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Therapeutic entecavir
Entecavir is a guanosine nucleoside analog that selectively inhibits the replication of hepatitis B virus (HBV) DNA polymerase.
Entecavir is an antiviral medication primarily used for the treatment of chronic hepatitis B. Developed and marketed by Bristol Myers Squibb, it is not associated with Taipei Veterans General Hospital, Taiwan. The drug works by inhibiting the replication of the hepatitis B virus. Despite its efficacy, entecavir has no FDA-approved label from Taipei Veterans General Hospital. Common side effects include headache, fatigue, and dizziness. The drug is generally well-tolerated but requires careful monitoring in patients with renal impairment.
At a glance
| Generic name | Therapeutic entecavir |
|---|---|
| Also known as | Baraclude |
| Sponsor | Taipei Veterans General Hospital, Taiwan |
| Drug class | Nucleoside analog reverse transcriptase inhibitor (NRTI) |
| Target | HBV DNA polymerase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Entecavir interferes with the viral DNA synthesis process by competing with the natural substrate deoxyguanosine triphosphate (dGTP) and terminating the growing DNA chain.
Approved indications
Common side effects
- Headache
- Fatigue
- Dizziness
Key clinical trials
- Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP (PHASE3)
- Entecavir Resistance-Associated Mutations in Chronic HBV Patients in Turkey (STREAM Study)
- Stopping Antiviral Treatment in Chronic Hepatitis B
- A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection (PHASE1)
- 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)
- A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection (PHASE2)
- Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV) (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:
- Therapeutic entecavir CI brief — competitive landscape report
- Therapeutic entecavir updates RSS · CI watch RSS
- Taipei Veterans General Hospital, Taiwan portfolio CI