Baraclude

(Entecavir)

ApprovedSmall molecule

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Entecavir is used to treat chronic hepatitis B infection by slowing down the virus's ability to reproduce and damage the liver.[2] Baraclude is currently approved and in use across 22 indications[4].[1]

Baraclude is one of 482 small molecule programs targeting Hepatitis B. It is currently in Approved.

Indications

164

Total Trials

Active Trials

481

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Hepatitis BCompleted

Elevated Circulating Hepatic Transaminase ConcentrationActive, not recruiting

Viral DiseaseActive, not recruiting

Hepatocellular CarcinomaApproved

Liver CancerApproved

Non-Hodgkins LymphomaApproved

Colorectal NeoplasmApproved

Liver FailureApproved

Stomach NeoplasmApproved

Acute-on-Chronic Liver FailureActive, not recruiting

Hepatitis BApproved

Completed

Elevated Circulating Hepatic Transaminase ConcentrationApproved

Active, not recruiting

Viral DiseaseApproved

Active, not recruiting

Hepatocellular CarcinomaApproved

Approved

Liver CancerApproved

Approved

Non-Hodgkins LymphomaApproved

Approved

Colorectal NeoplasmApproved

Approved

Liver FailureApproved

Approved

Stomach NeoplasmApproved

Approved

Acute-on-Chronic Liver FailurePreclinical

Active, not recruiting

Showing 10 of 21 indications

Competition

Competitive Landscape

265 competitors in Hepatocellular Carcinoma

#DrugCompanyPhaseTrials

Baraclude

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Approved

3 2

Cysteine Hydrochloride

Novartis

Preclinical

1 3

Ibrance

Pfizer

Preclinical

1 4

Viread

Gilead

Preclinical

1 5

Sovaldi

Gilead

Preclinical

1 6

Hepsera

Gilead

Preclinical

—7

Miraclid

TTechpool Bio-Pharma Co., Ltd.

Preclinical

1 8

Vermox

WWim Janssens

Preclinical

1 9

Doptelet

AAkarx

Preclinical

1 10

Valemetostat

Bristol-Myers Squibb

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Active, not recruiting

Chronic Kidney Disease

NCT05423834

Active, not recruiting

Chronic Hepatitis

NCT04431245

Q1 2027

ApprovedRecruiting

Hepatitis B

NCT07816094

Q2 2027

Phase 3Recruiting

Intestinal Cancer

NCT06966232

Q3 2027

Post-ApprovalRecruiting

Donor

NCT07189377

Clinical

Trials by Indication[1]

Chronic Hepatitis80 trials

Pegasys Plus Entecavir Versus Entecavir Alone for Hepatitis Be Antigen-Positive Chronic Hepatitis B

Unknown status·NNational Taiwan University Hospital·Phase 4·NCT00597259·294 enrolled

A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Negative for Hepatitis B e Antigen

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00035789

Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00096785·69 enrolled

Show 77 more trials

Myrcludex B vs Entecavir in Patients With HBeAg Negative Chronic Hepatitis B

Completed·HHepatera Ltd.·Phase 1/2·NCT02881008·48 enrolled

Telbivudine Versus Entecavir in Reducing Serum HBsAg Levels in Patients With HBeAg-positive Chronic Hepatitis B

Completed·—·Phase 3·NCT01595685·98 enrolled

Tenofovir Disoproxil Fumarate vs. Entecavir in Chronic Hepatitis B Patients With Partial Virologic Response to Entecavir

Completed·KKorea University·Phase 4·NCT01711567·60 enrolled

Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) Infection

Terminated· Arrowhead Pharmaceuticals logo

Arrowhead Pharmaceuticals·Phase 2·NCT02738008·12 enrolled

A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Positive for Hepatitis B E Antigen

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00035633

A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT00423891·64 enrolled

Antiviral Efficacy of the Combination Treatment With Poly IC and Entecavir for Chronic Hepatitis B

Unknown status·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 4·NCT02532413·180 enrolled

A Randomized Controlled Trial on the Efficacy of Tenofovir Disoproxil Fumarate (TDF)-Switch Therapy in Chronic Hepatitis B Patients With Incomplete Response to Entecavir

