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entecavir (BARACLUDE®)
Entecavir inhibits hepatitis B virus reverse transcriptase and protein priming, blocking viral DNA replication.
Entecavir inhibits hepatitis B virus reverse transcriptase and protein priming, blocking viral DNA replication. Used for Chronic hepatitis B infection in adults, Chronic hepatitis B infection in pediatric patients (2 years and older).
At a glance
| Generic name | entecavir (BARACLUDE®) |
|---|---|
| Also known as | BARACLUDE® |
| Sponsor | National Taiwan University Hospital |
| Drug class | Nucleoside reverse transcriptase inhibitor (NRTI) |
| Target | Hepatitis B virus reverse transcriptase / HBV polymerase |
| Modality | Small molecule |
| Therapeutic area | Virology / Hepatology |
| Phase | FDA-approved |
Mechanism of action
Entecavir is a nucleoside analog that selectively inhibits HBV polymerase (reverse transcriptase), preventing the conversion of pregenomic RNA to viral DNA. It also inhibits protein priming, a critical early step in HBV replication. This dual mechanism makes it highly potent against wild-type and lamivudine-resistant HBV strains.
Approved indications
- Chronic hepatitis B infection in adults
- Chronic hepatitis B infection in pediatric patients (2 years and older)
Common side effects
- Headache
- Fatigue
- Dizziness
- Nausea
- Lactic acidosis (rare but serious)
Key clinical trials
- Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Tolerant Chronic Hepatitis B (PHASE4)
- Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Active Chronic Hepatitis B (PHASE4)
- Prophylactic Entecavir for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation (NA)
- Phase I Safety and Immunogenicity of FP-02.2 in Chronic Hepatitis B (PHASE1)
- A Study to Evaluate the Efficacy and Safety of ZM-H1505R in Combination With ETV Compared With ETV Monotherapy in Patients With CHB (PHASE2)
- Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Participants With Chronic Hepatitis B Virus (HBV) Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant (PHASE2)
- DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO) (PHASE2, PHASE3)
- Safety, Tolerability and Antiviral Activity of Selgantolimod in Virally-Suppressed Participants With Chronic Hepatitis B (PHASE2)
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:
- entecavir (BARACLUDE®) CI brief — competitive landscape report
- entecavir (BARACLUDE®) updates RSS · CI watch RSS
- National Taiwan University Hospital portfolio CI