Rezolute announces alignment with FDA on streamlined design for ongoing Phase 3 trial of Ersodetug in tumor hyperinsulinism.
Open-label study includes as few as 16 tumor hyperinsulinism (HI) patients, with enrollment in the U.S. and Europe.
Topline data expected in the second half of 2026.
FDA Alignment
FDA agrees to a streamlined design for the Phase 3 study, removing the need for a randomized placebo trial, focusing on open-label single-arm study.
Clinical Development Path
Rezolute gains FDA's recognition of the broad applicability of ersodetug in treating multiple forms of hypoglycemia caused by hyperinsulinism.
Pivotal Study
SunRIZE trial in congenital HI to serve as confirmatory evidence, signaling a significant step in the company's clinical development path.
- The alignment with FDA on the streamlined study design indicates a positive regulatory outcome for Rezolute, expediting the development process.
- The approval pathway for ersodetug in hypoglycemia caused by tumor HI marks a crucial advancement in addressing the unmet medical need in the patient community.
Rezolute's alignment with FDA for the Phase 3 study of Ersodetug represents a pivotal moment in advancing treatment for rare diseases. This regulatory milestone underscores the company's commitment to simplifying clinical development and accelerating therapy availability.