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A Phase 3 Study to Evaluate the Glucose Response of G-Pen (Glucagon Injection) in Pediatric Patients With Type 1 Diabetes

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Trial Profile

A Phase 3 Study to Evaluate the Glucose Response of G-Pen (Glucagon Injection) in Pediatric Patients With Type 1 Diabetes

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Mar 2020

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At a glance

  • Drugs Glucagon (Primary)
  • Indications Hypoglycaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors XERIS Pharmaceuticals
  • Most Recent Events

    • 10 Sep 2019 According to a Xeris Pharmaceuticals media release, it has received regulatory approval from the U.S. Food and Drug Administration (FDA) for GVOKE (glucagon) injection, its ready-to-use, room-temperature stable liquid glucagon for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above.This is based on positive results from three Phase 3 clinical trials (NCT02656069, NCT03091673, NCT03439072).
    • 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.
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