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Afatinib Dimaleate

FDA-approved product (tablet, oral), marketed as Afatinib Dimaleate, Gilotrif.

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

Chemical structure

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

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Non-small cell lung carcinoma

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

WHO therapeutic group
Epidermal growth factor receptor (egfr) 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 E. coli, MRSA 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
  • MRSA58.4% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli44.4% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae39.8% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis49.8% 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)

-8.7 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-6.9 kcal/mol

0better fit →-12

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

-9.5 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-8.9 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 Afatinib Dimaleate 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.

  • Afatinib Osimertinib Sequencing NIS

    NCT03370770 · start 2017-12-28

    Registered record
    Registry ID
    NCT03370770
    Conditions
    Carcinoma, Non-Small-Cell Lung
    Interventions
    Afatinib; Osimertinib
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2017-12-28
    Completion
    2019-11-28
    Enrolment
    204

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

    ConditionCarcinoma, Non-Small-Cell Lung
    InterventionAfatinib; Osimertinib
    PhaseNot recorded
    Registry statusCompleted
  • Afatinib in Advanced Refractory Urothelial Cancer

    NCT02122172 · start 2017-09-13

    Registered record
    Registry ID
    NCT02122172
    Conditions
    Distal Urethral Cancer; Proximal Urethral Cancer; Recurrent Bladder Cancer; Recurrent Urethral Cancer; Stage III Bladder Cancer; Stage III Urethral Cancer; Stage IV Bladder Cancer; Stage IV Urethral Cancer; Ureter Cancer
    Interventions
    afatinib dimaleate; laboratory biomarker analysis
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2017-09-13
    Completion
    2024-04-04
    Enrolment
    32

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

    ConditionDistal Urethral Cancer; Proximal Urethral Cancer; Recurrent Bladder Cancer; Recurrent Urethral Cancer +5 more
    Interventionafatinib dimaleate; laboratory biomarker analysis
    PhasePhase 2
    Registry statusTerminated
  • Phase II Study of Afatinib as Third- or Further-line Treatment for Patients With Stage IV Bronchial Adenocarcinoma, Harboring Wild-type EGFR, Expressing the Neurotensin - Neurotensin Receptor Complex

    NCT02876081 · start 2017-09-01

    Registered record
    Registry ID
    NCT02876081
    Conditions
    SMALL CELL LUNG CARCINOMA
    Interventions
    Afatinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Withdrawn
    Start
    2017-09-01
    Completion
    2018-12
    Enrolment
    0

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

    ConditionSMALL CELL LUNG CARCINOMA
    InterventionAfatinib
    PhasePhase 2
    Registry statusWithdrawn
  • Prophylactic TCM for Mitigation of EGFR-TKI Related Dermatological Adverse Effect

    NCT05204758 · start 2016-05-12

    Registered record
    Registry ID
    NCT05204758
    Conditions
    Advanced Lung Adenocarcinoma
    Interventions
    TCM Formula; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2016-05-12
    Completion
    2021-02-28
    Enrolment
    30

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

    ConditionAdvanced Lung Adenocarcinoma
    InterventionTCM Formula; Placebo
    PhasePhase 3
    Registry statusCompleted
  • Biomarker Study Accompanying the AIO-TRK-0114 Study (MARBLE)

    NCT02595840 · start 2015-11-25

    Registered record
    Registry ID
    NCT02595840
    Conditions
    Non-small-cell Lung Cancer With Somatic EGFR Mutations
    Interventions
    Afatinib; Pemetrexed
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2015-11-25
    Completion
    2017-11-20
    Enrolment
    4

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

    ConditionNon-small-cell Lung Cancer With Somatic EGFR Mutations
    InterventionAfatinib; Pemetrexed
    PhasePhase 2
    Registry statusTerminated
  • Pembrolizumab and Afatinib in Patients With Non-small Cell Lung Cancer With Resistance to Erlotinib

    NCT02364609 · start 2015-09-30

    Registered record
    Registry ID
    NCT02364609
    Conditions
    Recurrent Non-Small Cell Lung Carcinoma; Stage IIIA Non-Small Cell Lung Cancer; Stage IIIB Non-Small Cell Lung Cancer; Stage IV Non-Small Cell Lung Cancer
    Interventions
    Afatinib Dimaleate; Pembrolizumab
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2015-09-30
    Completion
    2020-05-01
    Enrolment
    11

