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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.

  • Adapting Treatment to the Tumor Molecular Alterations for Patients With Advanced Solid Tumors: MyOwnSpecificTreatment

    NCT02029001 · start 2014-03

    Registered record
    Registry ID
    NCT02029001
    Conditions
    Malignant Solid Neoplasms
    Interventions
    Nilotinib (400 mg BID); Everolimus (10 mg QD); Sorafenib (400 mg BID); Lapatinib (1500 mg QD); Pazopanib (800 mg QD); Olaparib (300 mg BID); Durvalumab + Tremelimumab
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2014-03
    Completion
    2028-10
    Enrolment
    900

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

    ConditionMalignant Solid Neoplasms
    InterventionNilotinib (400 mg BID); Everolimus (10 mg QD); Sorafenib (400 mg BID); Lapatinib (1500 mg QD) +3 more
    PhasePhase 2
    Registry statusRecruiting
  • An Open-label, Randomised Multicenter Phase 3b Study to Determine the Confirmed Rate of Molecular Response ≥ 4 Log (MR4) at Two Years

    NCT02174445 · start 2014-03

    Registered record
    Registry ID
    NCT02174445
    Conditions
    Chronic Myeloid Leukemia
    Interventions
    Imatinib; Nilotinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Terminated
    Start
    2014-03
    Completion
    2019-10
    Enrolment
    14

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

    ConditionChronic Myeloid Leukemia
    InterventionImatinib; Nilotinib
    PhasePhase 3
    Registry statusTerminated
  • Trial Evaluating Nilotinib as Treatment for Newly Diagnosed CML Patients in Accelerated Phase.

    NCT01605981 · start 2014-02

    Registered record
    Registry ID
    NCT01605981
    Conditions
    Chronic Myeloid Leukemia (CML)
    Interventions
    AMN107
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Withdrawn
    Start
    2014-02
    Completion
    2017-01
    Enrolment
    0

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

    ConditionChronic Myeloid Leukemia (CML)
    InterventionAMN107
    PhasePhase 4
    Registry statusWithdrawn
  • Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.

    NCT01844765 · start 2013-08-20

    Registered record
    Registry ID
    NCT01844765
    Conditions
    Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia
    Interventions
    nilotinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2013-08-20
    Completion
    2020-08-28
    Enrolment
    59

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

    ConditionPhiladelphia Positive (Ph+) Chronic Myelogenous Leukemia
    Interventionnilotinib
    PhasePhase 2
    Registry statusCompleted
  • Phase I/II Study of Nilotinib/Ruxolitinb Therapy for TKI Resistant Ph-Leukemia

    NCT01914484 · start 2013-08-01

    Registered record
    Registry ID
    NCT01914484
    Conditions
    Chronic Phase Chronic Myeloid Leukemia; Accelerated Phase Chronic Myeloid Leukemia; Blastic Phase Chronic Myeloid Leukemia; Philadelphia Positive Acute Lymphoblastic Leukemia; Resistant to Tyrosine Kinase Inhibitor Therapy
    Interventions
    Nilotinib; Ruxolitinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Completed
    Start
    2013-08-01
    Completion
    2018-12-31
    Enrolment
    4

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

    ConditionChronic Phase Chronic Myeloid Leukemia; Accelerated Phase Chronic Myeloid Leukemia; Blastic Phase Chronic Myeloid Leukemia; Philadelphia Positive Acute Lymphoblastic Leukemia +1 more
    InterventionNilotinib; Ruxolitinib
    PhasePhase 1 / Phase 2
    Registry statusCompleted
  • TKI Therapy Based on Molecular Monitoring in Allogeneic-HSCT Recipients With Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

    NCT01883219 · start 2013-06

    Registered record
    Registry ID
    NCT01883219
    Conditions
    Philadelphia Chromosome Positive Acute Lymphocytic Leukemia; Stem Cell Transplantation; Minimal Residual Disease
    Interventions
    TKIs
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Unknown
    Start
    2013-06
    Completion
    2017-11
    Enrolment
    80

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

    ConditionPhiladelphia Chromosome Positive Acute Lymphocytic Leukemia; Stem Cell Transplantation; Minimal Residual Disease
    InterventionTKIs
    PhasePhase 2
    Registry statusUnknown
  • A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML.

