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
Existing / approved use
Documented · FDA, WHO, ChEMBLApproved 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 evidenceClinical
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 measuredDihydrofolate 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 measuredOther 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.
- Galantamine HydrobromideExisting use: Alzheimer disease, Dementia89.6% AI-predicted activityagainst K. pneumoniaeLab records exist50+ registered studies
- Chlorhexidine GluconateExisting use: Eye infection, Gingivitis, Infection and 2 more69.3% AI-predicted activityagainst K. pneumoniaeLab records exist50+ registered studies
- TriclosanExisting use: Phenol and derivatives, Medicated dressings with antiinfectives68.0% AI-predicted activityagainst K. pneumoniaeLab records exist50+ registered studies
- ElvitegravirExisting use: HIV infection, HIV-1 infection, Viral disease60.2% AI-predicted activityagainst K. pneumoniae50+ registered studies
- Caspofungin AcetateExisting use: Aspergillosis, Candidemia, Candidiasis and 1 more57.5% AI-predicted activityagainst K. pneumoniae50+ registered studies
- DactinomycinExisting use: Kidney Wilms tumor, Neoplasm56.8% AI-predicted activityagainst K. pneumoniae50+ registered studies
- CyclosporineExisting use: Conjunctivitis, Corneal disease, Eye disease and 6 more56.1% AI-predicted activityagainst K. pneumoniae50+ registered studies
- LinaclotideExisting use: Constipation, Constipation disorder, Irritable bowel syndrome56.0% AI-predicted activityagainst K. pneumoniae50+ registered studies
- Irinotecan HydrochlorideExisting use: Adenocarcinoma, Cancer, Carcinoma and 4 more54.5% AI-predicted activityagainst K. pneumoniae50+ registered studies
- OxytocinExisting use: Hemorrhage, Uterine Inertia52.7% AI-predicted activityagainst K. pneumoniae50+ registered studies
- Micafungin SodiumExisting use: Candidiasis52.4% AI-predicted activityagainst K. pneumoniae50+ registered studies
- VoclosporinExisting use: Immune system disease, Lupus nephritis52.2% AI-predicted activityagainst K. pneumoniae28 registered studies
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.
ConditionHealthyInterventionMontelukast sodiumPhasePhase 1Registry statusCompletedBioequivalence 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.
ConditionHealthyInterventionMontelukast sodiumPhasePhase 1Registry statusCompletedBioequivalence 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.
ConditionHealthyInterventionMontelukast sodiumPhasePhase 1Registry statusCompletedBioequivalence 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.
ConditionHealthyInterventionMontelukast sodium chewable tablets 4mg and 5mgPhasePhase 1Registry statusCompletedUsefulness 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.
ConditionAsthmaInterventioncyklezonid; montelukast sodium; placebo; formoterol 12 mcg twice dailyPhasePhase 2Registry statusUnknownTrial 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.
ConditionBronchiolitisInterventionmontelukast sodium; sucrosePhaseNot applicableRegistry statusCompletedMontelukast 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 moreInterventionSingulair (Montelukast Sodium)PhasePhase 2Registry statusCompletedThe 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 4Registry statusCompletedBioequivalency 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.
ConditionAsthmaInterventionMontelukast; SingulairPhaseEarly phase 1Registry statusCompletedBioequivalency 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.
ConditionAsthmaInterventionMontelukast; SingulairPhaseEarly phase 1Registry statusCompletedA 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.
ConditionAsthmaInterventionMontelukast; PlaceboPhasePhase 1Registry statusCompletedExercise 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-inducedInterventionmontelukast sodium; Comparator: placebo (unspecified)PhasePhase 1Registry statusCompletedComparison 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 RhinitisInterventionmontelukast; cetirizine; montelukast and cetirizine; placeboPhasePhase 4Registry statusUnknownDoes 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 SyndromeInterventionMontelukast SodiumPhasePhase 4Registry statusTerminatedMontelukast 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.
ConditionAsthmaInterventionmontelukast sodium; Comparator: Placebo; Comparator: fluticasone; Comparator: PlaceboPhasePhase 3Registry statusCompleted