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Comparator: montelukast/loratadine
This is a fixed-dose combination of montelukast (a cysteinyl leukotriene receptor antagonist) and loratadine (a selective H1-receptor antagonist) that reduces airway inflammation and blocks allergic mediators.
This is a fixed-dose combination of montelukast (a cysteinyl leukotriene receptor antagonist) and loratadine (a selective H1-receptor antagonist) that reduces airway inflammation and blocks allergic mediators. Used for Allergic rhinitis and asthma (combination indication).
At a glance
| Generic name | Comparator: montelukast/loratadine |
|---|---|
| Sponsor | Organon and Co |
| Drug class | Leukotriene receptor antagonist / Antihistamine combination |
| Target | Cysteinyl leukotriene receptor (CysLT1) and H1 histamine receptor |
| Modality | Small molecule |
| Therapeutic area | Immunology / Allergy / Respiratory |
| Phase | Phase 3 |
Mechanism of action
Montelukast blocks cysteinyl leukotriene receptors on airway smooth muscle and inflammatory cells, reducing bronchoconstriction and inflammation. Loratadine competitively antagonizes H1 histamine receptors, reducing allergic symptoms such as itching, sneezing, and rhinitis. Together, they provide dual anti-inflammatory and antihistamine effects for allergic airway disease.
Approved indications
- Allergic rhinitis and asthma (combination indication)
Common side effects
- Headache
- Somnolence
- Pharyngitis
- Elevated liver enzymes
Key clinical trials
- Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED) (PHASE3)
- Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117) (PHASE3)
- A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED) (PHASE3)
- Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235) (PHASE3)
- Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240) (PHASE3)
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/loratadine CI brief — competitive landscape report
- Comparator: montelukast/loratadine updates RSS · CI watch RSS
- Organon and Co portfolio CI