Chronic Hepatitis B

Infectious Diseases
79
Pipeline Programs
16
Companies
50
Clinical Trials
1 recruiting
5
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
19
4
32
0
9
15
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
5100%
+ 81 programs with unclassified modality

On Market (5)

Approved therapies currently available

Bristol Myers Squibb
BARACLUDEApproved
entecavir
Bristol Myers Squibb
oral2005
GS
COMPLERAApproved
emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate
Gilead Sciences
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]oral2011
U
ENTECAVIRApproved
entecavir
Unknown Company
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]oral2017
U
TENOFOVIR DISOPROXIL FUMARATEApproved
tenofovir disoproxil fumarate
Unknown Company
oral2024
GS
VIREADApproved
tenofovir disoproxil fumarate
Gilead Sciences
oral2001

Competitive Landscape

16 companies ranked by most advanced pipeline stage

GS
Gilead SciencesFOSTER CITY, CA
32 programs
13
5
6
TDFPhase 44 trials
TDFPhase 4
Tenofovir disoproxil fumaratePhase 41 trial
tenofovirPhase 4Small Molecule1 trial
tenofovirPhase 4Small Molecule
+27 more programs
Active Trials
NCT07449091Not Yet Recruiting55Est. Sep 2027
NCT02258581Terminated241Est. Aug 2017
NCT04980664Unknown2,000Est. Jul 2023
+28 more trials
CT
9 programs
2
4
1
Entecavir maleate tabletsPhase 41 trial
ETVPhase 21 trial
TQ-A3334Phase 21 trial
TQA3605 tablets PlaceboPhase 21 trial
TQA3810 tablets+NUCPhase 21 trial
+4 more programs
Active Trials
NCT03847246CompletedEst. Dec 2018
NCT02287857UnknownEst. Oct 2019
NCT06085053UnknownEst. Dec 2025
+6 more trials
Bristol Myers Squibb
3 programs
1
1
Group APhase 41 trial
EntecavirPhase 3Small Molecule1 trial
Effectiveness of Nucleos(t)Ide Analogs (NUC) Therapy Among Naive CHB Patients in ChinaN/A1 trial
Active Trials
NCT01726439Completed3,434Est. Dec 2018
NCT01063036Completed144Est. Feb 2014
NCT01597934Unknown104Est. May 2014
Roche
RocheSTAVANGER NORWAY, Norway
3 programs
1
1
1
Pegylated Interferon-alfa-2aPhase 41 trial
Pegylated interferon-alpha-2aPhase 31 trial
RO7565020Phase 11 trial
Active Trials
NCT05763576Terminated60Est. Dec 2024
NCT01172392Unknown185Est. Jun 2015
NCT00226382Completed50Est. Apr 2008
M&
Merck & Co.RAHWAY, NJ
2 programs
1
1
peg-interferon alpha 2b, 1.5mcg/kg s/c given weeklyPhase 41 trial
TelbivudinePhase 31 trial
Active Trials
NCT00142298Completed1,869Est. Nov 2009
NCT01928511Completed254Est. Dec 2018
E
EisaiChina - Liaoning
1 program
1
ClevudinePhase 31 trial
Active Trials
NCT01192854Completed288Est. May 2011
Assembly Biosciences
Assembly BiosciencesSOUTH SAN FRANCISCO, CA
16 programs
9
1
6
ABI-H0731Phase 21 trial
ABI-H0731Phase 21 trial
ABI-H0731Phase 21 trial
ABI-H0731Phase 21 trial
ABI-H2158Phase 21 trial
+11 more programs
Active Trials
NCT06384131CompletedEst. May 2025
NCT05569941CompletedEst. Apr 2023
NCT02908191CompletedEst. Jun 2018
+13 more trials
Vir Biotechnology
Vir BiotechnologyCA - San Francisco
5 programs
2
1
2
Tenofovir AlafenamidePhase 2
VIR-2218Phase 2
VIR-2218Phase 1/2
VIR-3434Phase 11 trial
VRON-0200-AdC6Phase 11 trial
Active Trials
NCT04423393CompletedEst. Nov 2022
NCT06070051Active Not RecruitingEst. Mar 2026
Qilu Pharmaceutical
Qilu PharmaceuticalChina - Jinan
4 programs
2
2
TDF tabletPhase 21 trial
TDF tabletPhase 21 trial
QL-007 tabletPhase 11 trial
QL-007 tabletPhase 11 trial
Active Trials
NCT03244085UnknownEst. Dec 2018
NCT03770624UnknownEst. Apr 2019
NCT04157257UnknownEst. Oct 2022
+1 more trials
Suzhou Ribo Life Science Company
2 programs
1
1
RBD1016Phase 21 trial
RBD1016Phase 11 trial
Active Trials
NCT05017116CompletedEst. Oct 2023
NCT05961098CompletedEst. Oct 2025
Alnylam Pharmaceuticals
2 programs
1
1
VIR-2218Phase 21 trial
VIR-2218Phase 1/21 trial
Active Trials
NCT03672188Completed82Est. Sep 2020
NCT04412863Completed84Est. Mar 2024
Arrowhead Pharmaceuticals
2 programs
2
ARC-520Phase 21 trial
ARC-520 InjectionPhase 21 trial
Active Trials
NCT02452528Terminated4Est. Dec 2016
NCT02349126Withdrawn0Est. Mar 2016
Biotest Pharmaceuticals
Biotest PharmaceuticalsGermany - Dreieich
1 program
1
Human hepatitis B ImmunoglobulinPhase 21 trial
Active Trials
NCT05345990TerminatedEst. Jul 2025
Novartis
NovartisBASEL, Switzerland
1 program
1
albinterferon alfa-2bPhase 1/21 trial
Active Trials
NCT00964665Terminated141
Transgene
TransgeneFrance - Illkirch-Graffenstaden
2 programs
1
TG1050Phase 11 trial
blood drawN/A1 trial
Active Trials
NCT02355951CompletedEst. Feb 2016
NCT02428400CompletedEst. Nov 2018
GC Biopharma
GC BiopharmaKorea - Yongin
1 program
1
GC1102Phase 11 trial
Active Trials
NCT02569372CompletedEst. Oct 2017

