A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study to Evaluate the Efficacy and Safety of RZ358 in Patients with Congenital Hyperinsulinism
Latest Information Update: 30 May 2025
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.