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Drug ReportsHepsera
Adefovir dipivoxil
Adefovir Dipivoxil, Hepsera (adefovir dipivoxil) is a small molecule pharmaceutical. Adefovir dipivoxil was first approved as Hepsera on 2002-09-20. 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.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name
Status
Last Update
adefovir dipivoxilANDA2024-09-17
hepseraNew Drug Application2009-10-27
Indications
FDA
EMA
No data
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
— J05AF08: Adefovir dipivoxil
HCPCS
No data
Clinical
Clinical Trials
147 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 bD006509——518245020114
HepatitisD006505HP_0012115K75.9418234516103
Chronic hepatitis bD019694EFO_0004239B18.131119481090
Hepatitis aD006506EFO_0007305B1531522371488
Chronic hepatitisD006521—K73.9251426753
Liver cirrhosisD008103EFO_0001422K74.011—348
FibrosisD005355——11—416
CarcinomaD002277—C80.0—1—225
Hepatocellular carcinomaD006528—C22.0—1—225
Liver neoplasmsD008113EFO_1001513C22.0—1—135
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B206113—424
InfectionsD007239EFO_0000544—123—17
Acquired immunodeficiency syndromeD000163EFO_0000765B201—1—13
Chronic diseaseD002908————1——1
Chronic hepatitis cD019698EFO_0004220B18.2——1——1
Cytomegalovirus infectionsD003586EFO_0001062B25——1——1
Communicable diseasesD003141————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatitis b virusD006515———2——13
Liver failureD017093HP_0001399K72.911——12
Liver transplantationD016031EFO_0010682—11——12
Hepatic insufficiencyD048550——11———1
Hepatitis cD006526—B19.2—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug interactionsD004347——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I10————22
Portal hypertensionD006975EFO_0000666K76.6————22
Sustained virologic responseD000072230——————11
Esophageal and gastric varicesD004932EFO_0009545I85————11
Acute liver failureD017114HP_0004448—————11
Cardiac surgical proceduresD006348——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAdefovir dipivoxil
INN—
Description
Adefovir is a member of the class of phosphonic acids that is methylphosphonic acid in which one of the methyl hydrogens has been replaced by a 2-(6-amino-9H-purin-9-yl)ethoxy group. An inhibitor of HIV-1 reverse transcriptase, the bis(t-butoxycarbonyloxymethyl) ester (dipivoxil ester) prodrug is used to treat chronic hepatitis B viral infection. It has a role as a HIV-1 reverse transcriptase inhibitor, a drug metabolite, an antiviral drug, a nephrotoxic agent and a DNA synthesis inhibitor. It is a member of 6-aminopurines, an ether and a member of phosphonic acids. It is functionally related to an adenine. It is a conjugate acid of an adefovir(1-).
Classification
Small molecule
Drug classantivirals
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Structure (InChI/SMILES or Protein Sequence)
CC(C)(C)C(=O)OCOP(=O)(COCCn1cnc2c(N)ncnc21)OCOC(=O)C(C)(C)C
Identifiers
PDB—
CAS-ID142340-99-6
RxCUI—
ChEMBL IDCHEMBL922
ChEBI ID—
PubChem CID60172
DrugBankDB00718
UNII ID—
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Hepsera – Gilead Sciences
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,188 documents
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Safety
Black-box Warning
Black-box warning for: Adefovir dipivoxil, Hepsera
Adverse Events
Top Adverse Reactions
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2,686 adverse events reported
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