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HBF Drug Watch

Compounds in Development for Chronic Hepatitis B

Updated December 2008

FAMILY/DRUG NAME MECHANISM COMPANY STATUS
Interferons - Mimic naturally-occurring, infection-fighting immune substance produced in the body
Intron A
(Interferon
alfa-2b
Immunomodulator Schering-Plough
Madison, NJ
FDA Approved
1991
Pegasys
(Peginterferon alfa-2a)
Immunomodulator Roche
Switzerland
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 Idenix
Cambridge, MA
FDA Approved
2006
Viread
(Tenofovir)
Inhibits viral DNA polymerase Gilead
Foster City, CA
FDA Approved 2008
Emtricitabine
(FTC)
Inhibits viral DNA polymerase Gilead
Foster City, CA
Phase III
Clevudine
(L-FMAU)
Levovir (S. Korea)
Inhibits viral DNA polymerase Pharmasset
Princeton, NJ
Bukwang

South Korea
Eiasai, Japan
Phase III, USA
Approved S. Korea (Nov. 2006)
Valtorcitabine
(monoval LdC)
Inhibits viral DNA polymerase Idenix
Cambridge, MA
Phase II
Amdoxovir
(DAPD)
Inhibits viral DNA polymerase RFS Pharm LLC
Tucker, GA
Phase II
Pradefovir
(Remofovir)
Inhibits viral DNA polymerase Schering-Plough
Madison, NJ
Phase II
RCV
(Racivir)
Inhibits viral DNA polymerase Pharmasset
Princeton, NJ
Phase II
Non-Nucleoside Antivirals -  Interfere with proteins involved in viral reproduction
NOV-205
(BAM 205)
Small Molecule Novelos
Newton, MA
Approved in Russia
HepeX-B
(XTL-001)
Human monoclonal antibodies XTL Biopharm
and Cubist Pharm, Cambridge, MA
Phase II/III
Orphan drug approval in US for liver cancer
Nitazoxanide (Alinia) Small Molecule Romark Labs
Tampa, FL
Phase II Egypt
UT 231-B
*Discovered by HBF Scientists
Small Molecule United Therapeutics
Silver Spring, MD
Preclinical HBV
(Phase II HCV)
Bay 41-4109  Inhibits viral nucleocapsid Bayer AG
Germany
Preclinical
Non-Interferon Immune Enhancers -  Boost T-cell infection-fighting immune cells and natural interferon production
EHT899 Oral Viral Protein Enzo Biochem
New York, N.Y.
Phase II Israel
Zadaxin
(Thymosin
alpha-1)
Immune stimulator SciClone
San Mateo, CA
Orphan drug approval in US for liver cancer
Hi-8 HBV Therapeutic HBV Vaccine Oxxon
U.K.
Phase II
NUC B1000 Expressed Interfering RNA Nucleonics
Horsham, PA
Phase I
HepaVaxx B Therapeutic HBV Vaccine Virexx
Canada
Phase I
HBV Core Antigen Vaccine  Therapeutic HBV Vaccine Emergent Europe
U.K.
Phase I
SpecifEx-HepB Immunological Cell Transfer Chromos
Burnaby, BC
Preclinical/
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 Nabi
Boca Raton, FL
FDA Approved
1999
Hepa Gam B HBV Immuneglobulin Cangene
Canada
FDA Approved 2006