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Loratadine/montelukast combination
This combination blocks histamine H1 receptors (loratadine) and cysteinyl leukotriene receptors (montelukast) to reduce allergic and inflammatory responses in the airways.
This combination blocks histamine H1 receptors (loratadine) and cysteinyl leukotriene receptors (montelukast) to reduce allergic and inflammatory responses in the airways. Used for Allergic rhinitis, Asthma with allergic component.
At a glance
| Generic name | Loratadine/montelukast combination |
|---|---|
| Sponsor | Organon and Co |
| Drug class | Antihistamine and leukotriene receptor antagonist combination |
| Target | H1 receptor and CysLT1 receptor |
| Modality | Small molecule |
| Therapeutic area | Immunology / Allergy / Respiratory |
| Phase | Phase 3 |
Mechanism of action
Loratadine is a selective H1-receptor antagonist that prevents histamine-mediated allergic symptoms such as itching, sneezing, and rhinorrhea. Montelukast is a cysteinyl leukotriene receptor antagonist that blocks inflammatory mediators involved in asthma and allergic rhinitis. Together, they provide dual anti-inflammatory and antihistamine activity targeting complementary pathways in allergic airway disease.
Approved indications
- Allergic rhinitis
- Asthma with allergic component
Common side effects
- Headache
- Somnolence
- Pharyngitis
- Neuropsychiatric effects (montelukast component)
Key clinical trials
- A Study to Evaluate the Safety of Combination Montelukast/Loratadine in Mexican Participants With Allergic Rhinitis (MK-0476A-484) (PHASE3)
- Effect of Loratadine/Montelukast Combination on Congestion in SAR Patients Exposed to Pollen in an EEU (Study P04822) (PHASE3)
- Effects of Loratadine/Montelukast vs Pseudoephedrine and Placebo in Patients With Seasonal Allergic Rhinitis (Study P04095) (COMPLETED) (PHASE3)
- 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)
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:
- Loratadine/montelukast combination CI brief — competitive landscape report
- Loratadine/montelukast combination updates RSS · CI watch RSS
- Organon and Co portfolio CI