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HBF Drug Watch

Compounds in Development for Chronic Hepatitis B

Updated November 12, 2015

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 Agenix, Australia 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 Research, 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 (ISIS-HBVRx) Antisense drug ISIS Pharma (w/ GSK), Carlsbad, CA
Phase II
SB 9200 HBV Small molecule nucleic acid hybrids or “SMNH” Spring Bank Pharma,
Milford, MA
Phase II
Rep 2139-Ca HBsAg release inhibitor REPLICor Inc.,
Canada
Phase II
AIC 649 (Bay 41-4109) Capsid Inhibitor AiCuris, Germany Phase I
TKM-HBV RNAi gene silencer Tekmira,
Canada
Phase I
IONIS-HBV-LRx (ISIS-GSK6-LRx) Ligand Conjugated Antisense (LICA) Technology ISIS Pharma (w/ GSK), Carlsbad, CA Phase I
Alinia (Nitazoxanide) Small molecule Romark Labs,
Tampa, FL
Preclinical
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
OCB-030 Cyclophilin inhibitor

Arbutus Biopharma (formerly Tekmira), 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
CYT107
(Interleukin-7)
Immunomodulator Cytheris,
France
Phase I/IIa
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
CYT-003 TLR9 agonist Arbutus Biopharma (formerly Tekmira), Canada Preclinical
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 January 15, 2016


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