On December 31, 2012, Oramed Pharmaceuticals Inc. filed an Investigational New Drug, or IND, application with the U.S. Food and Drug Administration to begin a Phase 2 clinical trial of its orally ingested insulin candidate, ORMD-0801. The trial is to include 147 type 2 diabetic patients in multiple centers across the United States. Oramed plans to initiate the trial following FDA approval of the IND.

If Oramed does not receive comments from the FDA on the IND application within 30 days from filing, Oramed intends to immediately commence the trial to evaluate the safety, tolerability and efficacy of its oral insulin capsule on type 2 diabetic volunteers.