for patients

understanding Hyperinsulinism

Focused on substantially improving the quality of life for individuals living with hyperinsulinism.

Hypoglycemia is a severe and potentially life-threatening complication of overactivation of the insulin receptor. It can result in neurological damage, coma, and even death, and it has serious implications for both pediatric and adult patients.

There are multiple forms of hyperinsulinism (HI) that can result in hypoglycemia. Congenital HI primarily affects infants and children, while tumor HI generally impacts adults with insulinomas or non-islet cell tumors (NICT). Despite the persistent and dangerous nature of hypoglycemia in these populations, today’s treatment options are limited, often ineffective, and poorly tolerated.

This critical gap leaves many patients vulnerable to recurrent, unpredictable hypoglycemic lows, highlighting the urgent need for innovative, effective therapies.

Congenital Hyperinsulinism

Congenital Hyperinsulinism

Congenital HI is the most common cause of recurrent and persistent hypoglycemia in children. Patients with congenital HI typically present with signs or symptoms of hypoglycemia within the first month of life. These episodes can result in significant brain injury and death if not recognized and managed appropriately. Additionally, recurrent, or cumulative, hypoglycemia can lead to progressive and irreversible damage over time, including serious and devastating brain injury, seizures, neuro-developmental problems, feeding difficulties, and significant impact on patient and family quality of life. In cases of congenital HI that are unresponsive to medical management, surgical removal of the pancreas may be required. More than half of children with congenital HI require long-term medical treatment for hypoglycemia that is not addressed by available therapies.
Tumor Hyperinsulinism

Tumor Hyperinsulinism

Tumor HI is a rare disease that may be caused by two distinct types of tumors: islet cell tumors (ICTs) and non-islet cell tumors (NICTs), both of which lead to hypoglycemia as a result of over-activation of the insulin receptor. Insulinomas are the most common type of ICT and cause hypoglycemia by stimulating the over production of insulin. A variety of different NICTs, particularly hepatocellular carcinoma, can cause hypoglycemia by producing and secreting insulin-like paraneoplastic substances such as IGF-2 that bind to and activate the insulin receptor. With high morbidity and mortality rates within tumor HI, there remains a significant unmet need for new therapies directed at hypoglycemia treatment. Ersodetug has shown real-world benefit in patients with insulinoma and NICTs.
about ersodetug

Ersodetug is an insulin receptor modulating antibody that binds allosterically to the insulin receptor to decrease receptor over-activation by insulin and related substances (such as IGF-2) in the setting of hyperinsulinism (HI), thereby improving hypoglycemia. Because ersodetug acts downstream from the pancreas, it has the potential to be universally effective at treating hypoglycemia due to any form of HI.

Compassionate Use

When no approved treatments are available, some patients may qualify for compassionate use, also called an Expanded Access Program (EAP). Rezolute supports EAPs to help patients with serious conditions access investigational therapies like ersodetug.

Our EAP is designed for patients who benefited from ersodetug during clinical trials and wish to continue treatment, or for those with severe, frequent low blood sugar due to high insulin levels who have no other options.

If you think you may qualify, talk to your healthcare provider, or contact us at: [email protected]

patient voices

Hear Paula’s Story
A Congenital HI Story
Ersodetug is an investigational drug candidate. The FDA has not determined that ersodetug is safe or effective. No indication(s), warnings, precautions, adverse reactions, dosage or administration information for ersodetug have been approved by the FDA. This video depicts the favorable results of ersodetug use for a single patient. It is not intended to guarantee or promote that ersodetug will provide similar results for other subjects participating in the ersodetug Phase III clinical trial or Expanded Access Program.

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