- In January 2025, Lucid Pharma, announced the launch of a novel genetic screening test designed to improve the early diagnosis of congenital hyperinsulinism (CHI). This test is designed to detect genetic mutations responsible for CHI in newborns and infants, providing early identification and enabling timely intervention. The test is designed to be accessible and efficient, enabling quicker diagnosis, which is crucial for managing CHI and preventing severe hypoglycemic events. The test has been approved by regulatory authorities in the European Union and is expected to be available in key global markets by mid-2025. This new development is expected to revolutionize CHI diagnosis, particularly in developing countries with limited access to traditional diagnostic tools
- In October 2024, Insulin Therapeutics, Inc. showcased innovations in CHI treatment at the American Diabetes Association (ADA) Annual Meeting. The company presented new clinical data on the use of its long-acting diazoxide formulation for managing congenital hyperinsulinism. The long-acting formulation, which aims to reduce the frequency of administration and improve patient compliance, showed promising results in clinical trials for both focal and diffuse CHI types. This product has the potential to improve long-term management for CHI patients, particularly in pediatric populations
- In September 2024, Orphan Care Pharmaceuticals announced the launch of an expanded line of CHI treatment options, including a new injectable form of octreotide aimed at providing fast-acting relief for CHI patients experiencing hypoglycemic episodes. This new injectable treatment aims to offer healthcare professionals a more effective and immediate solution during acute episodes while maintaining the same efficacy and safety profile as the standard octreotide treatments. This innovation is expected to significantly enhance the management of severe CHI cases and improve patient outcomes
- In June 2023, Zealand Pharma A/S announced that it had submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for dasiglucagon, intended for the prevention and treatment of hypoglycemia in pediatric patients aged seven days and older with congenital hyperinsulinism