Completed·—·N/A·NCT01918631·36 enrolled

Simvastatin for the Treatment of Chronic Hepatitis B

Completed·—·Phase 1·NCT00994773·32 enrolled

Entecavir for Chronic Hepatitis B Patients With Persistently Normal ALT

Unknown status·NNational Cheng-Kung University Hospital·Phase 4·NCT01833611·130 enrolled

Combination or Sequential Therapy of Peginterferon Alfa-2a and Entecavir for Patients With Chronic Hepatitis B

Unknown status·—·Phase 4·NCT01906580·105 enrolled

Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00410072·669 enrolled

An Open-Label Rollover Study of Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01037062·282 enrolled

A Phase II Dose Response Study in Japan in Chronic Hepatitis B

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01022801·120 enrolled

Augmenting Response to Entecavir With Peginterferon a-2a for the Treatment of HBeAg-positive Chronic Hepatitis B

Completed·FFoundation for Liver Research·Phase 4·NCT00877760·184 enrolled

Study of ARC-520 in Participants With Hepatitis B Virus e Antigen (HBeAg) Positive Chronic Hepatitis B Virus

Terminated· Arrowhead Pharmaceuticals logo

Arrowhead Pharmaceuticals·Phase 2·NCT02452528·4 enrolled

Effect of Entecavir in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT00371150·131 enrolled

A Single and Repeated Dose Escalation of RBD1016 in Subjects with Chronic Hepatitis B Virus (HBV) Infection

Completed·SSuzhou Ribo Life Science Co. Ltd.·Phase 1·NCT05017116·40 enrolled

A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection

Terminated· Arrowhead Pharmaceuticals logo

Arrowhead Pharmaceuticals·Phase 2·NCT02604199·58 enrolled

Sequential/Combination Therapy in Nucleoside or Nucleotide Analogue (NA)-Suppressed Chronic Hepatitis B Patients

Unknown status·QQin Ning·Phase 4·NCT03332329·15 enrolled

A Phase III Study of Entecavir vs Lamivudine in Chronic Hepatitis B Subjects With Incomplete Response to Lamivudine

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00036608

A Study in Healthy Volunteers and Patients With Chronic Hepatitis B

Completed·AAssembly Biosciences·Phase 1·NCT02908191·86 enrolled

Tenofovir Plus Entecavir vs. Tenofovir in Adefovir-Resistant Chronic Hepatitis B

Completed·—·Phase 4·NCT01639066·102 enrolled

A Study to Assess DV-601 in Subjects With Chronic Hepatitis B

Completed·DDynavax Technologies Corporation·Phase 1·NCT01023230·14 enrolled

A Study of Treatment With RO6864018 in Virologically Suppressed Participants With Chronic Hepatitis B Virus (HBV) Infection

Completed· Roche logo

Roche·Phase 2·NCT02391805·31 enrolled

Combination Treatment With REP 2139-Ca and Pegasys in Patients With Chronic Hepatitis B

Completed·RReplicor Inc.·Phase 2·NCT02726789·5 enrolled

Clinical and Basic Research of ETV Plus GM-CSF in Chronic Hepatitis B Patients

Terminated·—·N/A·NCT03164889·80 enrolled

A Study of FG-3019 in Subjects With Liver Fibrosis Due to Chronic Hepatitis B Infection

Terminated·KKyntra Bio·Phase 2·NCT01217632·114 enrolled

Tenofovir vs. Tenofovir Plus Entecavir in Entecavir-Resistant Chronic Hepatitis B

Completed·—·Phase 4·NCT01639092·88 enrolled

Stopping Antiviral Treatment in Chronic Hepatitis B

Active, not recruiting·TThe University of Hong Kong··NCT04431245·54 enrolled

Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT00388674·12,522 enrolled

A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT00393484·122 enrolled

Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Tolerant Chronic Hepatitis B

Not yet recruiting·QQing-Lei Zeng·Phase 4·NCT07345624·80 enrolled

Entecavir for Subjects With Chronic Hepatitis B Infection: An Early Access Program

No longer available· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT00096811

Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00410202·629 enrolled

Efficacy and Safety of Peginterferon a-2a in Patients of Chronic Hepatitis B With Spontaneous Decline of HBV DNA

Completed·TThird Affiliated Hospital, Sun Yat-Sen University·Phase 3·NCT01892241·74 enrolled

Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Active Chronic Hepatitis B

Not yet recruiting·QQing-Lei Zeng·Phase 4·NCT07345611·60 enrolled

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

Completed·EEnyo Pharma·Phase 2·NCT04365933·20 enrolled

A Clinical Study of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment Naive and Treated Patients With Chronic Hepatitis B

Active, not recruiting· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 1/2·NCT06150014·88 enrolled

Long-term Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B

Unknown status·LLG Life Sciences·Phase 2·NCT01242787·115 enrolled

Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B

Completed·LLG Life Sciences·Phase 2·NCT01026610·115 enrolled

Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00065507·195 enrolled

Evaluation Freethiadine Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study

Completed· Sunshine Lake Pharma Co., Ltd. logo

Sunshine Lake Pharma Co., Ltd.·Phase 1·NCT05391360·128 enrolled

Evaluation HEC121120 Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study

Terminated· Sunshine Lake Pharma Co., Ltd. logo

Sunshine Lake Pharma Co., Ltd.·Phase 1/2·NCT04536532·52 enrolled

A Study of TQ-A3334 Combined With Entecavir in the Treatment of Chronic Hepatitis B

Unknown status· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 2·NCT04180150·12 enrolled

A Clinical Study of APG-1387 in Combination With Entecavir in Patients With Chronic Hepatitis B

Unknown status· Ascentage Pharma Group Inc. logo

Ascentage Pharma Group Inc.·Phase 2·NCT04568265·122 enrolled

An Study to Evaluate Safety and Efficacy of QL-007 Tablets in Combination With Entecavir or Tenofovir in Patients With Chronic Hepatitis b Who Have Received Nucleoside (Acid) Therapy

Unknown status· Qilu Pharmaceutical Co., Ltd. logo

Qilu Pharmaceutical Co., Ltd.·Phase 2·NCT04157257·60 enrolled

A Real-World Study of Pegylated Interferon In Nucleoside-treated Patients With Chronic Hepatitis B

Unknown status·TTongji Hospital·Phase 4·NCT03357822·2,000 enrolled

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

Terminated· Arrowhead Pharmaceuticals logo

Arrowhead Pharmaceuticals·Phase 2·NCT02065336·58 enrolled

Magnesium Isoglycyrrhizinate Followed by Diammonium Glycyrrhizinate and Combined With Entecavir in Chronic Hepatitis B

Unknown status·CCttq·Phase 4·NCT03349008·480 enrolled

A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB)

Terminated· Arrowhead Pharmaceuticals logo

Arrowhead Pharmaceuticals·Phase 1·NCT02797522·47 enrolled

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

Completed· Roche logo

Roche·Phase 3·NCT02263079·62 enrolled

Safety and Antiviral Activity of Entecavir in Participants With Chronic Hepatitis B Following Monotherapy in Other Entecavir Trials

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01438424·1,053 enrolled

Entecavir for Chronic Hepatitis B

Completed·FFoundation for Liver Research··NCT01323452·418 enrolled

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Entecavir in Treatment-Naive Patients With HBeAg-Positive Chronic Hepatitis B.

Completed· Roche logo

Roche·Phase 4·NCT00614471·219 enrolled

Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy

Unknown status·NNanfang Hospital, Southern Medical University·Phase 4·NCT01341743·360 enrolled

Influence of Hepatic Steatosis on the Therapeutic Effect of Entecavir in Chronic Hepatitis B Patients

Unknown status·ZZhejiang University·Phase 4·NCT01148576·1,200 enrolled

Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B

Recruiting·TTaichung Veterans General Hospital·Phase 4·NCT03933384·140 enrolled

Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B

Completed· Novartis logo

Novartis·Phase 3·NCT00412529·44 enrolled

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B

Completed· Roche logo

Roche·Phase 4·NCT00922207·280 enrolled

Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B

Completed·AAssembly Biosciences·Phase 1/2·NCT03109730·38 enrolled

Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV)

