Skip to content

Repotrectinib

FDA-approved product (capsule, oral), marketed as Augtyro.

Registered studies
17
Lab records
0
Pathogens at ≥40%
4 of 4

Chemical structure

Chemical structure of Repotrectinib
A drawing shows what the molecule is, not what it does.

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Cancer
  • Neoplasm

Indications ChEMBL records as approved, from FDA and DailyMed labels.

WHO therapeutic group
Other protein kinase inhibitors
FDA pharmacologic class
Kinase Inhibitor FDA label ↗
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against MRSA, E. coli, K. pneumoniae and M. tuberculosis. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA57.4% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli55.0% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae41.8% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis54.4% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.

A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.

Evidence

Clinical and experimental

Documented evidence

Clinical

17registered studies name this medicine, for any condition. See them below.

Experimental

No evidence found

No laboratory measurement against the four pathogens in the ChEMBL records loaded here.

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-6.2 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

Not yet docked: queued in the docking rundetails

Enoyl-ACP reductase (InhA) ↗ (M. tuberculosis)

-5.7 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-5.7 kcal/mol

0better fit →-12

AutoDock Vina, one experimentally solved protein per pathogen. This project’s screening target is -7.0 kcal/mol, its own mark rather than a universal cutoff. A docking score is a structural hypothesis, not proof of binding, and requires experimental validation.

Other medicines to investigate

AI prediction · nothing measured

Other repurposing candidates: approved medicines besides Repotrectinib with AI-predicted activity ≥40% against the chosen pathogen, leaving out existing antimicrobials. They are computational candidates for further investigation, not alternatives and not recommendations.

Sorted by AI-predicted activity, high to low. The order is not a ranking of which medicine is better.

Registered studies

A registration describes a study; it does not establish a positive result.

  • Repotrectinib Post-Marketing Surveillance in Korean Patients With ROS1-Positive Non-Small Cell Lung Cancer (NSCLC) or Solid Tumors Harboring a Neurotrophic Tyrosine Receptor Kinase (NTRK) Gene Fusion

    NCT07599007 · start 2026-05-24

    Registered record
    Registry ID
    NCT07599007
    Conditions
    Non-Small Cell Lung Cancer
    Interventions
    Repotrectinib
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Not yet recruiting
    Start
    2026-05-24
    Completion
    2028-01-31
    Enrolment
    10

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionNon-Small Cell Lung Cancer
    InterventionRepotrectinib
    PhaseNot recorded
    Registry statusNot yet recruiting
  • Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants

    NCT07223671 · start 2025-12-31

    Registered record
    Registry ID
    NCT07223671
    Conditions
    Healthy Volunteers
    Interventions
    Repotrectinib; Metformin; Digoxin; Rosuvastatin; Bupropion; Flurbiprofen; Omeprazole
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2025-12-31
    Completion
    2026-03-19
    Enrolment
    30

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy Volunteers
    InterventionRepotrectinib; Metformin; Digoxin; Rosuvastatin +3 more
    PhasePhase 1
    Registry statusCompleted
  • Repotrectinib Post-Marketing Surveillance in Pediatric Patients With NTRK Fusion-Positive Tumors in Japan

    NCT07755826 · start 2025-11-20

    Registered record
    Registry ID
    NCT07755826
    Conditions
    NTRK Fusion-positive Solid Tumors
    Interventions
    Repotrectinib
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2025-11-20
    Completion
    2034-04-30
    Enrolment
    20

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionNTRK Fusion-positive Solid Tumors
    InterventionRepotrectinib
    PhaseNot recorded
    Registry statusRecruiting
  • Repotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain Metastasis

    NCT06315010 · start 2025-06-27

    Registered record
    Registry ID
    NCT06315010
    Conditions
    NSCLC; Brain Metastases; ROS1 Gene Rearrangement
    Interventions
    Repotrectinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2025-06-27
    Completion
    2028-04
    Enrolment
    20

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionNSCLC; Brain Metastases; ROS1 Gene Rearrangement
    InterventionRepotrectinib
    PhasePhase 2
    Registry statusRecruiting
  • A Phase 1 Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors

    NCT05828303 · start 2024-11-15

    Registered record
    Registry ID
    NCT05828303
    Conditions
    Advanced Solid Tumor; Metastatic Solid Tumor
    Interventions
    TPX-0005; Metformin Hydrochloride; Digoxin; Rosuvastatin Calcium
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Withdrawn
    Start
    2024-11-15
    Completion
    2025-11-30
    Enrolment
    0

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAdvanced Solid Tumor; Metastatic Solid Tumor
    InterventionTPX-0005; Metformin Hydrochloride; Digoxin; Rosuvastatin Calcium
    PhasePhase 1
    Registry statusWithdrawn
  • Phase II Efficacy Study of Repotrectinib in Frail and/or Elderly Patients With ROS1-rearranged Advanced NSCLC

    NCT06552234 · start 2024-10-01

    Registered record
    Registry ID
    NCT06552234
    Conditions
    NSCLC Stage IV; NSCLC, Stage III
    Interventions
    Repotrectinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2024-10-01
    Completion
    2031-09
    Enrolment
    30

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionNSCLC Stage IV; NSCLC, Stage III
    InterventionRepotrectinib
    PhasePhase 2
    Registry statusRecruiting
  • A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants

