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Drug ReportsAzelastine
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
Therapeutic Area
MeSH
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
eye diseasesD005128
immune system diseasesD007154
Trade Name
FDA
EMA
Astepro (generic drugs available since 2009-04-30, discontinued: Astelin, Optivar)
Combinations
Dymista (generic drugs available since 2009-04-30)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Azelastine hydrochloride
Tradename
Company
Number
Date
Products
ASTEPRO ALLERGYBayerN-213872 OTC2021-06-17
1 products, RLD, RS
CHILDREN'S ASTEPRO ALLERGYBayerN-213872 OTC2021-06-17
1 products, RLD, RS
Show 3 discontinued
Azelastine hydrochloride
+
Fluticasone propionate
Tradename
Company
Number
Date
Products
DYMISTAMylanN-202236 RX2012-05-01
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
astelinNew Drug Application2010-05-18
astepro allergyNew Drug Application2023-09-21
azelastineANDA2022-11-04
azelastine hcl nasalANDA2023-01-26
azelastine hydrochlorideANDA2024-01-30
azelastine hydrochloride and fluticasone propionateANDA2024-02-08
azelastine hydrochloride ophthalmic solution 0.05%ANDA2022-05-12
children astepro allergyNew Drug Application2023-11-30
dymistaNew Drug Application2022-08-08
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
allergic conjunctivitisEFO_0007141D003233H10.44
allergic rhinitis perennialEFO_1001417D012221J30.89
vasomotor rhinitisEFO_0007533D012223J30.0
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Azelastine Hydrochloride, Astepro, Mylan Speciality Lp
80710732028-06-04DP
85189192025-11-22U-1430, U-3166
99190502025-11-22DP
Azelastine Hydrochloride / Fluticasone Propionate, Dymista, Mylan Speciality Lp
81686202026-02-24DP
81637232023-08-29U-77, U-81, U-644, U-707, U-1667
92594282023-06-13U-644
99015852023-06-13DP
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
63 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Allergic rhinitis seasonalD006255EFO_0003956J3015145125
Allergic rhinitisD065631—J30.92368423
Allergic rhinitis perennialD012221EFO_1001417J30.89——41—5
HypersensitivityD006967HP_0012393T78.40———213
Vasomotor rhinitisD012223EFO_0007533J30.0———1—1
AsthmaD001249EFO_0000270J45———1—1
Covid-19D000086382—U07.1———1—1
Indications Phases 3
No data
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
Allergic conjunctivitisD003233EFO_0007141H10.44————22
KeratoconusD007640EFO_0004223H18.6————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAzelastine
INNazelastine
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 classantihistaminics (histamine-H1 receptor antagonists)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN1CCCC(n2nc(Cc3ccc(Cl)cc3)c3ccccc3c2=O)CC1
Identifiers
PDB—
CAS-ID58581-89-8
RxCUI—
ChEMBL IDCHEMBL639
ChEBI ID2950
PubChem CID2267
DrugBankDB00972
UNII IDZQI909440X (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Dymista – Viatris
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Estimated US medical usage
Azelastine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,082 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,924 adverse events reported
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