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Montelukast Sodium

FDA-approved product (tablet, oral), marketed as Montelukast Sodium, Singulair.

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

Chemical structure

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

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Airway obstruction
  • Allergic rhinitis
  • Asthma
  • Rhinitis, Allergic, Perennial
  • Seasonal allergic rhinitis

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

WHO therapeutic group
Leukotriene receptor antagonists
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against M. tuberculosis, MRSA and E. coli. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA62.0% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli46.9% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae33.2% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis57.3% 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)

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 Montelukast Sodium 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.

  • Bioequivalence Study of Montelukast Sodium Oral Granules 4mg Under Fed Condition

    NCT01691469 · start 2011-01

    Registered record
    Registry ID
    NCT01691469
    Conditions
    Healthy
    Interventions
    Montelukast sodium
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2011-01
    Completion
    2011-02
    Enrolment
    31

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

    ConditionHealthy
    InterventionMontelukast sodium
    PhasePhase 1
    Registry statusCompleted
  • Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fasting Condition

    NCT01671709 · start 2010-02

    Registered record
    Registry ID
    NCT01671709
    Conditions
    Healthy
    Interventions
    Montelukast sodium
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2010-02
    Completion
    2010-03
    Enrolment
    41

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

    ConditionHealthy
    InterventionMontelukast sodium
    PhasePhase 1
    Registry statusCompleted
  • Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fed Condition

    NCT01671722 · start 2010-02

    Registered record
    Registry ID
    NCT01671722
    Conditions
    Healthy
    Interventions
    Montelukast sodium
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2010-02
    Completion
    2010-03
    Enrolment
    43

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

    ConditionHealthy
    InterventionMontelukast sodium
    PhasePhase 1
    Registry statusCompleted
  • Bioequivalence Study of Montelukast Sodium Chewable Tablets 4mg and 5mg Under Fed Condition

    NCT01674517 · start 2010-02

    Registered record
    Registry ID
    NCT01674517
    Conditions
    Healthy
    Interventions
    Montelukast sodium chewable tablets 4mg and 5mg
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2010-02
    Completion
    2010-02
    Enrolment
    35

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

    ConditionHealthy
    InterventionMontelukast sodium chewable tablets 4mg and 5mg
    PhasePhase 1
    Registry statusCompleted
  • Usefulness of Exhaled Breath Condensate for Evaluation of Markers of Airway Inflammation in Children With Asthma

    NCT00961155 · start 2009-08

    Registered record
    Registry ID
    NCT00961155
    Conditions
    Asthma
    Interventions
    cyklezonid; montelukast sodium; placebo; formoterol 12 mcg twice daily
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Unknown
    Start
    2009-08
    Completion
    2014-06
    Enrolment
    200

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

    ConditionAsthma
    Interventioncyklezonid; montelukast sodium; placebo; formoterol 12 mcg twice daily
    PhasePhase 2
    Registry statusUnknown
  • Trial of Montelukast for Treatment of Acute Bronchiolitis

    NCT00863317 · start 2008-12

    Registered record
    Registry ID
    NCT00863317
    Conditions
    Bronchiolitis
    Interventions
    montelukast sodium; sucrose
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Completed
    Start
    2008-12
    Completion
    2011-07
    Enrolment
    141

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

    ConditionBronchiolitis
    Interventionmontelukast sodium; sucrose
    PhaseNot applicable
    Registry statusCompleted
  • Montelukast to Treat Bronchiolitis Obliterans

    NCT00656058 · start 2008-06-17

    Registered record
    Registry ID
    NCT00656058
    Conditions
    Bronchiolitis Obliterans; Chronic Graft Versus Host Disease; Leukotriene; Montelukast; Stem Cell Transplant
    Interventions
    Singulair (Montelukast Sodium)
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2008-06-17
    Completion
    2018-02-22
    Enrolment
    25

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

    ConditionBronchiolitis Obliterans; Chronic Graft Versus Host Disease; Leukotriene; Montelukast +1 more
    InterventionSingulair (Montelukast Sodium)
    PhasePhase 2
    Registry statusCompleted
  • The Effect of Montelukast on Difficulty in Breathing After Exercise in Pediatric Patients (MK0476-377)(COMPLETED)

