What were the key findings for tumor hyperinsulinism (HI) presented by Rezolute (NASDAQ:RZLT) at ENDO 2026?

Rezolute (NASDAQ:RZLT) presented a case series from its Expanded Access Program (EAP) showing that 75% of tumor HI patients who were dependent on intravenous dextrose or TPN achieved complete discontinuation of these requirements after treatment with ersodetug.

What is the clinical status of the Phase 3 sunRIZE study in congenital hyperinsulinism?

The sunRIZE study was a global, randomized, double-blind, placebo-controlled trial evaluating ersodetug in patients aged 3 months to 45 years. While the company reported that the study provided meaningful data on therapeutic benefit, recent reports indicate the trial missed its primary endpoint, leading the company to consult with the FDA on future directions.

What is ersodetug and how does it work for hyperinsulinism?

Ersodetug is a fully human monoclonal antibody designed to treat hyperinsulinism by binding allosterically to the insulin receptor. By decreasing receptor over-activation caused by insulin and related substances like IGF-2, it helps normalize glucose levels in patients with refractory hypoglycemia.

Is ersodetug by Rezolute (NASDAQ:RZLT) currently FDA approved?

No, ersodetug is an investigational drug and is not yet FDA-approved. It has, however, received several regulatory designations, including FDA Breakthrough Therapy designation and Orphan Drug designation, to facilitate its development for hyperinsulinism.

How is Rezolute (NASDAQ:RZLT) addressing the impact of congenital hyperinsulinism beyond clinical trials?

In addition to clinical trials, Rezolute (NASDAQ:RZLT) is conducting systematic analyses of natural history, neurologic outcomes, and health-economic data. These efforts aim to quantify the disease burden of congenital HI and support the long-term clinical and economic case for ersodetug.

Image for illustrative purposes only. Not a real photo.

Rezolute shares new hyperinsulinism clinical data

Written by Brie CarterPublished Jan 17, 2026, 2:04 PMLast Updated Jun 17, 2026, 2:07 PM

Rezolute (NASDAQ:RZLT) presented four studies at the 2026 Annual Meeting of the Endocrine Society (ENDO) detailing the impact of congenital and tumor hyperinsulinism (HI) and the clinical activity of its lead candidate, ersodetug.
The presentations included topline results from the Phase 3 sunRIZE study in congenital HI, alongside an analysis of real-world outcomes for tumor HI patients using an Expanded Access Program (EAP).
Key data from the EAP showed that 75% of tumor HI patients requiring intravenous dextrose or total parenteral nutrition (TPN) achieved complete discontinuation of those glucose requirements while on ersodetug.

Rezolute (NASDAQ:RZLT) utilized the ENDO 2026 meeting to highlight progress across its two late-stage clinical programs.

The company’s data package focused on quantifying the broader disease impact of HI while demonstrating the potential of ersodetug as a universal treatment for refractory hypoglycemia.

Two poster presentations focused on the natural history of congenital HI, providing systematic analyses of adverse neurologic and health-economic outcomes.

Rezolute noted that these studies are intended to facilitate future health economics and outcomes research (HEOR) to support the potential commercialization of ersodetug.

The clinical program for ersodetug, an insulin receptor-modulating monoclonal antibody, continues to be evaluated for its ability to reduce receptor over-activation by insulin and IGF-2.

While ersodetug is currently an investigational candidate and has not yet received FDA approval, Rezolute continues to leverage various regulatory pathways, including Orphan Drug and Breakthrough Therapy designations, to advance its development timeline.

The company remains focused on consolidating its findings to determine the optimal path forward for ersodetug in both congenital and tumor-based HI indications.

Rezolute shares new hyperinsulinism clinical data

Frequently asked questions

Assets related to this article