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Epinastine
Elestat (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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
eye diseasesD005128
immune system diseasesD007154
Trade Name
FDA
EMA
No data
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 hydrochlorideANDA2021-12-14
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
allergic conjunctivitisEFO_0007141D003233H10.44
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
13 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Migraine disordersD008881EFO_0003821G43—154111
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Migraine without auraD020326EFO_0005296G43.0——1——1
Migraine with auraD020325EFO_0005295G43.1——1——1
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—1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Headache disordersD020773EFO_0009550G44————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)
Image (chem structure or protein)
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
3269
Protein name
histamine H1 receptor
Protein synonyms
histamine receptor, subclass H1
Uniprot ID
Q6P9E5
Mouse ortholog
Hrh1 (15465)
histamine H1 receptor (Q91XN3)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 360 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,050 adverse events reported
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