Skip to content

Tucatinib

FDA-approved product (tablet, oral), marketed as Tukysa.

Registered studies
50+
Lab records
0
Pathogens at ≥40%
3 of 4

Chemical structure

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

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Breast cancer
  • Breast carcinoma
  • Breast neoplasm
  • Cancer
  • Colorectal carcinoma
  • Colorectal neoplasm
  • HER2 Positive Breast Carcinoma
  • Metastasis
  • Neoplasm

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

WHO therapeutic group
Human epidermal growth factor receptor 2 (her2) tyrosine 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 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
  • MRSA51.9% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli51.6% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae28.5% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis54.0% 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

50+registered studies name this medicine, for any condition. The registry search keeps the first 50, so there may be more. 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)

-9.4 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-8.5 kcal/mol

0better fit →-12

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

-9.6 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-10.2 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 Tucatinib 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.

  • Patient Navigation for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib

    NCT06983691 · start 2026-08-11

    Registered record
    Registry ID
    NCT06983691
    Conditions
    HER2+ Metastatic Breast Cancer (MBC)
    Interventions
    Patient Navigation Program
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Recruiting
    Start
    2026-08-11
    Completion
    2027-03
    Enrolment
    26

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

    ConditionHER2+ Metastatic Breast Cancer (MBC)
    InterventionPatient Navigation Program
    PhaseNot applicable
    Registry statusRecruiting
  • Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer

    NCT07494448 · start 2026-07-01

    Registered record
    Registry ID
    NCT07494448
    Conditions
    HER 2 Positive Advanced Breast Cancer; Breast Cancer
    Interventions
    Zanidatamab; Tucatinib; Capecitabine; Eribulin Mesilate injection
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Not yet recruiting
    Start
    2026-07-01
    Completion
    2028-05-31
    Enrolment
    24

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

    ConditionHER 2 Positive Advanced Breast Cancer; Breast Cancer
    InterventionZanidatamab; Tucatinib; Capecitabine; Eribulin Mesilate injection
    PhasePhase 1 / Phase 2
    Registry statusNot yet recruiting
  • RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive

    NCT07413939 · start 2026-05-21

    Registered record
    Registry ID
    NCT07413939
    Conditions
    HER2-positive Breast Cancer
    Interventions
    RO7771950; Tucatinib; Trastuzumab; Capecitabine
    Study type
    INTERVENTIONAL
    Phase
    Phase 2 / Phase 3
    Registry status
    Recruiting
    Start
    2026-05-21
    Completion
    2032-09-29
    Enrolment
    650

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

    ConditionHER2-positive Breast Cancer
    InterventionRO7771950; Tucatinib; Trastuzumab; Capecitabine
    PhasePhase 2 / Phase 3
    Registry statusRecruiting
  • Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy

    NCT06828588 · start 2026-04-16

    Registered record
    Registry ID
    NCT06828588
    Conditions
    Locally Advanced Cancer; Metastatic Cancer; HER2; HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma; HER 2 Low-expressing Breast Cancer
    Interventions
    [68Ga]Ga-ABY-025
    Study type
    INTERVENTIONAL
    Phase
    Early phase 1
    Registry status
    Recruiting
    Start
    2026-04-16
    Completion
    2029-12
    Enrolment
    30

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

    ConditionLocally Advanced Cancer; Metastatic Cancer; HER2; HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma +1 more
    Intervention[68Ga]Ga-ABY-025
    PhaseEarly phase 1
    Registry statusRecruiting
  • Real World-clinical Outcomes of Tucatinib, Trastuzumab, and Capecitabine Following Trastuzumab Deruxtecan (T-DXd) for the Treatment of HER2-positive Metastatic Breast Cancer.

    NCT06961331 · start 2025-05-07

    Registered record
    Registry ID
    NCT06961331
    Conditions
    Metastatic HER2+ Advanced Breast Cancer
    Interventions
    Tucatinib; Trastuzumab; Capecitabine
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2025-05-07
    Completion
    2025-09-25
    Enrolment
    86

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

    ConditionMetastatic HER2+ Advanced Breast Cancer
    InterventionTucatinib; Trastuzumab; Capecitabine
    PhaseNot recorded
    Registry statusCompleted
  • A Prospective, Multicenter, Observational Cohort Study to Evaluate the Efficacy and Safety of a Novel Anti-tumor Drug as a Radiosensitizer in Patients With Advanced Breast Cancer Brain Metastasis.

    NCT06839547 · start 2025-03-01

    Registered record
    Registry ID
    NCT06839547
    Conditions
    Advanced Breast Cancer Brain Metastasis
    Interventions
    Radiotherapy + Novel Anti-tumor Drug
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2025-03-01
    Completion
    2028-09-10
    Enrolment
    100

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

    ConditionAdvanced Breast Cancer Brain Metastasis
    InterventionRadiotherapy + Novel Anti-tumor Drug
    PhaseNot recorded
    Registry statusRecruiting
  • The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer

    NCT06439693 · start 2024-08-08

    Registered record
    Registry ID
    NCT06439693
    Conditions
    Breast Cancer Female; Breast Cancer; Breast Cancer Metastatic; Estrogen Receptor-positive Breast Cancer; HER2-positive Breast Cancer; Stage IV Breast Cancer
    Interventions
    Nab-Paclitaxel; Paclitaxel; Docetaxel; Phesgo; T-DM1; Pertuzumab; Trastuzumab Deruxtecan; Trastuzumab Subcutaneous Subcutaneous; Tucatinib; Trastuzumab
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2024-08-08
    Completion
    2033-03-30
    Enrolment
    72

