The US Food and Drug Administration (FDA) has cleared Oramed's investigational new drug (IND) application for ORMD-0801, an oral insulin capsule, allowing the company to begin clinical trials of the drug.
ORMD-0801 is an orally ingestible insulin capsule indicated for the early stages of type 2 diabetes, when it can still slow the rate of degeneration of the disease by offering additional insulin to the body and allowing pancreatic respite.
Orally administered insulin also has the benefit of enhanced patient compliance at a crucial stage and the advantage of mimicking insulin's natural location and gradients in the body by first passing through the liver before entering the bloodstream.
Oramed CEO Nadav Kidron said, "The upcoming trial is a major milestone for Oramed and we look forward to continuing to progress ORMD-0801's clinical development in the US."
