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