Ersodetug granted breakthrough therapy designation for congenital hyperinsulinism

The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to ersodetug (RZ358; Rezolute, Inc) for treating hypoglycemia associated with congenital hyperinsulinism (HI), according to a press release.

This designation highlights ersodetug’s potential to address a critical unmet need in managing this rare and life-threatening condition. It is based on promising results from the Phase 2b RIZE study, where the therapy safely reduced hypoglycemia by 75% or more without significant hyperglycemia.

Topline data from the ongoing Phase 3 sunRIZE trial is anticipated in the second half of 2025.

Read the full press release here.