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montelukast (Singulair)
Montelukast blocks cysteinyl leukotriene receptors (CysLT1) on airway and immune cells, preventing leukotriene-mediated inflammation and bronchoconstriction.
Montelukast blocks cysteinyl leukotriene receptors (CysLT1) on airway and immune cells, preventing leukotriene-mediated inflammation and bronchoconstriction. Used for Asthma (chronic maintenance treatment), Allergic rhinitis, Exercise-induced bronchoconstriction.
At a glance
| Generic name | montelukast (Singulair) |
|---|---|
| Also known as | Singulair |
| Sponsor | University of Bologna |
| Drug class | Cysteinyl leukotriene receptor antagonist (LTRA) |
| Target | CysLT1 receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Immunology |
| Phase | FDA-approved |
Mechanism of action
Leukotrienes are inflammatory mediators released by mast cells and eosinophils that bind to CysLT1 receptors, causing airway smooth muscle contraction, mucus secretion, and eosinophil recruitment. By antagonizing these receptors, montelukast reduces airway inflammation and improves airflow in asthma and allergic rhinitis. This mechanism is particularly effective in leukotriene-driven inflammatory pathways.
Approved indications
- Asthma (chronic maintenance treatment)
- Allergic rhinitis
- Exercise-induced bronchoconstriction
Common side effects
- Headache
- Influenza-like illness
- Abdominal pain
- Cough
- Neuropsychiatric effects (mood changes, suicidality)
Key clinical trials
- PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia (PHASE1, PHASE2)
- BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP) (PHASE2)
- Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease (PHASE2)
- Efficacy of Montelukast in Reducing the Incidence and Severity of Monoclonal Antibodies Associated Infusion Reactions (PHASE2)
- ACTIV-6: COVID-19 Study of Repurposed Medications (PHASE3)
- Clinical Evaluation of Montelukast in Veterans With Gulf War Illness (PHASE1)
- Treating Exacerbations of Asthma With Oral Montelukast in Children (PHASE2)
- MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial) (EARLY_PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- montelukast (Singulair) CI brief — competitive landscape report
- montelukast (Singulair) updates RSS · CI watch RSS
- University of Bologna portfolio CI