    NCT01743989 · start 2013-04-15

    Registered record
    Registry ID
    NCT01743989
    Conditions
    Philadelphia Chromosome Positive (PH+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
    Interventions
    Nilotinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2013-04-15
    Completion
    2020-07-08
    Enrolment
    620

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

    ConditionPhiladelphia Chromosome Positive (PH+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
    InterventionNilotinib
    PhasePhase 3
    Registry statusCompleted
  • Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study

    NCT01735955 · start 2013-03-29

    Registered record
    Registry ID
    NCT01735955
    Conditions
    Chronic Myelogenous Leukemia (CML); Metastatic Gastrointestinal Stromal Tumors (GIST); Acute Lymphoblastic Leukemia (ALL); Receptor Tyrosine Kinase (KIT) Mutated Melanoma
    Interventions
    Nilotinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2013-03-29
    Completion
    2023-07-07
    Enrolment
    57

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

    ConditionChronic Myelogenous Leukemia (CML); Metastatic Gastrointestinal Stromal Tumors (GIST); Acute Lymphoblastic Leukemia (ALL); Receptor Tyrosine Kinase (KIT) Mutated Melanoma
    InterventionNilotinib
    PhasePhase 4
    Registry statusCompleted
  • Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients

    NCT01784068 · start 2013-03-19

    Registered record
    Registry ID
    NCT01784068
    Conditions
    Chronic Myelogenous Leukemia
    Interventions
    Nilotinib followed by treatment-free
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2013-03-19
    Completion
    2025-01-23
    Enrolment
    215

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

    ConditionChronic Myelogenous Leukemia
    InterventionNilotinib followed by treatment-free
    PhasePhase 2
    Registry statusCompleted
  • Efficacy and Safety of Nilotinib in Patients With a Chronic Disease of the Graft Against the Host

    NCT02891395 · start 2012-12-24

    Registered record
    Registry ID
    NCT02891395
    Conditions
    Graft Versus Host Disease
    Interventions
    Imatinib Mesylate and Nilotinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2012-12-24
    Completion
    2017-07-26
    Enrolment
    65

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

    ConditionGraft Versus Host Disease
    InterventionImatinib Mesylate and Nilotinib
    PhasePhase 2
    Registry statusCompleted
  • Determining the Maximum Tolerated Dose of Low Dose Interferon-alpha in Conjunction With Nilotinib in Pretreated Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Patients in Chronic Phase (CML-CP)

    NCT01220648 · start 2012-04

    Registered record
    Registry ID
    NCT01220648
    Conditions
    Chronic Myeloid Leukemia
    Interventions
    Nilotinib, interferon-alfa
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2012-04
    Completion
    2014-01
    Enrolment
    4

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

    ConditionChronic Myeloid Leukemia
    InterventionNilotinib, interferon-alfa
    PhasePhase 1
    Registry statusCompleted
  • Nilotinib in PH+, BCR-, ABL+ CML Patients

    NCT01535391 · start 2012-01

    Registered record
    Registry ID
    NCT01535391
    Conditions
    Chronic Myeloid Leukemia
    Interventions
    Nilotinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2012-01
    Completion
    2018-04-27
    Enrolment
    109

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

    ConditionChronic Myeloid Leukemia
    InterventionNilotinib
    PhasePhase 3
    Registry statusCompleted
  • Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia Patients

    NCT01169753 · start 2011-05

    Registered record
    Registry ID
    NCT01169753
    Conditions
    Chronic Myeloid Leukemia
    Interventions
    Placebo; Armodafinil
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Terminated
    Start
    2011-05
    Completion
    2013-02
    Enrolment
    1

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

    ConditionChronic Myeloid Leukemia
    InterventionPlacebo; Armodafinil
    PhaseNot applicable
    Registry statusTerminated
  • Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations

    NCT01131325 · start 2010-10-21

    Registered record
    Registry ID
    NCT01131325
    Conditions
    CML; Philadelphia Chromosome Positive (Ph+); Chronic Myelogenous Leukemia Chronic Phase(CML-CP) Patients With Low Imatinib Trough Levels
    Interventions
    nilotinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Terminated
    Start
    2010-10-21
    Completion
    2011-05-12
    Enrolment
    3

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

    ConditionCML; Philadelphia Chromosome Positive (Ph+); Chronic Myelogenous Leukemia Chronic Phase(CML-CP) Patients With Low Imatinib Trough Levels
    Interventionnilotinib
    PhasePhase 4
    Registry statusTerminated
  • A Study of Nilotinib in Growing Vestibular Schwannomas

    NCT01201538 · start 2010-10

    Registered record
    Registry ID
    NCT01201538
    Conditions
    Growing Vestibular Schwannomas
    Interventions
    Nilotinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2010-10
    Completion
    2013-10
    Enrolment
    2

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

    ConditionGrowing Vestibular Schwannomas
    InterventionNilotinib
    PhasePhase 2
    Registry statusTerminated