Hepatitis B

Infectious Diseases
44
Pipeline Programs
18
Companies
50
Clinical Trials
1 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
10
2
13
1
14
4
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Vaccine
267%
Small Molecule
133%
+ 54 programs with unclassified modality

On Market (1)

Approved therapies currently available

Bristol Myers Squibb
BARACLUDEApproved
entecavir
Bristol Myers Squibb
oral2005

Competitive Landscape

18 companies ranked by most advanced pipeline stage

GS
Gilead SciencesFOSTER CITY, CA
21 programs
3
1
3
1
1
1
Tenofovir DFPhase 41 trial
TDFPhase 31 trial
TRUVADAPhase 2/31 trial
Adefovir DipivoxilPhase 21 trial
Tenofovir DFPhase 21 trial
+16 more programs
Active Trials
NCT01590615Completed54Est. Apr 2017
NCT02687061Unknown300Est. Dec 2016
NCT01767597Completed1,000Est. Jan 2013
+15 more trials
M&
Merck & Co.RAHWAY, NJ
5 programs
1
3
1
Hep-V VaxPhase 41 trial
HBVAXPRO™Phase 31 trial
LdTPhase 31 trial
Modified Process Hepatitis B VaccinePhase 3Vaccine5 trials
HepeX-BPhase 21 trial
Active Trials
NCT00228592TerminatedEst. Aug 2005
NCT04490499Completed207Est. Dec 2020
NCT00275652Completed6Est. Aug 2007
+6 more trials
VBI Vaccines
VBI VaccinesMA - Cambridge
3 programs
2
1
Sci-B-Vac™Phase 41 trial
Sci-B-Vac-Lot BPhase 31 trial
Sci-B-Vac®Phase 31 trial
Active Trials
NCT04531098CompletedEst. Dec 2008
NCT04209400CompletedEst. Apr 2015
NCT04179786CompletedEst. Apr 2017
Bristol Myers Squibb
1 program
1
1
entecavirPhase 3Small Molecule1 trial
Active Trials
NCT00096785Completed69Est. Apr 2008
Dynavax Technologies
Dynavax TechnologiesCA - Emeryville
5 programs
2
2
1
HEPLISAV and/or PlaceboPhase 31 trial
1018 ISS-HBsAg-SinglePhase 21 trial
HEPLISAVPhase 21 trial
1018 ISS immunostimulatory oligonucleotide with HBV surface antigenPhase 11 trial
HEPLISAVPhase 11 trial
Active Trials
NCT00426712Completed42Est. Mar 2008
NCT01999699Completed25Est. Mar 2015
NCT00498212Terminated41Est. Oct 2008
+2 more trials
GC Biopharma
GC BiopharmaKorea - Yongin
3 programs
1
1
1
Undiluted I.V.-Hepabig injPhase 31 trial
GC1102Phase 21 trial
GC1102Phase 11 trial
Active Trials
NCT01606163CompletedEst. Dec 2013
NCT03801798UnknownEst. Dec 2021
NCT05686759RecruitingEst. Jun 2026
Sanofi
SanofiPARIS, France
3 programs
3
DTaP-IPV-HB-PRP~TPhase 35 trials
Euvax B®: Hepatitis B vaccinePhase 3Vaccine1 trial
HBVaxPRO® 5 µg / 0.5 mLPhase 31 trial
Active Trials
NCT02610348Completed122Est. Mar 2016
NCT00619502Completed254Est. Jul 2008
NCT00404651Completed1,189Est. Jul 2008
+4 more trials
Grifols
GrifolsNEW YORK, NY
1 program
1
Hepatitis B immune globulinPhase 31 trial
Active Trials
NCT01131065CompletedEst. Jun 2014
Biotest Pharmaceuticals
Biotest PharmaceuticalsGermany - Dreieich
1 program
1
ZutectraPhase 31 trial
Active Trials
NCT01856413CompletedEst. Sep 2014
Arrowhead Pharmaceuticals
6 programs
1
1
4
ARC-520Phase 21 trial
ARC-520Phase 21 trial
ARC-520 InjectionPhase 21 trial
ARC-520 InjectionPhase 21 trial
ARO-HBVPhase 1/21 trial
+1 more programs
Active Trials
NCT02797522Terminated47Est. Nov 2016
NCT03365947Completed114Est. Apr 2020
NCT02577029Terminated79Est. Dec 2016
+3 more trials
Ionis Pharmaceuticals
1 program
1
IONIS-HBVRxPhase 21 trial
Active Trials
NCT02981602Completed31Est. Dec 2019
Novartis
NovartisBASEL, Switzerland
1 program
1
telbivudinePhase 21 trial
Active Trials
NCT00124241CompletedEst. Nov 2005
Alnylam Pharmaceuticals
1 program
1
ALN-HBVPhase 11 trial
Active Trials
NCT02826018Terminated24Est. Oct 2017
Hepion Pharmaceuticals
1 program
1
CRV431Phase 11 trial
Active Trials
NCT03596697Completed92Est. Jun 2021
CT
1 program
1
TQ-A3334 tabletsPhase 11 trial
Active Trials
NCT06160895CompletedEst. Aug 2024
Roche
RocheSTAVANGER NORWAY, Norway
1 program
ELISA testingN/A
Mission Therapeutics
Mission TherapeuticsUK - Cambridge
1 program
HBSAgN/A1 trial
Active Trials
NCT04325542Completed743Est. Feb 2018
Abbott
AbbottABBOTT PARK, IL
1 program
birth dose vaccination against hepatitis B strategyN/A

