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A Two-Period, Open-label Trial Evaluating the Efficacy and Safety of Dasiglucagon for the Treatment of Children with Congenital Hyperinsulinism

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Trial Profile

A Two-Period, Open-label Trial Evaluating the Efficacy and Safety of Dasiglucagon for the Treatment of Children with Congenital Hyperinsulinism

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Feb 2025

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At a glance

  • Drugs Dasiglucagon (Primary)
  • Indications Congenital hyperinsulinism
  • Focus Registrational; Therapeutic Use
  • Sponsors Zealand Pharma

Most Recent Events

  • 20 Feb 2025 According to a Zealand Pharma media release, company is prepared to resubmit the New Drug Application (NDA) for three weeks of dosing to the U.S. FDA.
  • 08 Oct 2024 According to a Zealand Pharma media release, .S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Part 1 of the New Drug Application (NDA) for dasiglucagon for the prevention and treatment of hypoglycemia in pediatric patients 7 days of age and older with congenital hyperinsulinism (CHI) for up to 3 weeks of dosing.
  • 01 Nov 2023 Results evaluating the efficacy and safety of dasiglucagon in children with CHI and persistent hypoglycaemia as add-on to standard of care (SoC), published in the Journal of Clinical Endocrinology and Metabolism.

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