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Drug Watch

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Compounds in Development for Chronic Hepatitis B

Updated Sept. 13, 2021

 

FAMILY/DRUG NAME

 

 

MECHANISM

 

COMPANY

 

WEBSITE


USA STATUS

Interferons: Mimic infection-fighting immune substances naturally produced in the body

 

Intron A (Interferon alfa 2b) Immunomodulator Merck, USA merck.com Approved 1991

Pegasys (Peginterferon alfa 2a)

Immunomodulator

Genentech, USA

genentech.com

Approved 2005

 

Nucleos(t)ide Analogues: Interfere with viral DNA polymerase used for HBV replication

Epivir (Lamivudine) *Generics available

Inhibits viral DNA polymerase  GlaxoSmithKline (GSK) gsk.com Approved 1998
Hepsera (Adefovir dipivoxil) *Generics available Inhibits viral DNA polymerase  Gilead Sciences, USA gilead.com Approved 2002

Baraclude (Entecavir) *Generics available

Inhibits viral DNA polymerase  Bristol-Myers Squibb, USA  bms.com Approved 2005 
Tyzeka (Telbivudine) *Generics available Inhibits viral DNA polymerase   Novartis, USA  novartis.com Approved 2006 
Viread (Tenofovir) *Generics available Inhibits viral DNA polymerase  Gilead Sciences  gilead.com Approved 2008 
Vemlidy (TAF or tenofovir alfenamide) Prodrug of Tenofovir  Gilead Sciences  gilead.com  Approved 2016 

Levovir (Cledvudine)

Inhibits viral DNA polymerase  Bukwang, S. Korea  bukwang.co.kr  Approved 2006 in S. Korea 

Besivo (formerly ANA 380/LB80380)

Inhibits viral DNA polymerase  Ildong Pharma, S. Korea  ildong.com  Approved 2017 in S. Korea 

Zadaxin

Immunomodulator SciClone, USA  sciclone.com  Approved outside USA 

ATI-2173 (Clevudine prodrug)

Inhibits HBV polymerase 

Antios Therapeutics, USA 

antiostherapeutics.com

Phase II

Direct Acting Antivirals: Targets the virus and interferes in the HBV replication process

Silencing RNA’s (siRNAs): Interferes and destroys viral RNA

VIR-2218

RNAi gene silencer 

Vir Biotech, USA

vir.bio

Phase II

RG6346 (DCR HBVS)

RNAi gene silencer

Roche, Switzerland, with Dicerna

roche.com

Phase II

JNJ-3989 (ARO-HBV)

RNAi gene silencer

J&J with Arrowhead, USA

arrowheadpharma.com

Phase II

AB-729

RNAi gene silencer

Arbutus Biopharma, USA

arbutusbio.com

Phase I

BB-103

RNAi gene silencer

Benitec, Australia

benitec.com

Preclinical

ALG-125097

RNAi gene silencer

Aligos Therapeutics, USA 

aligos.com

Preclinical

Entry Inhibitors: Interferes with HBV getting into liver cells

Hepcludex (Bulevirtide formerly Myrcludex B)

Entry inhibitor

MYR GmbH,             Germany

myr-pharma.com

Phase II

hzVSF

Entry inhibitor

ImmuneMed, South Korea

immunemed.co.kr/eng

 Phase I

Capsid or Core Inhibitors: Interferes with the viral DNA protein shield

Vebicorvir (ABI-H0731)

Capsid inhibitor

Assembly Biosciences, USA

assemblybio.com

Phase II/III

Morphothiadin                      

Capsid inhibitor 

HEC Pharma, PR China

pharm.hec.cn/en/ Phase II

JNJ 56136379

Capsid inhibitor

Janssen, Ireland

janssen.com

Phase II

EDP-514

Capsid inhibitor

Enanta, Pharma, USA

enanta.com

Phase II

R07049389 (RG7907)

Capsid inhibitor

Roche, Switzerland

roche.com

Phase I

QL-007

Capsid inhibitor

Qilu, PR China

en.qilu-pharma.com

Phase I

ABI-H3733

Capsid inhibitor

Assembly Biosciences, USA

assemblybio.com

Phase I

ZM-H1505R

Capsid inhibitor

ZhiMeng Biopharma, PR China

core-biopharma.com 

Phase I

ALG-000184

Capsid inhibitor

Aligos Therapeutics, USA

aligos.com

Phase I

B-836

Capsid Inhibitor

Arbutus, USA

arbutusbio.com

Phase I

VNRX-9945

Capsid Inhibitor

Venatorx, USA

venatorx.com

Phase I

GLP-26

Capsid inhibitor

Emory University, USA

emory.edu

Preclinical

ABI-4334

Capsid Inhibitor

Assembly Biosciences, USA

assemblybio.com

Preclinical

HBsAg Inhibitors: Interferes with production of HBV surface antigen (sAg)

REP 2139

sAg inhibitor

Replicor, Canada

replicor.com

Phase II

REP 2165

sAg inhibitor

Replicor, Canada

replicor.com

Phase II

ALG-10133

sAg inhibitor

Aligos Therapeutics, USA

aligos.com

Phase I

Antisense Molecules: Binds to the viral mRNA to prevent it from turning into viral protein

IONIS-HBVRx (GSK 3228836)