Terminated· Arrowhead Pharmaceuticals logo

Arrowhead Pharmaceuticals·Phase 2·NCT02577029·79 enrolled

Three Types of Nucleotide/Nucleoside Analogues Therapy in Patients With Chronic Hepatitis b

Unknown status·TThird Affiliated Hospital, Sun Yat-Sen University·N/A·NCT04195074·300 enrolled

Compare Continuing Lamivudine Plus Adefovir or Adefovir Versus Switching to Entecavir Plus Adefovir in Patients With LAM-resistant Chronic Hepatitis B

Unknown status·—·Phase 4·NCT02482272·90 enrolled

Combination Therapy With Interferon Plus Interleukin 2 and Hepatitis B Vaccine in Chronic Hepatitis B Patients

Completed·TTongji Hospital·Phase 4·NCT02360592·94 enrolled

Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Patients Who Fail Lamivudine Plus Adefovir

Completed·—·Phase 4·NCT01023217·90 enrolled

Efficacy and Safety Study of Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Who Failed Previous Treatment

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01063036·144 enrolled

A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.

Withdrawn· Roche logo

Roche·Phase 4·NCT01179594

A Study in Japan of the Safety and Antiviral Activity With Chronic Hepatitis B Infection

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01020565·60 enrolled

Antiviral Therapy for Patients With Chronic Hepatitis B Infection

Unknown status·SSun Yat-sen University·Phase 2·NCT05382351·238 enrolled

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

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT05275023·37 enrolled

A Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis

Completed·SShanghai Genomics, Inc.·Phase 2·NCT02499562·168 enrolled

Study of Therapeutic Vaccination With Intensified Schedule Plus Pegasys Dual Therapy on Chronic Hepatitis B Infection

Completed·SSeoul National University Hospital·Phase 4·NCT02097004·111 enrolled

Therapeutic Hepatitis B Vaccine (Mimogen-based) Joint Entecavir in Treating Chronic Hepatitis B Patients

Completed·CChongqing Jiachen Biotechnology Ltd.·Phase 2·NCT01326546·378 enrolled

The Efficacy and Safety of Entecavir Treatment of Patients With Acute on Chronic Hepatitis B Liver Failure

Completed·SSun Yat-sen University·Phase 2·NCT01254994·108 enrolled

Study in Japan of the Safety And Antiviral Activity in Adults With Chronic Hepatitis B Current Lamivudine Therapy

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01037166·84 enrolled

A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B

Completed· Roche logo

Roche·Phase 4·NCT00940485·200 enrolled

Hepatitis B16 trials

Comparing P1101 to Entecavir in Patients With HBeAg(-) Hepatitis B Under Long-term Nucleos(t)Ide Analogue Therapy

Unknown status·NNational Taiwan University Hospital·N/A·NCT05494528·90 enrolled

Detecting Occult HBV Infection in Liver Donors Positive for Antibody to Hepatitis B Core Antigen (Anti-HBc)

Unknown status·TThe University of Hong Kong·N/A·NCT04199819·100 enrolled

Entecavir for Patients With Decompensated Hepatitis B Virus (HBV)-Related Cirrhosis

Unknown status·SShanghai Changzheng Hospital·Phase 4·NCT00663182·200 enrolled

Show 13 more trials

Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Reactivation in NHL

Unknown status·FFudan University·Phase 2·NCT01914744·82 enrolled

Dose Ranging Study of Pegylated Interferon Lambda in Patients With Hepatitis B and Positive for the Hepatitis B e Antigen

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01204762·197 enrolled

Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable Hepatitis B Virus DNA

Completed·PPusan National University Hospital·Phase 4·NCT00637663·72 enrolled

A Clinical Trial on Hepatitis B Vaccine Activated-Dendritic Cells Combined With Anti-HBV Drugs in CHB

Unknown status·TThird Affiliated Hospital, Sun Yat-Sen University·Phase 1/2·NCT02615639·450 enrolled

A RCT of TNF and ENT in the Treatment of Long-term Prognosis With Hepatitis B-related HCC After Curative Resection

Unknown status·SSun Yat-sen University·Phase 3·NCT04392700·706 enrolled

Clinical Pharmacokinetics of TKIs in Chinese Patients of Hepatitis B (HBV)