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

    ConditionBreast Cancer Female; Breast Cancer; Breast Cancer Metastatic; Estrogen Receptor-positive Breast Cancer +2 more
    InterventionNab-Paclitaxel; Paclitaxel; Docetaxel; Phesgo +6 more
    PhasePhase 2
    Registry statusRecruiting
  • GIM27-THERapy: a Study to Describe the Effectiveness of Tucatinib in Combination With Capecitabine and Trastuzumab in the Treatment of Metastatic HER-2 Positive Breast Cancer Patients in Real World Setting

    NCT07583485 · start 2024-07-01

    Registered record
    Registry ID
    NCT07583485
    Conditions
    Breast Cancer
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2024-07-01
    Completion
    2029-07
    Enrolment
    300

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

    ConditionBreast Cancer
    InterventionNot recorded
    PhaseNot recorded
    Registry statusRecruiting
  • A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors

    NCT06157892 · start 2024-05-20

    Registered record
    Registry ID
    NCT06157892
    Conditions
    Breast Neoplasms; Gastroesophageal Junction Adenocarcinoma; HER2 Low Breast Neoplasms; HER2 Positive Breast Neoplasms; Stomach Neoplasms; Triple Negative Breast Neoplasms; Metastatic Breast Cancer; Metastatic Gastric Cancer; Advanced Breast Cancer; Advanced Gastric Cancer
    Interventions
    disitamab vedotin; tucatinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2024-05-20
    Completion
    2029-07-28
    Enrolment
    54

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

    ConditionBreast Neoplasms; Gastroesophageal Junction Adenocarcinoma; HER2 Low Breast Neoplasms; HER2 Positive Breast Neoplasms +6 more
    Interventiondisitamab vedotin; tucatinib
    PhasePhase 2
    Registry statusActive not recruiting
  • First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer

    NCT06239467 · start 2024-02-26

    Registered record
    Registry ID
    NCT06239467
    Conditions
    Advanced Cancer; Breast Cancer; Advanced Solid Tumors; PI3K Gene Mutation
    Interventions
    OKI-219; Fulvestrant; Trastuzumab; Tucatinib; Atirmociclib; Ribociclib
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Active not recruiting
    Start
    2024-02-26
    Completion
    2027-08-01
    Enrolment
    200

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

    ConditionAdvanced Cancer; Breast Cancer; Advanced Solid Tumors; PI3K Gene Mutation
    InterventionOKI-219; Fulvestrant; Trastuzumab; Tucatinib +2 more
    PhasePhase 1
    Registry statusActive not recruiting
  • Tucatinib+Trastuzumab+Eribulin in HER2+ MBC

    NCT05458674 · start 2024-01-30

    Registered record
    Registry ID
    NCT05458674
    Conditions
    Breast Cancer; Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer
    Interventions
    Tucatinib; Eribulin; Trastuzumab
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2024-01-30
    Completion
    2027-08-01
    Enrolment
    17

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

    ConditionBreast Cancer; Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer
    InterventionTucatinib; Eribulin; Trastuzumab
    PhasePhase 2
    Registry statusActive not recruiting
  • Tucatinib, Trastuzumab, and Capecitabine With SRS for Brain Metastases From HER-2 Positive Breast Cancer

    NCT05553522 · start 2024-01-29

    Registered record
    Registry ID
    NCT05553522
    Conditions
    Brain Metastases; HER2-positive Breast Cancer
    Interventions
    Combined use of SRS with Tucatinib, Trastuzumab, and Capecitabine
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Terminated
    Start
    2024-01-29
    Completion
    2025-12-17
    Enrolment
    1

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

    ConditionBrain Metastases; HER2-positive Breast Cancer
    InterventionCombined use of SRS with Tucatinib, Trastuzumab, and Capecitabine
    PhasePhase 1
    Registry statusTerminated
  • Osimertinib, Cetuximab, and Tucatinib for the Treatment of EGFR-Mutant Stage IV or Recurrent Non-small Lung Cell Cancer

    NCT06067776 · start 2024-01-01

    Registered record
    Registry ID
    NCT06067776
    Conditions
    Metastatic Lung Non-Small Cell Carcinoma; Recurrent Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8
    Interventions
    Cetuximab; Osimertinib; Tucatinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Not yet recruiting
    Start
    2024-01-01
    Completion
    2026-11-01
    Enrolment
    36

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

    ConditionMetastatic Lung Non-Small Cell Carcinoma; Recurrent Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8
    InterventionCetuximab; Osimertinib; Tucatinib
    PhasePhase 1
    Registry statusNot yet recruiting
  • Tucatinib in Combination With Oral Etoposide andTrastuzumab in Patients With Metastatic HER2+ Breast Cancer

    NCT05955170 · start 2023-12-19

    Registered record
    Registry ID
    NCT05955170
    Conditions
    HER2-positive Breast Cancer
    Interventions
    Tucatinib in Combination of Oral VP16 and trastuzumab
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2023-12-19
    Completion
    2028-12-19
    Enrolment
    66

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

    ConditionHER2-positive Breast Cancer
    InterventionTucatinib in Combination of Oral VP16 and trastuzumab
    PhasePhase 2
    Registry statusRecruiting
  • Neoadjuvant Trastuzumab, Pertuzumab and Tucatinib Without Chemotherapy in HER2-positive Breast Cancer: the TRAIN-4 Study

    NCT06162559 · start 2023-12-18

    Registered record
    Registry ID
    NCT06162559
    Conditions
    Breast Cancer
    Interventions
    Tucatinib; Trastuzumab; Pertuzumab
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Recruiting
    Start
    2023-12-18
    Completion
    2036-05
    Enrolment
    30

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

    ConditionBreast Cancer
    InterventionTucatinib; Trastuzumab; Pertuzumab
    PhasePhase 1
    Registry statusRecruiting