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HBF Drug Watch

Compounds in Development for Chronic Hepatitis B

Updated March 25, 2016

FAMILY/DRUG NAME MECHANISM COMPANY STATUS
Interferons - Mimic naturally-occurring, infection-fighting immune substances produced in the body
Intron A
(Interferon
alfa-2b)
Immunomodulator Merck,
Whitehouse Station, NJ
FDA Approved
1991
Pegasys
(Peginterferon alfa-2a)
Immunomodulator Genentech,
South San Francisco, CA
FDA Approved 2005
There are other brands of interferon approved for HCV treatment, but they have not been FDA-approved for HBV: Wellferon (Glaxo), Roferon(Hoffman-La Roche), and Infergen (Amgen)
Nucleoside Analogues -  Interfere with the viral DNA polymerase enzyme used for hepatitis B virus reproduction
Epivir-HBV
(Lamivudine)
Inhibits viral DNA polymerase GlaxoSmithKline, Philadelphia, PA FDA Approved
1998
Hepsera
(Adefovir Dipivoxil)
Inhibits viral DNA polymerase Gilead Sciences,
Foster City, CA
FDA Approved
2002
Baraclude
(Entecavir)
Inhibits viral DNA polymerase Bristol-Myers Squibb,
Princeton, NJ
FDA Approved
2005
Tyzeka
(Telbivudine)
Inhibits viral DNA polymerase Novartis,
Switzerland
FDA Approved
2006
Viread
(Tenofovir)
Inhibits viral DNA polymerase Gilead Sciences,
Foster City, CA
FDA Approved 2008
Clevudine
(L-FMAU)
Inhibits viral DNA polymerase Bukwang,
South Korea
Eisai, Japan
Approved S. Korea
2006 (Levovir)
Tenofovir alafenamide (TAF)
Prodrug of Tenofovir Gilead Sciences,
Foster City, CA
Phase III
CMX157 Prodrug of Tenofovir ContraVir Pharmaceuticals,
Edison, NJ
Phase II
AGX-1009 Prodrug of Tenofovir

Cinkate Pharma
Oak Park, IL

Phase I, China
Non-Nucleoside Antivirals -  Interfere with proteins involved in viral reproduction
Myrcludex B Entry Inhibitor Hepatera, Russia with Myr-GmbH, Germany Phase II for HBV and HDV
ARC520 RNAi gene silencer Arrowhead Pharmaceuticals, Pasadena, CA Phase II/III
NVR 3-778 Capsid inhibitor Novira Therapeutics, Doylestown, PA Phase IIa
Morphothiadine mesilate (GLS4) Capsid inhibitor Sunshine Lake Pharma of HEC, China
Phase II
IONIS-HBVRx Antisense drug Ionis Pharma, Carlsbad, CA
Phase II
SB 9200 HBV RIG-1 and NOD2 agonist Spring Bank Pharma,
Milford, MA
Phase II
Rep 2139-Ca HBsAg release inhibitor REPLICor Inc.,
Canada
Phase II
ARB-1467 RNAi gene silencer Tekmira,
Canada
Phase II
ARC521 RNAi gene silencer Arrowhead Pharmaceuticals, Pasadena, CA 
Phase II/I
AIC 649 Capsid Inhibitor AiCuris, Germany Phase I
IONIS-HBV-LRx Antisense drug Ionis Pharma (w/ GSK), Carlsbad, CA Phase I
EYP001 FXR agonist

Enyo Pharma
France

Phase I
CpAMS HBV Core Protein Assembly Biosciences, NY, NY Preclinical
ALN-HBV RNAi gene silencer

Alnylam,
Cambridge, MA

Preclinical
CPI-431-32 Cyclophilin inhibitor

Ciclofilin Pharma,
San Diego, CA

Preclinical
Hepbarna RNAi gene silencing

Benitec, Australia

Preclinical
ARB-1740 Gene silencer

Arbutus Biopharma Canada

Preclinical
Non-Interferon Immune Enhancers -  Boost T-cell infection-fighting immune cells and natural interferon production
ABX 203 Therapeutic vaccine ABIVAX,
Paris, France
Phase IIb/III
GS-4774 Therapeutic vaccine Gilead Sciences with Globe Immune,
Louisville, CO
Phase II
GS-9620 TLR7 agonist Gilead Sciences,
Foster City, CA
Phase II
RG7795 (formerly ANA773) TLR7 agonist Roche, Switzerland Phase II
INO-1800 Therapeutic vaccine Inovio,
Blue Bell, PA
Phase I
NCT01641536 Therapeutic vaccine Ichor Medical Systems (w/Janssen), San Diego, CA Phase I
TG 1050 Immunotherapeutic Transgene,
Shanghai
Phase I
ARB-1598 TLR9 agonist Arbutus Biopharma Canada Phase I
Hepatitis Delta Virus (HDV) Drug Watch
Myrcludex B Entry Inhibitor (Targeting NTCP) Hepatera, Russia with Myr-GmbH, Germany "Orphan Drug Designation" by US FDA and EMA for HDV
Lonafarnib Prenylation Inhibitor Eiger BioPharmaceuticals, Palo Alto, CA Phase II for HDV
Rep 2139 HBsAg Release Inhibitor  REPLICor, Canada Phase II for HDV

Page last modified March 25, 2016


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