Unknown status·—··NCT03680183·300 enrolled

Efficacy of Peg-interferon α-2a in Hepatitis B Patients Treated by Entecavir Without HBeAg Loss

Unknown status·SSun Yat-sen University·N/A·NCT01599130·60 enrolled

Hepatitis B Virus (HBV) Viral Suppression by Entecavir in Adefovir Partial Responders

Completed·PPacific Health Foundation··NCT00704106·60 enrolled

Switch or Sequential Combination Therapy of Peginterferon in Hepatitis B Patients With Longterm Entecavir Therapy

Unknown status·HHuashan Hospital··NCT02589652·294 enrolled

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)

Recruiting·SSun Yat-sen University·Phase 2·NCT05453435·84 enrolled

Incidence of Hepatitis B Reactivation in Non-Hodgkin's Lymphoma Patients

Unknown status·NNational Health Research Institutes, Taiwan·N/A·NCT00931229·202 enrolled

Three Types of Nucleotide/Nucleoside Analogues Therapy in Patients With Hepatitis b Virus Related Compensated Cirrhosis

Unknown status·TThird Affiliated Hospital, Sun Yat-Sen University·N/A·NCT04196998·150 enrolled

Comparison of Viral Suppression With 0.5 mg and 1.0 mg Daily Doses of Entecavir in Decompensated HBV Cirrhosis of Liver

Recruiting·BBangladesh Medical University·Approved·NCT07816094·48 enrolled

Treatment7 trials

Efficacies of Entecavir Add on HBeAg Positive Patients With HBV DNA Positive During Peginterferon Alpha 2a Treatment

Unknown status·—·Phase 4·NCT02368288·200 enrolled

Three Types of Nucleotide/Nucleoside Analogues Treatment in HBV Related ACLF

Recruiting·TThird Affiliated Hospital, Sun Yat-Sen University·N/A·NCT03920618·150 enrolled

Tubular Function in Asian-American Patients Receiving TDF or ETV for HBV Treatment

Terminated·NNew Discovery LLC··NCT01715987·48 enrolled

Show 4 more trials

Lamivudine Therapy in Patients With Prior Entecavir Treatment and Undetectable Viral Load

Completed·TThe University of Hong Kong·N/A·NCT01013272·50 enrolled

Efficacies of Entecavir Add on HBeAg Negative Patients With HBV DNA Positive During Peginterferon Alpha 2a Treatment

Unknown status·—·Phase 4·NCT02365402·180 enrolled

Comparison Between Lamivudine and Entecavir Treatment in Spontaneous Severe Acute Exacerbation

Terminated·TTaichung Veterans General Hospital·Phase 4·NCT01627223·17 enrolled

DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO)

Completed·HHumanity and Health Research Centre·Phase 2/3·NCT02555943·23 enrolled

Chronic Hepatitis B Virus Infection5 trials

A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus Infection

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01079806·180 enrolled

A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection

Terminated· Arrowhead Pharmaceuticals logo

Arrowhead Pharmaceuticals·Phase 2·NCT02604212·32 enrolled

A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection

Terminated·AAssembly Biosciences·Phase 2·NCT04398134·88 enrolled

Show 2 more trials

A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04585789·24 enrolled

Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00395018·109 enrolled

Cirrhosis5 trials

Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis

Unknown status·—··NCT01720238·621 enrolled

Entecavir for Decompensated HBV Cirrhosis

Completed·SSanjay Gandhi Postgraduate Institute of Medical Sciences··NCT03345498·32 enrolled

Effect of Entecavir Treatment on Regression and Disease Outcome in HBV-induced Liver Fibrosis and Cirrhosis Patients

Unknown status·—·Phase 4·NCT02849132·800 enrolled

Show 2 more trials

Optimized Treatment and Regression of HBV-induced Early Cirrhosis

Completed·—·Phase 4·NCT01938820·82 enrolled

Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis

Completed·—·Phase 4·NCT01943617·606 enrolled

40 more indications

Hepatocellular Carcinoma3 trials

Entecavir for Chronic Hepatitis B in Hepatocellular Carcinoma Patients Underwent Radiofrequency Ablation Therapy