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
Gilead Sciencestenofovir disoproxil fumarate
Merck & Co.peg-interferon alpha 2b, 1.5mcg/kg s/c given weekly
Gilead Sciencestenofovir
Bristol Myers SquibbGroup A
Gilead Sciencestenofovir disoproxil fumarate 300mg per day
Gilead SciencesTDF
Gilead SciencesTDF
Chia Tai TianQing Pharmaceutical GroupEntecavir maleate tablets
Gilead SciencesTenofovir disoproxil fumarate
Gilead SciencesTDF
RochePegylated Interferon-alfa-2a
Gilead SciencesTAF
Gilead Sciencestenofovir disoproxil fumarate
Gilead Sciencestenofovir disoproxil fumarate
Gilead Sciencestenofovir disoproxil fumarate

Showing 15 of 47 trials with date data

Clinical Trials (50)

Total enrollment: 11,951 patients across 50 trials

NCT02957864Gilead Sciencestenofovir disoproxil fumarate

Switching From Tenofovir Disoproxil Fumarate to Abacavir or Tenofovir Alafenamide

Start: Oct 2016Est. completion: Sep 202080 patients
Phase 4Unknown
NCT01928511Merck & Co.peg-interferon alpha 2b, 1.5mcg/kg s/c given weekly

Efficacy of Switching or Adding Pegylated Interferon in Chronic Hepatitis B Patients on Long Term Oral Antiviral Therapy

Start: Jan 2014Est. completion: Dec 2018254 patients
Phase 4Completed
NCT01711567Gilead Sciencestenofovir

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

Start: Apr 2013Est. completion: Nov 201660 patients
Phase 4Completed
NCT01597934Bristol Myers SquibbGroup A

Antiviral Efficacy of Switching to ETV Plus TDF

Start: Aug 2012Est. completion: May 2014104 patients
Phase 4Unknown
NCT01522625Gilead Sciencestenofovir disoproxil fumarate 300mg per day

Tenofovir in Chronic Hepatitis B With Mild ALT Elevation

Start: Jan 2012Est. completion: Dec 2018160 patients
Phase 4Completed
NCT01277601Gilead SciencesTDF

Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B

Start: Apr 2011Est. completion: Jul 2015751 patients
Phase 4Completed
NCT01751555Gilead SciencesTDF

Efficacy and Safety of TDF+3TC+EFV in Adults With HIV/HBV Coinfection

Start: Feb 2011Est. completion: Jun 2013100 patients
Phase 4Completed
NCT01926288Chia Tai TianQing Pharmaceutical GroupEntecavir maleate tablets

Efficacy and Safety of Entecavir Maleate Tablets in Chinese Patients With Hepatitis B

Start: Oct 2008Est. completion: Mar 2014
Phase 4Completed
NCT00736190Gilead SciencesTenofovir disoproxil fumarate

