Hepatitis B Virus

Infectious Diseases
8
Pipeline Programs
5
Companies
35
Clinical Trials
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
2
3
0
0
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
250%
Vaccine
125%
Small Molecule
125%
+ 4 programs with unclassified modality

On Market (1)

Approved therapies currently available

Bristol Myers Squibb
BARACLUDEApproved
entecavir
Bristol Myers Squibb
oral2005

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Bristol Myers Squibb
3 programs
1
2
1
BARACLUDE(Entecavir)Phase 2Small Molecule5 trials
pegIFNPhase 21 trial
BaracludePhase 11 trial
Active Trials
NCT03083821Completed6Est. Dec 2017
NCT01594905Unknown90Est. Apr 2014
NCT01356901Completed230Est. Jan 2015
+4 more trials
GS
Gilead SciencesFOSTER CITY, CA
2 programs
1
1
EmtricitabinePhase 21 trial
TAFPhase 11 trial
Active Trials
NCT02296853Completed20Est. Apr 2015
NCT00476463Completed24Est. Dec 2008
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
1 program
1
CemiplimabPhase 1/2Monoclonal Antibody
Regeneron
RegeneronTARRYTOWN, NY
1 program
1
CemiplimabPhase 1/2Monoclonal Antibody1 trial
Active Trials
NCT04046107Withdrawn0Est. Sep 2027
Dynavax Technologies
Dynavax TechnologiesCA - Emeryville
1 program
Adjuvanted Hepatitis B VaccineN/AVaccine1 trial
Active Trials
NCT04385524Withdrawn0Est. Feb 2021

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Bristol Myers SquibbEntecavir
Bristol Myers SquibbEntecavir
Bristol Myers SquibbEntecavir
Bristol Myers SquibbEntecavir
Bristol Myers SquibbEntecavir
Bristol Myers SquibbEntecavir
Bristol Myers SquibbEntecavir
Bristol Myers SquibbEntecavir
Bristol Myers SquibbEntecavir
Bristol Myers SquibbEntecavir
Bristol Myers SquibbEntecavir
Bristol Myers SquibbEntecavir
Bristol Myers SquibbEntecavir
Bristol Myers SquibbEntecavir
Bristol Myers SquibbEntecavir

Showing 15 of 35 trials with date data

Clinical Trials (35)

Total enrollment: 19,311 patients across 35 trials

NCT01594905Bristol Myers SquibbEntecavir

Entecavir Plus Tenofovir Combination in Subjects With Multi-drug Resistant Chronic Hepatitis B Virus Infection

Start: Aug 2012Est. completion: Apr 201490 patients
Phase 4Unknown
NCT00986778Bristol Myers SquibbEntecavir

Entecavir Plus Adefovir in Lamivudine-Resistant Patients

Start: Dec 2009Est. completion: Jun 20140
Phase 4Withdrawn
NCT00926757Bristol Myers SquibbEntecavir

Prophylactic Use of Entecavir for Non-Hodgkin's Lymphoma Patients With Resolved Hepatitis B

Start: Apr 2009Est. completion: Nov 201280 patients
Phase 4Completed
NCT00823550Bristol Myers SquibbEntecavir

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

Start: Jan 2009Est. completion: Jul 2015462 patients
Phase 4Unknown
NCT00718887Bristol Myers SquibbEntecavir

Suboptimal Responders to Adefovir Switching to Entecavir

Start: Jul 2008Est. completion: Jan 2011228 patients
Phase 4Completed
NCT00662545Bristol Myers SquibbEntecavir

Entecavir Intensification for Persistent HBV Viremia in HIV-HBV Infection

Start: Apr 2008Est. completion: May 201010 patients
Phase 4Completed
NCT00597259Bristol Myers SquibbEntecavir

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

Start: Jan 2008Est. completion: Feb 2014294 patients
Phase 4Unknown
NCT00393484Bristol Myers SquibbEntecavir

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

Start: Feb 2007Est. completion: Sep 2013122 patients
Phase 4Completed
NCT00605384Bristol Myers SquibbEntecavir

A Phase IIIb Study to Compare Entecavir Plus Tenofovir vs. Adefovir Added to Continuing Lamivudine Therapy in Adult Patients With Lamivudine-Resistant Hepatitis B Infection

Start: Aug 2008Est. completion: Feb 20094 patients
Phase 3Terminated
NCT00410202Bristol Myers SquibbEntecavir

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

Start: Mar 2008Est. completion: Jul 2012629 patients
Phase 3Completed
NCT00395018Bristol Myers SquibbEntecavir

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

Start: Apr 2007Est. completion: Mar 2011109 patients
Phase 3Completed
NCT00410072Bristol Myers SquibbEntecavir