    NCT06493409 · start 2024-08-26

    Registered record
    Registry ID
    NCT06493409
    Conditions
    Healthy Volunteers
    Interventions
    Repotrectinib; Voriconazole; Quinidine
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2024-08-26
    Completion
    2024-12-07
    Enrolment
    32

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy Volunteers
    InterventionRepotrectinib; Voriconazole; Quinidine
    PhasePhase 1
    Registry statusCompleted
  • Phase II Study of REPotrectinib With or Without Fulvestrant in Patients With Hormone Receptor-positive Human Epidermal Growth Factor 2-negative Metastatic Invasive LObular Carcinoma Who Received a Prior Endocrine Therapy in Combination With Cyclin-dependent Kinase 4 and 6 Inhibitor (REPLOT Trial)

    NCT06408168 · start 2024-08-08

    Registered record
    Registry ID
    NCT06408168
    Conditions
    Hormone Receptor-positive Human Epidermal Growth Factor 2-negative; Metastatic Invasive LObular Carcinoma
    Interventions
    Fulvestrant; Repotrectinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2024-08-08
    Completion
    2025-12-08
    Enrolment
    6

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHormone Receptor-positive Human Epidermal Growth Factor 2-negative; Metastatic Invasive LObular Carcinoma
    InterventionFulvestrant; Repotrectinib
    PhasePhase 2
    Registry statusTerminated
  • A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment

    NCT06352528 · start 2024-04-29

    Registered record
    Registry ID
    NCT06352528
    Conditions
    Hepatic Impairment; Healthy Volunteers
    Interventions
    Repotrectinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2024-04-29
    Completion
    2025-09-16
    Enrolment
    18

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHepatic Impairment; Healthy Volunteers
    InterventionRepotrectinib
    PhasePhase 1
    Registry statusCompleted
  • 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)

    NCT06140836 · start 2023-12-21

    Registered record
    Registry ID
    NCT06140836
    Conditions
    Carcinoma, Non-Small-Cell Lung
    Interventions
    Repotrectinib; Crizotinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Active not recruiting
    Start
    2023-12-21
    Completion
    2027-03-15
    Enrolment
    190

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionCarcinoma, Non-Small-Cell Lung
    InterventionRepotrectinib; Crizotinib
    PhasePhase 3
    Registry statusActive not recruiting
  • A Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Repotrectinib in Advanced Cancer Patients

    NCT05828277 · start 2022-07-28

    Registered record
    Registry ID
    NCT05828277
    Conditions
    Locally Advanced Solid Tumor; Metastatic Solid Tumor
    Interventions
    repotrectinib (TPX-0005)
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Withdrawn
    Start
    2022-07-28
    Completion
    2025-12-31
    Enrolment
    0

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionLocally Advanced Solid Tumor; Metastatic Solid Tumor
    Interventionrepotrectinib (TPX-0005)
    PhasePhase 1
    Registry statusWithdrawn
  • Phase I Study of Repotrectinib and Osimertinib in NSCLC Patients

    NCT04772235 · start 2022-02-11

    Registered record
    Registry ID
    NCT04772235
    Conditions
    Nsclc
    Interventions
    Repotrectinib; Osimertinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Unknown
    Start
    2022-02-11
    Completion
    2026-06
    Enrolment
    32

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionNsclc
    InterventionRepotrectinib; Osimertinib
    PhasePhase 1
    Registry statusUnknown
  • A Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Solid Tumors

    NCT05071183 · start 2021-09-23

    Registered record
    Registry ID
    NCT05071183
    Conditions
    KRAS Mutation-Related Tumors; Metastatic Solid Tumor; Advanced Solid Tumor
    Interventions
    TPX-0005; Trametinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Terminated
    Start
    2021-09-23
    Completion
    2023-03-01
    Enrolment
    9

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionKRAS Mutation-Related Tumors; Metastatic Solid Tumor; Advanced Solid Tumor
    InterventionTPX-0005; Trametinib
    PhasePhase 1 / Phase 2
    Registry statusTerminated
  • A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer

    NCT05004116 · start 2021-08-09

    Registered record
    Registry ID
    NCT05004116
    Conditions
    Advanced Cancer; Metastatic Solid Tumor
    Interventions
    Repotrectinib; Irinotecan and temozolomide
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Recruiting
    Start
    2021-08-09
    Completion
    2028-08
    Enrolment
    77

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAdvanced Cancer; Metastatic Solid Tumor
    InterventionRepotrectinib; Irinotecan and temozolomide
    PhasePhase 1 / Phase 2
    Registry statusRecruiting
  • A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations

    NCT04094610 · start 2020-03-12

    Registered record
    Registry ID
    NCT04094610
    Conditions
    Locally Advanced Solid Tumors; Metastatic Solid Tumors; Lymphoma; Primary CNS Tumors
    Interventions
    Oral repotrectinib (TPX-0005)
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Recruiting
    Start
    2020-03-12
    Completion
    2027-09-30
    Enrolment
    75

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionLocally Advanced Solid Tumors; Metastatic Solid Tumors; Lymphoma; Primary CNS Tumors
    InterventionOral repotrectinib (TPX-0005)
    PhasePhase 1 / Phase 2
    Registry statusRecruiting