Drug Watch

Compounds in Development for Chronic Hepatitis B

Updated November 19, 2019

 

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

gene.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)
*Generic 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 alafenamide)

Prodrug of tenofovir

Gilead Sciences

gilead.com 

Approved 2016

Levovir (Clevudine)

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/eng/main/main.id

Approved 2017 in S. Korea

Zadaxin 

Immunomodulator

SciClone, USA

sciclone.com

Approved outside USA

 

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 

Alnylam and Vir Biotech, USA

alnylam.com

Phase II

RG6004 

RNAi gene silencer

Roche, Switzerland

roche.com

Phase I/II

ARO-HBV

RNAi gene silencer

Arrowhead Pharma with Janssen, USA

arrowheadpharma.com

Phase I/II

AB-729

RNAi gene silencer

Arbutus Biopharma, USA

arbutusbio.com

Phase I

DCR-HBVS

RNAi gene silencer

Dicerna, USA with Roche

dicerna.com

Phase I

BB-103

RNAi gene silencer

Benitec, Australia

benitec.com

Preclinical

Lunar-HBV

RNAi gene silencer

Arcturus with Janssen, USA 

arcturusrx.com

Preclinical

 

Entry Inhibitors: Interferes with HBV getting into liver cells

Bulevirtide  (Myrcludex B)

Entry inhibitor

Hepatera, Russia with MYR GmbH, Germany

myr-pharma.com

Phase IIb

 

Capsid Inhibitors: Interferes with the viral DNA protein shield

Morphothiadin 

Capsid inhibitor

HEC Pharma,
PR China

pharm.hec.cn/en

Phase II

JNJ 56136379

Capsid inhibitor

Janssen, Ireland

janssen.com

Phase II

ABI-H0731

Capsid inhibitor

Assembly Biosciences, USA

assemblybio.com

Phase II

ABI-H2158

Capsid inhibitor

Assembly Biosciences, USA

assemblybio.com

Phase I

RG7907

Capsid inhibitor

Roche, Switzerland

roche.com

Phase I

QL-007

Capsid inhibitor

Qilu, PR China

qilu-pharma.com

Phase I

EDP-514

Capsid inhibitor

Enanta Pharma, USA

enanta.com

Phase I 

GLP-26

Capsid inhibitor

Emory University, USA

emory.edu

Preclinical

ABI-H3733

Capsid inhibitor

Assembly Biosciences, USA

assemblybio.com

Preclinical

CB-HBV-001

Capsid inhibitor

ZhiMeng Biopharma, PR China

core-biopharma.com 

Preclinical

ALG-000184

Capsid inhibitor

Aligos Therapeutics, USA

aligos.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

STOPs (s-Antigen transport inhibiting oligonucleotide polymers)

Aligos Therapeutics, USA

aligos.com

Preclinical 

 

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

IONIS-HBVRx 

Prevent viral protein production

Ionis with GSK, USA

ionispharma.com

Phase II

IONIS-HBVLRx 

Prevent viral protein production

Ionis with GSK, USA

ionispharma.com

Phase II

ALG-ASO

Prevent viral protein production  

Aligos Therapeutics, USA

aligos.com

Preclinical 

 

INDIRECT ACTING ANTIVIRALS: Targets the human immune system to attack the HBV virus

 

Therapeutic Vaccines: Vaccine technology used to stimulate the immune system as a treatment 

AIC 649

Therapeutic vaccine

AiCuris, Germany

aicuris.com

Phase I

INO-1800

Therapeutic vaccine

Inovio, USA

inovio.com

Phase I

HB-110

Therapeutic vaccine

Ichor Medical Genexine, USA

ichorms.com

Phase I

TG1050

Therapeutic vaccine

Transgene, France

transgene.com

Phase I

HepTcell

Therapeutic vaccine

Altimmune, USA

altimmune.com

Phase I

JNJ 64300535

Therapeutic vaccine

Janssen, Ireland

janssen.com

Preclinical

HBV

Therapeutic vaccine

GeoVax, USA

geovax.com

Preclinical

VBI-2601 

Therapeutic vaccine

VBI Vaccines, USA 

vbivaccines.com Preclinical

Chimigen HBV

Therapeutic vaccine

Akshaya, Canada

akshayabio.com Preclinical

CARG-201

Therapeutic vaccine

CaroGen, USA

carogencorp.com Preclinical

 

Innate Immune Defense Pathway: Compounds that activate the innate immune system 

Inarigivir

RIG -1 and NOD2 agonist

Spring Bank with
Gilead Sciences, USA

springbankpharm.com

Phase II

GS9688

TLR-8 agonist

Gilead Sciences, USA

gilead.com

Phase I

RG7854

TLR-7 agonist

Roche, Switzerland

roche.com

Phase I

 

Host Acting Pathway: Compounds that target cell functions needed by the hepatitis B virus

APG-1387

Apoptosis Inducer

Ascentage Pharma, PR China

ascentagepharma.com

Phase I

CRV 431 

Ciclofillin inhibitor

Hepion, USA (formerly ContraVir)

hepionpharma.com

Phase I

AB-452

RNA destabilizer

Arbutus Biopharma, USA

arbutusbio.com

Preclinical

Gene Editing

EBT106

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

HBV 

ARCUS platform Precision Bio with Gilead, USA precisionsciences.com Preclinical


Other

GC1102

monoclonal anti-HBsAg antibody Green Cross, South Korea www.globalgreencross.com Phase II

EYP001

FXR agonist Enyo Pharma, France enyopharma.com Phase I 

RG6084

Host targeting antisense (LNA) Roche, Switzerland roche.com Phase I

RG6217

Host targeting antisense (LNA) Roche, Switzerland roche.com Phase I

LTCR-H2-1

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

HBV

MicroRNA Regulus, USA regulusrx.com Preclinical

 

HEPATITIS DELTA VIRUS (HDV)- A virus that co-infects people already infected with HBV

Lambda (Pegylated Interferon)

Immunomodulator

Eiger Biopharma, USA

eigerbio.com

Orphan drug 
Phase III

Bulevirtide (Myrcludex B)

Entry inhibitor

MYR-GmbH, Germany

myr-pharma.com

Phase III

Lonafarnib

Prenylation inhibitor

Eiger Biopharma, USA

eigerbio.com

Orphan drug 
Phase III

REP 2139

HBsAg inhibitor

Replicor, Canada

replicor.com

Phase II

Ezetimibe

NTCP inhibitor

Ziauddin University Hospital, Pakistan

zu.edu.pk

Phase II

GI-18000

Immune Response Stimulator

GlobeImmune

globeimmune.com

Preclinical