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
VBI VaccinesSci-B-Vac™
Gilead SciencesTenofovir DF
Merck & Co.Hep-V Vax
GC BiopharmaUndiluted I.V.-Hepabig inj
Merck & Co.HBVAXPRO™
SanofiEuvax B®: Hepatitis B vaccine
VBI VaccinesSci-B-Vac®
Biotest PharmaceuticalsZutectra
Merck & Co.Modified Process Hepatitis B Vaccine
Merck & Co.Modified Process Hepatitis B Vaccine
GrifolsHepatitis B immune globulin
SanofiHBVaxPRO® 5 µg / 0.5 mL
Gilead SciencesTDF
SanofiDTaP-IPV-HB-PRP~T
Dynavax TechnologiesHEPLISAV and/or Placebo

Showing 15 of 48 trials with date data

Clinical Trials (50)

Total enrollment: 16,139 patients across 50 trials

NCT04179786VBI VaccinesSci-B-Vac™

A Study to Qualify an In-house Reference Standard Batch of Sci-B-Vac™

Start: Nov 2015Est. completion: Apr 2017
Phase 4Completed
NCT02479880Gilead SciencesTenofovir DF

Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection

Start: Jul 2015Est. completion: Apr 201830 patients
Phase 4Terminated
NCT00222664Merck & Co.Hep-V Vax

Qidong Hepatitis B Intervention Study

Start: Sep 1983Est. completion: Dec 2004
Phase 4Completed
NCT05686759GC BiopharmaUndiluted I.V.-Hepabig inj

A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.

Start: Apr 2023Est. completion: Jun 2026
Phase 3Recruiting
NCT04490499Merck & Co.HBVAXPRO™

A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)

Start: Sep 2020Est. completion: Dec 2020207 patients
Phase 3Completed
NCT02697474SanofiEuvax B®: Hepatitis B vaccine

Anti-Hep B Antibodies at Age 9 to 10 Years After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine.

Start: Feb 2016Est. completion: Jan 2017150 patients
Phase 3Completed
NCT04209400VBI VaccinesSci-B-Vac®

Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Sci-B-Vac® Compared to Engerix-B®

Start: Apr 2014Est. completion: Apr 2015
Phase 3Completed
NCT01856413Biotest PharmaceuticalsZutectra

A Clinical Trial of Zutectra in Patients Who Recently Received a Liver Transplant

Start: Dec 2012Est. completion: Sep 2014
Phase 3Completed
NCT01463683Merck & Co.Modified Process Hepatitis B Vaccine

Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062)

Start: Nov 2011Est. completion: Nov 2012722 patients
Phase 3Completed
NCT01251276Merck & Co.Modified Process Hepatitis B Vaccine

Hepatitis B Challenge Dose in Adults (V232-059-10)

