Hepsera(adefovir)
Hepsera (adefovir) is a small molecule pharmaceutical. Adefovir 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
Trade Name
FDA
EMA
Hepsera (generic drugs available since 2013-08-29)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Adefovir dipivoxil
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| HEPSERA | Gilead Sciences | N-021449 RX | 2002-09-20 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| adefovir dipivoxil | ANDA | 2023-03-24 |
| hepsera | New Drug Application | 2023-02-07 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| chronic hepatitis b | EFO_0004239 | D019694 | B18.1 |
| hepatitis b | — | D006509 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
111 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic hepatitis b | D019694 | EFO_0004197 | B18.1 | 2 | 4 | 11 | 33 | 3 | 53 |
| Hepatitis b | D006509 | 2 | 8 | 6 | 3 | 8 | 25 | ||
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | 1 | 2 | 3 |
| Chronic hepatitis | D006521 | K73.9 | — | — | 2 | 1 | — | 3 | |
| Fibrosis | D005355 | — | — | — | 2 | — | 2 | ||
| Healthy volunteers/patients | — | 1 | — | — | 1 | — | 2 | ||
| Hepatocellular carcinoma | D006528 | C22.0 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 6 | 11 | 3 | — | 4 | 24 |
| Chronic disease | D002908 | — | — | 1 | — | — | 1 | ||
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | — | — | 1 | — | — | 1 |
| Cytomegalovirus infections | D003586 | EFO_0001062 | B25 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | 1 | — | — | 2 | 3 |
| Liver transplantation | D016031 | EFO_0010682 | 1 | 1 | — | — | 1 | 2 | |
| Hepatitis c | D006526 | B19.2 | — | 1 | — | — | — | 1 | |
| Hepatitis | D006505 | HP_0012115 | K75.9 | — | 1 | — | — | — | 1 |
| Hepatitis b virus | D006515 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acute liver failure | D017114 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ADEFOVIR |
| INN | adefovir |
| 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 class | antivirals |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | Nc1ncnc2c1ncn2CCOCP(=O)(O)O |
Identifiers
| PDB | — |
| CAS-ID | 106941-25-7 |
| RxCUI | 16521 |
| ChEMBL ID | CHEMBL484 |
| ChEBI ID | — |
| PubChem CID | 60172 |
| DrugBank | DB00718 |
| UNII ID | 6GQP90I798 (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
No data
Variants
Clinical Variant
No data
Financial
Hepsera - Gilead Sciences
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,173 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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3,919 adverse events reported
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