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MK0476; montelukast sodium
Montelukast sodium blocks cysteinyl leukotriene receptors (CysLT1) on airway and inflammatory cells, preventing leukotriene-mediated bronchoconstriction and inflammation.
Montelukast sodium blocks cysteinyl leukotriene receptors (CysLT1) on airway and inflammatory cells, preventing leukotriene-mediated bronchoconstriction and inflammation. Used for Asthma (maintenance and prophylaxis), Allergic rhinitis, Exercise-induced bronchoconstriction prophylaxis.
At a glance
| Generic name | MK0476; montelukast sodium |
|---|---|
| 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 during allergic and asthmatic responses that bind to cysteinyl leukotriene receptors, causing airway constriction, mucus secretion, and eosinophil recruitment. By selectively antagonizing the CysLT1 receptor, montelukast reduces these inflammatory cascades and improves airway function. This mechanism makes it effective for both asthma maintenance and acute allergic rhinitis symptoms.
Approved indications
- Asthma (maintenance and prophylaxis)
- Allergic rhinitis
- Exercise-induced bronchoconstriction prophylaxis
Common side effects
- Headache
- Influenza-like illness
- Abdominal pain
- Dyspepsia
- Neuropsychiatric events (rare)
Key clinical trials
- PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia (PHASE1, PHASE2)
- ACTIV-6: COVID-19 Study of Repurposed Medications (PHASE3)
- The Effect of Omalizumab on Allergic Rhinitis Symptoms: a Comparative Study (PHASE4)
- ACTIV-6: COVID-19 Study of Repurposed Medications - Arm F (Montelukast) (PHASE3)
- To Evaluate the Efficacy and Safety of TQC3564 Tablets in the Treatment of Persistent Allergic Rhinitis (PHASE1)
- First Step With Singulair® Therapy (0476-323) (PHASE4)
- To Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy (0476-366) (PHASE3)
- MK0476 Study in Adult Patients With Allergic Rhinitis (0476-378) (PHASE2)
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
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- MK0476; montelukast sodium CI brief — competitive landscape report
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