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HBF Drug Watch

Compounds in Development for Chronic Hepatitis B

Updated May 2014

FAMILY/DRUG NAME MECHANISM COMPANY STATUS
Interferons - Mimic naturally-occurring, infection-fighting immune substance produced in the body
Intron A
(Interferon
alfa-2b
Immunomodulator Merck,
Whitehouse Station, NJ
FDA Approved
1991
Pegasys
(Peginterferon alfa-2a)
Immunomodulator Genentech,
South SanFrancisco, 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
Foster City, CA
FDA Approved
2002
Baraclude
(Entecavir)
Inhibits viral DNA polymerase Bristol-Myers Squibb
Princeton, NJ
FDA Approved
2005
Tyzeka
Sebivo (Europe)
(Telbivudine)
Inhibits viral DNA polymerase Novartis,
Switzerland
FDA Approved
2006
Viread
(Tenofovir)
Inhibits viral DNA polymerase Gilead
Foster City, CA
FDA Approved 2008
Clevudine
(L-FMAU)
Inhibits viral DNA polymerase Bukwang
South Korea
Eiasai, Japan
Approved S. Korea
2006 (Levovir)
Tenofovir alafenamide (TAF)
Prodrug of Tenofovir Gilead
Foster City, CA
Phase III
Besifovir (LB80380) Inhibits viral DNA polymerase LG Life Sciences,
S. Korea
Phase II
AGX-1009 Prodrug of Tenofovir Agenix, Australia Phase I, China
Non-Nucleoside Antivirals -  Interfere with proteins involved in viral reproduction
NOV-205
(BAM 205)
Small Molecule Novelos
Newton, MA
Approved in Russia
Myrcludex B Entry Inhibition Myr-GmbH,
Germany
Phase IIa, Russia
ARC-520 RNAi gene silencer Arrowhead Research, Pasadena, CA Phase IIa
HAP Compound
Bay 41-4109
Inhibits viral nucleocapsid AiCuris, Germany Phase I
REP 9AC     HBsAg Release Inhibitor REPLICor Inc.
Montreal, Quebec
Phase I
Alinia (Nitazoxanide) Small Molecule Romark Labs
Tampa, FL
Preclinical
dd-RNAi compound Gene silencing Benitec, Australia
and Biomics, China
Preclinical
NVR-1221 (NVR 3-778)  Capsid inhibitor Novira Therapeutics, Doylestown, PA Phase 2a
BSBI-25 cccDNA inhibitor Baruch S. Blumberg Intsitute,
Doylestown, PA
Preclinical
TKM-HBV RNAi gene silencer Tekmira,
Vancouver, CA
www.tekmira.com
Preclinical
ALN-HBV RNAi gene silencer

Alnylam,
Cambridge, MA
www.alnylam.com

Preclinical
Non-Interferon Immune Enhancers -  Boost T-cell infection-fighting immune cells and natural interferon production
Zadaxin
(Thymosin
alpha-1)
Immune stimulator SciClone
San Mateo, CA
Orphan drug approval in US for liver cancer
GS-4774 Therapeutic Vaccine Gilead Sciences with Globe Immune
Louisville, CO
Phase II
CYT107 (Interleukin-7) Immunemodulator Cytheris,
Paris, France
Phase I/IIa
DV-601 HBV surface and core antigens Dynavax,
Berkeley, CA
Phase Ib
HBV Core Antigen Vaccine Therapeutic HBV vaccine Emergent Europe, U.K. Phase I
GS-9620 TLR7 agonist Gilead
Foster City, USA
Phase I
Post-Exposure and/or Post-Liver Transplant Treatment
HyperHEP S/D HBV Immuneglobulin Talecris
RTP, NC
FDA Approved 1977
Nabi-HB HBV Immuneglobulin Biotest,
Boca Raton, FL
FDA Approved
1999
Hepa Gam B HBV Immuneglobulin Cangene
Canada
FDA Approved 2006

 

Page last modified August 25, 2014


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