Start: Nov 2010Est. completion: Apr 2011204 patients
Phase 3Completed
NCT01131065GrifolsHepatitis B immune globulin

Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients

Start: Jul 2010Est. completion: Jun 2014
Phase 3Completed
NCT00693186SanofiHBVaxPRO® 5 µg / 0.5 mL

A Study to Assess the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children After a Primary Vaccination Series With Either HEXAVAC® or INFANRIX®-HEXA

Start: Oct 2008Est. completion: Mar 2010410 patients
Phase 3Completed
NCT00737568Gilead SciencesTDF

Tenofovir Disoproxil Fumarate (Tenofovir DF) Versus Emtricitabine/Tenofovir DF in Subjects Resistant to Lamivudine

Start: Sep 2008Est. completion: Feb 2015280 patients
Phase 3Completed
NCT00619502SanofiDTaP-IPV-HB-PRP~T

Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants

Start: Dec 2007Est. completion: Jul 2008254 patients
Phase 3Completed
NCT00435812Dynavax TechnologiesHEPLISAV and/or Placebo

Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine

Start: Dec 2006Est. completion: Mar 20082,428 patients
Phase 3Completed
NCT00404651SanofiDTaP-IPV-HB-PRP~T

Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants

Start: Nov 2006Est. completion: Jul 20081,189 patients
Phase 3Completed
NCT00440531Merck & Co.Modified Process Hepatitis B Vaccine

Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)

Start: Nov 2006Est. completion: Nov 2007540 patients
Phase 3Completed
NCT00414050Merck & Co.Modified Process Hepatitis B Vaccine

A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)

Start: Oct 2006Est. completion: Oct 20071,718 patients
Phase 3Completed
NCT00401531SanofiDTaP-IPV-HB-PRP~T

Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants

Start: Oct 2006Est. completion: Aug 2008412 patients
Phase 3Completed
NCT00393523Merck & Co.Modified Process Hepatitis B Vaccine

Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED)

Start: Sep 2006Est. completion: Jun 20081,478 patients
Phase 3Completed
NCT00362336SanofiDTaP-IPV-HB-PRP~T

Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV

Start: Aug 2006Est. completion: Aug 2009622 patients
Phase 3Completed
NCT00315055SanofiDTaP-IPV-HB-PRP~T

Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule

Start: Jul 2006Est. completion: Feb 2008310 patients
Phase 3Completed
NCT00313911SanofiDTaP-IPV-HB-PRP~T

Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.

Start: Jul 2006Est. completion: Feb 20082,133 patients
Phase 3Completed
NCT04531098VBI VaccinesSci-B-Vac-Lot B

A Bridging Study: Comparing Two Lots of Sci-B-Vac™ and Engerix-B in Healthy Adults

Start: Mar 2006Est. completion: Dec 2008
Phase 3Completed
NCT00489099Merck & Co.Modified Process Hepatitis B Vaccine

A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054)

Start: Jun 2005Est. completion: May 2006860 patients
Phase 3Completed
NCT00096785Bristol Myers Squibbentecavir

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

Start: Dec 2004Est. completion: Apr 200869 patients
Phase 3Completed
NCT00275652Merck & Co.LdT

A Comparison of the Drug Telbivudine (LdT) and Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis.

Start: Jun 2004Est. completion: Aug 20076 patients
Phase 3Completed
NCT00391638Gilead SciencesTRUVADA

Efficacy and Tolerance of Peg-interferon Alpha 2a Added to Tenofovir and Emtricitabine in AgHBe Positive HBV-HIV Co-infected Patients

Start: Jan 2007Est. completion: Oct 201256 patients
Phase 2/3Completed
NCT00002219Gilead SciencesAdefovir dipivoxil

Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children

36 patients
Phase 2Unknown
NCT00124241Novartistelbivudine

An Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients With Chronic Hepatitis B

Est. completion: Nov 2005
Phase 2Completed
NCT00228592Merck & Co.HepeX-B

HepeX-B in Post Hepatic Allografts for Treatment of End Stage Liver Disease Due to Hepatitis B Infection