Unknown status·TTaipei Veterans General Hospital, Taiwan··NCT01270178·420 enrolled

Arabinoxylan Rice Bran (MGN-3/Biobran) for the Treatment of Hepatocellular Carcinoma and Hepatitis B and C Infection

Completed·—·N/A·NCT01018381·130 enrolled

Risk of Hepatocellular Carcinoma in Patients Treated With ETV vs TDF for Chronic Hepatitis B With Compensated Cirrhosis

Unknown status·QQing XIe··NCT04160897·4,000 enrolled

Itching3 trials

Continuing Lamivudine vs Switching to Entecavir in Patients With Detectable HBV DNA

Completed·YYonsei University·Phase 4·NCT00625560·72 enrolled

Suboptimal Responders to Adefovir Switching to Entecavir

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT00718887·228 enrolled

Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable HBV DNA

Completed·YYonsei University·Phase 4·NCT00625339·72 enrolled

Acute-on-Chronic Liver Failure2 trials

The Renal Safety of Tenofovir Alafenamide in HBV-related Acute-on-chronic Liver Failure: Real-World Study

Completed·XXiangya Hospital of Central South University·N/A·NCT05453448·272 enrolled

The Efficacy and Safety of Nucleos(t)Ide Analogues in the Treatment of HBV-related Acute-on-chronic Liver Failure

Unknown status·FFirst Affiliated Hospital Xi'an Jiaotong University··NCT03640728·200 enrolled

Fibrosis2 trials

Optimized Treatment and Regression of HBV-induced Liver Fibrosis

Completed·—·Phase 4·NCT01938781·400 enrolled

Zinc Sulphate in Treatment Fibrosis in HBV Patient Receiving Antiviral Therapy

Not yet recruiting·TTanta University·Phase 2·NCT07145268·44 enrolled

Liver Disease2 trials

Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine (FTC)/TDF, and Entecavir (ETV) in the Treatment of Chronic HBV in Subjects With Decompensated Liver Disease.

Completed· Gilead logo

Gilead·Phase 2·NCT00298363·112 enrolled

Antiviral Therapy in Hepatitis B Virus (HBV)-Related Advanced Liver Disease Patients

Unknown status·YYonsei University·Phase 4·NCT00823550·462 enrolled

Tenofovir2 trials

Adjuvant Entecavir or Tenofovir for Postoperative HBV-HCC

Completed·GGuangxi Medical University·Phase 3·NCT02650271·240 enrolled

Efficacy of Telbivudine With or Without add-on Tenofovir According to Roadmap Strategy Compare With Entecavir

Unknown status·PPusan National University Yangsan Hospital·Phase 4·NCT01588912·104 enrolled

HBV2 trials

Evaluation of the Safety and Pharmacology of EYP001 in HBV Subjects

Completed·EEnyo Pharma·Phase 1·NCT03272009·73 enrolled

Study of Adding Entecavir to Current Lamivudine Therapy in HIV and HBV Co-Infected Patients

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2/3·NCT00051038

Chronic Kidney Disease1 trial

Chronic Kidney Disease Progression in Chronic Hepatitis B Patients on Tenofovir Alafenamide (TAF) Versus Entecavir

Active, not recruiting·—··NCT05423834·1,800 enrolled

Intestinal Cancer1 trial

Prophylactic or Preemptive Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriers

Recruiting·SSun Yat-sen University·Phase 3·NCT06966232·136 enrolled

Prophylaxis1 trial

Study of Anti-Viral Prophylaxis for HBsAg(+) or HBcAb(+)/HBsAb(-) Patients Starting Anti-TNFα

Terminated·SSeoul National University Hospital·Phase 3·NCT01694264·43 enrolled

Liver Cancer1 trial

Efficacy and Significance of Antiviral Therapy for Unresectable Hepatitis B Virus-related Primary Liver Cancer

Completed·—·N/A·NCT00824707·200 enrolled

Hepatitis B Virus Infection1 trial

Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus Infection Receiving Anti-Cancer Therapy for Solid Tumors