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

Start: Apr 2007Est. completion: Oct 2010669 patients
Phase 3Completed
NCT00975091Bristol Myers SquibbEntecavir

Continue Entecavir Rollover From China

Start: May 2004Est. completion: Aug 2007600 patients
Phase 3Completed
NCT00065507Bristol Myers SquibbEntecavir

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

Start: Aug 2003Est. completion: May 2013195 patients
Phase 3Completed
NCT00036608Bristol Myers SquibbEntecavir

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

Start: Jan 2002Est. completion: Feb 2005
Phase 3Completed
NCT00035633Bristol Myers SquibbEntecavir

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

Start: Dec 2001Est. completion: Feb 2005
Phase 3Completed
NCT00035789Bristol Myers SquibbEntecavir

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

Start: Nov 2001Est. completion: May 2005
Phase 3Completed
NCT00051038Bristol Myers SquibbEntecavir

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

Start: Sep 2002Est. completion: Oct 2005
Phase 2/3Completed
NCT01204762Bristol Myers SquibbpegIFN

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

Start: Nov 2010Est. completion: Dec 2013197 patients
Phase 2Completed
NCT00476463Gilead SciencesEmtricitabine

Efficacy of Tenofovir and Emtricitabine in ARV-naive Patients With HIV/HBV Co-infection

Start: Apr 2005Est. completion: Dec 200824 patients
Phase 2Completed
NCT01037062Bristol Myers SquibbEntecavir

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

Start: Dec 2003Est. completion: Dec 2006282 patients
Phase 2Completed
NCT01022801Bristol Myers SquibbEntecavir

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

Start: Aug 2003Est. completion: Mar 2005120 patients
Phase 2Completed
NCT01020565Bristol Myers SquibbEntecavir

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

Start: Feb 2003Est. completion: Feb 200560 patients
Phase 2Completed
NCT01037166Bristol Myers SquibbEntecavir

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

Start: Dec 2002Est. completion: Feb 200584 patients
Phase 2Completed
NCT01438424Bristol Myers SquibbEntecavir

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

Start: Jan 2001Est. completion: Apr 20111,053 patients
Phase 2Completed
NCT04046107RegeneronCemiplimab

Safety and Immunotherapeutic Activity of Cemiplimab in Participants With HBV on Suppressive Antiviral Therapy

Start: Jan 2024Est. completion: Sep 20270
Phase 1/2Withdrawn
NCT00423891Bristol Myers SquibbEntecavir

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

Start: Jun 2007Est. completion: Sep 201764 patients
Phase 1/2Completed
NCT03083821Bristol Myers SquibbBaraclude

A Study to Provide a Better Understanding of Baraclude's Pharmacokinetic Properties in a Real World Clinical Setting

Start: May 2017Est. completion: Dec 20176 patients
Phase 1Completed
NCT02296853Gilead SciencesTAF

Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Adults With Normal Hepatic Function and Adults With Severe Hepatic Impairment

Start: Dec 2014Est. completion: Apr 201520 patients
Phase 1Completed
NCT04385524Dynavax TechnologiesAdjuvanted Hepatitis B Vaccine

Use of Dynavax Heplisav B in Healthcare Workers Previously Vaccinated With 3-dose Vaccine Who Failed to Demonstrate Seroprotection

Start: Jun 2020Est. completion: Feb 20210
N/AWithdrawn
NCT01356901Bristol Myers SquibbEntecavir

Persistence, Adherence and Clinical Effectiveness of Entecavir in Chronic Hepatitis B Patients

Start: Jan 2011Est. completion: Jan 2015230 patients
N/ACompleted
NCT00704106Bristol Myers SquibbEntecavir

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

Start: May 2008Est. completion: Oct 201160 patients
N/ACompleted
NCT00388674Bristol Myers SquibbEntecavir

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

Start: Dec 2006Est. completion: Oct 201612,522 patients
N/ACompleted
NCT00096811Bristol Myers SquibbEntecavir

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

Start: Sep 2003Est. completion: Aug 2008
N/ANo Longer Available
NCT01337479Bristol Myers SquibbEntecavir

A Phase IIIb: Long-Term Outcomes for Hepatitis B (HepB) Patients in Some Previous Entecavir (ETV) Trials

Start: Feb 2003Est. completion: Sep 20101,097 patients
N/ACompleted

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

5 companies competing in this space

Related Indications

HIV Infections(449)COVID-19(223)Hepatitis C(191)Influenza(173)HIV(138)HIV-1-infection(115)Hepatitis C, Chronic(94)Chronic Hepatitis B(93)Chronic Hepatitis C(91)Covid19(79)