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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: 10 Oct 2024

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At a glance

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

    • Most Recent Events

    • 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.
    • 30 Aug 2023 According to a Zealand Pharma media release, to ensure the most efficient regulatory process, the review by the US FDA will be conducted in two parts under NDA. Part 1 relates to dosing for up to 3 weeks, whereas Part 2 relates to use beyond 3 weeks; The PDUFA date for Part 2 will be set following submission of additional analyses from existing datasets requested by the US FDA, which is expected before the end of the year.

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