A phase III study of ORMD-0801 in patients with diabetes mellitus

Trial Profile

A phase III study of ORMD-0801 in patients with diabetes mellitus

Planning
Phase of Trial: Phase III

Latest Information Update: 05 Sep 2017

At a glance

  • Drugs Insulin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Therapeutic Use
  • Most Recent Events

    • 05 Sep 2017 According to an Oramed Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) gave clear guidance that the regulatory pathway for submission of ORMD-0801, would be a Biologics License Application (BLA).
    • 05 Sep 2017 According to an Oramed Pharmaceuticals media release, this trial is anticipated to begin in late 2017.
    • 11 Jul 2017 This study will support the submission of an NDA to the US FDA according to an Oramed Pharmaceuticals media release.
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