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.

openfdaRegulatory3 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2024-06-13 (see label)	approved	Jun 13, 2024	openfda
US FDA	ROS1-Positive Lung Non-Small Cell Carcinoma	AUGTYRO is a kinase inhibitor indicated for the treatment of • adult patients with locally advanced or metastatic ROS1- positive non-small cell lung cancer (NSCLC).	approved	Nov 15, 2023	openfda
US FDA	Tumor-agnostic	adult and pediatric patients 12 years of age and older with solid tumors that: • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion and • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity. • have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.accelerated	approved	Nov 15, 2023	openfda

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