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AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDE is a drug. It is currently FDA-approved (first approved 1996).
Azelastine hydrochloride is used to treat conditions such as allergic rhinitis, seasonal allergic rhinitis, and seasonal allergic conjunctivitis. It is available in various formulations, including nasal sprays, often in combination with other medications like fluticasone propionate.
At a glance
| Generic name | AZELASTINE HYDROCHLORIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1996 |
Approved indications
Common side effects
Key clinical trials
- INTRANASAL FLUTICASONE VERSUS FLUTICASONE-AZELASTINE COMBINATION (PHASE4)
- Clinical and Biological Evaluation of NAAGA Versus Azelastine Eye Drops in Allergic Subjects With Tear Film Dysfunction (PHASE4)
- Azelastine Allergen Chamber - Onset of Action Study (PHASE2)
- A Study to Evaluate the Efficacy and Safety of Epinastine Hydrochloride Eye Drops in the Treatment of Chinese Seasonal Allergic Conjunctivitis Patients (PHASE3)
- Bioequivalence Study of Azelastine Hydrochloride/ Fluticasone Propionate 137 Microgram/50 Microgram Nasal Spray and Dymista Nasal Spray (PHASE1)
- To Investigate Drug-drug Interaction and Relative Bioavailability Between the FDC AzelastineHCL/Beclomethasone Dipropionate Nasal Spray, & Beclomethasone Dipropionate Nasal Spray in the Test Vehicle, and RinoClenil® Nasal Spray (PHASE1, PHASE2)
- Observational Study to Evaluate the Actual Use and Effectiveness of Dymista® Nasal Spray in Asian Patients
- Allergic Rhinitis Combination Pharmacotherapy Efficacy Study (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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- AZELASTINE HYDROCHLORIDE CI brief — competitive landscape report
- AZELASTINE HYDROCHLORIDE updates RSS · CI watch RSS
Frequently asked questions about AZELASTINE HYDROCHLORIDE
What is AZELASTINE HYDROCHLORIDE?
When was AZELASTINE HYDROCHLORIDE approved?
What development phase is AZELASTINE HYDROCHLORIDE in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing