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Drug ReportsEpinastine
Epinastine
Epinastine (epinastine) is a small molecule pharmaceutical. Epinastine was first approved as Elestat on 2003-10-16. It is used to treat allergic conjunctivitis in the USA. The pharmaceutical is active against histamine H1 receptor.
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3M
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YTD
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2Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
eye diseasesD005128
immune system diseasesD007154
Trade Name
FDA
EMA
Epinastine (discontinued: Elestat, Epinastine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Epinastine hydrochloride
Tradename
Company
Number
Date
Products
ELESTATAllerganN-021565 DISCN2003-10-16
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
epinastine hydrochlorideANDA2023-11-09
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
R: Respiratory system drugs
— R06: Antihistamines for systemic use
— R06A: Antihistamines for systemic use
— R06AX: Other antihistamines for systemic use in atc
— R06AX24: Epinastine
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01G: Decongestants and antiallergics
— S01GX: Other antiallergics in atc
— S01GX10: Epinastine
HCPCS
No data
Clinical
Clinical Trials
20 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ConjunctivitisD003231HP_0000509H10——24—6
Allergic conjunctivitisD003233EFO_0007141H10.44——24—6
Drug hypersensitivityD004342EFO_0009482T88.7———1—1
HypersensitivityD006967HP_0012393T78.40———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Allergic rhinitisD065631—J30.9—23—27
RhinitisD012220EFO_0008521J31—23—27
Allergic rhinitis perennialD012221EFO_1001417J30.89——2—24
Atopic dermatitisD003876EFO_0000274L20——2——2
DermatitisD003872HP_0011123L30.9——2——2
Allergic rhinitis seasonalD006255EFO_0003956J30—11——2
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———4————4
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
UrticariaD014581EFO_0005531L50————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEpinastine
INNepinastine
Description
Epinastine is a benzazepine that is 6,11-dihydro-5H-dibenzo[b,e]azepine in which the azepine ring is fused to the e side of 4,5-dihydro-1H-imidazol-2-amine. It has a role as an anti-allergic agent, a histamine antagonist, an ophthalmology drug and a H1-receptor antagonist. It is a member of guanidines and a benzazepine.
Classification
Small molecule
Drug classantihistaminics (histamine-H1 receptor antagonists)
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Structure (InChI/SMILES or Protein Sequence)
NC1=NCC2c3ccccc3Cc3ccccc3N12
Identifiers
PDB—
CAS-ID80012-43-7
RxCUI—
ChEMBL IDCHEMBL1106
ChEBI ID51032
PubChem CID3241
DrugBankDB00751
UNII IDQ13WX941EF (ChemIDplus, GSRS)
Target
Agency Approved
HRH1
HRH1
Organism
Homo sapiens
Gene name
HRH1
Gene synonyms
NCBI Gene ID
Protein name
histamine H1 receptor
Protein synonyms
histamine receptor, subclass H1
Uniprot ID
Mouse ortholog
Hrh1 (15465)
histamine H1 receptor (Q91XN3)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Epinastine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 410 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,091 adverse events reported
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