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Ersodetug is a fully human monoclonal antibody developed as an intravenous therapy for the treatment of hypoglycemia due to hyperinsulinism (HI), including both congenital and tumor-induced forms. It acts by binding allosterically to a unique site on the insulin receptor, thereby antagonizing excessive activation caused by insulin and related substances such as IGF-2. This mechanism allows it to normalize insulin receptor signaling downstream from the pancreas, making it potentially effective across all forms of HI regardless of etiology. Ersodetug has demonstrated substantial benefit in clinical trials and real-world use, showing significant improvements in hypoglycemia without causing clinically significant hyperglycemia. The drug has received Orphan Drug Designation and Breakthrough Therapy Designation from the FDA for both congenital HI and tumor HI, with ongoing Phase 3 studies in these indications[1][4][5][7].
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