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Comparator: Montelukast
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 (maintenance and acute prevention), Allergic rhinitis, Aspirin-exacerbated respiratory disease (AERD).
At a glance
| Generic name | Comparator: Montelukast |
|---|---|
| Also known as | Singulair, SINGULAIR®, PROAIR® HFA |
| Sponsor | Organon and Co |
| Drug class | Cysteinyl leukotriene receptor antagonist (LTRA) |
| Target | CysLT1 (cysteinyl leukotriene receptor 1) |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Immunology |
| Phase | FDA-approved |
Mechanism of action
Leukotrienes are inflammatory mediators released by mast cells and eosinophils that promote airway constriction, mucus secretion, and eosinophil recruitment. By antagonizing the CysLT1 receptor, montelukast reduces these inflammatory responses in asthma and allergic rhinitis. This mechanism is distinct from beta-agonists and corticosteroids, making it useful as add-on therapy or for specific phenotypes like aspirin-exacerbated respiratory disease.
Approved indications
- Asthma (maintenance and acute prevention)
- Allergic rhinitis
- Aspirin-exacerbated respiratory disease (AERD)
- Exercise-induced bronchoconstriction
Common side effects
- Headache
- Influenza-like illness
- Abdominal pain
- Cough
- Neuropsychiatric effects (mood changes, suicidality)
Key clinical trials
- Anti-Inflammatory Reliever South Africa (PHASE3)
- ACTIV-6: COVID-19 Study of Repurposed Medications (PHASE3)
- ACTIV-6: COVID-19 Study of Repurposed Medications - Arm F (Montelukast) (PHASE3)
- First Step With Singulair® Therapy (0476-323) (PHASE4)
- MK0476 Study in Adult Patients With Allergic Rhinitis (0476-378) (PHASE2)
- An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327) (PHASE3)
- A Study to Evaluate MK0476 and Fluticasone to Control Asthma in Patients With Mild Persistent Asthma (0476-910) (PHASE3)
- Montelukast Post-Marketing Comparative Study With Ketotifen (0476-379) (PHASE4)
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:
- Comparator: Montelukast CI brief — competitive landscape report
- Comparator: Montelukast updates RSS · CI watch RSS
- Organon and Co portfolio CI