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Astelin (AZELASTINE)
Astelin (azelastine) is a small molecule histamine-1 receptor antagonist developed by Meda Pharmas and currently owned by Bayer Healthcare. It was FDA approved in 1996 for the treatment of allergic conjunctivitis, allergic rhinitis, seasonal allergic rhinitis, and vasomotor rhinitis. Astelin works by blocking the histamine H1 receptor, which is involved in the allergic response. It has a high bioavailability of 99% and a half-life of 22 hours. Astelin is available as a generic medication, with 18 generic manufacturers.
At a glance
| Generic name | AZELASTINE |
|---|---|
| Sponsor | Bayer |
| Drug class | Histamine-1 Receptor Antagonist |
| Target | Histamine H1 receptor |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1996 |
Approved indications
- Allergic conjunctivitis
- Allergic rhinitis
- Seasonal allergic rhinitis
- Vasomotor rhinitis
Common side effects
- Treatment failure
- Sinusitis
- Asthma
- Product delivery mechanism issue
- Product dose omission issue
- Impaired quality of life
- COVID-19
- Infusion site swelling
- Toxicity to various agents
- Infusion site erythema
- Infusion site pruritus
- Bronchitis
Drug interactions
- alcohol or other central nervous system depressants
Key clinical trials
- Acupuncture for Nasal Congestion in Allergic Rhinitis (NA)
- INTRANASAL FLUTICASONE VERSUS FLUTICASONE-AZELASTINE COMBINATION (PHASE4)
- A Pilot Clinical Evaluation of Astepro® Nasal Spray for Management of Early SARS-CoV-2 Infection (PHASE4)
- Clinical and Biological Evaluation of NAAGA Versus Azelastine Eye Drops in Allergic Subjects With Tear Film Dysfunction (PHASE4)
- Contribution of Nasal IgE Production to the Boost of Systemic Allergen-specific IgE Upon Nasal Allergen Contact (NA)
- Posterior Nasal Nerve Combined with Anterior Ethmoid Neurotomy for Idiopathic Rhinitis (NA)
- Factors Involved in Dymista's Superior Clinical Efficacy in the Treatment of Seasonal Allergic Rhinitis (PHASE4)
- Efficacy and Safety of On-demand and Continuous Administration of Nasal Spray in the Treatment of Allergic Rhinitis (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Astelin CI brief — competitive landscape report
- Astelin updates RSS · CI watch RSS
- Bayer portfolio CI