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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: 28 May 2026

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At a glance

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

Most Recent Events

  • 07 May 2026 According to Zealand Pharma media release, In the second half of 2026, Zealand Pharma expects to resubmit the New Drug Application (NDA) for three weeks of dosing to the U.S. FDA (Part 1 of the original NDA) and to submit the required and detailed analyses from existing continuous glucose monitoring datasets to support the use of dasiglucagon beyond three weeks (Part 2 of the original NDA).
  • 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.

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