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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 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
  • 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.

  • Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)

    NCT00127166 · start 2005-12

    Registered record
    Registry ID
    NCT00127166
    Conditions
    Exercise Induced Asthma
    Interventions
    Montelukast sodium; Salmeterol xinafoate; Fluticasone propionate; Montelukast matching placebo; Salmeterol matching placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2005-12
    Completion
    2008-11
    Enrolment
    154

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

    ConditionExercise Induced Asthma
    InterventionMontelukast sodium; Salmeterol xinafoate; Fluticasone propionate; Montelukast matching placebo +1 more
    PhasePhase 3
    Registry statusCompleted
  • SINGULAIR (R) as Complementary Therapy to Fixed Association Regimen (0476-363)

    NCT00445107 · start 2005-11-01

    Registered record
    Registry ID
    NCT00445107
    Conditions
    Asthma
    Interventions
    MK0476, montelukast sodium / Duration of Treatment: 8 Weeks
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2005-11-01
    Completion
    2006-05-17
    Enrolment
    198

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

    ConditionAsthma
    InterventionMK0476, montelukast sodium / Duration of Treatment: 8 Weeks
    PhasePhase 3
    Registry statusCompleted
  • MK0476 Study in Adult Patients With Acute Asthma (0476-322)

    NCT00229970 · start 2005-09

    Registered record
    Registry ID
    NCT00229970
    Conditions
    Asthma
    Interventions
    montelukast sodium; Comparator: Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2005-09
    Completion
    2007-06
    Enrolment
    225

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

    ConditionAsthma
    Interventionmontelukast sodium; Comparator: Placebo
    PhasePhase 3
    Registry statusCompleted
  • Effects of Montelukast in Children With Asthma

    NCT00675285 · start 2005-09

    Registered record
    Registry ID
    NCT00675285
    Conditions
    Asthma
    Interventions
    montelukast sodium; placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2005-09
    Completion
    2006-07
    Enrolment
    26

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

    ConditionAsthma
    Interventionmontelukast sodium; placebo
    PhasePhase 3
    Registry statusCompleted
  • A Study of an Intravenous Drug in Pediatric Patients With Acute Asthma (0476-301)

    NCT00117338 · start 2005-07

    Registered record
    Registry ID
    NCT00117338
    Conditions
    Asthma
    Interventions
    montelukast sodium; Comparator: placebo (unspecified)
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2005-07
    Completion
    2008-03
    Enrolment
    276

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

    ConditionAsthma
    Interventionmontelukast sodium; Comparator: placebo (unspecified)
    PhasePhase 3
    Registry statusCompleted
  • Safety and Pk Study in 1- to 3- Month-Old Children With Bronchiolitis (0476-297)

    NCT00394160 · start 2004-12

    Registered record
    Registry ID
    NCT00394160
    Conditions
    Bronchiolitis
    Interventions
    MK0476, Montelukast Sodium /Duration of Treatment : 14 Days
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2004-12
    Completion
    2005-10
    Enrolment
    12

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

    ConditionBronchiolitis
    InterventionMK0476, Montelukast Sodium /Duration of Treatment : 14 Days
    PhasePhase 2
    Registry statusCompleted
  • An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)

    NCT00127647 · start 2004-11

    Registered record
    Registry ID
    NCT00127647
    Conditions
    Rhinitis, Allergic, Seasonal
    Interventions
    montelukast sodium; Comparator: pranlukast
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2004-11
    Completion
    2005-04
    Enrolment
    1,375

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

    ConditionRhinitis, Allergic, Seasonal
    Interventionmontelukast sodium; Comparator: pranlukast
    PhasePhase 3
    Registry statusCompleted
  • Investigation of Intravenous (IV) Administration of an Approved Drug (MK-0476, Montelukast Sodium) for Acute Asthma (MK-0476-288)

    NCT00092989 · start 2004-07

    Registered record
    Registry ID
    NCT00092989
    Conditions
    Asthma
    Interventions
    montelukast sodium; placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2004-07
    Completion
    2007-03
    Enrolment
    650

