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Drug ReportsEntecavir
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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EMA approval date
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Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Baraclude, Entecavir (discontinued: Entecavir)
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 Application2024-05-09
entecavirANDA2024-08-29
Indications
FDA
EMA
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
311 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatitis bD0065092973328572280
HepatitisD006505HP_0012115K75.92573287364252
Chronic hepatitis bD019694EFO_0004239B18.12765226751222
Hepatitis aD006506EFO_0007305B152364246553219
Chronic hepatitisD006521K73.91235133628117
Liver cirrhosisD008103EFO_0001422K74.01539724
FibrosisD0053551429520
Hepatocellular carcinomaD006528C22.01125817
Liver neoplasmsD008113EFO_1001513C22.0235817
CarcinomaD002277C80.01125514
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Indications Phases 3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatitis dD003699EFO_00073041214
Chronic hepatitis dD0197011113
Chronic renal insufficiencyD051436N18112
Kidney diseasesD007674EFO_0003086N08112
Colorectal neoplasmsD01517911
Stomach neoplasmsD013274EFO_0003897C1611
Lung transplantationD01604011
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients213
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Self efficacyD02037722
Disease progressionD01845022
Non-small-cell lung carcinomaD00228911
Sustained virologic responseD00007223011
Esophageal and gastric varicesD004932EFO_0009545I8511
PrognosisD01137911
Renal insufficiencyD051437HP_0000083N1911
NecrosisD00933611
Body weightD001835EFO_000433811
Hematopoietic stem cell transplantationD01838011
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEntecavir
INNentecavir
Description
Entecavir (anhydrous) is guanine substituted at the 9 position by a 4-hydroxy-3-(hydroxymethyl)-2-methylidenecyclopentyl group. A synthetic analogue of 2'-deoxyguanosine, it is a nucleoside reverse transcriptase inhibitor with selective antiviral activity against hepatitis B virus. Entecavir is phosphorylated intracellularly to the active triphosphate form, which competes with deoxyguanosine triphosphate, the natural substrate of hepatitis B virus reverse transcriptase, inhibiting every stage of the enzyme's activity, although it has no activity against HIV. It is used for the treatment of chronic hepatitis B. It has a role as an EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor and an antiviral drug. It is a member of 2-aminopurines, an oxopurine, a primary alcohol and a secondary alcohol.
Classification
Small molecule
Drug classantivirals: carbocyclic nucleosides
Image (chem structure or protein)Loading
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
RxCUI
ChEMBL IDCHEMBL713
ChEBI ID473990
PubChem CID135398508
DrugBankDB00442
UNII IDNNU2O4609D (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
Baraclude Bristol Myers Squibb
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Estimated US medical usage
Entecavir
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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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 8,095 documents
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Safety
Black-box Warning
Black-box warning for: Baraclude, Entecavir
Adverse Events
Top Adverse Reactions
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6,720 adverse events reported
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