The oral insulin pill (ORMD-0801), based on over 30 years of research by Hadassah Medical Center scientists, and developed by the Israeli company, Oramed Pharmaceuticals Inc., has been cleared by the United States Food and Drug Administration (FDA) for Phase 2 clinical trials in the US.
The orally ingestible capsule is indicated for those with early stage type two diabetes, when it can slow the rate of disease progression by providing additional insulin to the body and allowing the pancreas a respite. The pill delivery system has the advantage of mimicking insulin's natural location and gradients in the body by first passing through the liver before entering the bloodstream. "We are very pleased to have the FDA clearance to proceed," stated Nadav Kidron, Chief Executive Officer of Oramed. "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."