Rezolute Inc. (NASDAQ: RZLT) is waiting on FDA feedback following a supplemental submission that the company says showed consistent glycemic improvements in treatment arms versus placebo across multiple continuous glucose monitoring–based outcomes.
The Redwood City, Calif.–based biotech announced in December 2025 that its Phase 3 sunRIZE study did not meet its primary endpoint of reducing hypoglycemia events compared with placebo, and the observed reductions from baseline were not statistically significant. The trial enrolled 63 participants across multiple countries who received ersodetug at doses of either 5 mg/kg or 10 mg/kg or a placebo, all as an add-on to existing standard-of-care therapy.
During a Type B meeting with the FDA in March, the agency acknowledged behavioral challenges inherent in conducting clinical trials for the congenital hyperinsulinism population, including limitations with self-monitored blood glucose measures. In June, Rezolute submitted source and analysis datasets, incorporating pre-specified, post-hoc, and sensitivity analyses centered on CGM-based glucose outcomes.
The company stated those analyses demonstrated consistent glycemic improvements in both ersodetug dose groups relative to placebo across multiple CGM-derived endpoints. The FDA is now reviewing the package to evaluate a potential regulatory path forward; no timeline has been provided for feedback.
An open-label extension of the sunRIZE study continues with high retention rates, and cumulative ersodetug treatment duration ranges from approximately nine months to more than two years among enrolled patients.
Separately, Rezolute is continuing enrollment in its Phase 3 upLIFT study of ersodetug for tumor hyperinsulinism, with topline results expected before the end of 2026.
