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

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

  • Drugs Ersodetug (Primary)
  • Indications Congenital hyperinsulinism
  • Focus Registrational; Therapeutic Use
  • Acronyms sunRIZE
  • Sponsors Rezolute

Most Recent Events

  • 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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