A Study to Evaluate Tenofovir Disoproxil Fumarate (DF) in Asian-American Adults With Chronic Hepatitis B Infection

Start: Aug 2008Est. completion: Jul 201090 patients
Phase 4Completed
NCT00389194Gilead SciencesTDF

PREventing Progression of Adipose Tissue Redistribution

Start: Apr 2006Est. completion: Oct 2008120 patients
Phase 4Completed
NCT00226382RochePegylated Interferon-alfa-2a

Treatment With Peginterferon Alfa-2a (40 KD) of Chronic Hepatitis B Patients, Who Have Failed Anti-viral Treatment

Start: Jan 2005Est. completion: Apr 200850 patients
Phase 4Completed
NCT00007436Gilead Sciencestenofovir disoproxil fumarate

The Safety of Tenofovir Disoproxil Fumarate Taken With Other Anti-HIV Drugs to Treat HIV-Infected Patients

Phase 3Unknown
NCT00002450Gilead Sciencestenofovir disoproxil fumarate

Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients

600 patients
Phase 3Completed
NCT02979613Gilead SciencesTAF

Study to Evaluate Efficacy and Safety of Switching From TDF to TAF in Adults With Chronic Hepatitis B Who Are Virologically Suppressed

Start: Dec 2016Est. completion: Jan 2020490 patients
Phase 3Completed
NCT02600117Gilead Sciencestenofovir disoproxil fumarate

Use of TDF in Patients With Inactive Chronic Hepatitis B Infection

Start: Jan 2016Est. completion: Feb 202350 patients
Phase 3Completed
NCT02616783Gilead Sciencestenofovir disoproxil fumarate

Switching From a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Adults Aged ≥ 60 Years

Start: Dec 2015Est. completion: Mar 2018167 patients
Phase 3Completed
NCT02836249Gilead Sciencestenofovir disoproxil fumarate

Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Positive Hepatitis B (China)

Start: Jun 2015Est. completion: Aug 2023181 patients
Phase 3Completed
NCT02836236Gilead Sciencestenofovir disoproxil fumarate

Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B (China)

Start: Jun 2015Est. completion: Sep 2023155 patients
Phase 3Completed
NCT01940471Gilead Sciencestenofovir disoproxil fumarate

Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Positive for Hepatitis B e Antigen

Start: Sep 2013Est. completion: Oct 2022875 patients
Phase 3Completed
NCT01745822Gilead Sciencestenofovir disoproxil fumarate

Maternal Antiviral Prophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus in Thailand

Start: Jan 2013Est. completion: Oct 2018654 patients
Phase 3Completed
NCT01651403Gilead SciencesTenofovir DF

Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection

Start: Dec 2012Est. completion: Jul 202790 patients
Phase 3Active Not Recruiting
NCT01872988Gilead SciencesTenofovir

Tenofovir Antiviral Therapy Following Transarterial Chemoembolization for HBV Related Hepatocellular Carcinoma

Start: Sep 2012Est. completion: Feb 2018320 patients
Phase 3Terminated
NCT01309243Gilead Sciencestenofovir disoproxil fumarate

Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Start: Feb 2011Est. completion: Feb 2014799 patients
Phase 3Completed
NCT01172392RochePegylated interferon-alpha-2a

A Randomized Study to Assess the Loss of HbsAg After a 48-week Treatment Period With Pegylated Interferon Alpha 2a in Patients With Chronic Hepatitis B

Start: Jan 2011Est. completion: Jun 2015185 patients
Phase 3Unknown
NCT01063036Bristol Myers SquibbEntecavir

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

Start: May 2010Est. completion: Feb 2014144 patients
Phase 3Completed
NCT01108510Gilead Sciencestenofovir disoproxil fumarate

Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Start: Apr 2010Est. completion: Apr 2015698 patients
Phase 3Completed
NCT01192854EisaiClevudine

An Study of Efficacy and Safety of Clevudine

Start: Feb 2010Est. completion: May 2011288 patients
Phase 3Completed
NCT00734162Gilead Sciencestenofovir disoproxil fumarate

Evaluation of Tenofovir Disoproxil Fumarate in Adolescents With Chronic Hepatitis B Infection

Start: Dec 2008Est. completion: Dec 2015106 patients
Phase 3Completed
NCT00116805Gilead Sciencestenofovir disoproxil fumarate

A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Positive Chronic Hepatitis B

Start: Jun 2005Est. completion: Jan 2016266 patients
Phase 3Completed
NCT00142298Merck & Co.Telbivudine

Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies

Start: Mar 2005Est. completion: Nov 20091,869 patients
Phase 3Completed
NCT00117676Gilead SciencesTDF

A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Negative Chronic Hepatitis B

Start: Feb 2005Est. completion: Jan 2016382 patients
Phase 3Completed
NCT00071201Gilead SciencesAdefovir Dipivoxil for oral suspension, 2 mg/mL

Evaluate Efficacy, Safety and PK of Adefovir Dipivoxil Liquid Suspension in Patients With Chronic Hepatitis B

Start: Jun 2003Est. completion: Mar 200648 patients
Phase 3Completed
NCT00111150Gilead Sciencestenofovir disoproxil fumarate

Botswana Tenofovir Oral HIV Prophylaxis Trial

Start: Sep 2005Est. completion: Mar 20071,200 patients
Phase 2/3Terminated
NCT00002415Gilead Sciencestenofovir disoproxil fumarate

Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients

175 patients
Phase 2Completed
NCT06990776Chia Tai TianQing Pharmaceutical GroupTQA3605 tablets Placebo

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

Start: Jul 2025Est. completion: Jul 2025
Phase 2Withdrawn
NCT06566248Chia Tai TianQing Pharmaceutical GroupTQA3810 tablets+NUC

A Clinical Trial to Evaluate the Efficacy and Safety of TQA3810 Tablets in Combination/Non Combination With Nucleoside (Acid) Analogues in Patients With Primary/Treated Chronic Hepatitis B

Start: Mar 2024Est. completion: Mar 2025
Phase 2Recruiting
NCT06101329Gilead Sciencestenofovir disoproxil fumarate

Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)

Start: Nov 2023Est. completion: Jan 2028253 patients
Phase 2Active Not Recruiting
NCT05961098Suzhou Ribo Life Science CompanyRBD1016

A Study of RBD1016 in CHB Participants

Start: Oct 2023Est. completion: Oct 2025
Phase 2Completed
NCT05345990Biotest PharmaceuticalsHuman hepatitis B Immunoglobulin

Treatment of Patients With Chronic Hepatitis B With Hepatitis B Immunoglobulins

Start: Aug 2022Est. completion: Jul 2025
Phase 2Terminated
NCT04891770Gilead SciencesTenofovir Alafenamide

Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)

Start: Aug 2021Est. completion: Jul 2024103 patients
Phase 2Completed
NCT04820686Assembly BiosciencesVBR

A Study Evaluating Treatment Regimens Containing Vebicorvir (ABI-H0731) in Participants With Chronic Hepatitis B Infection

Start: May 2021Est. completion: Mar 2023
Phase 2Terminated
NCT04781647Assembly BiosciencesABI-H0731

A Study Evaluating ABI-H0731-containing Regimens in Chinese Participants With Chronic Hepatitis B Virus Infection

Start: Feb 2021Est. completion: Dec 2022
Phase 2Terminated
NCT04454567Assembly BiosciencesABI-H0731

A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors

Start: Nov 2020Est. completion: Apr 2021
Phase 2Terminated
NCT04398134Assembly BiosciencesABI-H2158

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

Start: Aug 2020Est. completion: Dec 2021
Phase 2Terminated
NCT04412863Alnylam PharmaceuticalsVIR-2218

Study of VIR-2218 With or Without Pegylated Interferon Alpha-2a for Treatment of Chronic Hepatitis B Virus Infection

Start: Jul 2020Est. completion: Mar 202484 patients
Phase 2Completed
NCT04202653Chia Tai TianQing Pharmaceutical GroupETV

Combination of ETV, TQ-A3334 and TQ-B2450 for CHB (Neptune Study)

Start: Jan 2020Est. completion: Jun 2021
Phase 2Unknown
NCT04180150Chia Tai TianQing Pharmaceutical GroupTQ-A3334

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

Start: Nov 2019Est. completion: Dec 2021
Phase 2Unknown
NCT04157257Qilu PharmaceuticalTDF tablet

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

Start: Jul 2019Est. completion: Oct 2022
Phase 2Unknown
NCT04157699Qilu PharmaceuticalTDF tablet

An Study to Evaluate Safety and Efficacy of QL-007 Tablets in Combination With Tenofovir in Naive Patients With Chronic Hepatitis b

Start: Jul 2019Est. completion: Oct 2022
Phase 2Unknown
NCT03577171Assembly BiosciencesABI-H0731

A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)

Start: Jun 2018Est. completion: Jun 2019
Phase 2Completed

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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

9 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 11,951 patients
16 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 C(91)Covid19(79)HIV Infection(75)