BARACLUDE (entecavir)
Baraclude is an antiviral medication used for patients with chronic hepatitis B virus infection. It helps both adults and children at least 2 years old who show signs that the virus is actively replicating. Doctors prescribe this drug when patients have evidence of liver inflammation, such as elevated liver enzymes or active disease seen in tissue samples.
How BARACLUDE Works
This drug works by acting as a nucleoside analogue reverse transcriptase inhibitor to target the hepatitis B virus. It functions as an antiviral that interferes with the virus's ability to replicate. This helps manage the infection by preventing the virus from multiplying within the body.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2005-03-29
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION
BARACLUDE Approval History
What BARACLUDE Treats
1 indicationsBARACLUDE is approved for 1 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hepatitis B
BARACLUDE Boxed Warning
SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warran...
WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ]. Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if BARACLUDE is used to treat chronic hepatitis B virus (HBV) infection in patients with HIV infection that is not being treated. Therapy with BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART) [see Warnings and Precautions (5.2) ] . Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogue inhibitors alone or in combination with antiretrovirals [see Warnings and Precautions (5.3) ] . WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY See full prescribing information for complete boxed warning. • Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely for at least several months after discontinuation. Initiation of anti-hepatitis B therapy may be warranted. (5.1) • BARACLUDE is not recommended for patients co-infected with human immunodeficiency virus (HIV) and hepatitis B virus (HBV) who are not also receiving highly active antiretroviral therapy (HAART), because of the potential for the devel
BARACLUDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
68 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07345624 | 2025-KY-1632-001 | Ph 4 | not yet recruiting | Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Tolerant Chronic Hepatitis B |
| NCT07345611 | 2025-KY-1631-001 | Ph 4 | not yet recruiting | Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Active Chronic Hepatitis B |
| NCT02065336 results posted | Heparc-2001 | Ph 2 | terminated | A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection |
| NCT02604199 results posted | Heparc-2002 2014-004145-27 | Ph 2 | terminated | A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection |
| NCT02604212 results posted | Heparc-2003 2014-004751-31 | Ph 2 | terminated | A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection |
| NCT02738008 results posted | Heparc-2007 2014-004201-33 | Ph 2 | terminated | Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) Infection |
| NCT02577029 MONARCH results posted | Heparc-2008 2015-005499-46 | Ph 2 | terminated | Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV) |
| NCT02797522 results posted | ARC5211001 | Ph 1 | terminated | A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB) |
| NCT07295873 | KDN-F351-202505 | Ph 1 | not yet recruiting | Drug-Drug Interaction Study Between Hydronidone and Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide, and Tenofovir Amibufenamide |
| NCT04536337 | ALG-000184-201 | Ph 1 | completed | A Study of ALG-000184 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects |
| NCT07189377 CLEAR-HBV | 24-6051 | Ph 4 | recruiting | Combined Light, ExVivo, and Antivirals for Recipients of Lungs From HBV Donors |
| NCT02452528 results posted | Heparc-2004 | Ph 2 | terminated | Study of ARC-520 in Participants With Hepatitis B Virus e Antigen (HBeAg) Positive Chronic Hepatitis B Virus |
| NCT06966232 | GIC-HBV | Ph 3 | recruiting | Prophylactic or Preemptive Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriers |
| NCT05275023 OCTOPUS-1 results posted | CR109161 73763989PAHPB2008, 2021-005132-33 | Ph 2 | completed | An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants |
| NCT03933384 | CF18341A 106DHA0500150 | Ph 4 | recruiting | Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B |
| NCT05017116 | RBHB1103-HK | Ph 1 | completed | A Single and Repeated Dose Escalation of RBD1016 in Subjects with Chronic Hepatitis B Virus (HBV) Infection |
| NCT03887702 results posted | S1614 NCI-2018-00592, S1614 | Ph 3 | terminated | Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus Infection Receiving Anti-Cancer Therapy for Solid Tumors |
| NCT05453435 REHEB | B2022-352-01 | Ph 2 | recruiting | Entecavir Prophylaxis for Hepatitis B Reactivation for CD20 Positive B-cell Lymphoma Patients With Resolved Hepatitis B (Negative Hepatitis B Surface Antigen, Positive Hepatitis B Core Antibody) |
| NCT05107778 | ASC42-201 | Ph 2 | completed | Study to Evaluate Safety and Efficacy of ASC42 Combined With ETV and PEG-IFN α-2a in Subjects With HBV |
