Hepsera(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
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Trade Name
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Hepsera (generic drugs available since 2013-08-29)
Drug Products
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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 | 2023-12-01 |
| hepsera | New Drug Application | 2009-10-27 |
Indications
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Clinical
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99 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 b | D006509 | — | — | 5 | 12 | 15 | 29 | 14 | 72 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | 4 | 12 | 15 | 27 | 10 | 65 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | 3 | 6 | 13 | 29 | 7 | 57 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 3 | 11 | 15 | 23 | 8 | 57 |
| Chronic hepatitis | D006521 | — | K73.9 | 2 | 5 | 8 | 18 | 5 | 37 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 1 | 1 | — | 1 | 4 | 6 |
| Fibrosis | D005355 | — | — | 1 | 1 | — | 2 | 1 | 4 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 4 | 11 | 3 | — | 4 | 22 |
| Infections | D007239 | EFO_0000544 | — | 1 | 2 | 2 | — | 1 | 6 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | 1 | — | 1 | 2 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | — | — | 1 | — | — | 1 |
| Cytomegalovirus infections | D003586 | EFO_0001062 | B25 | — | — | 1 | — | — | 1 |
| Communicable diseases | D003141 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver failure | D017093 | HP_0001399 | K72.9 | 1 | 1 | — | — | 1 | 2 |
| Hepatic insufficiency | D048550 | — | — | 1 | 1 | — | — | — | 1 |
| Hepatitis c | D006526 | — | B19.2 | — | 1 | — | — | — | 1 |
| Liver transplantation | D016031 | EFO_0010682 | — | 1 | 1 | — | — | — | 1 |
| Hepatitis b virus | D006515 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 2 | 2 |
| Portal hypertension | D006975 | EFO_0000666 | K76.6 | — | — | — | — | 2 | 2 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | — | — | 2 | 2 |
| Sustained virologic response | D000072230 | — | — | — | — | — | — | 1 | 1 |
| Esophageal and gastric varices | D004932 | EFO_0009545 | I85 | — | — | — | — | 1 | 1 |
| Carcinoma | D002277 | — | C80.0 | — | — | — | — | 1 | 1 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | — | — | — | — | 1 | 1 |
| Acute liver failure | D017114 | HP_0004448 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Adefovir 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 class | antivirals |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)(C)C(=O)OCOP(=O)(COCCn1cnc2c(N)ncnc21)OCOC(=O)C(C)(C)C |
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Hepsera – Gilead Sciences
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Safety
Black-box Warning
Black-box warning for: Adefovir dipivoxil, Hepsera
Adverse Events
Top Adverse Reactions
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3,942 adverse events reported
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