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Montelukast + Levocetirizine
Montelukast + Levocetirizine is a Leukotriene receptor antagonist + Selective H1-receptor antagonist Small molecule drug developed by Hanmi Pharmaceutical Company Limited. It is currently in Phase 3 development for Allergic rhinitis, Asthma (allergic component), Allergic conditions with combined leukotriene and histamine involvement. Also known as: Singulair Tablet, Xyzal Tablet.
This combination blocks cysteinyl leukotriene receptors (montelukast) and histamine H1 receptors (levocetirizine) to reduce allergic inflammation and symptoms.
This combination blocks cysteinyl leukotriene receptors (montelukast) and histamine H1 receptors (levocetirizine) to reduce allergic inflammation and symptoms. Used for Allergic rhinitis, Asthma (allergic component), Allergic conditions with combined leukotriene and histamine involvement.
At a glance
| Generic name | Montelukast + Levocetirizine |
|---|---|
| Also known as | Singulair Tablet, Xyzal Tablet |
| Sponsor | Hanmi Pharmaceutical Company Limited |
| Drug class | Leukotriene receptor antagonist + Selective H1-receptor antagonist |
| Target | CysLT1 receptor (montelukast); H1 histamine receptor (levocetirizine) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Allergy |
| Phase | Phase 3 |
Mechanism of action
Montelukast is a selective cysteinyl leukotriene receptor antagonist that inhibits the inflammatory cascade triggered by leukotrienes, which are potent mediators of allergic and asthmatic responses. Levocetirizine is a selective H1-receptor antagonist that blocks histamine-mediated allergic symptoms. Together, they provide dual anti-inflammatory and antihistamine activity for allergic conditions.
Approved indications
- Allergic rhinitis
- Asthma (allergic component)
- Allergic conditions with combined leukotriene and histamine involvement
Common side effects
- Headache
- Somnolence
- Pharyngitis
- Abdominal pain
- Dizziness
Key clinical trials
- Efficacy and Safety of HCP1102 Capsule in Patients With Perennial Allergic Rhinitis (PHASE3)
- Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing Seasonal Allergic Rhinitis (SAR) Symptoms in Ragweed Sensitive Subjects (PHASE4)
- PK and Safety Study of HCP1102, HGP0813 and HGP1408 (PHASE1)
- Montelukast and Fexofenadine Versus Montelukast and Levocetrizine Combination in Allergic Rhinitis (PHASE4)
- Compare the Efficacy of Levocetirizine to Montelukast in Reducing Symptoms of SAR in Sensitive Subjects Exposed to Ragweed Pollen (PHASE3)
- Study to Evaluate the Pharmacokinetics and Safety of Singulair and Xyzal in Free Combination and Fixed-dose Combination (PHASE1)
- Efficacy and Safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) Patients (PHASE3)
- A Drug Interaction Study of Montelukast and Levocetirizine (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:
- Montelukast + Levocetirizine CI brief — competitive landscape report
- Montelukast + Levocetirizine updates RSS · CI watch RSS
- Hanmi Pharmaceutical Company Limited portfolio CI
Frequently asked questions about Montelukast + Levocetirizine
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Related
- Drug class: All Leukotriene receptor antagonist + Selective H1-receptor antagonist drugs
- Target: All drugs targeting CysLT1 receptor (montelukast); H1 histamine receptor (levocetirizine)
- Manufacturer: Hanmi Pharmaceutical Company Limited — full pipeline
- Therapeutic area: All drugs in Immunology / Allergy
- Indication: Drugs for Allergic rhinitis
- Indication: Drugs for Asthma (allergic component)
- Indication: Drugs for Allergic conditions with combined leukotriene and histamine involvement
- Also known as: Singulair Tablet, Xyzal Tablet
- Compare: Montelukast + Levocetirizine vs similar drugs
- Pricing: Montelukast + Levocetirizine cost, discount & access