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azelastine hydrochloride 0.05%
Azelastine hydrochloride is a selective H1-receptor antagonist that blocks histamine-mediated allergic responses in the nasal mucosa.
Azelastine hydrochloride is a selective H1-receptor antagonist that blocks histamine-mediated allergic responses in the nasal mucosa. Used for Allergic rhinitis (seasonal and perennial), Vasomotor rhinitis.
At a glance
| Generic name | azelastine hydrochloride 0.05% |
|---|---|
| Sponsor | Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona |
| Drug class | H1-receptor antagonist (second-generation antihistamine) |
| Target | H1 receptor |
| Modality | Small molecule |
| Therapeutic area | Allergy/Immunology |
| Phase | FDA-approved |
Mechanism of action
Azelastine is a second-generation antihistamine that selectively antagonizes H1 receptors on mast cells and other immune cells in nasal tissue, preventing histamine release and reducing allergic inflammation. It also has anti-inflammatory properties independent of H1 blockade. The 0.05% nasal spray formulation delivers the drug topically to provide rapid relief of allergic rhinitis symptoms.
Approved indications
- Allergic rhinitis (seasonal and perennial)
- Vasomotor rhinitis
Common side effects
- Bitter taste
- Nasal irritation
- Headache
- Somnolence
- Epistaxis
Key clinical trials
- Clinical and Biological Evaluation of NAAGA Versus Azelastine Eye Drops in Allergic Subjects With Tear Film Dysfunction (PHASE4)
- A Study to Evaluate the Efficacy and Safety of Epinastine Hydrochloride Eye Drops in the Treatment of Chinese Seasonal Allergic Conjunctivitis Patients (PHASE3)
- DYmista NAsal Spray in CHInese Patients (PHASE3)
- Azelastine Fluticasone Combination vs. Fluticasone (PHASE4)
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 |
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