Orphan Drug Designation Awarded to RG1068

The U.S. Food and Drug Administration has granted orphan drug designation to Repligen Corp.’s synthetic human secretin known as RG1068, to be used with magnetic resonance imaging of the pancreas. Orphan drug designation qualifies Repligen for seven years of exclusive marketing rights in the United States, if the company is first to receive marketing approval for RG1068 for MRI imaging of the pancreas.

Repligen is currently conducting a multi-center, Phase 2/3 clinical trial of RG1068 as an agent to improve the detection of structural abnormalities of the pancreatic ducts during imaging of the pancreas, as well as a Phase 1 investigator study to assess the utility of secretin for functional imaging of the pancreas.