Terminated·SSWOG Cancer Research Network·Phase 3·NCT03887702·4 enrolled

Portal Hypertension1 trial

Treatment of Low-grade Cirrhotic Portal Hypertension Due to Hepatitis B Virus With Fuzheng Huayu and Entecavir

Unknown status·SShuGuang Hospital·Phase 4·NCT02945956·192 enrolled

Maintenance Treatment1 trial

Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP

Recruiting·OOu Bai, MD/PHD·Phase 3·NCT07493109·200 enrolled

Efficacy and Safety1 trial

A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects

Withdrawn· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 2·NCT06990776

ACL1 trial

Bioequivalence Study of Entecavir Tablets and Baraclude® Under Fasting Condition in Chinese Healthy Volunteers

Completed· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·N/A·NCT03847246·26 enrolled

Hepatitis1 trial

Using Entecavir to Reduce Hepatitis in Highly Viremic HBV Patients During Anti-tuberculous Treatment

Unknown status·NNational Taiwan University Hospital·Phase 4·NCT01724723·50 enrolled

Interaction1 trial

Drug Drug Interaction Study for EYP001 With Entecavir

Completed·EEnyo Pharma·Phase 1·NCT03469583·16 enrolled

Complication1 trial

Synbiotics Interventions for Managing Cirrhosis and Its Complications

Completed·FFirst Affiliated Hospital of Zhejiang University·Phase 4·NCT05687409·120 enrolled

Hepatic fibrosis1 trial

A Study in Reversing Hepatic Fibrosis or Cirrhosis Related to Hepatitis B Virus and Finding Biomarkers

Unknown status·PPeking University First Hospital·N/A·NCT03568578·450 enrolled

Safety and Efficacy1 trial

Study to Evaluate Safety and Efficacy of ASC42 Combined With ETV and PEG-IFN α-2a in Subjects With HBV

Completed·AAscletis Pharmaceuticals Co., Ltd.·Phase 2·NCT05107778·43 enrolled

Arthritis1 trial

Entecavir for Biological Agents Associated HBV Reactivation in Inflammatory Arthritis Patients

Unknown status·TTaipei Veterans General Hospital, Taiwan·Phase 4·NCT01907230·115 enrolled

Efficacy1 trial

Efficacy of HBV Vaccine in Consolidation of Nucleos(t)Ide Analogues Therapy

Completed·—·Phase 4·NCT02505009·116 enrolled

Tenofovir Disoproxil Fumarate1 trial

Study of the Relative Oral Bioavailability of AL-3778 Tablets and Drug Interaction With Entecavir or Tenofovir Disoproxil Fumarate in Healthy Volunteers

Terminated·AAlios Biopharma Inc.·Phase 1·NCT03032536·54 enrolled

Clinical Trial1 trial

The Curative Effect of Entecavir Combined Resveratrol on HBV patients-a Multi-center, Random, Open Clinical Trial

Completed·TThe First Hospital of Jilin University·N/A·NCT03509688·312 enrolled

Phase 11 trial

A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Entecavir Extended Release (XR) in Healthy Subjects

Completed·AAucta Pharmaceuticals, Inc·Phase 1·NCT03239353·40 enrolled

Tics1 trial

A Study of ALG-000184 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects

Completed·AAligos Therapeutics·Phase 1·NCT04536337·165 enrolled

Lymphoma1 trial

Entecavir and Tenofovir Versus Entecavir in Lymphoma Patients With Positive HBV DNA

Unknown status·RRuijin Hospital·Phase 3·NCT04539119·120 enrolled

Prognosis1 trial

RCT of Different Effects of Nucleot(s)Ide Analogues on the Prognosis of HBV-HCC Patients After Curative Resection

Active, not recruiting·WWest China Hospital·Phase 4·NCT04032860·104 enrolled

Combination Therapy1 trial

Efficacy and Safety of Combination Therapy of Thymalfasin and Entecavir in HBeAg-positive ETV-experienced Patients

Unknown status·WWen-hong Zhang·Phase 4·NCT03448744·240 enrolled

Donor1 trial

Combined Light, ExVivo, and Antivirals for Recipients of Lungs From HBV Donors

Recruiting·UUniversity Health Network, Toronto·Phase 4·NCT07189377·20 enrolled

Chemotherapy1 trial

Comparison of Prophylactic Antiviral Efficacy in Patients Undergoing Chemotherapy: Entecavir Versus Lamivudine

