Trial Profile

An Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon for the Treatment of Children With Congenital Hyperinsulinism

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 02 Jun 2025

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At a glance

Drugs Dasiglucagon (Primary)
Indications Congenital hyperinsulinism
Focus Adverse reactions; Registrational
Sponsors Zealand Pharma

Most Recent Events

28 May 2025 Planned End Date changed from 1 Jan 2025 to 31 Dec 2026.
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.
05 Apr 2024 Planned End Date changed from 1 Apr 2024 to 1 Jan 2025.

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