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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| eye diseases | D005128 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Epinastine (discontinued: Elestat, Epinastine)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| epinastine hydrochloride | ANDA | 2025-03-22 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| allergic conjunctivitis | EFO_0007141 | D003233 | H10.44 |
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
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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 |
|---|---|---|---|---|---|---|---|---|---|
| Conjunctivitis | D003231 | — | H10 | — | — | 2 | 4 | — | 6 |
| Allergic conjunctivitis | D003233 | EFO_0007141 | H10.44 | — | — | 2 | 4 | — | 6 |
| Drug hypersensitivity | D004342 | EFO_0009482 | T88.7 | — | — | — | 1 | — | 1 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Allergic rhinitis | D065631 | — | J30.9 | — | 2 | 3 | — | 2 | 7 |
| Rhinitis | D012220 | EFO_0008521 | J31 | — | 2 | 3 | — | 2 | 7 |
| Allergic rhinitis perennial | D012221 | EFO_1001417 | J30.89 | — | — | 2 | — | 2 | 4 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | — | 2 | — | — | 2 |
| Dermatitis | D003872 | — | L30.9 | — | — | 2 | — | — | 2 |
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | — | 1 | 1 | — | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Urticaria | D014581 | EFO_0005531 | L50 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Epinastine |
| INN | epinastine |
| 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 class | antihistaminics (histamine-H1 receptor antagonists) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | NC1=NCC2c3ccccc3Cc3ccccc3N12 |
Identifiers
| PDB | — |
| CAS-ID | 80012-43-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1106 |
| ChEBI ID | 51032 |
| PubChem CID | 3241 |
| DrugBank | DB00751 |
| UNII ID | Q13WX941EF (ChemIDplus, GSRS) |
Target
Variants
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Financial
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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 461 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,098 adverse events reported
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