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AMR Drug RepurposingSmart Screeningresearch prototype

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.

Open Montelukast Sodium in ChEMBL Registered studies below

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.

  • PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia

    NCT07101640 · start 2026-02-23

    Registered record
    Registry ID
    NCT07101640
    Conditions
    Bronchopulmonary Dysplasia (BPD); Premature Births; Critical Illness
    Interventions
    montelukast 4 mg granule; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Recruiting
    Start
    2026-02-23
    Completion
    2028-06-30
    Enrolment
    28

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

    ConditionBronchopulmonary Dysplasia (BPD); Premature Births; Critical Illness
    Interventionmontelukast 4 mg granule; Placebo
    PhasePhase 1 / Phase 2
    Registry statusRecruiting

  • The Impact of Airway Allergic Diseases on Children's and Parents' Quality of Life

    NCT06535087 · start 2024-07-20

    Registered record
    Registry ID
    NCT06535087
    Conditions
    Pediatric Asthma; Rhinitis, Allergic; Quality of Life
    Interventions
    Subcutaneous immunotherapy / Standard Treatment for Asthma and Rhinitis
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2024-07-20
    Completion
    2027-05-31
    Enrolment
    600

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

    ConditionPediatric Asthma; Rhinitis, Allergic; Quality of Life
    InterventionSubcutaneous immunotherapy / Standard Treatment for Asthma and Rhinitis
    PhaseNot recorded
    Registry statusRecruiting

  • To Evaluate the Efficacy and Safety of TQC3564 Tablets in the Treatment of Persistent Allergic Rhinitis

    NCT05607446 · start 2022-09-14

    Registered record
    Registry ID
    NCT05607446
    Conditions
    Allergic Rhinitis
    Interventions
    TQC3564 tablets; Placebo tablets; TQC3564 tablets, montelukast sodium tablets; Placebo tablets, montelukast sodium tablets
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Terminated
    Start
    2022-09-14
    Completion
    2023-12-14
    Enrolment
    12

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

    ConditionAllergic Rhinitis
    InterventionTQC3564 tablets; Placebo tablets; TQC3564 tablets, montelukast sodium tablets; Placebo tablets, montelukast sodium tablets
    PhasePhase 1
    Registry statusTerminated

  • ACTIV-6: COVID-19 Study of Repurposed Medications

    NCT04885530 · start 2021-06-08

    Registered record
    Registry ID
    NCT04885530
    Conditions
    Covid19
    Interventions
    Ivermectin; Fluvoxamine; Fluticasone; Placebo; Montelukast; Metformin
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2021-06-08
    Completion
    2024-04-29
    Enrolment
    10,956

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

    ConditionCovid19
    InterventionIvermectin; Fluvoxamine; Fluticasone; Placebo +2 more
    PhasePhase 3
    Registry statusCompleted

  • Role of Montelukast in Modulation of Response to Sepsis in Preterm Infants

    NCT04474327 · start 2020-07-24

    Registered record
    Registry ID
    NCT04474327
    Conditions
    Neonatal Sepsis
    Interventions
    Montelukast Sodium
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2020-07-24
    Completion
    2021-02-10
    Enrolment
    40

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

    ConditionNeonatal Sepsis
    InterventionMontelukast Sodium
    PhasePhase 1
    Registry statusCompleted

  • Establishment of a Diagnosis and Treatment System for Information Processing Damage in Children With OSAHS

    NCT04080089 · start 2019-10-01

    Registered record
    Registry ID
    NCT04080089
    Conditions
    Sleep Apnea, Obstructive
    Interventions
    Surgical treatment, drug therapy, remote cognitive training
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Unknown
    Start
    2019-10-01
    Completion
    2020-12-31
    Enrolment
    50

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

    ConditionSleep Apnea, Obstructive
    InterventionSurgical treatment, drug therapy, remote cognitive training
    PhaseNot recorded
    Registry statusUnknown

  • The Effect of Omalizumab on Allergic Rhinitis Symptoms: a Comparative Study

    NCT06806826 · start 2019-01-01

    Registered record
    Registry ID
    NCT06806826
    Conditions
    Allergic Rhinitis
    Interventions
    Omalizumab
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2019-01-01
    Completion
    2020-03-01
    Enrolment
    50

