Zegalogue Authorised for Extreme Hypoglycemia in Sufferers With Diabetes


The Food and Drug Administration (FDA) has approved Zegalogue® (dasiglucagon) for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and over.

Zegalogue is a glucagon analog that is formulated in a ready-to-use aqueous solution for subcutaneous administration. The approval was based on data from 3 double-blind, placebo-controlled phase 3 studies in adult and pediatric patients with type 1 diabetes.

In a study of 170 adults (ClinicalTrials.gov: NCT03378635), dasiglucagon was associated with a median time to plasma glucose recovery of 10 minutes versus 40 minutes with placebo (P <0.001) and 12 minutes with glucagon for injection. Similarly, in a study of 45 adult patients (ClinicalTrials.gov: NCT03688711), the median time to plasma glucose recovery was statistically shorter for dasiglucagon (10 minutes) than for placebo (35 minutes) (P <0.001).

In pediatric patients 6-17 years of age weighing at least 20 kg (N = 42) (ClinicalTrials.gov: NCT03667053), the median time to plasma glucose recovery was statistically significant for dasiglucagon (10 minutes) versus placebo (30 minutes) shorter (30 minutes) (30 minutes) P <0.001) and was numerically similar to glucagon for injection (10 minutes).

“The magnitude and consistency of effects seen in the pivotal phase 3 studies are clinically significant as minutes are involved in severe hypoglycemia,” said Dr. Jeremy Pettus, MD, Assistant Professor of Medicine at the University of California at San Diego.

For safety reasons, the most common side effects reported in studies were nausea, vomiting, headache, diarrhea and injection site pain. Zegalogue is contraindicated in patients with pheochromocytoma because of the risk of a significant increase in blood pressure and in patients with insulinoma its administration may lead to hypoglycaemia.

Zegalogue is supplied as a 0.6 mg / 0.6 ml single-dose auto-injector or pre-filled syringe for subcutaneous injection. The product should be kept in the refrigerator, but can be kept at room temperature for up to 12 months. Each device contains a single dose of dasiglucagon and cannot be reused. An additional 0.6 mg dose from a new device can be given if there is no response after 15 minutes.

Zegalogue is expected to be available in the US in June 2021.


1. Zealand Pharma Announces FDA Approval of Zegalogue® (dasiglucagon) injection for the treatment of severe hypoglycemia in people with diabetes. [press release]. Copenhagen, Denmark and Boston, MA: Zealand Pharma; March 22, 2021.

2. Zegalog [prescribing information]. Søborg, Denmark: Zealand Pharma A / S. 2021