HEPSERA (adefovir dipivoxil) · Gilead Sciences
HEPSERA is FDA-approved to treat 1 condition (same as ADEFOVIR DIPIVOXIL).
Details
- Status
- Discontinued
- First Approved
- 2002-09-20
- Routes
- ORAL
- Dosage Forms
- TABLET
HEPSERA Approval History
What HEPSERA Treats
1 indicationsHEPSERA is approved for 1 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Hepatitis B
Same approved indications as ADEFOVIR DIPIVOXIL (same active ingredient).
Gilead Sciences's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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.
HEPSERA FDA Label Details
Indications & Usage
FDA Label (PDF)HEPSERA is FDA-approved to treat 1 condition — same approved indications as ADEFOVIR DIPIVOXIL.
Track HEPSERA with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.