Skip to content

Nilotinib

FDA-approved product (tablet, orally disintegrating, oral), marketed as Cavhanza, Nilotinib D-Tartrate, Nilotinib Hydrochloride and 2 more.

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

Chemical structure

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

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Chronic myelogenous leukemia

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

WHO therapeutic group
Bcr-abl 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
  • MRSA60.0% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli40.0% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae21.4% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis57.7% 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)

-9.6 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-8.1 kcal/mol

0better fit →-12

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

-10.0 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-10.1 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 Nilotinib 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.

  • Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL)

    NCT01207440 · start 2010-09-30

    Registered record
    Registry ID
    NCT01207440
    Conditions
    Chronic Myeloid Leukemia; Ph+ Acute Lymphoblastic Leukemia
    Interventions
    Ponatinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2010-09-30
    Completion
    2019-01-17
    Enrolment
    449

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

    ConditionChronic Myeloid Leukemia; Ph+ Acute Lymphoblastic Leukemia
    InterventionPonatinib
    PhasePhase 2
    Registry statusCompleted
  • Phase 1 Nilotinib in Steroid Dependent/Refractory Chronic Graft Versus Host Disease

    NCT01155817 · start 2010-08

    Registered record
    Registry ID
    NCT01155817
    Conditions
    Bone Marrow Transplant Failure; Lymphoma, Non-Hodgkin; Lymphoma, T-Cell, Peripheral
    Interventions
    Nilotinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2010-08
    Completion
    2013-12
    Enrolment
    33

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

    ConditionBone Marrow Transplant Failure; Lymphoma, Non-Hodgkin; Lymphoma, T-Cell, Peripheral
    InterventionNilotinib
    PhasePhase 1
    Registry statusCompleted
  • Biomarkers in Pulmonary Arterial Hypertension Treated With Nilotinib

    NCT01320865 · start 2010-08

    Registered record
    Registry ID
    NCT01320865
    Conditions
    PAH
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Withdrawn
    Start
    2010-08
    Completion
    2012-12
    Enrolment
    0

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

    ConditionPAH
    InterventionNot recorded
    PhaseNot recorded
    Registry statusWithdrawn
  • A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation

    NCT01028222 · start 2010-06

    Registered record
    Registry ID
    NCT01028222
    Conditions
    Melanoma
    Interventions
    Nilotinib; DTIC
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2010-06
    Completion
    2014-12
    Enrolment
    55

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

    ConditionMelanoma
    InterventionNilotinib; DTIC
    PhasePhase 2
    Registry statusCompleted
  • Nilotinib Versus Standard Imatinib (400/600 mg Every Day (QD)) Comparing the Kinetics of Complete Molecular Response for Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Pts With Evidence of Persistent Leukemia by Real-time Quantitative Polymerase Chain Reaction (RQ-PCR)

    NCT00760877 · start 2009-06

    Registered record
    Registry ID
    NCT00760877
    Conditions
    CHRONIC MYELOGENOUS LEUKEMIA
    Interventions
    Nilotinib; Imatinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2009-06
    Completion
    2015-07
    Enrolment
    207

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

    ConditionCHRONIC MYELOGENOUS LEUKEMIA
    InterventionNilotinib; Imatinib
    PhasePhase 3
    Registry statusCompleted
  • Randomized Phase Lll Study of Imatinib Dose Optimization vs Nilotinib in CML Patients With Suboptimal Response to Imatinib

    NCT00802841 · start 2009-05

    Registered record
    Registry ID
    NCT00802841
    Conditions
    Chronic Myelogenous Leukemia
    Interventions
    nilotinib; imatinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2009-05
    Completion
    2014-07
    Enrolment
    191

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

    ConditionChronic Myelogenous Leukemia
    Interventionnilotinib; imatinib
    PhasePhase 3
    Registry statusCompleted
  • Nilotinib With Chemotherapy for the Treatment of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

    NCT00905398 · start 2009-05

    Registered record
    Registry ID
    NCT00905398
    Conditions
    Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Acute Lymphoblastic Leukemia
    Interventions
    Nilotinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Terminated
    Start
    2009-05
    Completion
    2015-07
    Enrolment
    8

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

    ConditionPrecursor B-Cell Lymphoblastic Leukemia-Lymphoma; Acute Lymphoblastic Leukemia
    InterventionNilotinib
    PhasePhase 1 / Phase 2
    Registry statusTerminated
  • A Study of Nilotinib Versus Imatinib in GIST Patients

    NCT00785785 · start 2009-03

    Registered record
    Registry ID
    NCT00785785
    Conditions
    Gastrointestinal Stromal Tumor (GIST)
    Interventions
    Nilotinib (AMN107); imatinib (STI571)
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2009-03
    Completion
    2014-10
    Enrolment
    644

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

    ConditionGastrointestinal Stromal Tumor (GIST)
    InterventionNilotinib (AMN107); imatinib (STI571)
    PhasePhase 3
    Registry statusCompleted
  • Nilotinib in TKI Resistant or Intolerant Patients With Metastatic Mucosal, Acral, or Chronically Sun Damaged Melanoma

    NCT00788775 · start 2009-01-23

    Registered record
    Registry ID
    NCT00788775
    Conditions
    Mucosal Lentiginous Melanoma; Acral Melanoma; Melanoma
    Interventions
    Nilotinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2009-01-23
    Completion
    2014-03
    Enrolment
    20

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

    ConditionMucosal Lentiginous Melanoma; Acral Melanoma; Melanoma
    InterventionNilotinib
    PhasePhase 2
    Registry statusCompleted
  • Treatment of Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line With Nilotinib

    NCT00756509 · start 2008-08-29

    Registered record
    Registry ID
    NCT00756509
    Conditions
    Gastrointestinal Stromal Tumors
    Interventions
    Nilotinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2008-08-29
    Completion
    2024-12-18
    Enrolment
    34

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

    ConditionGastrointestinal Stromal Tumors
    InterventionNilotinib
    PhasePhase 4
    Registry statusCompleted
  • Study Evaluating IPI-504 in Patients With Gastrointestinal Stromal Tumors (GIST) Following Failure of at Least Imatinib and Sunitinib

    NCT00688766 · start 2008-08

    Registered record
    Registry ID
    NCT00688766
    Conditions
    Gastrointestinal Stromal Tumors
    Interventions
    retaspimycin hydrochloride (IPI-504); placebo; Best supportive care
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Terminated
    Start
    2008-08
    Completion
    2009-05
    Enrolment
    47

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

    ConditionGastrointestinal Stromal Tumors
    Interventionretaspimycin hydrochloride (IPI-504); placebo; Best supportive care
    PhasePhase 3
    Registry statusTerminated
  • Phase II Study Aiming to Evaluate the Efficacy and Safety of Nilotinib Patients With Gastrointestinal Stromal Tumors (GIST) Resistant or Intolerant to Imatinib and or to 2nd Line Tyrosine Kinas (TK) Inhibitor

    NCT00633295 · start 2008-06

    Registered record
    Registry ID
    NCT00633295
    Conditions
    Gastrointestinal Stromal Tumors (GIST)
    Interventions
    AMN107- NILOTINIB
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2008-06
    Completion
    2010-05
    Enrolment
    9

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

    ConditionGastrointestinal Stromal Tumors (GIST)
    InterventionAMN107- NILOTINIB
    PhasePhase 2
    Registry statusCompleted
  • Combination of Nilotinib (AMN107) and RAD001 in Patients With Acute Myeloid Leukemia

    NCT00762632 · start 2007-12

    Registered record
    Registry ID
    NCT00762632
    Conditions
    Acute Myeloid Leukemia
    Interventions
    NILOTINIB; EVEROLIMUS
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Completed
    Start
    2007-12
    Completion
    Not recorded
    Enrolment
    40

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

    ConditionAcute Myeloid Leukemia
    InterventionNILOTINIB; EVEROLIMUS
    PhasePhase 1 / Phase 2
    Registry statusCompleted
  • Pharmacokinetics of Nilotinib in Subjects With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function

    NCT00418626 · start 2006-11

    Registered record
    Registry ID
    NCT00418626
    Conditions
    Healthy
    Interventions
    Nilotinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2006-11
    Completion
    Not recorded
    Enrolment
    27

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

    ConditionHealthy
    InterventionNilotinib
    PhasePhase 1
    Registry statusCompleted
  • Expanded Access Program of AMN107 in Imatinib-resistant or Intolerant Adult Patients With Chronic Myeloid Leukemia

    NCT00302016 · start 2006-01

    Registered record
    Registry ID
    NCT00302016
    Conditions
    Chronic Myeloid Leukemia
    Interventions
    AMN107
    Study type
    EXPANDED_ACCESS
    Phase
    Not recorded
    Registry status
    No longer available
    Start
    2006-01
    Completion
    Not recorded
    Enrolment
    Not recorded

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

    ConditionChronic Myeloid Leukemia
    InterventionAMN107
    PhaseNot recorded
    Registry statusNo longer available