Drug Watch
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Compounds in Development for Chronic Hepatitis B
Updated September 25, 2024
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 | ||||||||||||||||||||
Pegasys (Peginterferon alfa 2a) |
Immunomodulator |
Approved 2005 |
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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 |
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Silencing RNA’s (siRNAs): Interferes and destroys viral RNA |
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VIR-2218 (Elebsiran) |
RNAi gene silencer |
Vir Biotech with |
Phase II |
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Xalnesiran (RG6346, |
RNAi gene silencer |
Phase II |
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Imdurisan (AB-729) |
RNAi gene silencer |
Phase II | ||||||||||||||||||||||
BW-20507 |
RNAi gene silencer |
Phase II |
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ALG-125755 |
RNAi gene silencer |
Holding for new partner |
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BB-103 |
RNAi gene silencer |
benitec.com | Preclinical | |||||||||||||||||||||
JNJ-3989 (ARO-HBV) |
RNAi gene silencer |
gsk.com | Phase II | |||||||||||||||||||||
HT-101 |
RNAi gene silencer |
www.hepathera.com/eng | Phase I (outside USA) | |||||||||||||||||||||
Entry Inhibitors: Interferes with HBV getting into liver cells |
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Bulevirtide (Hepcludex) |
Entry inhibitor |
Phase III |
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Capsid or Core Inhibitors: Interferes with the viral DNA protein shield |
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ZM-H1505R |
Capsid inhibitor |
Phase II |
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EDP-514 |
Capsid inhibitor |
Phase I |
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ALG-000184 |
Capsid inhibitor |
Phase I | ||||||||||||||||||||||
ABI-H4334 |
Capsid inhibitor |
Phase I | ||||||||||||||||||||||
CS12088 |
Capsid inhibitor |
Preclinical | ||||||||||||||||||||||
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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AHB-137 |
HBV Antisense |
Phase I |
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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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VBI-2601 (BRII-179) |
Therapeutic vaccine |
VBI Vaccines with |
Phase II | |||||||||||||||||||||
VVX001 |
Therapeutic vaccine |
Phase II |
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GSK 3528869A |
Therapeutic vaccine |
Phase II | ||||||||||||||||||||||
VTP-300 |
Therapeutic vaccine |
Barinthus Biotherapeutics, UK (formerly Vaccitech) |
Phase II |
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CVI-HBV-002 |
Therapeutic vaccine |
Phase I/II |
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HB-400 (GS2829/GS6779) |
Therapeutic vaccine |
hookipapharma.com | Phase I | |||||||||||||||||||||
ISA104 |
Therapeutic vaccine |
isa-pharma.com | Phase I | |||||||||||||||||||||
VRON-0200 |
Therapeutic vaccine |
viriontx.com | Phase I | |||||||||||||||||||||
CLB-3000 |
Therapeutic vaccine |
Clear B Therapeutics, USA | clearbtherapeutics.com | Phase I | ||||||||||||||||||||
CARG-201 | Therapeutic vaccine | CaroGen, USA | carogencorp.com | Preclinical | ||||||||||||||||||||
TherVacB |
Therapeutic vaccine |
Phase I | ||||||||||||||||||||||
PRGN-2013 |
Therapeutic vaccine |
precigen.com | Preclinical | |||||||||||||||||||||
HBV vaccine |
Therapeutic vaccine |
astrivax.com | Preclinical | |||||||||||||||||||||
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 | ||||||||||||||||||||||
CB06 |
TLR-8 agonist |
core-biopharma.com | Phase I | |||||||||||||||||||||
GSK 5251738 |
TLR-8 agonist |
gilead.com | Phase I | |||||||||||||||||||||
PRTX007 |
TLR-7 agonist |
www.primmunerx.com | Phase I | |||||||||||||||||||||
Cavrotolomid |
TLR9-agonist |
Blue Jay
|
bluejaytx.com | Phase I | ||||||||||||||||||||
YS-HBV-002 |
Activator of TLR3, RIG1, MDA5 |
ysbiopharma.com | Preclinical | |||||||||||||||||||||
Monoclonal Antibodies: Neutralize or bind the HBV proteins to reduce infection |
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VIR-3434 |
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 | ||||||||||||||||||||
GIGA-2339 |
Polyclonal antibody | GigaGen, USA | gigagen.com | Phase I | ||||||||||||||||||||
HT-102 |
Monoclonal antibody | Hepa Thera, PR China | www.hepathera.com/eng | Preclinical | ||||||||||||||||||||
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 | ||||||||||||||||||||
RG6084 |
PDL1 inhibitor | Roche | roche.com | Phase II | ||||||||||||||||||||
AB-101 |
PDL1 inhibitor | Arbutus, USA | arbutusbio.com | Phase I | ||||||||||||||||||||
Other Immunologicals |
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IMC-I109V |
T-cell Receptor | Immunocore, UK and USA | immunocore.com | Phase I | ||||||||||||||||||||
Additional HBV Drugs Under Investigation |
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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, PR China | drug-farm.com | Phase I | ||||||||||||||||||||
AB359 |
CD8 IL-2 immunotherapy | Asher Biotherapeutics, USA | 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 |
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Hepcludex (Bulevirtide formerly Myrcludex B) |
Entry inhibitor |
EU approved 2023 Phase III USA |
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Lonafarnib |
Prenylation inhibitor |
Holding for new partner |
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REP 2139 |
HBsAg inhibitor |
Phase II |
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VIR-2218 + VIR 3434 |
RNAi gene silencer + Monoclonal antibody |
Phase II | ||||||||||||||||||||||
BJT-778 |
Monoclonal antibody |
Phase II | ||||||||||||||||||||||
ABI-6250 |
Entry inhibitor |
assemblybio.com | Preclinical | |||||||||||||||||||||
Elebsiran (VIR-2218) Tobevibart (VIR-3434) |
RNAi + mAb |
vir.bio | Phase II |
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