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Baraclude(entecavir)
Baraclude (entecavir) is a small molecule pharmaceutical. Entecavir was first approved as Baraclude on 2005-03-29. It is used to treat chronic hepatitis b and hepatitis b in the USA. It has been approved in Europe to treat chronic hepatitis b and hepatitis b.
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BMS
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Baraclude (generic drugs available since 2015-08-21)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Entecavir
Tradename
Company
Number
Date
Products
BARACLUDEBristol Myers SquibbN-021797 RX2005-03-29
2 products, RLD, RS
BARACLUDEBristol Myers SquibbN-021798 RX2005-03-29
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
baracludeNew Drug Application2019-11-06
entecavirANDA2022-12-23
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
chronic hepatitis bEFO_0004239D019694B18.1
hepatitis bD006509
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
J: Antiinfectives for systemic use
J05: Antivirals for systemic use
J05A: Direct acting antivirals
J05AF: Nucleoside and nucleotide reverse transcriptase inhibitors
J05AF10: Entecavir
HCPCS
No data
Clinical
Clinical Trials
220 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic hepatitis bD019694EFO_0004197B18.11833164820127
Hepatitis bD006509499111547
Liver cirrhosisD008103EFO_0001422K74.07512
Liver neoplasmsD008113EFO_1001513C22.0133410
HepatitisD006505HP_0012115K75.921226
Hepatitis b virusD00651512216
Chronic hepatitisD006521K73.911114
Hiv infectionsD015658EFO_0000764B201123
Liver transplantationD016031EFO_00106821113
Non-hodgkin lymphomaD008228C85.91113
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic diseaseD002908112
B-cell lymphomaD01639311
Juvenile arthritisD001171EFO_0002609M0811
Psoriatic arthritisD015535EFO_0003778L40.511
Ankylosing spondylitisD013167EFO_0003898M4511
NeoplasmsD009369C8011
Liver diseasesD008107EFO_0001421K70-K7711
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Liver failureD017093HP_0001399K72.9112
Chronic hepatitis dD01970111
Colorectal neoplasmsD01517911
Stomach neoplasmsD013274EFO_0003897C1611
Hepatitis dD003699EFO_000730411
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients22
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD00228911
CoinfectionD06008511
Acute-on-chronic liver failureD06529011
Virus diseasesD014777B3411
Hematopoietic stem cell transplantationD01838011
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameENTECAVIR
INNentecavir
Description
Entecavir (ETV), sold under the brand name Baraclude, is an antiviral medication used in the treatment of hepatitis B virus (HBV) infection. In those with both HIV/AIDS and HBV antiretroviral medication should also be used. Entecavir is taken by mouth as a tablet or solution.
Classification
Small molecule
Drug classantivirals: carbocyclic nucleosides
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
C=C1[C@@H](n2cnc3c(=O)[nH]c(N)nc32)C[C@H](O)[C@H]1CO
Identifiers
PDB
CAS-ID142217-69-4
RxCUI1546027
ChEMBL IDCHEMBL713
ChEBI ID473990
PubChem CID153941
DrugBankDB00442
UNII IDNNU2O4609D (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Baraclude - Bristol Myers Squibb
$
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,818 documents
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Safety
Black-box Warning
Black-box warning for: Baraclude, Entecavir
Adverse Events
Top Adverse Reactions
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7,566 adverse events reported
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