Est. completion: Aug 2005
Phase 2Terminated
NCT03801798GC BiopharmaGC1102

A Study of GC1102(Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients

Start: Feb 2019Est. completion: Dec 2021
Phase 2Unknown
NCT02981602Ionis PharmaceuticalsIONIS-HBVRx

Safety, Tolerability, Pharmacokinetics and Antiviral Activity of IONIS-HBVRx in Treatment-Naïve Patients With Chronic HBV Infection

Start: Feb 2017Est. completion: Dec 201931 patients
Phase 2Completed
NCT02738008Arrowhead PharmaceuticalsARC-520 Injection

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

Start: Mar 2016Est. completion: Dec 201612 patients
Phase 2Terminated
NCT02577029Arrowhead PharmaceuticalsARC-520

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

Start: Dec 2015Est. completion: Dec 201679 patients
Phase 2Terminated
NCT02604212Arrowhead PharmaceuticalsARC-520

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

Start: Nov 2015Est. completion: Dec 201632 patients
Phase 2Terminated
NCT02604199Arrowhead PharmaceuticalsARC-520 Injection

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

Start: Sep 2015Est. completion: Jan 201758 patients
Phase 2Terminated
NCT01334567Gilead SciencesTenofovir DF

Rollover Protocol Continued Access to Tenofovir Disoproxil Fumarate (TDF) for Subjects in Taiwan

Start: Aug 2010Est. completion: Dec 201330 patients
Phase 2Completed
NCT00498212Dynavax Technologies1018 ISS-HBsAg-Single

A Safety and Efficacy Study of a Single or Double Dose of HEPLISAV™ Hepatitis B Vaccine in Adults With End-Stage Renal Disease

Start: Jul 2007Est. completion: Oct 200841 patients
Phase 2Terminated
NCT00511095Dynavax TechnologiesHEPLISAV

Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine

Start: Jun 2007Est. completion: Mar 2008207 patients
Phase 2Completed
NCT00322361Merck & Co.Modified Process Hepatitis B Vaccine

Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056)

Start: May 2006Est. completion: Jul 2007566 patients
Phase 2Completed
NCT00831311SanofiDTaP-IPV-HB-PRP~T

Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants

Start: Oct 2004Est. completion: Mar 2007624 patients
Phase 2Completed
NCT00644761Gilead SciencesAdefovir Dipivoxil

PK Study of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil in Post-Liver Transplant Patients

Start: Feb 2004Est. completion: May 200516 patients
Phase 2Completed
NCT03365947Arrowhead PharmaceuticalsARO-HBV

Study of ARO-HBV in Normal Adult Volunteers and Patients With Hepatitis B Virus (HBV)

Start: Mar 2018Est. completion: Apr 2020114 patients
Phase 1/2Completed
NCT01146808Gilead SciencesAdefovir dipivoxil

Adefovir Plus Vaccination in Transplant Patients Without Hepatitis B That Receive a Core Antibody Positive Liver

Start: Mar 2006Est. completion: Sep 201216 patients
Phase 1/2Completed
NCT00645294Gilead SciencesAdefovir dipivoxil

Open Label Study of Pharmacokinetics and Safety of Dose of Adefovir Dipivoxil in Children and Adolescents With HBV

Start: Feb 2003Est. completion: Aug 200347 patients
Phase 1/2Completed
NCT00002346Gilead SciencesAdefovir dipivoxil

The Safety and Effectiveness of Bis-POM PMEA in HIV-Infected Patients

36 patients
Phase 1Completed
NCT06160895Chia Tai TianQing Pharmaceutical GroupTQ-A3334 tablets

A Clinical Trial of TQ-A3334 Tablet After Multiple Administration in Adult Subjects

Start: Dec 2023Est. completion: Aug 2024
Phase 1Completed
NCT03596697Hepion PharmaceuticalsCRV431

A Study in Healthy Volunteers

Start: Jul 2019Est. completion: Jun 202192 patients
Phase 1Completed
NCT02826018Alnylam PharmaceuticalsALN-HBV

A Study of ALN-HBV in Healthy Adult Volunteers and Non-cirrhotic Patients With Chronic Hepatitis B Virus (HBV) Infection

Start: Jun 2016Est. completion: Oct 201724 patients
Phase 1Terminated

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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

14 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 16,139 patients
18 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)