| NCT02650271 | AEVT-HCC | Ph 3 | completed | Adjuvant Entecavir or Tenofovir for Postoperative HBV-HCC |
| NCT03083821 results posted | AI463-528 | Ph 1 | completed | A Study to Provide a Better Understanding of Baraclude's Pharmacokinetic Properties in a Real World Clinical Setting |
| NCT04365933 | EYP001-203 | Ph 2 | completed | A Study of the Oral Farnesoid X Receptor Modulator EYP001a to Assess Its Safety and Anti-viral Effect in Chronic Hepatitis B Patients in Combination With Pegylated Interferon alpha2a Alone and With Entecavir |
| NCT02499562 HBV | GNI-F351-201402 | Ph 2 | completed | A Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis |
| NCT04032860 | 1185022016 | Ph 4 | active not recruiting | RCT of Different Effects of Nucleot(s)Ide Analogues on the Prognosis of HBV-HCC Patients After Curative Resection |
| NCT02555943 DASCO | H&H_DASCO | Ph 2, Ph 3 | completed | DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO) |
| NCT02263079 results posted | NV25361 2006-000977-31 | Ph 3 | completed | A Study of Pegylated Interferon Alfa-2A in Combination With Lamivudine or Entecavir Compared With Untreated Control Group in Children With Hepatitis B Envelope Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB) in the Immune-Tolerant Phase |
| NCT02505009 | 104-3167C | Ph 4 | completed | Efficacy of HBV Vaccine in Consolidation of Nucleos(t)Ide Analogues Therapy |
| NCT01326546 results posted | 71006.04 | Ph 2 | completed | Therapeutic Hepatitis B Vaccine (Mimogen-based) Joint Entecavir in Treating Chronic Hepatitis B Patients |
| NCT01079806 results posted | AI463-189 ST | Ph 3 | completed | A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus Infection |
| NCT02726789 results posted | REP 201 | Ph 2 | completed | Combination Treatment With REP 2139-Ca and Pegasys in Patients With Chronic Hepatitis B |
| NCT01023230 | DV4-HBT-02 2009-010142-66 | Ph 1 | completed | A Study to Assess DV-601 in Subjects With Chronic Hepatitis B |
| NCT02908191 | ABI-H0731-101 | Ph 1 | completed | A Study in Healthy Volunteers and Patients With Chronic Hepatitis B |
| NCT02881008 results posted | MYR 201 (HBV) | Ph 1, Ph 2 | completed | Myrcludex B vs Entecavir in Patients With HBeAg Negative Chronic Hepatitis B |
| NCT03272009 | EYP001-103 2017-002211-33 | Ph 1 | completed | Evaluation of the Safety and Pharmacology of EYP001 in HBV Subjects |
| NCT01938820 | 2013ZX10002004-2 | Ph 4 | completed | Optimized Treatment and Regression of HBV-induced Early Cirrhosis |
| NCT01943617 | 2013ZX10002004-3 | Ph 4 | completed | Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis |
| NCT01938781 | 2013ZX10002004-1 | Ph 4 | completed | Optimized Treatment and Regression of HBV-induced Liver Fibrosis |
| NCT03109730 | ABI-H0731-101B | Ph 1, Ph 2 | completed | Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B |
| NCT03239353 | UAP008C001 | Ph 1 | completed | A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Entecavir Extended Release (XR) in Healthy Subjects |
| NCT02391805 | NP28938 | Ph 2 | completed | A Study of Treatment With RO6864018 in Virologically Suppressed Participants With Chronic Hepatitis B Virus (HBV) Infection |
| NCT02360592 | Endeavor study, a pilot study | Ph 4 | completed | Combination Therapy With Interferon Plus Interleukin 2 and Hepatitis B Vaccine in Chronic Hepatitis B Patients |
| NCT01639092 IN-US-0202 | AMC2012-1215 | Ph 4 | completed | Tenofovir vs. Tenofovir Plus Entecavir in Entecavir-Resistant Chronic Hepatitis B |
| NCT02097004 E+VIP | E+VIP | Ph 4 | completed | Study of Therapeutic Vaccination With Intensified Schedule Plus Pegasys Dual Therapy on Chronic Hepatitis B Infection |
| NCT01639066 IN-US-0205 | AMC2012-1208 | Ph 4 | completed | Tenofovir Plus Entecavir vs. Tenofovir in Adefovir-Resistant Chronic Hepatitis B |
| NCT03032536 | AL-3778-1002 U1111-1187-4391 | Ph 1 | terminated | Study of the Relative Oral Bioavailability of AL-3778 Tablets and Drug Interaction With Entecavir or Tenofovir Disoproxil Fumarate in Healthy Volunteers |
| NCT01580202 | AI463-246 | Ph 3 | completed | Comparison of Prophylactic Antiviral Efficacy in Patients Undergoing Chemotherapy: Entecavir Versus Lamivudine |
| NCT00922207 results posted | ML21827 | Ph 4 | completed | A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B |
| NCT01694264 | H-1112-073-390 | Ph 3 | terminated | Study of Anti-Viral Prophylaxis for HBsAg(+) or HBcAb(+)/HBsAb(-) Patients Starting Anti-TNFα |
| NCT01179594 | MV22597 2009-017602-36 | Ph 4 | withdrawn | A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B. |
| NCT01595685 TERESA | AMC2012-0201 | Ph 3 | completed | Telbivudine Versus Entecavir in Reducing Serum HBsAg Levels in Patients With HBeAg-positive Chronic Hepatitis B |
Showing 50 of 68 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BARACLUDE FDA Label Details
Indications & Usage
FDA Label (PDF)BARACLUDE is indicated for the treatment of Hepatitis B.
WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be mon...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment