Azelastine
Astepro, Azelastine, Dymista (azelastine) is a small molecule pharmaceutical. Azelastine was first approved as Astelin on 1996-11-01. It is used to treat allergic conjunctivitis, allergic rhinitis perennial, and vasomotor rhinitis in the USA. The pharmaceutical is active against histamine H1 receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Astepro, Azelastine (discontinued: Astelin, Astepro, Azelastine, Optivar)
CombinationsAzelastine fluticasone, Dymista
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Azelastine hydrochloride
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| astelin | New Drug Application | 2010-05-18 |
| astepro allergy | New Drug Application | 2023-09-21 |
| azelastine | ANDA | 2024-07-15 |
| azelastine hcl | ANDA | 2024-06-05 |
| azelastine hydrochloride | ANDA | 2024-09-18 |
| azelastine hydrochloride and fluticasone propionate | ANDA | 2024-10-04 |
| azelastine hydrochloride ophthalmic solution 0.05% | ANDA | 2022-05-12 |
| children astepro allergy | New Drug Application | 2023-11-30 |
| dymista | New Drug Application | 2022-08-08 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Azelastine Hydrochloride, Astepro, Mylan Speciality Lp | |||
| 8071073 | 2028-06-04 | DP | |
| 8518919 | 2025-11-22 | U-1430, U-3166 | |
| 9919050 | 2025-11-22 | DP | |
| Azelastine Hydrochloride / Fluticasone Propionate, Dymista, Mylan Speciality Lp | |||
| 8168620 | 2026-02-24 | DP | |
| 8163723 | 2023-08-29 | U-77, U-81, U-644, U-707, U-1667 | |
| 9259428 | 2023-06-13 | U-644 | |
| 9901585 | 2023-06-13 | DP | |
ATC Codes
R: Respiratory system drugs
— R01: Nasal preparations
— R01A: Decongestants and other nasal preparations for topical use
— R01AC: Antiallergic nasal preparations for topical use, excl. corticosteroids
— R01AC03: Azelastine
— R06: Antihistamines for systemic use
— R06A: Antihistamines for systemic use
— R06AX: Other antihistamines for systemic use in atc
— R06AX19: Azelastine
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01G: Decongestants and antiallergics
— S01GX: Other antiallergics in atc
— S01GX07: Azelastine
HCPCS
No data
Clinical
Clinical Trials
60 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rhinitis | D012220 | EFO_0008521 | J31 | 5 | 8 | 23 | 16 | 5 | 56 |
| Allergic rhinitis | D065631 | — | J30.9 | 5 | 8 | 23 | 14 | 5 | 54 |
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | 3 | 6 | 14 | 6 | 1 | 29 |
| Allergic rhinitis perennial | D012221 | EFO_1001417 | J30.89 | 1 | 1 | 4 | 1 | — | 7 |
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | — | — | — | 2 | 1 | 3 |
| Vasomotor rhinitis | D012223 | EFO_0007533 | J30.0 | — | — | — | 1 | — | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | 1 | — | 1 |
| Asthma | D001249 | EFO_0000270 | J45 | — | — | — | 1 | — | 1 |
| Dust mite allergy | D000092542 | — | — | — | — | — | 1 | — | 1 |
| Covid-19 | D000086382 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Allergic conjunctivitis | D003233 | EFO_0007141 | H10.44 | — | — | 1 | — | 2 | 3 |
| Conjunctivitis | D003231 | HP_0000509 | H10 | — | — | 1 | — | 1 | 2 |
| Common cold | D003139 | EFO_0007214 | J00 | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Keratoconus | D007640 | EFO_0004223 | H18.6 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Azelastine |
| INN | azelastine |
| Description | Azelastine is a phthalazine compound having an oxo substituent at the 1-position, a 1-methylazepan-4-yl group at the 2-position and a 4-chlorobenzyl substituent at the 4-position. It has a role as a H1-receptor antagonist, an anti-allergic agent, an anti-asthmatic drug, a bronchodilator agent, a platelet aggregation inhibitor and an EC 1.13.11.34 (arachidonate 5-lipoxygenase) inhibitor. It is a member of phthalazines, a tertiary amino compound and a member of monochlorobenzenes. |
| Classification | Small molecule |
| Drug class | antihistaminics (histamine-H1 receptor antagonists) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN1CCCC(n2nc(Cc3ccc(Cl)cc3)c3ccccc3c2=O)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 58581-89-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL639 |
| ChEBI ID | 2950 |
| PubChem CID | 2267 |
| DrugBank | DB00972 |
| UNII ID | ZQI909440X (ChemIDplus, GSRS) |
Target
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Financial
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Dymista – Viatris
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Estimated US medical usage
Azelastine
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,148 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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6,221 adverse events reported
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