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Adefovir Dipivoxil Tablets
Adefovir dipivoxil is a nucleotide reverse transcriptase inhibitor that blocks viral DNA polymerase, preventing replication of hepatitis B virus.
Adefovir dipivoxil is a nucleotide reverse transcriptase inhibitor that blocks viral DNA polymerase, preventing replication of hepatitis B virus. Used for Chronic hepatitis B infection, Lamivudine-resistant hepatitis B.
At a glance
| Generic name | Adefovir Dipivoxil Tablets |
|---|---|
| Sponsor | Sun Yat-sen University |
| Drug class | Nucleotide reverse transcriptase inhibitor |
| Target | Hepatitis B virus reverse transcriptase and DNA polymerase |
| Modality | Small molecule |
| Therapeutic area | Virology / Hepatology |
| Phase | FDA-approved |
Mechanism of action
Adefovir dipivoxil is a prodrug that is converted to adefovir in vivo. Adefovir acts as a nucleotide analog that inhibits hepatitis B virus (HBV) reverse transcriptase and DNA polymerase, thereby suppressing viral replication. It is effective against both wild-type HBV and lamivudine-resistant HBV strains.
Approved indications
- Chronic hepatitis B infection
- Lamivudine-resistant hepatitis B
Common side effects
- Nephrotoxicity / renal dysfunction
- Headache
- Asthenia
- Abdominal pain
- Elevated liver enzymes
Key clinical trials
- Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) 300mg in Chinese Subjects With Chronic Hepatitis B (CHB) (PHASE3)
- Lamivudine and Adefovir Dipivoxil Fixed Dose Combination (PHASE1)
- PegIntron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (P04498/MK-4031-278) (PHASE3)
- A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Positive Chronic Hepatitis B (PHASE3)
- A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Negative Chronic Hepatitis B (PHASE3)
- A Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (Pegasys) and Adeforvir Dipivoxil (ADV) in Participants With Lamivudine-Resistant Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B (PHASE4)
- Entecavir Plus Adefovir in Lamivudine-Resistant Patients (PHASE4)
- Efficacy and Safety Study of Adefovir and Entecavir for Elderly With Chronic Hepatitis B
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Adefovir Dipivoxil Tablets CI brief — competitive landscape report
- Adefovir Dipivoxil Tablets updates RSS · CI watch RSS
- Sun Yat-sen University portfolio CI