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

    ConditionAllergic Rhinitis
    InterventionOmalizumab
    PhasePhase 4
    Registry statusCompleted

  • Bioequivalence Study of Montelukast Sodium Oral Thin Film and Chewable Tablet in Fed Healthy Volunteers

    NCT05531994 · start 2018-11-27

    Registered record
    Registry ID
    NCT05531994
    Conditions
    Healthy Volunteers
    Interventions
    Montelukast sodium oral thin films with water (T); Montelukast sodium chewable tablets with water (R)
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Completed
    Start
    2018-11-27
    Completion
    2019-05-14
    Enrolment
    30

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

    ConditionHealthy Volunteers
    InterventionMontelukast sodium oral thin films with water (T); Montelukast sodium chewable tablets with water (R)
    PhaseNot applicable
    Registry statusCompleted

  • TEAM (Trial on Efficacy and Quality of Life Among Asthmatic Patient With Montelukast)

    NCT03096327 · start 2017-05-01

    Registered record
    Registry ID
    NCT03096327
    Conditions
    Asthma
    Interventions
    Montelukast; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2017-05-01
    Completion
    2018-05-30
    Enrolment
    180

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

    ConditionAsthma
    InterventionMontelukast; Placebo
    PhasePhase 4
    Registry statusCompleted

  • The Utility of feNO in the Differential Diagnosis of Chronic Cough

    NCT02479074 · start 2016-01

    Registered record
    Registry ID
    NCT02479074
    Conditions
    Cough
    Interventions
    Montelukast (High FeNO group); Prednisolon, Montelukast (High FeNO); Montelukast (Low FeNO group)
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2016-01
    Completion
    2017-03-09
    Enrolment
    49

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

    ConditionCough
    InterventionMontelukast (High FeNO group); Prednisolon, Montelukast (High FeNO); Montelukast (Low FeNO group)
    PhasePhase 4
    Registry statusCompleted

  • Montelukast for Postinfectious Cough

    NCT02352545 · start 2014-08

    Registered record
    Registry ID
    NCT02352545
    Conditions
    Cough
    Interventions
    Montelukast
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Unknown
    Start
    2014-08
    Completion
    2015-10
    Enrolment
    200

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

    ConditionCough
    InterventionMontelukast
    PhasePhase 2
    Registry statusUnknown

  • Preoperative Use of Montelukast Sodium

    NCT02494466 · start 2014-05

    Registered record
    Registry ID
    NCT02494466
    Conditions
    Airway Reactivity
    Interventions
    montelukast sodium
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2014-05
    Completion
    2015-06
    Enrolment
    30

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

    ConditionAirway Reactivity
    Interventionmontelukast sodium
    PhasePhase 4
    Registry statusCompleted

  • Safety and the Pharmacokinetic Study of Characteristics of MKT-N2 (Montelukast) and Singulair® (Montelukast Sodium)to Treat Asthma

    NCT02029313 · start 2013-11

    Registered record
    Registry ID
    NCT02029313
    Conditions
    Asthma and Allergic Rhinitis
    Interventions
    Montelukast; Montelukast sodium
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2013-11
    Completion
    2014-03
    Enrolment
    40

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

    ConditionAsthma and Allergic Rhinitis
    InterventionMontelukast; Montelukast sodium
    PhasePhase 1
    Registry statusCompleted

  • A Drug Interaction Study of Montelukast and Levocetirizine

    NCT01491503 · start 2011-11

    Registered record
    Registry ID
    NCT01491503
    Conditions
    Healthy
    Interventions
    Levocetirizine; montelukast sodium; Montelukast & levocetirizine
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2011-11
    Completion
    2012-01
    Enrolment
    30

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

    ConditionHealthy
    InterventionLevocetirizine; montelukast sodium; Montelukast & levocetirizine
    PhasePhase 1
    Registry statusCompleted

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

    NCT01691456 · start 2011-01

    Registered record
    Registry ID
    NCT01691456
    Conditions
    Healthy
    Interventions
    Montelukast sodium
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2011-01
    Completion
    2011-02
    Enrolment
    45

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

    ConditionHealthy
    InterventionMontelukast sodium
    PhasePhase 1
    Registry statusCompleted