Bepotastine
Bepreve (bepotastine) is a small molecule pharmaceutical. Bepotastine was first approved as Bepreve on 2009-09-08. It is used to treat allergic conjunctivitis in the USA.
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Commercial
Trade Name
FDA
EMA
Bepreve (generic drugs available since 2019-03-05)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Bepotastine besilate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
BEPREVE | Bausch Health Companies | N-022288 RX | 2009-09-08 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
bepreve | New Drug Application | 2019-09-02 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
allergic conjunctivitis | EFO_0007141 | D003233 | H10.44 |
Agency Specific
FDA
EMA
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ATC Codes
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HCPCS
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Clinical
Clinical Trials
21 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 conjunctivitis | D003233 | EFO_0007141 | H10.44 | — | 2 | 3 | 4 | — | 8 |
Allergic rhinitis | D065631 | J30.9 | 1 | — | — | 1 | — | 2 | |
Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | — | — | 1 | — | 1 |
Cough | D003371 | HP_0012735 | R05 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Allergic rhinitis perennial | D012221 | EFO_1001417 | J30.89 | — | — | 3 | — | — | 3 |
Dermatitis | D003872 | HP_0011123 | L30.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | 1 | 4 | — | — | — | 4 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Healthy volunteers/patients | — | 1 | — | — | — | — | 1 | ||
Pruritus | D011537 | HP_0000989 | L29 | 1 | — | — | — | — | 1 |
Urticaria | D014581 | EFO_0005531 | L50 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | BEPOTASTINE |
INN | bepotastine |
Description | Bepotastine is an ether that is (S)-(4-chlorophenyl)(pyridin-2-yl)methanol in which the hydroxyl hydrogen is substituted by a 1-(3-carboxypropyl)piperidin-4-yl group. A topical, selective and non-sedating histamine (H1) receptor antagonist used (as its benzenesulfonate salt) for treatment of itching associated with allergic conjunctivitis. It has a role as a H1-receptor antagonist and an anti-allergic agent. It is a member of pyridines, a monocarboxylic acid, a member of piperidines, an ether and a member of monochlorobenzenes. It is a conjugate base of a bepotastine(1+). |
Classification | Small molecule |
Drug class | antihistaminics (histamine-H1 receptor antagonists) |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | O=C(O)CCCN1CCC(O[C@@H](c2ccc(Cl)cc2)c2ccccn2)CC1 |
Identifiers
PDB | — |
CAS-ID | 125602-71-3 |
RxCUI | 863035 |
ChEMBL ID | CHEMBL1201758 |
ChEBI ID | 71204 |
PubChem CID | 164522 |
DrugBank | DB04890 |
UNII ID | HYD2U48IAS (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
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Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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288 adverse events reported
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