Rezolute's Ersodetug Gets Orphan Drug Designation To Treat Hypoglycemia Due To Tumor Hyperinsulinism

(RTTNews) - Rezolute, Inc. (RZLT),a late-stage biopharmaceutical company, Tuesday said that the U.S. Food and Drug Administration or FDA has granted orphan drug designation to ersodetug for the treatment of hypoglycemia due to tumor hyperinsulinism (HI).

Orphan Drug Designation offers benefits including seven years of market exclusivity after approval, tax credits for clinical trials, and potential qualification for expedited pathways to approval.

A Phase 3 Registrational trial of ersodetug in patients with hypoglycemia due to tumor HI is expected to start in 2025.