Rezolute, Inc.

Rezolute, Inc. is a clinical-stage biopharmaceutical company dedicated to developing transformative therapies for rare and metabolic diseases. Founded in 2010 and formerly known as AntriaBio, Inc. until its name change in December 2017, the company's core mission is to significantly improve the quality of life for individuals suffering from hypoglycemia caused by hyperinsulinism (HI) by alleviating the burden of severe and debilitating hypoglycemia. Rezolute's headquarters are located in Redwood City, California.

The company's lead clinical asset is ersodetug (formerly RZ358), an intravenously administered human monoclonal antibody designed to reduce excess insulin action by binding to a unique site on the insulin receptor. Ersodetug is currently in Phase 3 clinical trials for the treatment of both congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI). Beyond hyperinsulinism, Rezolute also has a pipeline focus on diabetic retinal disease, including diabetic macular edema (DME) and diabetic retinopathy (DR), utilizing an oral small-molecule pathway inhibitor.

Nevan Charles Elam serves as the Founder, CEO, Principal Financial Officer, and Acting Chairman of the Board, having been appointed CEO in January 2013. In December 2025, Rezolute announced that its Phase 3 sunRIZE study for ersodetug in congenital hyperinsulinism did not meet its primary or key secondary endpoints, which led to a significant decline in its stock price. Despite this setback, the company reported observed pharmacologic activity and glycemic improvements, and is engaging in discussions with the FDA under ersodetug's Breakthrough Therapy Designation. Rezolute remains a development-stage company with no current revenue, focusing its efforts on advancing ersodetug, with topline data for its Phase 3 upLIFT study in tumor hyperinsulinism anticipated in the second half of 2026.