Schering-Plough has reported that the FDA has granted fast-track designation to its investigational oral hepatitis C protease inhibitor (SCH 503034), currently in Phase II clinical development for the treatment of chronic hepatitis C virus (HCV) infection.

The proposed first indication for SCH 503034 is for treatment of HCV in patients with HCV genotype 1 virus who have not responded to combination therapy with pegylated interferon and ribavirin, the current standard of care, thus representing an unmet medical need.

SCH 503034 is an orally active inhibitor of the hepatitis C virus serine protease that inhibits HCV replication. This mechanism is distinct from those of current therapies, thus SCH 503034 represents a novel class of HCV inhibitor.