TheraRadar
Data updated: May 26, 2026

HEPSERA (adefovir dipivoxil)

Infectious Disease Approved 2002-09-20
Jump to: Indications Approvals Trials Competitors Safety Patents
5
Indications
--
Phase 3 Trials
1
Priority Reviews
23
Years on Market

Details

Status
Discontinued
First Approved
2002-09-20
Routes
ORAL
Dosage Forms
TABLET

Companies

Gilead Sciences
Active Ingredient: ADEFOVIR DIPIVOXIL

HEPSERA Approval History

2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
13 FDA actions from 2002 to 2018 · 4 indication expansions
Dec 2018 SUPPL
Label · Labeling
FDA Letter Label
Feb 2014 SUPPL Priority
Mfg · Manufacturing (CMC)
Oct 2013 SUPPL Priority
Mfg · Manufacturing (CMC)

What HEPSERA Treats

5 FDA approvals

Originally approved for its first indication in 2002 . Covers 5 distinct patient populations.

  • Other (5)
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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
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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

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Data Sources

FDA Approval: NDA021449 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.