Prevent viral protein production

Ionis with GSK, USA

ionispharma.com

Phase II

ALG-020572

Prevent viral protein production  

Aligos Therapeutics, USA

aligos.com

Preclinical 

Gene Editing: Intended to destroy or repress HBV DNA

EBT107

CRISPR/Cas 9 Excision Bio, USA excisionbio.com Preclinical

HBV

ARCUS platform

Precision Bio, USA  precisionbiosciences.com Preclinical

Immunologicals: Targets the human immune system to attack the HBV virus

Therapeutic Vaccine Technology used to stimulate the immune system as a treatment  

NASVAC         

Therapeutic vaccine              

CIGB, Cuba

cigb.edu.cu/sobre-cigb/ Phase III 

GS-4774

Therapeutic vaccine

Gobelmmune with Gilead, USA

globeimmune.com

Phase II

HepTcell

Therapeutic vaccine

Altimmune, USA

altimmune.com

Phase II

VBI-2601 (BRII-179)

Therapeutic vaccine

VBI Vaccines, USA 

vbivaccines.com

Phase II

VVX001

Therapeutic vaccine

Viravaxx, Austria

viravaxx.com

Phase II

VTP-300

Therapeutic vaccine

Vaccitech, USA

vaccitech.co.uk

Phase I/II

CVI-HBV-002

Therapeutic vaccine

Cha Vaccine Institute, S. Korea

en.chavaccine.com

Phase I/II

AIC 649

Therapeutic vaccine

AiCuris, Germany

aicuris.com

Phase I

HB-110

Therapeutic vaccine

Ichor Medical with Genexine, USA

ichorms.com

Phase I

JNJ 64300535

Therapeutic vaccine

Janssen, Ireland

janssen.com

Phase I

CARG-201

Therapeutic vaccine

CaroGen, USA

carogencorp.com

Phase I

Chimigen HBV

Therapeutic vaccine

Akshaya, Canada

akshayabio.com Preclinical

HBV

Therapeutic vaccine

HOOKIPA Pharma, Austria, with Gilead

hookipapharma.com Preclinical 

TherVacB

Therapeutic vaccine

Helmholtz Zentrum Muenchen, Germany

dzif.de/en/hepatitis Preclinical

PRGN-2013

Therapeutic vaccine

Precigen

precigen.com Preclinical

ISA104

Therapeutic vaccine

ISA Pharma, The Netherlands

isa-pharma.com Preclinical

VRON-0200

Therapeutic vaccine

Viron Therapeutics, USA

viriontx.com Preclinical 

HBV Vaccine

Therapeutic vaccine

Clear B Therapeutics, USA and Australia

clearbtherapeutics.com Preclinical

Compounds that activate the innate immune system 

Selgantolimod (GS9688)

TLR-8 agonist

Gilead Sciences, USA

gilead.com

Phase II

RG7854

TLR-7 agonist

Roche, Switzerland

roche.com

Phase I

SBT 8230

TLR-8 agonist

Silverback Therapeutics, USA

silverbacktx.com Preclinical

YS-HBV-002

Activator of TLR3, RIG1, MDA5

YiSheng Biopharma, China

yishengbio.com Preclinical

Monoclonal Antibodies: Neutralize or bind the HBV proteins to reduce infection

Lenvervimab  (GC1102)

Monoclonal antibody GC Pharma, South Korea globalgreencross.com Phase II

Vir-3434

Monoclonal antibody Vir Biotech, USA vir.bio Phase I

Checkpoint Inhibitors: Stimulate exhausted T-cell recognition of HBV-Infected cells 

 

ASC22 (KN035 or Envafolimab)

PDL1 inhibitor Ascletis Pharma, PR China ascletis.com Phase II

GS 4224

PDL1 inhibitor  Gilead, USA gilead.com Phase I

Other Immunologicals

 

IMC-I109V

T-cell Receptor Immunocore immunocore.com Phase II

LTCR-H2-1

T Cell.             immunotherapy Lion TCR, Singapore liontcr.com Preclinical

Additional HBV Drugs Under Investigation

 

APG-1387

Apoptosis inducer Ascentage, PR China ascentagepharma.com Phase II

ASC42

FXR Agonist Ascletis, Hong Kong ascletis.com Phase II

EYP001

FXR agonist Enyo Pharma, France enyopharma.com Phase I 
EDP-721 RNA destabilizer Enanta Pharma, USA enanta.com Phase I

HBV

MicroRNA Regulus, USA regulusrx.com Preclinical

ENOB-HB-01

Gene modified cell therapy Enochian Bio, USA enochianbio.com Preclinical

GV1001

"Novel peptide" GemVax & KAEL, South Korea gemvax.com Preclinical

CP101

Oral microbiotic Finch Therapeutics, USA finchtherapeutics.com Preclinical

DF-006

Small molecule Drug Farm, Shanghai drug-farm.com  Preclinical

Hepatitis Delta Virus (HDV)- A virus that co-infects people already infected with HBV

Hepcludex (Bulevirtide formerly Myrcludex B)

Entry inhibitor

Gilead, USA

gilead.com

EU approved 2020

Phase III USA

Lonafarnib

Prenylation inhibitor

Eiger Biopharma,             USA

eigerbio.com

Orphan drug 
Phase III

Pegylated interferon-lambda

Immune modulator     

Eiger Biopharma    

eigerbio.com

Phase III Ready 

REP 2139

HBsAg inhibitor

Replicor, Canada

replicor.com

Phase II

Ezetimibe

NTCP inhibitor

Ziauddin University Hospital, Pakistan

zu.edu.pk

Phase II

JNJ-3989 (73763989) 

RNAi gene silencer

Janssen

janssen.com

 Phase II

GI-18000

Immune Response Stimulator

GlobeImmune, USA

globeimmune.com

Preclinical

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