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: 07 Nov 2018
At a glance
- Drugs Glucagon (Primary)
- Indications Hypoglycaemia
- Focus Registrational; Therapeutic Use
- Sponsors XERIS Pharmaceuticals
- 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.
- 25 Jun 2018 Results presented in a Xeris Pharmaceuticals media release.