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Drug Watch

This detailed and up-to-date list is made possible by the hard work and research performed by the Hepatitis B Foundation. Please help us continue to offer this kind of essential resource for the treatment of hepatitis B with a donation toward our important programs. Donate here.

To learn more about the drug development process, click here.

Compounds in Development for Chronic Hepatitis B

Updated Feb. 28, 2024

 

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) *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 

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

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

VIR-2218 (Elebsiran)
BRII-835

RNAi gene silencer 

Vir Biotech with
Brii Biosciences, USA

vir.bio and
briibio.com

Phase II

Xalnesiran (RG6346,
DCR HBVS)

RNAi gene silencer

Dicerna, USA with Roche

dicerna.com

Phase II

Imdurisan (AB-729)

RNAi gene silencer

Arbutus Biopharma, USA

arbutusbio.com

Phase II

BW-20507

RNAi gene silencer

Argo Biopharma Australia

private company

Phase II

ALG-125755

RNAi gene silencer

Aligos Therapeutics, USA 

aligos.com

Holding for new partner

BB-103

RNAi gene silencer

Benitec, Australia

benitec.com  Preclinical

JNJ-3989 (ARO-HBV)

RNAi gene silencer

GSK, USA

gsk.com Phase II

Entry Inhibitors: Interferes with HBV getting into liver cells

Bulevirtide (Hepcludex)

Entry inhibitor

Gilead, USA

gilead.com

Phase III

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

ZM-H1505R

Capsid inhibitor

Zhimeng Biopharma, PR China

core-biopharma.com

Phase II

EDP-514

Capsid inhibitor

Enanta Pharma, USA

enanta.com

Phase I

ALG-000184

Capsid inhibitor

Aligos Therapeutics, USA

aligos.com

Phase I

ABI-H4334

Capsid inhibitor

Assembly Biosciences, USA

assemblybio.com

Phase I

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

REP 2139

sAg inhibitor

Replicor, Canada

replicor.com

Phase II

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

Bepirovirsen 

HBV Antisense 

GSK, USA

gsk.com

Phase III

AHB-137

HBV Antisense

AusperBio, China

ausperbio.com

Phase I

Gene Editing: Intended to destroy or repress HBV DNA

EBT107

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

PBGENE-HBV

ARCUS platform

Precision Bio, USA  precisionbiosciences.com Preclinical

TUNE-401

TEMPO platform

Tune Therapeutics, USA

tunetx.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  

HeberNasvac       

Therapeutic vaccine              

CIGB, Cuba

Studies in Cuba Phase IV 

HepTcell

Therapeutic vaccine

Altimmune, USA

altimmune.com

Phase II

VBI-2601 (BRII-179)

Therapeutic vaccine

VBI Vaccines with
Brii Biosciences, USA 

vbivaccines.com and
briibio.com

Phase II

VVX001

Therapeutic vaccine

Viravaxx, Austria

viravaxx.com

Phase II

GSK 3528869A

Therapeutic vaccine

GSK, USA

gsk.com

Phase II

VTP-300

Therapeutic vaccine

Barinthus Biotherapeutics, UK (formerly Vaccitech)

www.barinthusbio.com  

Phase II

CVI-HBV-002

Therapeutic vaccine

Cha Vaccine Institute, S. Korea

en.chavaccine.com

Phase I/II

HB-400 (GS2829/GS6779)

Therapeutic vaccine

HOOKIPA Pharma, Austria, with Gilead

hookipapharma.com Phase I

ISA104

Therapeutic vaccine

ISA Pharma, The Netherlands

isa-pharma.com Phase I

VRON-0200

Therapeutic vaccine

Viron Therapeutics, USA

viriontx.com Phase I
CLB-3000

Therapeutic vaccine

Clear B Therapeutics, USA and Australia clearbtherapeutics.com Phase I
CARG-201 Therapeutic vaccine CaroGen, USA carogencorp.com Preclinical

TherVacB

Therapeutic vaccine

Helmholtz Zentrum Muenchen, Germany

thervacb.eu

Phase I

PRGN-2013

Therapeutic vaccine

Precigen

precigen.com Preclinical

HBV vaccine

Therapeutic vaccine

Astrivax, Belgium

astrivax.com Preclinical

Compounds that activate the innate immune system 

Selgantolimod (GS9688)

TLR-8 agonist

Gilead Sciences, USA

gilead.com

Phase II

Ruzotolimod (RG7854)

TLR-7 agonist

Roche, Switzerland

roche.com

Phase II

CB06

TLR-8 agonist

Zhimeng Biopharma, PR China

core-biopharma.com  Phase I

GSK 5251738

TLR-8 agonist

Gilead, USA

gilead.com Phase I

PRTX007

TLR-7 agonist

Primmune Therapeutics, USA

www.primmunerx.com Phase I

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

VIR-3434
(Tobevibart)
BRII-837

Monoclonal antibody Vir Biotech with
Brii Biosciences, USA 
vir.bio and
briibio.com 
Phase II
Burfiralimab (IgG4) Monoclonal antibody  ImmuneMed, South Korea  immunemed.co.kr/eng  Phase II

BJT-778

Monoclonal antibody Blue Jay Therapeutics, USA  bluejaytx.com Phase I

RG6449

Monoclonal antibody Roche roche.com 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

RG6084

PDL1 inhibitor Roche roche.com Phase II

AB-101

PDL1 inhibitor Arbutus, USA arbutusbio.com FDA hold 4/25/23

Other Immunologicals

 

IMC-I109V

T-cell Receptor Immunocore immunocore.com Phase I

Additional HBV Drugs Under Investigation

 

GSK 4388067A

Targeted immunotherapy GSK, USA gsk.com Phase II

APG-1387

Apoptosis inducer Ascentage, PR China
ascentagepharma.com Phase II

GSK 3965193

PAPD5/PAPD7
inhibitor
GSK, USA gsk.com Phase I

DF-006

Small molecule Drug Farm, Shanghai drug-farm.com  Phase I

AB359 

CD8 IL-2 immunotherapy Asher Biotherapeutics, USA

asherbio.com

Preclinical

BJT-628

Small molecule  Blue Jay Therapeutics, USA bluejaytx.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 2023

Phase III USA

Lonafarnib

Prenylation inhibitor

Eiger Biopharma, USA

eigerbio.com

Holding for new partner

REP 2139

HBsAg inhibitor

Replicor, Canada

replicor.com

Phase II

VIR-2218 + VIR 3434

RNAi gene silencer + Monoclonal antibody 

Vir Biotech, USA

vir bio

Phase II

BJT-778

Monoclonal antibody

Blue Jay Therapeutics, USA

Bluejaytx.com

Phase I

ABI-6250

Entry inhibitor

Assembly Biosciences, USA

assemblybio.com Preclinical

If you are a person with hepatitis B who is looking for clinical trial or other research opportunities, please visit our patient and provider opportunities page here