Dasiglucagon: Continuous infusion
A glucagon analog for the treatment of congenital hyperinsulinism.
Dasiglucagon is a glucagon analog designed to allow for continuous subcutaneous infusion via a wearable pump system.
Dasiglucagon is an investigational candidate, not approved by the U.S. Food & Drug Administration (FDA) or any health authority for congenital hyperinsulinism (CHI), and the safety and effectiveness of dasiglucagon in CHI has not yet been established.
- PROGRAM Dasiglucagon: Continuous infusion
- Registration
Development status
The use of dasiglucagon in congenital hyperinsulinism (CHI) for up to three weeks of dosing is currently under review by the US Food and Drug Administration (FDA). We expect to submit the second part of the New Drug Application (NDA) covering use of dasiglucagon in CHI beyond three weeks of dosing in the coming months.
We have evaluated the potential of dasiglucagon in the management of CHI in three Phase 3 clinical trials in newborns and children up to 12 years of age. One Phase 3 trial assessed the potential for dasiglucagon to reduce the requirement for intravenous glucose in newly diagnosed newborns and infants who were being treated in a hospital setting, and potentially avoid pancreatectomy.
Another Phase 3 trial investigated the potential for dasiglucagon to reduce the time in hypoglycemia for children aged between 3 months and 12 years administered in a homecare setting. The most frequently reported adverse events in both trials were skin reactions and gastrointestinal disturbances. 42 out of the 44 patients who participated in these two Phase 3 trials enrolled into a long-term extension trial that is ongoing.
Scientific publications are available upon request
Please contact investor relations to request references or scientific publications and presentations related to dasiglucagon in congenital hyperinsulinism.
Learn about clinical trials involving dasiglucagon in CHI
Collaboration and Partnerships
Zealand Pharma has partnered with DEKA Research & Development Corporation and its affiliates for a continuous infusion pump to be used with dasiglucagon for the potential treatment of CHI.
Zealand is also pursuing a partnership for the commercialization of dasiglucagon for CHI.
Congenital Hyperinsulinism (CHI)
More about the disease area
CHI is a rare disease affecting newborns, infants and children caused by a defect in pancreatic beta-cells, resulting in insulin overproduction and leading to frequent, recurrent and often severe episodes of low glucose (hypoglycemia).