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

    ConditionRecurrent Non-Small Cell Lung Carcinoma; Stage IIIA Non-Small Cell Lung Cancer; Stage IIIB Non-Small Cell Lung Cancer; Stage IV Non-Small Cell Lung Cancer
    InterventionAfatinib Dimaleate; Pembrolizumab
    PhasePhase 1
    Registry statusCompleted
  • Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

    NCT02465060 · start 2015-08-17

    Registered record
    Registry ID
    NCT02465060
    Conditions
    Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Bladder Carcinoma; Breast Carcinoma; Cervical Carcinoma; Colon Carcinoma; Colorectal Carcinoma; Endometrial Carcinoma; Esophageal Carcinoma; Exocrine Pancreas Carcinoma; Gastric Carcinoma; Glioma; Head and Neck Carcinoma; Hematopoietic and Lymphoid Cell Neoplasm; Kidney Carcinoma; Liver Carcinoma; Lung Carcinoma; Lymphoma; Malignant Uterine Corpus Neoplasm; Malignant Uterine Neoplasm; Melanoma; Multiple Myeloma; Ovarian Carcinoma; Prostate Carcinoma; Rectal Carcinoma; Recurrent Bladder Carcinoma; Recurrent Breast Carcinoma; Recurrent Cervical Carcinoma; Recurrent Colon Carcinoma; Recurrent Colorectal Carcinoma; Recurrent Esophageal Carcinoma; Recurrent Gastric Carcinoma; Recurrent Glioma; Recurrent Head and Neck Carcinoma; Recurrent Liver Carcinoma; Recurrent Lung Carcinoma; Recurrent Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Malignant Uterine Corpus Neoplasm; Recurrent Melanoma; Recurrent Multiple Myeloma; Recurrent O
    Interventions
    Adavosertib; Afatinib; Afatinib Dimaleate; Binimetinib; Biopsy Procedure; Biospecimen Collection; Capivasertib; Computed Tomography; Copanlisib; Copanlisib Hydrochloride; Crizotinib; Cytology Specimen Collection Procedure; Dabrafenib; Dabrafenib Mesylate; Dasatinib; Defactinib; Defactinib Hydrochloride; Echocardiography Test; Erdafitinib; Fexagratinib; Ipatasertib; Laboratory Biomarker Analysis; Larotrectinib; Larotrectinib Sulfate; Magnetic Resonance Imaging; Multigated Acquisition Scan; Nivolumab; Osimertinib; Palbociclib; Pertuzumab; PI3K-beta Inhibitor GSK2636771; Radiologic Examination; Radionuclide Imaging; Relatlimab; Sapanisertib; Sunitinib Malate; Taselisib; Trametinib; Trastuzumab; Trastuzumab Emtansine; Ulixertinib; Vismodegib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2015-08-17
    Completion
    2026-12-31
    Enrolment
    6,452

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

    ConditionAdvanced Lymphoma; Advanced Malignant Solid Neoplasm; Bladder Carcinoma; Breast Carcinoma +38 more
    InterventionAdavosertib; Afatinib; Afatinib Dimaleate; Binimetinib +38 more
    PhasePhase 2
    Registry statusActive not recruiting
  • Testing Afatinib as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol B)

    NCT04439136 · start 2015-08-12

    Registered record
    Registry ID
    NCT04439136
    Conditions
    Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma
    Interventions
    Afatinib Dimaleate
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2015-08-12
    Completion
    2027-03-03
    Enrolment
    40

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

    ConditionAdvanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma +2 more
    InterventionAfatinib Dimaleate
    PhasePhase 2
    Registry statusActive not recruiting
  • A Phase II Evaluation of Afatinib in Patients With Persistent or Recurrent HER2-positive Uterine Serous Carcinoma

    NCT02491099 · start 2015-06

    Registered record
    Registry ID
    NCT02491099
    Conditions
    HER2/Neu+ Uterine Serous Carcinoma
    Interventions
    Afatinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2015-06
    Completion
    2028-12
    Enrolment
    50

