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Baraclude tablets
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 tablets |
|---|---|
| Sponsor | Chia Tai Tianqing Pharmaceutical Group 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 other viruses, making it a potent and selective antiviral agent for chronic hepatitis B infection.
Approved indications
- Chronic hepatitis B infection in adults
- Chronic hepatitis B infection in children and adolescents
Common side effects
- Headache
- Fatigue
- Dizziness
- Nausea
- Lactic acidosis (rare but serious)
Key clinical trials
- Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP (PHASE3)
- A Study of ALG-000184 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects (PHASE1)
- A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects (PHASE2)
- A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection (PHASE1)
- A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection (PHASE2)
- Prophylactic or Preemptive Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriers (PHASE3)
- Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients (PHASE4)
- A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus (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:
- Baraclude tablets CI brief — competitive landscape report
- Baraclude tablets updates RSS · CI watch RSS
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. portfolio CI