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Baraclude
Baraclude, marketed by Bristol-Myers Squibb, is a treatment for chronic type B viral hepatitis with a well-established presence in the market. The drug's key strength lies in its mechanism of action, which effectively targets the virus, and it benefits from a key composition patent that remains in effect until 2028. The primary risk to Baraclude is the eventual patent expiry in 2028, which could lead to increased competition from generic alternatives.
At a glance
| Generic name | Baraclude |
|---|---|
| Also known as | entecavir |
| Sponsor | Bristol-Myers Squibb |
| Target | Capsid protein, Protein P, Protein P |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Approved indications
- Chronic type B viral hepatitis
- Lamivudine-Refractory Chronic Hepatitis B
Common side effects
- Headache
- Fatigue
- Dizziness
- Nausea
- Diarrhea
- Dyspepsia
- Vomiting
- Somnolence
- Insomnia
Serious adverse events
- ALT >5 × ULN
- Lipase ≥2.1 × ULN
- Hematuria
- Glycosuria
- Hyperglycemia (fasting >250 mg/dL)
- Total bilirubin >2.5 × ULN
- ALT >10 × ULN and >2 × baseline
- Albumin <2.5 g/dL
- Confirmed creatinine increase ≥0.5 mg/dL
- Platelets <50,000/mm3
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)
- Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) Infection (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 CI brief — competitive landscape report
- Baraclude updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI