ADEFOVIR DIPIVOXIL
ADEFOVIR DIPIVOXIL is indicated for the treatment of Chronic Hepatitis B.
How ADEFOVIR DIPIVOXIL Works
Adefovir dipivoxil is an acyclic nucleotide analogue of adenosine monophosphate. It is intracellularly phosphorylated to its active metabolite, adefovir diphosphate, which inhibits hepatitis B virus (HBV) DNA polymerase (reverse transcriptase). It functions by competing with the natural substrate deoxyadenosine triphosphate (dATP) for incorporation into viral DNA, leading to DNA chain termination and the subsequent inhibition of viral replication.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2013-08-29
- Routes
- ORAL
- Dosage Forms
- TABLET
ADEFOVIR DIPIVOXIL Approval History
What ADEFOVIR DIPIVOXIL Treats
1 indicationsADEFOVIR DIPIVOXIL is approved for 1 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Hepatitis B
ADEFOVIR DIPIVOXIL Boxed Warning
SEVERE ACUTE EXACERBATIONS OF HEPATITIS, NEPHROTOXICITY, HIV RESISTANCE, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS Severe acute exacerbations of hepatitis have been reported in patients who have discontinued anti-Hepatitis B therapy including adefovir dipivoxil tablets. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-Hepatitis B therapy. If appropriate, resumption of anti-Hepatitis ...
WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS, NEPHROTOXICITY, HIV RESISTANCE, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS Severe acute exacerbations of hepatitis have been reported in patients who have discontinued anti-Hepatitis B therapy including adefovir dipivoxil tablets. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-Hepatitis B therapy. If appropriate, resumption of anti-Hepatitis B therapy may be warranted [See Warnings and Precautions (5. 1 ) ]. In patients at risk of or having underlying renal dysfunction, chronic administration of adefovir dipivoxil tablets may result in nephrotoxicity. These patients should be monitored closely for renal function and may require dose adjustment [See Warnings and Precautions (5. 2 ) and Dosage and Administration (2.2) ] . HIV resistance may emerge in chronic hepatitis B patients with unrecognized or untreated Human Immunodeficiency Virus (HIV) infection treated with anti-hepatitis B therapies, such as therapy with adefovir dipivoxil tablets, that may have activity against HIV [See Warnings and Precautions (5. 3 ) ] . Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals [See Warnings and Precautions (5. 4 ) ] . WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS, NEPHROTOXICITY, HIV RESISTANCE, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS See full prescribing information for complete boxed warning . Severe acute exacerbations of hepatitis may occur in patients who discontinue adefovir dipivoxil tablets. Monitor hepatic function closely in these patients. ( 5.1 ) Chronic use of adefovir dipivoxil tablets may result in nephrotoxicity in patients at risk of renal dysfunction or having underlying renal dysfunction. Monitor renal function closely in these patients. Dose adjust
ADEFOVIR DIPIVOXIL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01353742 | 114957 | Ph 1 | completed | Lamivudine and Adefovir Dipivoxil Fixed Dose Combination |
| NCT00661076 | ML20622 | Ph 3 | completed | ADVANCE Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) + Adefovir Dipivoxil in Patients With Hbe(-) Chronic Hepatitis B |
| NCT00641082 | CLV-401 | Ph 4 | completed | A Double-Blind Randomized Clinical Trial Comparing the Safety and Antiviral Activity of 48-week Clevudine and Adefovir Dipivoxil in HBeAg(-) Chronic Hepatitis B With Compensated Liver Function |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ADEFOVIR DIPIVOXIL FDA Label Details
Indications & Usage
FDA Label (PDF)ADEFOVIR DIPIVOXIL is indicated for the treatment of Chronic Hepatitis B.
WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS, NEPHROTOXICITY, HIV RESISTANCE, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS Severe acute exacerbations of hepatitis have been reported in patients who have discontinued anti-Hepatitis B therapy including adefovir dipivoxil tablets. Hepatic...
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HEPSERA
Full clinical data, patents, trials, and competitive landscape for adefovir dipivoxil.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment