Prepared on behalf of the PES Drugs and Therapeutics Committee by
Kristal Matlock, MD, Dania Al-Hamad, MD, Vandana Raman, MD and Amit Lahoti, MD
FDA approval for Zegalogue (dasiglucagon) marks the third FDA-approved, ready-to-use, stable glucagon preparation since 2019 that does not require reconstitution. Zegalogue 0.6 mg/0.6 mL autoinjector or pre-filled syringe was approved in 2021 for use in adults and children age 6 years and older with diabetes, indicated for treatment of severe hypoglycemia.
Dasiglucagon 0.6 mg performed similarly to reconstituted glucagon 1 mg with 99% and 95% plasma glucose recovery within 15 minutes, respectively, in a randomized, double-blind study of adults with type 1 diabetes. It was also studied in pediatric patients with diabetes ages 6-17 years in a randomized placebo-controlled trial. Mean time to plasma glucose recovery was 10 minutes, which is similar to the reconstituted glucagon formulation. Overall, it was found to be safe and effective for treatment of severe hypoglycemia in children with diabetes who are at least 6 years of age.
The evolution of glucagon formulations to include ready-to-use medications promotes safe, effective, simplified, and rapid intervention for all caregivers during a hypoglycemic emergency. Stability at room temperature also allows for use and storage across multiple environments. This may also allow for evolving indications beyond emergency use, such as development of dual‐hormone artificial pancreas systems and treatment of children with congenital hyperinsulinism.