Drug Watch
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Compounds in Development for Chronic Hepatitis B
Updated Sept. 13, 2021
FAMILY/DRUG NAME |
MECHANISM |
COMPANY |
WEBSITE |
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Interferons: Mimic infection-fighting immune substances naturally produced in the body
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| Intron A (Interferon alfa 2b) | Immunomodulator | Merck, USA | merck.com | Approved 1991 | |||||||||||||||
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Pegasys (Peginterferon alfa 2a) |
Immunomodulator |
Genentech, USA |
Approved 2005 |
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Nucleos(t)ide Analogues: Interfere with viral DNA polymerase used for HBV replication |
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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 | |||||||||||||||
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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 | |||||||||||||||
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Levovir (Cledvudine) |
Inhibits viral DNA polymerase | Bukwang, S. Korea | bukwang.co.kr | Approved 2006 in S. Korea | |||||||||||||||
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Besivo (formerly ANA 380/LB80380) |
Inhibits viral DNA polymerase | Ildong Pharma, S. Korea | ildong.com | Approved 2017 in S. Korea | |||||||||||||||
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Zadaxin |
Immunomodulator | SciClone, USA | sciclone.com | Approved outside USA | |||||||||||||||
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ATI-2173 (Clevudine prodrug) |
Inhibits HBV polymerase |
Antios Therapeutics, USA |
Phase II |
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Direct Acting Antivirals: Targets the virus and interferes in the HBV replication process |
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Silencing RNA’s (siRNAs): Interferes and destroys viral RNA |
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VIR-2218 |
RNAi gene silencer |
Vir Biotech, USA |
Phase II |
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RG6346 (DCR HBVS) |
RNAi gene silencer |
Roche, Switzerland, with Dicerna |
Phase II |
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JNJ-3989 (ARO-HBV) |
RNAi gene silencer |
J&J with Arrowhead, USA |
Phase II | ||||||||||||||||
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AB-729 |
RNAi gene silencer |
Arbutus Biopharma, USA |
Phase I | ||||||||||||||||
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BB-103 |
RNAi gene silencer |
Benitec, Australia |
Preclinical |
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ALG-125097 |
RNAi gene silencer |
Aligos Therapeutics, USA |
Preclinical |
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Entry Inhibitors: Interferes with HBV getting into liver cells |
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Hepcludex (Bulevirtide formerly Myrcludex B) |
Entry inhibitor |
MYR GmbH, Germany |
Phase II |
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hzVSF |
Entry inhibitor |
ImmuneMed, South Korea |
Phase I | ||||||||||||||||
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Capsid or Core Inhibitors: Interferes with the viral DNA protein shield |
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Vebicorvir (ABI-H0731) |
Capsid inhibitor |
Assembly Biosciences, USA |
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Morphothiadin |
Capsid inhibitor |
HEC Pharma, PR China |
pharm.hec.cn/en/ | Phase II | |||||||||||||||
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JNJ 56136379 |
Capsid inhibitor |
Janssen, Ireland |
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EDP-514 |
Capsid inhibitor |
Enanta, Pharma, USA |
Phase II |
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R07049389 (RG7907) |
Capsid inhibitor |
Roche, Switzerland |
Phase I | ||||||||||||||||
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QL-007 |
Capsid inhibitor |
Qilu, PR China |
Phase I | ||||||||||||||||
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ABI-H3733 |
Capsid inhibitor |
Assembly Biosciences, USA |
Phase I | ||||||||||||||||
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ZM-H1505R |
Capsid inhibitor |
ZhiMeng Biopharma, PR China |
Phase I | ||||||||||||||||
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ALG-000184 |
Capsid inhibitor |
Aligos Therapeutics, USA |
Phase I | ||||||||||||||||
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B-836 |
Capsid Inhibitor |
Arbutus, USA |
Phase I | ||||||||||||||||
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VNRX-9945 |
Capsid Inhibitor |
Venatorx, USA |
Phase I | ||||||||||||||||
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GLP-26 |
Capsid inhibitor |
Emory University, USA |
Preclinical | ||||||||||||||||
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ABI-4334 |
Capsid Inhibitor |
Assembly Biosciences, USA |
Preclinical | ||||||||||||||||
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HBsAg Inhibitors: Interferes with production of HBV surface antigen (sAg) |
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REP 2139 |
sAg inhibitor |
Replicor, Canada |
Phase II |
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REP 2165 |
sAg inhibitor |
Replicor, Canada |
Phase II |
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ALG-10133 |
sAg inhibitor |
Aligos Therapeutics, USA |
Phase I | ||||||||||||||||
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Antisense Molecules: Binds to the viral mRNA to prevent it from turning into viral protein |
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IONIS-HBVRx (GSK 3228836) |
Prevent viral protein production |
Ionis with GSK, USA |
Phase II |
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ALG-020572 |
Prevent viral protein production |
Aligos Therapeutics, USA |
Preclinical | ||||||||||||||||
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Immunologicals: Targets the human immune system to attack the HBV virus |
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Therapeutic Vaccine Technology used to stimulate the immune system as a treatment |
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NASVAC |
Therapeutic vaccine |
CIGB, Cuba |
cigb.edu.cu/sobre-cigb/ | Phase III | |||||||||||||||
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GS-4774 |
Therapeutic vaccine |
Gobelmmune with Gilead, USA |
globeimmune.com |
Phase II |
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HepTcell |
Therapeutic vaccine |
Altimmune, USA |
Phase II |
