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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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Results 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
entecavirANDA2025-06-08
entecavir entecavirANDA2025-01-09
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hepatitis b—D006509—
chronic hepatitis bEFO_0004239D019694B18.1
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
319 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic hepatitis bD019694EFO_0004239B18.132———4
Hepatitis bD006509——21———2
HepatitisD006505—K75.921———2
Hepatitis aD006506EFO_0007305B1521———2
Indications Phases 1
No data
Indications Without Phase
No data
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
$
€
£
â‚£
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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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,000 documents
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Safety
Black-box Warning
Black-box warning for: Baraclude, Entecavir, Entecavir entecavir
Adverse Events
Top Adverse Reactions
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7,125 adverse events reported
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