Drug Watch
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Compounds in Development for Chronic Hepatitis B
Updated May 12, 2023
FAMILY/DRUG NAME |
MECHANISM |
COMPANY |
WEBSITE |
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| Interferons: Mimic infection-fighting immune substances naturally produced in the body | |||||||||||||||||||
| Intron A (Interferon alfa 2b) | Immunomodulator | Merck, USA | merck.com | Approved 1991 | |||||||||||||||
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Pegasys (Peginterferon alfa 2a) |
Immunomodulator |
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 | antiostherapeutics.com | FDA Hold | |||||||||||||||
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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 |
Phase II |
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Xalnesiran (RG6346, |
RNAi gene silencer |
Phase II |
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JNJ-3989 |
RNAi gene silencer |
Phase II | |||||||||||||||||
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AB-729 |
RNAi gene silencer |
Phase II | |||||||||||||||||
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ALG-125755 |
RNAi gene silencer |
Phase I |
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BB-103 |
RNAi gene silencer |
benitec.com
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Preclinical | ||||||||||||||||
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Entry Inhibitors: Interferes with HBV getting into liver cells |
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Bulevirtide (Hepcludex) |
Entry inhibitor |
Phase III |
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A2342 |
Entry inhibitor |
Preclinical | |||||||||||||||||
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Capsid or Core Inhibitors: Interferes with the viral DNA protein shield |
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JNJ 56136379 |
Capsid inhibitor |
Phase II |
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Canocapavir (ZM-H1505R) |
Capsid inhibitor |
Zhimeng Biopharma, PR China |
Phase II |
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EDP-514 |
Capsid inhibitor |
Phase I |
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ALG-000184 |
Capsid inhibitor |
Phase I | |||||||||||||||||
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ABI-H4334 |
Capsid inhibitor |
Phase I | |||||||||||||||||
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ATI-1428 |
Capsid inhibitor |
Preclinical | |||||||||||||||||
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HBsAg Inhibitors: Interferes with production of HBV surface antigen (sAg) |
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REP 2139 |
sAg inhibitor |
Phase II |
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Antisense Molecules: Binds to the viral mRNA to prevent it from turning into viral protein |
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Bepirovirsen |
HBV Antisense |
Phase III |
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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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HeberNasvac |
Therapeutic vaccine |
Clinical trials in Cuba | Phase IV | ||||||||||||||||
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HepTcell |
Therapeutic vaccine |
Phase II |
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VBI-2601 (BRII-179) |
Therapeutic vaccine |
Phase II | |||||||||||||||||
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VVX001 |
Therapeutic vaccine |
Phase II |
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GSK 3528869A |
Therapeutic vaccine |
Phase II | |||||||||||||||||
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VTP-300 |
Therapeutic vaccine |
Phase II |
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CVI-HBV-002 |
Therapeutic vaccine |
Phase I/II |
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JNJ 64300535 |
Therapeutic vaccine |
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CARG-201 |
Therapeutic vaccine |
Preclinical | |||||||||||||||||
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HB-400 |
Therapeutic vaccine |
hookipapharma.com | Phase I | ||||||||||||||||
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TherVacB |
Therapeutic vaccine |
Preclinical | |||||||||||||||||
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PRGN-2013 |
Therapeutic vaccine |
precigen.com | Preclinical | ||||||||||||||||
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ISA104 |
Therapeutic vaccine |
isa-pharma.com | Preclinical | ||||||||||||||||
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VRON-0200 |
Therapeutic vaccine |
viriontx.com | Preclinical | ||||||||||||||||
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CLB-3000 |
Therapeutic vaccine |
clearbtherapeutics.com | Preclinical | ||||||||||||||||
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“Decoy 20”
|
Therapeutic vaccine |
Preclinical | |||||||||||||||||
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Compounds that activate the innate immune system |
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Selgantolimod (GS9688) |
TLR-8 agonist |
Phase II |
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Ruzotolimod (RG7854) |
TLR-7 agonist |
Phase II | |||||||||||||||||
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CB06 |
TLR-8 agonist |
core-biopharma.com | Phase I | ||||||||||||||||
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YS-HBV-002 |
Activator of TLR3, RIG1, MDA5 |
yishengbio.com | Preclinical | ||||||||||||||||
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Monoclonal Antibodies: Neutralize or bind the HBV proteins to reduce infection |
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VIR-3434 |
Monoclonal antibody | Vir Biotech, USA | vir.bio | Phase II | |||||||||||||||
| Burfiralimab (IgG4) | Monoclonal antibody | ImmuneMed, South Korea | immunemed.co.kr/eng | Phase II | |||||||||||||||
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BJT-778 |
Monoclonal antibody | Blue Jay Therapeutics, USA | bluejaytx.com | 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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RG6084 |
PDL1 inhibitor | Roche | roche.com | Phase II | |||||||||||||||
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AB-101 |
PDL1 inhibitor | Arbutus | arbutusbio.com | FDA hold 4/25/23 | |||||||||||||||
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Other Immunologicals |
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IMC-I109V |
T-cell Receptor | Immunocore | immunocore.com | Phase I | |||||||||||||||
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Additional HBV Drugs Under Investigation |
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GSK 4388067A |
Targeted immunotherapy | GSK, USA | gsk.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 II | |||||||||||||||
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APG-1387 |
Apoptosis inducer | Ascentage, PR China |
ascentagepharma.com | Phase II | |||||||||||||||
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GSK 3965193 |
PAPD5/PAPD7 inhibitor |
GSK, USA | gsk.com | Phase I | |||||||||||||||
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AB-161 |
RNA Destabilizer | Arbutus | Arbutusbio.com | Phase I | |||||||||||||||
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DF-006 |
Small molecule | Drug Farm, Shanghai | drug-farm.com | Phase I | |||||||||||||||
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AB359 |
CD8 IL-2 immunotherapy | Asher Biotherapeutics, USA | Preclinical | ||||||||||||||||
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BJT-628 |
Small molecule | Blue Jay Therapeutics, USA | bluejaytx.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 |
EU approved 2023 Phase III USA |
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Lonafarnib |
Prenylation inhibitor |
Orphan drug |
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Pegylated interferon-lambda |
Immune modulator |
Phase III | |||||||||||||||||
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REP 2139 |
HBsAg inhibitor |
Phase II |
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JNJ-3989 |
RNAi gene silencer |
Phase II | |||||||||||||||||
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VIR-2218 + VIR 3434 |
RNAi gene silencer + Monoclonal antibody |
Phase II | |||||||||||||||||
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BJT-778 |
Monoclonal antibody |
Phase I | |||||||||||||||||
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GI-18000 |
Immune Response Stimulator |
Preclinical |
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AB-543 |
Entry inhibitor |
assemblybio.com | Preclinical | ||||||||||||||||
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