Rezolute Inc. has outlined progress in its late-stage rare disease programs targeting hyperinsulinism, a serious condition characterized by excessive insulin production leading to hypoglycemia. The company’s lead candidate, ersodetug (RZ358), is an antibody therapy being evaluated for both congenital and tumor-induced hyperinsulinism. Ersodetug has received Breakthrough Therapy Designation from the US FDA, PRIME designation from the European Medicines Agency, and Orphan Drug Designation in both the US and EU. Data from clinical trials and real-world use suggest activity against hypoglycemia in patients with hyperinsulinism. Rezolute plans to report topline data from a Phase 3 trial in tumor hyperinsulinism in the second half of 2026, with ongoing regulatory engagement for congenital hyperinsulinism. Current standard of care remains inadequate, as a significant portion of patients do not respond to existing therapies such as diazoxide and may experience serious side effects. You can access the full presentation through the link below.

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