Overview
Adefovir dipivoxil, previously called bis-POM PMEA, with trade names Preveon and Hepsera, is an orally-administered acyclic nucleotide analog reverse transcriptase inhibitor (ntRTI) used for treatment of hepatitis B. It is ineffective against HIV-1. Adefovir dipivoxil is the diester prodrug of adefovir.
Background
Adefovir dipivoxil, previously called bis-POM PMEA, with trade names Preveon and Hepsera, is an orally-administered acyclic nucleotide analog reverse transcriptase inhibitor (ntRTI) used for treatment of hepatitis B. It is ineffective against HIV-1. Adefovir dipivoxil is the diester prodrug of adefovir.
Indication
Indicated for the treatment of chronic hepatitis B in adult patients with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease; this is based on histological, virological, biochemical, and serological responses in adult patients with HBeAg+ and HBeAg- chronic hepatitis B with compensated liver function, and in adult patients with clinical evidence of lamivudine-resistant hepatitis B virus with either compensated or decompensated liver function.
Associated Conditions
- Chronic Hepatitis B Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2016/07/07 | Phase 4 | UNKNOWN | |||
2015/11/05 | Phase 4 | Completed | |||
2011/09/19 | Phase 4 | UNKNOWN | Jun Cheng | ||
2011/05/16 | Phase 1 | Completed | |||
2011/04/05 | N/A | Completed | |||
2008/09/16 | Phase 2 | UNKNOWN | |||
2008/05/06 | Phase 3 | Completed | Bukwang Pharmaceutical | ||
2008/04/18 | Phase 3 | Completed | |||
2008/03/27 | Phase 2 | Completed | |||
2008/03/27 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Excella GmbH | 46014-0501 | ORAL | 10 mg in 1 1 | 10/27/2009 | |
| Sigmapharm Laboratories, LLC | 42794-003 | ORAL | 10 mg in 1 1 | 3/24/2023 | |
| Apotex Corp. | 60505-3947 | ORAL | 10 mg in 1 1 | 12/1/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Adefovir Dipivoxil Tablets | 国药准字H20100172 | 化学药品 | 片剂 | 8/19/2020 | |
| Adefovir Dipivoxil Tablets | 国药准字H20140111 | 化学药品 | 片剂 | 4/22/2024 | |
| Adefovir Dipivoxil Tablets | 国药准字H20140073 | 化学药品 | 片剂 | 9/25/2023 | |
| Adefovir Dipivoxil Tablets | 国药准字H20080365 | 化学药品 | 片剂 | 3/23/2023 | |
| Adefovir Dipivoxil Tablets | 国药准字H20163410 | 化学药品 | 片剂 | 6/11/2021 | |
| Adefovir Dipivoxil Tablets | 国药准字H20080032 | 化学药品 | 片剂 | 10/12/2021 | |
| Adefovir Dipivoxil Tablets | 国药准字H20100028 | 化学药品 | 片剂 | 1/6/2021 | |
| Adefovir Dipivoxil Tablets | 国药准字H20120119 | 化学药品 | 片剂 | 7/20/2023 | |
| Adefovir Dipivoxil Tablets | 国药准字H20100023 | 化学药品 | 片剂 | 6/22/2020 | |
| Adefovir Dipivoxil Tablets | 国药准字H20100092 | 化学药品 | 片剂 | 12/2/2019 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| APO-Adefovir adefovir dipivoxil 10mg tablet bottle | 212048 | Medicine | A | 5/12/2014 | |
| APOTEX-Adefovir adefovir dipivoxil 10mg tablet bottle | 212044 | Medicine | A | 5/12/2014 |