G-Pen (Glucagon Injection) Compared to Lilly Glucagon (Glucagon for Injection [RDNA Origin]) for Induced Hypoglycemia Rescue in Adults With T1D: a Phase 3 B Multi-Centered, Randomized, Controlled, Single Blind, 2-Way Crossover Study to Evaluate Efficacy and Safety
Phase of Trial: Phase III
Latest Information Update: 12 Jun 2019
Price : $35 *
At a glance
- Drugs Glucagon (Primary)
- Indications Hypoglycaemia
- Focus Registrational; Therapeutic Use
- Sponsors XERIS Pharmaceuticals
- 06 Jun 2019 According to a Xeris Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has extended the initial Prescription Drug User Fee Act (PDUFA) goal date for the review of NDA for Gvoke by three months. The new PDUFA goal date is September 10, 2019.
- 07 Nov 2018 According to a Xeris Pharmaceuticals media release, NDA for the glucagon pen for the treatment of severe hypoglycemia has been submitted.The FDA has accepted for review the New Drug Application (NDA), and assigned a PDUFA goal date of June 10, 2019.
- 26 Jun 2018 Status changed from recruiting to completed as reported by ClinicalTrials.gov record.