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Baraclude Tab.®
Baraclude (entecavir) inhibits hepatitis B virus reverse transcriptase, blocking viral replication.
Baraclude (entecavir) inhibits hepatitis B virus reverse transcriptase, blocking viral replication. Used for Chronic hepatitis B infection in adults, Chronic hepatitis B infection in children and adolescents.
At a glance
| Generic name | Baraclude Tab.® |
|---|---|
| Sponsor | Dong-A ST Co., Ltd. |
| 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 virus from copying its genetic material and reducing viral load. It has high specificity for HBV and minimal activity against human reverse transcriptase, making it well-tolerated for chronic hepatitis B treatment.
Approved indications
- Chronic hepatitis B infection in adults
- Chronic hepatitis B infection in children and adolescents
Common side effects
- Headache
- Fatigue
- Nausea
- Diarrhea
- Lactic acidosis (rare but serious)
Key clinical trials
- Prophylactic Entecavir for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation (NA)
- 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)
- Bioequivalence Study of Entecavir Tablets and Baraclude® Under Fasting Condition in Chinese Healthy Volunteers (NA)
- Baracle Tab. ® Versus Baraclude Tab.® for Patients With HBeAg Chronic Hepatitis B (PHASE4)
- Induction of Fibrosis Regression on Patients With Chronic Hepatitis B Infection (PHASE4)
- Study to Evaluate the Non-inferiority of Cavir in HBeAg(+)Chronic Hepatitis B Patients Treated With Baraclude (PHASE4)
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:
- Baraclude Tab.® CI brief — competitive landscape report
- Baraclude Tab.® updates RSS · CI watch RSS
- Dong-A ST Co., Ltd. portfolio CI