    NCT00534976 · start 2008-02

    Registered record
    Registry ID
    NCT00534976
    Conditions
    Exercise-induced Bronchoconstriction (EIB)
    Interventions
    Comparator: montelukast sodium; Comparator: Comparator: placebo (unspecified)
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2008-02
    Completion
    2010-03
    Enrolment
    364

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

    ConditionExercise-induced Bronchoconstriction (EIB)
    InterventionComparator: montelukast sodium; Comparator: Comparator: placebo (unspecified)
    PhasePhase 4
    Registry statusCompleted
  • Bioequivalency Study of Montelukast 10 mg Tablets Under Fed Conditions

    NCT01659918 · start 2008-02

    Registered record
    Registry ID
    NCT01659918
    Conditions
    Asthma
    Interventions
    Montelukast; Singulair
    Study type
    INTERVENTIONAL
    Phase
    Early phase 1
    Registry status
    Completed
    Start
    2008-02
    Completion
    2008-02
    Enrolment
    35

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

    ConditionAsthma
    InterventionMontelukast; Singulair
    PhaseEarly phase 1
    Registry statusCompleted
  • Bioequivalency Study of Montelukast 10 mg Tablets Under Fasted Conditions

    NCT01659931 · start 2008-02

    Registered record
    Registry ID
    NCT01659931
    Conditions
    Asthma
    Interventions
    Montelukast; Singulair
    Study type
    INTERVENTIONAL
    Phase
    Early phase 1
    Registry status
    Completed
    Start
    2008-02
    Completion
    2008-02
    Enrolment
    34

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

    ConditionAsthma
    InterventionMontelukast; Singulair
    PhaseEarly phase 1
    Registry statusCompleted
  • A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Montelukast (MK-0476) in Participants With Mild or Moderate Asthma (MK-0476-380 AM3)(COMPLETED)

    NCT00636207 · start 2007-08

    Registered record
    Registry ID
    NCT00636207
    Conditions
    Asthma
    Interventions
    Montelukast; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2007-08
    Completion
    2008-10
    Enrolment
    46

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

    ConditionAsthma
    InterventionMontelukast; Placebo
    PhasePhase 1
    Registry statusCompleted
  • Exercise Induced Bronchoconstriction (0476-359)

    NCT00664937 · start 2007-05

    Registered record
    Registry ID
    NCT00664937
    Conditions
    Asthma, Exercise-induced
    Interventions
    montelukast sodium; Comparator: placebo (unspecified)
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2007-05
    Completion
    2008-10
    Enrolment
    24

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

    ConditionAsthma, Exercise-induced
    Interventionmontelukast sodium; Comparator: placebo (unspecified)
    PhasePhase 1
    Registry statusCompleted
  • Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation in Children With Allergic Rhinitis

    NCT00488176 · start 2007-04

    Registered record
    Registry ID
    NCT00488176
    Conditions
    Seasonal Allergic Rhinitis
    Interventions
    montelukast; cetirizine; montelukast and cetirizine; placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Unknown
    Start
    2007-04
    Completion
    2013-12
    Enrolment
    116

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

    ConditionSeasonal Allergic Rhinitis
    Interventionmontelukast; cetirizine; montelukast and cetirizine; placebo
    PhasePhase 4
    Registry statusUnknown
  • Does Montelukast Have an Affect on the Function of the Artery in Patients With Heart Disease

    NCT00351364 · start 2006-07

    Registered record
    Registry ID
    NCT00351364
    Conditions
    Coronary Artery Disease; Acute Coronary Syndrome
    Interventions
    Montelukast Sodium
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Terminated
    Start
    2006-07
    Completion
    2010-07
    Enrolment
    40

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

    ConditionCoronary Artery Disease; Acute Coronary Syndrome
    InterventionMontelukast Sodium
    PhasePhase 4
    Registry statusTerminated
  • Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED)

    NCT00284856 · start 2006-05

    Registered record
    Registry ID
    NCT00284856
    Conditions
    Asthma
    Interventions
    montelukast sodium; Comparator: Placebo; Comparator: fluticasone; Comparator: Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2006-05
    Completion
    2010-04
    Enrolment
    1,640

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

    ConditionAsthma
    Interventionmontelukast sodium; Comparator: Placebo; Comparator: fluticasone; Comparator: Placebo
    PhasePhase 3
    Registry statusCompleted