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# FDA Asks for Rezolute’s Ersodetug Data After Trial Miss
- URL: https://www.fdaweb.com/fda-asks-for-rezolutes-ersodetug-data-after-trial-miss/
- Published: 2026-03-25T12:00:00.000Z
- Updated: 2026-09-14T13:36:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160872

Rezolute is trying to chart a path forward for its congenital hyperinsulinism program after its Phase 3 trial of ersodetug missed the primary endpoint, with FDA now asking for a deeper dive into the data before weighing next steps. Following a Type B meeting earlier this month, the agency encouraged the company to submit comprehensive results from its sunRIZE study, along with data from an ongoing open-label extension, for independent review — stopping short of signaling whether the dataset could support a filing.

Rezolute reported in December that sunRIZE, a placebo-controlled Phase 3 study of ersodetug in Congenital Hyperinsulinism, failed to hit its primary endpoint. While patients saw reductions in hypoglycemia events, the improvements did not reach statistical significance versus placebo.

At the FDA meeting, the company argued that the trial results were confounded by behavioral factors tied to disease management. Because patients rely on real-time glucose monitoring as part of standard care, awareness of treatment assignment may have influenced behavior — potentially blunting differences between study arms, it says.

FDA appeared to acknowledge those challenges, particularly the limitations of self-monitored blood glucose as an endpoint in this heterogeneous population. But regulators also reiterated the need for “adequate and well-controlled” evidence to support approval, according to the company.

Still, Rezolute says it pointed to signals it believes support the drug’s activity, including:

- Consistent improvements in continuous glucose monitoring (CGM)-based measures of time spent in hypoglycemia
- Biomarker evidence of insulin receptor pathway modulation
- Early data from the open-label extension showing continued glycemic improvement and reduced reliance on background therapies

The company now plans to hand over full datasets for FDA analysis, after which regulators will determine whether the existing evidence could support a marketing application or if additional studies will be required. Rezolute says it expects to provide an update in the second half of 2026.