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.

Rezolution logo

The Rezolution empowers families, fosters meaningful connections, and drives toward a shared rezolution for better care and brighter futures for the HI community.

Congenital Hyperinsulinism

Congenital Hyperinsulinism

Congenital Hyperinsulinism (cHI) is the leading cause of repeated low blood sugar (hypoglycemia) in newborns and infants. It is considered a rare disease and affects about 1 in 22,000 persons born worldwide. In some countries, cHI can occur as often as 1 in 2,500 births. Researchers have identified over 30 different genetic causes of cHI, but in more than one-third of children, the exact cause remains unknown.

Most children with cHI begin showing signs in the first week of life. These early symptoms can be hard to recognize, but they are related to the brain not having enough fuel (blood glucose or ketones, another important energy source). If not detected and treated early, severe or repeated episodes of hypoglycemia can cause permanent brain injury, seizures, developmental delays, or learning difficulties that impact the patient and family for the rest of their lives.

For many patients, the treatments we have today don’t work well enough. The early years of life with cHI demand constant vigilance from caregivers to prevent dangerous hypoglycemia, creating an exhausting burden that impacts not only immediate well-being but also the long-term quality of life for both patients and families.

Tumor Hyperinsulinism

Tumor Hyperinsulinism

Two types of tumors are known to cause hypoglycemia – the medical term for low blood sugar. Insulinomas are a rare type of tumor that usually form from the insulin-secreting cells in the pancreas. When too much insulin is present in the body, it can cause blood sugar levels to drop suddenly and unpredictably. Even very small insulinomas can lead to symptoms of hypoglycemia.

Non-islet cell tumor hypoglycemia (NICTH), sometimes called “Doege-Potter syndrome” or “paraneoplastic hypoglycemia,” is a rare condition where certain tumors outside the pancreas make too much hormone growth factors that can act like insulin and are able to decrease blood sugar below the normal level.

With both tumor types, patients are sometimes misdiagnosed or go through many tests before answers are found. Unfortunately, these delays can put patients at risk of ongoing low blood sugars that may cause lasting harm to the brain. Early recognition of the condition is key to improving outcomes and reducing these risks.

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. An investigational therapy is one that is being studied but has not yet been approved for any use by any health authority.

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.

This video, may contain certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of Rezolute, are generally identified by use of words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “project,” “prove,” “potential,” “seek,” “strive,” “try,” or future or conditional verbs such as “predict,” “could,” “may,” “likely,” “should,” “will,” “would,” or similar expressions. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Viewers are cautioned not to place undue reliance on these forward-looking statements, which speak only as an individual patient. Except as required by applicable law or regulation, Rezolute undertakes no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made. Important factors that may cause such a difference include any other factors discussed in our filings with the SEC, including the Risk Factors contained in the Rezolute’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available at the SEC’s website at www.sec.gov.

You are urged to consider these factors carefully in evaluating the forward-looking statements in this release and are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. This video shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

Join the Rezolution

Be a part of the movement. Complete this form to stay up to date on therapy innovations, events, and educational resources.

"(Required)" indicates required fields

I am interested in*:(Required)
Want to share your HI story with us? Check the box below to have someone contact you and help get you started.
By clicking "Submit," you:
  • Confirm you are 18 years of age or older
  • Agree for Rezolute and companies working on behalf of Rezolute to use the information provided on this form to stay in contact with you by email for marketing and educational purposes
  • Understand you can unsubscribe at any time from future communications from Rezolute by clicking the “Unsubscribe” link provided in emails from Rezolute