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

    ConditionAsthma
    Interventionmontelukast sodium; placebo
    PhasePhase 3
    Registry statusCompleted
  • Study of an Approved Drug in Patients With Asthma (0476-289)(COMPLETED)

    NCT00092144 · start 2004-02-26

    Registered record
    Registry ID
    NCT00092144
    Conditions
    Asthma
    Interventions
    MK0476, montelukast sodium / Duration of Treatment: 4 weeks; Comparator: placebo / Duration of Treatment: 4 weeks
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2004-02-26
    Completion
    2004-06-15
    Enrolment
    500

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

    ConditionAsthma
    InterventionMK0476, montelukast sodium / Duration of Treatment: 4 weeks; Comparator: placebo / Duration of Treatment: 4 weeks
    PhasePhase 3
    Registry statusCompleted
  • An Investigational Drug Study to Treat Respiratory Symptoms Associated With Respiratory Syncytial Virus (RSV) Bronchiolitis (0476-272)

    NCT00076973 · start 2003-08

    Registered record
    Registry ID
    NCT00076973
    Conditions
    Bronchiolitis
    Interventions
    montelukast sodium; Comparator: placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2003-08
    Completion
    2006-10
    Enrolment
    1,125

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

    ConditionBronchiolitis
    Interventionmontelukast sodium; Comparator: placebo
    PhasePhase 3
    Registry statusCompleted
  • An Approved Drug to Study a New Indication for Seasonal Allergic Rhinitis in Patients With Asthma (0476-269)

    NCT00092885 · start 2003-03

    Registered record
    Registry ID
    NCT00092885
    Conditions
    Rhinitis, Allergic, Seasonal; Asthma, Bronchial
    Interventions
    MK0476, montelukast sodium; Comparator: placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2003-03
    Completion
    2003-10
    Enrolment
    831

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

    ConditionRhinitis, Allergic, Seasonal; Asthma, Bronchial
    InterventionMK0476, montelukast sodium; Comparator: placebo
    PhasePhase 3
    Registry statusCompleted
  • Fexofenadine HCl 180 mg, Montelukast Sodium 10 mg and Placebo in Suppression of Wheal and Flare Induced by Seasonal Allergen

    NCT00638118 · start 2003-02

    Registered record
    Registry ID
    NCT00638118
    Conditions
    Allergic Rhinitis
    Interventions
    Fexofenadine
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2003-02
    Completion
    2003-05
    Enrolment
    48

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

    ConditionAllergic Rhinitis
    InterventionFexofenadine
    PhasePhase 4
    Registry statusCompleted
  • Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children

    NCT00641472 · start 2002-10

    Registered record
    Registry ID
    NCT00641472
    Conditions
    Asthma
    Interventions
    Budesonide inhalation suspension; Montelukast Sodium
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2002-10
    Completion
    2005-02
    Enrolment
    380

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

    ConditionAsthma
    InterventionBudesonide inhalation suspension; Montelukast Sodium
    PhasePhase 4
    Registry statusCompleted
  • Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)

    NCT00963469 · start 2001-08

    Registered record
    Registry ID
    NCT00963469
    Conditions
    Seasonal Allergic Rhinitis
    Interventions
    montelukast sodium; Comparator: loratadine; Comparator: placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2001-08
    Completion
    2001-11
    Enrolment
    1,079

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

    ConditionSeasonal Allergic Rhinitis
    Interventionmontelukast sodium; Comparator: loratadine; Comparator: placebo
    PhasePhase 3
    Registry statusCompleted
  • A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis (0476-219)(COMPLETED)

    NCT00968149 · start 2001-03

    Registered record
    Registry ID
    NCT00968149
    Conditions
    Seasonal Allergic Rhinitis
    Interventions
    montelukast sodium; Comparator: Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2001-03
    Completion
    2001-07
    Enrolment
    413

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

    ConditionSeasonal Allergic Rhinitis
    Interventionmontelukast sodium; Comparator: Placebo
    PhasePhase 3
    Registry statusCompleted