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Placebo to montelukast chewable tablets
Montelukast is a leukotriene receptor antagonist that blocks cysteinyl leukotriene receptors to reduce airway inflammation and bronchoconstriction.
Montelukast is a leukotriene receptor antagonist that blocks cysteinyl leukotriene receptors to reduce airway inflammation and bronchoconstriction. Used for Asthma (prophylaxis and chronic treatment), Allergic rhinitis, Exercise-induced bronchoconstriction.
At a glance
| Generic name | Placebo to montelukast chewable tablets |
|---|---|
| Sponsor | Organon and Co |
| Drug class | Leukotriene receptor antagonist |
| Target | CysLT1 receptor (cysteinyl leukotriene type-1 receptor) |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Immunology |
| Phase | FDA-approved |
Mechanism of action
Montelukast selectively antagonizes cysteinyl leukotriene type-1 (CysLT1) receptors on airway smooth muscle and inflammatory cells. By blocking these receptors, it prevents the inflammatory cascade triggered by leukotrienes, which are potent mediators released during allergic and asthmatic responses. This reduces airway inflammation, mucus production, and bronchoconstriction.
Approved indications
- Asthma (prophylaxis and chronic treatment)
- Allergic rhinitis
- Exercise-induced bronchoconstriction
Common side effects
- Headache
- Dizziness
- Dyspepsia
- Elevated liver enzymes
- Neuropsychiatric events (rare)
Key clinical trials
- A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years (0476-907) (PHASE3)
- Study of Montelukast and Its Effect on Lower Leg Growth in Children With Asthma (MK-0476-254) (PHASE4)
- Study of the Efficacy and Safety of MK-0476 in Japanese Pediatric Participants With Seasonal Allergic Rhinitis (MK-0476-519) (PHASE3)
- The Effect of Montelukast on Difficulty in Breathing After Exercise in Pediatric Patients (MK0476-377)(COMPLETED) (PHASE4)
- Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911) (PHASE3)
- Effects of a Orally Inhaled Fluticasone Furoate on Growth Velocity in Prepubertal, Paediatric Subjects With Asthma Over a Year (PHASE4)
- SMILES: Study of Montelukast in Sickle Cell Disease (PHASE2, PHASE3)
- Investigation the Safety and Efficacy of The Antileukotriene Agents, Montelukast, as Adjuvant Therapy in Obese Patients With Type 2 Diabetes Mellitus (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:
- Placebo to montelukast chewable tablets CI brief — competitive landscape report
- Placebo to montelukast chewable tablets updates RSS · CI watch RSS
- Organon and Co portfolio CI