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# FDA Still Reviewing Rezolute Phase 3 Info
- URL: https://www.fdaweb.com/fda-still-reviewing-rezolute-phase-3-info/
- Published: 2026-09-09T12:00:00.000Z
- Updated: 2026-09-13T19:20:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161751

Rezolute says FDA officials have informed it that the agency is continuing to review data from the company’s Phase 3 sunRIZE study of ersodetug to treat hypoglycemia due to congenital hyperinsulinism (HI). A company update [statement](https://ir.rezolutebio.com/news/detail/383/rezolute-provides-update-on-fda-review-of-its-phase-3-sunrize-study-results-in-congenital-hyperinsulinism?ref=fdaweb.com) says that at a March Type B meeting, agency officials asked Rezolute to provide additional study data for its independent review.

The company says it submitted the requested data in June and believes the submission included data of target engagement, pharmacologic activity, and glycemic improvement. “Specifically,” it says, “there were consistent glycemic improvements in the treatment arms compared with placebo across multiple continuous glucose monitoring-based outcomes at both ersodetug dose levels, including but not limited to 50% or greater reductions in both average daily percent time in hypoglycemia and average weekly hypoglycemia events.”

Ersodetug is described as a fully human monoclonal antibody that binds allosterically to the insulin receptor to decrease receptor over-activation by insulin and related substances in the setting of hyperinsulinism, thereby improving hypoglycemia.