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VBI-2601 (BRII-179) |
Therapeutic vaccine |
VBI Vaccines, USA |
Phase II | ||||||||||||||||
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VVX001 |
Therapeutic vaccine |
Viravaxx, Austria |
Phase II |
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VTP-300 |
Therapeutic vaccine |
Vaccitech, USA |
Phase I/II |
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CVI-HBV-002 |
Therapeutic vaccine |
Cha Vaccine Institute, S. Korea |
Phase I/II |
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AIC 649 |
Therapeutic vaccine |
AiCuris, Germany |
Phase I |
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HB-110 |
Therapeutic vaccine |
Ichor Medical with Genexine, USA |
Phase I |
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JNJ 64300535 |
Therapeutic vaccine |
Janssen, Ireland |
Phase I |
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CARG-201 |
Therapeutic vaccine |
CaroGen, USA |
Phase I | ||||||||||||||||
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Chimigen HBV |
Therapeutic vaccine |
Akshaya, Canada |
akshayabio.com | Preclinical | |||||||||||||||
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HBV |
Therapeutic vaccine |
HOOKIPA Pharma, Austria, with Gilead |
hookipapharma.com | Preclinical | |||||||||||||||
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TherVacB |
Therapeutic vaccine |
Helmholtz Zentrum Muenchen, Germany |
dzif.de/en/hepatitis | Preclinical | |||||||||||||||
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PRGN-2013 |
Therapeutic vaccine |
Precigen |
precigen.com | Preclinical | |||||||||||||||
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ISA104 |
Therapeutic vaccine |
ISA Pharma, The Netherlands |
isa-pharma.com | Preclinical | |||||||||||||||
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VRON-0200 |
Therapeutic vaccine |
Viron Therapeutics, USA |
viriontx.com | Preclinical | |||||||||||||||
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HBV Vaccine |
Therapeutic vaccine |
Clear B Therapeutics, USA and Australia |
clearbtherapeutics.com | Preclinical | |||||||||||||||
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Compounds that activate the innate immune system |
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Selgantolimod (GS9688) |
TLR-8 agonist |
Gilead Sciences, USA |
Phase II |
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RG7854 |
TLR-7 agonist |
Roche, Switzerland |
Phase I | ||||||||||||||||
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SBT 8230 |
TLR-8 agonist |
Silverback Therapeutics, USA |
silverbacktx.com | Preclinical | |||||||||||||||
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YS-HBV-002 |
Activator of TLR3, RIG1, MDA5 |
YiSheng Biopharma, China |
yishengbio.com | Preclinical | |||||||||||||||
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Monoclonal Antibodies: Neutralize or bind the HBV proteins to reduce infection |
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Lenvervimab (GC1102) |
Monoclonal antibody | GC Pharma, South Korea | globalgreencross.com | Phase II | |||||||||||||||
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Vir-3434 |
Monoclonal antibody | Vir Biotech, USA | vir.bio | Phase I | |||||||||||||||
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Checkpoint Inhibitors: Stimulate exhausted T-cell recognition of HBV-Infected cells |
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ASC22 (KN035 or Envafolimab) |
PDL1 inhibitor | Ascletis Pharma, PR China | ascletis.com | Phase II | |||||||||||||||
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GS 4224 |
PDL1 inhibitor | Gilead, USA | gilead.com | Phase I | |||||||||||||||
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Other Immunologicals |
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IMC-I109V |
T-cell Receptor | Immunocore | immunocore.com | Phase II | |||||||||||||||
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LTCR-H2-1 |
T Cell. immunotherapy | Lion TCR, Singapore | liontcr.com | Preclinical | |||||||||||||||
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Additional HBV Drugs Under Investigation |
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APG-1387 |
Apoptosis inducer | Ascentage, PR China | ascentagepharma.com | Phase II | |||||||||||||||
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ASC42 |
FXR Agonist | Ascletis, Hong Kong | ascletis.com | Phase II | |||||||||||||||
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EYP001 |
FXR agonist | Enyo Pharma, France | enyopharma.com | Phase I | |||||||||||||||
| EDP-721 | RNA destabilizer | Enanta Pharma, USA | enanta.com | Phase I | |||||||||||||||
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HBV |
MicroRNA | Regulus, USA | regulusrx.com | Preclinical | |||||||||||||||
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ENOB-HB-01 |
Gene modified cell therapy | Enochian Bio, USA | enochianbio.com | Preclinical | |||||||||||||||
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GV1001 |
"Novel peptide" | GemVax & KAEL, South Korea | gemvax.com | Preclinical | |||||||||||||||
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CP101 |
Oral microbiotic | Finch Therapeutics, USA | finchtherapeutics.com | Preclinical | |||||||||||||||
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DF-006 |
Small molecule | Drug Farm, Shanghai | drug-farm.com | Preclinical | |||||||||||||||
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Hepatitis Delta Virus (HDV)- A virus that co-infects people already infected with HBV |
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Hepcludex (Bulevirtide formerly Myrcludex B) |
Entry inhibitor |
Gilead, USA |
EU approved 2020 Phase III USA |
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Lonafarnib |
Prenylation inhibitor |
Eiger Biopharma, USA |
Orphan drug |
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Pegylated interferon-lambda |
Immune modulator |
Eiger Biopharma |
Phase III Ready | ||||||||||||||||
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REP 2139 |
HBsAg inhibitor |
Replicor, Canada |
Phase II |
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Ezetimibe |
NTCP inhibitor |
Ziauddin University Hospital, Pakistan |
Phase II |
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JNJ-3989 (73763989) |
RNAi gene silencer |
Janssen |
Phase II | ||||||||||||||||
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GI-18000 |
Immune Response Stimulator |
GlobeImmune, USA |
Preclinical |
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