Completed·SSeoul National University Hospital·Phase 3·NCT01580202·180 enrolled

Liver Transplant1 trial

Prevention of Hepatitis B Virus Reinfection After Liver Transplantation With Entecavir

Completed·HHepNet Study House, German Liverfoundation·Phase 3·NCT01046799·20 enrolled

TED1 trial

HBsAg Related Response Guided Therapy

Unknown status·GGangnam Severance Hospital·Phase 4·NCT01456312·200 enrolled

LAM1 trial

Entecavir Plus Adefovir in Lamivudine-Resistant Patients

Withdrawn· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT00986778

Gastric Cancer1 trial

Prophylactic or Preemptive Entecavir in Patients With Gastric Cancer Who Are Inactive Hepatitis B Carriers

Unknown status·SSun Yat-sen University·Phase 2·NCT02777801·50 enrolled

Colorectal Cancer1 trial

Prophylactic or Preemptive Entecavir in Patients With Colorectal Cancer Who Are Inactive Hepatitis B Carriers

Unknown status·SSun Yat-sen University·Phase 2·NCT02777814·50 enrolled

Chronic1 trial

A Study to Compare and Evaluate Intrahepatic cccDNA Reduction After Administrating Clevudine or Entecavir in the Chronic HBV Patients

Terminated·BBukwang Pharmaceutical·Phase 4·NCT01266005·75 enrolled

Chronic Hepatitis b1 trial

A Single-Center, Open-Label, Single-Arm, Self-Controlled Phase I Clinical Study to Evaluate Drug-Drug Interactions of Hydronidone With Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide, and Tenofovir Amibufenamide in Healthy Chinese Subjects

Completed·BBeijing Continent Pharmaceutical Co, Ltd.·Phase 1·NCT07295873·64 enrolled

Unspecified3 trials

An Exploratory Study of RGT Strategy on Optimal NUC-experienced Patients

Unknown status·RRuijin Hospital·Phase 4·NCT02560649·324 enrolled

A Single and Multiple Ascending Dose Study of JNJ-64457744

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05423106·60 enrolled

Continue Entecavir Rollover From China

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00975091·600 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 29, 2005

BARACLUDE

NDA NDA021798

Mar 29, 2005

BARACLUDE

NDA NDA021797

Sources

References

[1]
ClinicalTrials.gov — 164 trial records for Entecavir. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Baraclude drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Entecavir compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Entecavir. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021798). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Karuna Therapeutics, Inc., a Bristol Myers Squibb company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: DNA Polymerase/reverse Transcriptase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Baraclude

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Chronic Hepatitis80 trials

Hepatitis B16 trials

Treatment7 trials

Chronic Hepatitis B Virus Infection5 trials

Cirrhosis5 trials

Hepatocellular Carcinoma3 trials

Itching3 trials

Acute-on-Chronic Liver Failure2 trials

Fibrosis2 trials

Liver Disease2 trials

Tenofovir2 trials

HBV2 trials

Chronic Kidney Disease1 trial

Intestinal Cancer1 trial

Prophylaxis1 trial

Liver Cancer1 trial

Hepatitis B Virus Infection1 trial

Portal Hypertension1 trial

Maintenance Treatment1 trial

Efficacy and Safety1 trial

ACL1 trial

Hepatitis1 trial

Interaction1 trial

Complication1 trial

Hepatic fibrosis1 trial

Safety and Efficacy1 trial

Arthritis1 trial

Efficacy1 trial

Tenofovir Disoproxil Fumarate1 trial

Clinical Trial1 trial

Phase 11 trial

Tics1 trial

Lymphoma1 trial

Prognosis1 trial

Combination Therapy1 trial

Donor1 trial

Chemotherapy1 trial

Liver Transplant1 trial

TED1 trial

LAM1 trial

Gastric Cancer1 trial

Colorectal Cancer1 trial

Chronic1 trial

Chronic Hepatitis b1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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