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AMR Drug RepurposingSmart Screeningresearch prototype

Neratinib Maleate

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

Registered studies
7
Lab records
0
Pathogens at ≥40%
3 of 4

Chemical structure

Chemical structure of Neratinib Maleate
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

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

WHO therapeutic group
Human epidermal growth factor receptor 2 (her2) tyrosine kinase inhibitors
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
  • MRSA52.7% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli46.1% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae25.5% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis42.6% 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

7registered 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.

Open Neratinib Maleate in ChEMBL Registered studies below

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

Not yet docked: queued in the docking rundetails

KPC-2 carbapenemase ↗ (K. pneumoniae)

Not yet docked: queued in the docking rundetails

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

Not yet docked: queued in the docking rundetails

Dihydrofolate reductase ↗ (MRSA)

Not yet docked: queued in the docking rundetails

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 Neratinib Maleate 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.

  • Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)

    NCT06126276 · start 2024-05-07

    Registered record
    Registry ID
    NCT06126276
    Conditions
    Malignant Female Reproductive System Neoplasm; Malignant Solid Neoplasm; Recurrent Malignant Female Reproductive System Neoplasm; Recurrent Malignant Solid Neoplasm
    Interventions
    Biopsy Procedure; Biospecimen Collection; Computed Tomography; Echocardiography Test; Magnetic Resonance Imaging; Multigated Acquisition Scan; Neratinib Maleate; Palbociclib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2024-05-07
    Completion
    2027-02-20
    Enrolment
    70

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

    ConditionMalignant Female Reproductive System Neoplasm; Malignant Solid Neoplasm; Recurrent Malignant Female Reproductive System Neoplasm; Recurrent Malignant Solid Neoplasm
    InterventionBiopsy Procedure; Biospecimen Collection; Computed Tomography; Echocardiography Test +4 more
    PhasePhase 2
    Registry statusRecruiting

  • Nilatinib Maleate Tablets Combined With Capecitabine in the Treatment of HER2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastases

    NCT06374888 · start 2024-04-30

    Registered record
    Registry ID
    NCT06374888
    Conditions
    Her2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastasis
    Interventions
    Neratinib maleate in combination with capecitabine
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2024-04-30
    Completion
    2027-07-30
    Enrolment
    28

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

    ConditionHer2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastasis
    InterventionNeratinib maleate in combination with capecitabine
    PhasePhase 2
    Registry statusNot yet recruiting

  • Efficacy and Safety of Disitamab Vedotin Plus Pyrotinib or Naratinib in HER2-positive Breast Cancer Patients With Brain Metastasis

    NCT06015113 · start 2023-09

    Registered record
    Registry ID
    NCT06015113
    Conditions
    Breast Cancer
    Interventions
    Disitamab Vedotin plus pyrotinib or naratinib
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Not yet recruiting
    Start
    2023-09
    Completion
    2027-04
    Enrolment
    20

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

    ConditionBreast Cancer
    InterventionDisitamab Vedotin plus pyrotinib or naratinib
    PhaseNot applicable
    Registry statusNot yet recruiting

  • Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial

    NCT05564377 · start 2023-04-07

    Registered record
    Registry ID
    NCT05564377
    Conditions
    Advanced Malignant Solid Neoplasm; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Locally Advanced Malignant Solid Neoplasm; Malignant Female Reproductive System Neoplasm; Metastatic HER2-Negative Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Recurrent Endometrial Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Malignant Female Reproductive System Neoplasm; Recurrent Malignant Solid Neoplasm; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Unresectable HER2-Negative Breast Carcinoma; Unresectable Malignant Solid Neoplasm
    Interventions
    Alpelisib; Binimetinib; Biopsy Procedure; Biospecimen Collection; Bone Marrow Aspiration; Bone Marrow Biopsy; Bone Scan; Computed Tomography; Echocardiography Test; Fluorouracil; Fulvestrant; Ipatasertib; Leucovorin; Magnetic Resonance Imaging; Multigated Acquisition Scan; Mutation Carrier Screening; Neratinib Maleate; Nilotinib Hydrochloride Monohydrate; Olaparib; Oxaliplatin; Paclitaxel; Palbociclib; Panitumumab; Positron Emission Tomography; Selumetinib Sulfate; Sotorasib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2023-04-07
    Completion
    2030-07-01
    Enrolment
    2,900

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

    ConditionAdvanced Malignant Solid Neoplasm; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Locally Advanced Malignant Solid Neoplasm +11 more
    InterventionAlpelisib; Binimetinib; Biopsy Procedure; Biospecimen Collection +22 more
    PhasePhase 2
    Registry statusRecruiting

  • Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene

    NCT05372614 · start 2022-10-05

    Registered record
    Registry ID
    NCT05372614
    Conditions
    Metastatic Malignant Solid Neoplasm; Metastatic Pancreatic Adenocarcinoma; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Malignant Solid Neoplasm; Unresectable Pancreatic Adenocarcinoma
    Interventions
    Biopsy Procedure; Biospecimen Collection; Computed Tomography; Echocardiography Test; Multigated Acquisition Scan; Neratinib Maleate; Trastuzumab Deruxtecan
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Recruiting
    Start
    2022-10-05
    Completion
    2028-07-17
    Enrolment
    58

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

    ConditionMetastatic Malignant Solid Neoplasm; Metastatic Pancreatic Adenocarcinoma; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8 +2 more
    InterventionBiopsy Procedure; Biospecimen Collection; Computed Tomography; Echocardiography Test +3 more
    PhasePhase 1
    Registry statusRecruiting

  • Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER-family and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test

    NCT05243641 · start 2022-08-18

    Registered record
    Registry ID
    NCT05243641
    Conditions
    Metastatic Breast Cancer; Breast Cancer
    Interventions
    Neratinib; Capmatinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Terminated
    Start
    2022-08-18
    Completion
    2024-11-19
    Enrolment
    10

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

    ConditionMetastatic Breast Cancer; Breast Cancer
    InterventionNeratinib; Capmatinib
    PhasePhase 1 / Phase 2
    Registry statusTerminated

  • Neratinib and Trastuzumab Biosimilar in Patients with HER2 Mutated Advanced Solid Cancers

    NCT06083662 · start 2021-06-15

    Registered record
    Registry ID
    NCT06083662
    Conditions
    Metastatic Cancer; HER2 Gene Mutation
    Interventions
    Neratinib Maleate
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2021-06-15
    Completion
    2024-12-30
    Enrolment
    42

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

    ConditionMetastatic Cancer; HER2 Gene Mutation
    InterventionNeratinib Maleate
    PhasePhase 2
    Registry statusCompleted