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

    ConditionHER2/Neu+ Uterine Serous Carcinoma
    InterventionAfatinib
    PhasePhase 2
    Registry statusRecruiting
  • S1403, Afatinib Dimaleate With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage IV or Recurrent, EGFR Mutation Positive Non-small Cell Lung Cancer

    NCT02438722 · start 2015-05-07

    Registered record
    Registry ID
    NCT02438722
    Conditions
    Recurrent Non-Small Cell Lung Carcinoma; Stage IV Non-Small Cell Lung Cancer
    Interventions
    Afatinib Dimaleate; Cetuximab; Laboratory Biomarker Analysis
    Study type
    INTERVENTIONAL
    Phase
    Phase 2 / Phase 3
    Registry status
    Completed
    Start
    2015-05-07
    Completion
    2026-04-17
    Enrolment
    174

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

    ConditionRecurrent Non-Small Cell Lung Carcinoma; Stage IV Non-Small Cell Lung Cancer
    InterventionAfatinib Dimaleate; Cetuximab; Laboratory Biomarker Analysis
    PhasePhase 2 / Phase 3
    Registry statusCompleted
  • The Molecular Epidemiology of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients With Advanced EGFR Mutation-positive Non-small Cell Lung Cancer Treated With Afatinib

    NCT04640870 · start 2015-03-15

    Registered record
    Registry ID
    NCT04640870
    Conditions
    Non Small Cell Lung Cancer; EGF-R Positive Non-Small Cell Lung Cancer; EGFR Gene Mutation
    Interventions
    Afatinib
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2015-03-15
    Completion
    2020-05
    Enrolment
    59

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

    ConditionNon Small Cell Lung Cancer; EGF-R Positive Non-Small Cell Lung Cancer; EGFR Gene Mutation
    InterventionAfatinib
    PhaseNot recorded
    Registry statusCompleted
  • Xentuzumab (BI 836845) Plus Afatinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)

    NCT02191891 · start 2014-10-21

    Registered record
    Registry ID
    NCT02191891
    Conditions
    Carcinoma, Non-Small-Cell Lung
    Interventions
    Xentuzumab; Afatinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2014-10-21
    Completion
    2018-04-18
    Enrolment
    32

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

    ConditionCarcinoma, Non-Small-Cell Lung
    InterventionXentuzumab; Afatinib
    PhasePhase 1
    Registry statusCompleted
  • Evaluation of the Tolerance of Afatinib in Combination With Docetaxel and Cisplatin in LAHNSCC Induction Chemotherapy

    NCT02216617 · start 2014-08-06

    Registered record
    Registry ID
    NCT02216617
    Conditions
    HNSCC
    Interventions
    Taxotere, Cisplatin, Afatinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2014-08-06
    Completion
    2015-09-15
    Enrolment
    8

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

    ConditionHNSCC
    InterventionTaxotere, Cisplatin, Afatinib
    PhasePhase 1
    Registry statusCompleted
  • Trial of Afatinib in Combination With Weekly Paclitaxel in the Second Line Treatment

    NCT02274012 · start 2014-05-29

    Registered record
    Registry ID
    NCT02274012
    Conditions
    HER-2 Positive Gastric Cancer; Gastrooesophageal Cancer; Esophageal Cancer
    Interventions
    Afatinib; Paclitaxel
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Withdrawn
    Start
    2014-05-29
    Completion
    2015-08-12
    Enrolment
    0

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

    ConditionHER-2 Positive Gastric Cancer; Gastrooesophageal Cancer; Esophageal Cancer
    InterventionAfatinib; Paclitaxel
    PhasePhase 2
    Registry statusWithdrawn
  • N-of-1 Trial: Actionable Target Identification in Metastatic Cancer for Palliative Systemic Therapy

    NCT02142036 · start 2014-05

    Registered record
    Registry ID
    NCT02142036
    Conditions
    Metastatic Cancer
    Interventions
    EMA-approved ATI based targeted therapy
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2014-05
    Completion
    2018-08
    Enrolment
    50

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

    ConditionMetastatic Cancer
    InterventionEMA-approved ATI based targeted therapy
    PhasePhase 2
    Registry statusCompleted