinase ROS inhibitor; NT-3 growth factor receptor inhibitor; CD74-ROS1 inhibitor; ROS1-SDC4 inhibitor
Targets: 6 genes
UNII: 08O3FQ4UNP
Aliases: ALK/ROS1/NTRK/SRC/FAK Multikinase Inhibitor TPX-0005, Augtyro, AUGTYRO, Multi-kinase Inhibitor TPX-0005, Multikinase Inhibitor TPX-0005, Repotrectinib, TPX 0005, TPX-0005, TPX0005, TRX-0005

Data updated 22 hours agoSource updated unknown

Identifiers

Codes (6)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EX28	REPOTRECTINIB
DIN (Health Canada)	02557444

ROS1 G2032R1
Repotrectinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	3	submitted	EID7687 A patient with ROS1 fusion-positive NSCLC was treated with crizotinib. After tumor progression, a repeat biopsy revealed ROS1 G2032R mutation. The patient subsequently enrolled in the phase I repotrec… (full text at CIViC) PMID 30093503 · Drilon et al., 2018 · Open in CIViC	civic

ROS1 G2032R1

Repotrectinib

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

submitted

EID7687

A patient with ROS1 fusion-positive NSCLC was treated with crizotinib. After tumor progression, a repeat biopsy revealed ROS1 G2032R mutation. The patient subsequently enrolled in the phase I repotrec… (full text at CIViC)

PMID 30093503 · Drilon et al., 2018 · Open in CIViC

civic

ROS1 G2032R + ROS1 Fusion1
Repotrectinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	submitted	EID12022 In a phase 1-2 trial (NCT03093116), the ROS1/ALK/NTRK inhibitor repotrectinib demonstrated efficacy in NSCLC with ROS1 fusions. In the 56 patients who had previously received one ROS1 tyrosine kinase… (full text at CIViC) PMID 38197815 · Drilon et al., 2024 · Open in CIViC	civic

ROS1 G2032R + ROS1 Fusion1

Repotrectinib

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

submitted

EID12022

In a phase 1-2 trial (NCT03093116), the ROS1/ALK/NTRK inhibitor repotrectinib demonstrated efficacy in NSCLC with ROS1 fusions. In the 56 patients who had previously received one ROS1 tyrosine kinase… (full text at CIViC)

PMID 38197815 · Drilon et al., 2024 · Open in CIViC

civic

ROS1 Fusion1
Repotrectinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	4	submitted	EID12021 In a phase 1-2 trial (NCT03093116), the ROS1/ALK/NTRK inhibitor repotrectinib demonstrated efficacy in NSCLC with ROS1 fusions. Among the 71 ROS1-inhibitor-naive patients, 56 (79%; 95% CI, 68 to 88) h… (full text at CIViC) PMID 38197815 · Drilon et al., 2024 · Open in CIViC	civic

ROS1 Fusion1

Repotrectinib

Lung Non-Small Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

submitted

EID12021

In a phase 1-2 trial (NCT03093116), the ROS1/ALK/NTRK inhibitor repotrectinib demonstrated efficacy in NSCLC with ROS1 fusions. Among the 71 ROS1-inhibitor-naive patients, 56 (79%; 95% CI, 68 to 88) h… (full text at CIViC)

PMID 38197815 · Drilon et al., 2024 · Open in CIViC

civic

NTRK1 Fusion1
Repotrectinib	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	3	accepted	EID11346 In a head-to-head comparison of 4 NTRK inhibitors (larotrectinib, entrectinib, repotrectinib, and selitrectinib) with Ba/F3 cells harboring LMNA::NTRK1 with or without kinase domain mutations, repotre… (full text at CIViC) PMID 34625502 · Murray et al., 2021 · Open in CIViC	civic

NTRK1 Fusion1

Repotrectinib

Malignant NeoplasmALIAS

Predictive

Supports Sensitivity Response

accepted

EID11346

In a head-to-head comparison of 4 NTRK inhibitors (larotrectinib, entrectinib, repotrectinib, and selitrectinib) with Ba/F3 cells harboring LMNA::NTRK1 with or without kinase domain mutations, repotre… (full text at CIViC)

PMID 34625502 · Murray et al., 2021 · Open in CIViC

civic

NTRK1 Fusion + NTRK1 F589L1
Repotrectinib	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	3	accepted	EID11348 In a head-to-head comparison of 4 NTRK inhibitors (larotrectinib, entrectinib, repotrectinib, and selitrectinib) with Ba/F3 cells harboring LMNA::NTRK1 with or without kinase domain mutations, repotre… (full text at CIViC) PMID 34625502 · Murray et al., 2021 · Open in CIViC	civic

NTRK1 Fusion + NTRK1 F589L1

Repotrectinib

Malignant NeoplasmALIAS

Predictive

Supports Sensitivity Response

accepted

EID11348

PMID 34625502 · Murray et al., 2021 · Open in CIViC

civic

NTRK1 Fusion + NTRK1 G595R1
Repotrectinib	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	3	accepted	EID11347 In a head-to-head comparison of 4 NTRK inhibitors (larotrectinib, entrectinib, repotrectinib, and selitrectinib) with Ba/F3 cells harboring LMNA::NTRK1 with or without kinase domain mutations, repotre… (full text at CIViC) PMID 34625502 · Murray et al., 2021 · Open in CIViC	civic

NTRK1 Fusion + NTRK1 G595R1

Repotrectinib

Malignant NeoplasmALIAS

Predictive

Supports Sensitivity Response

accepted

EID11347

PMID 34625502 · Murray et al., 2021 · Open in CIViC

civic

NTRK3 G623E1
Repotrectinib	Mammary Analogue Secretory CarcinomaUNRESOLVED	Predictive	C	Supports Sensitivity Response	3	submitted	EID7688 A patient with ETV6-NTRK3 fusion-positive mammary analog secretory carcinoma was treated with entrectinib for 6 months with partial response. After tumor progression, a repeat biopsy revealed NTRK3 G6… (full text at CIViC) PMID 30093503 · Drilon et al., 2018 · Open in CIViC	civic

NTRK3 G623E1

Repotrectinib

Mammary Analogue Secretory CarcinomaUNRESOLVED

Predictive

Supports Sensitivity Response

submitted

EID7688

A patient with ETV6-NTRK3 fusion-positive mammary analog secretory carcinoma was treated with entrectinib for 6 months with partial response. After tumor progression, a repeat biopsy revealed NTRK3 G6… (full text at CIViC)

PMID 30093503 · Drilon et al., 2018 · Open in CIViC

civic