Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study to Evaluate the Efficacy and Safety of RZ358 in Patients with Congenital Hyperinsulinism

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 30 May 2025

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At a glance

28 May 2025 According to a Rezolute media release, assuming supportive data from sunRIZE, the Company anticipates a clear path to submit a Biologics License Application to the U.S. Food and Drug Administration for ersodetug in 2026.
28 May 2025 Status changed from recruiting to active, no longer recruiting.Target enrollment exceeded with 62 participants enrolled, including approximately 15 percent from U.S. sites
23 Apr 2025 According to a Rezolute media release, enrollment is on track and expected to be completed in May 2025, topline data anticipated in December 2025.

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