Skip to main content

Zegalogue FDA Approval History

Last updated by Judith Stewart, BPharm on April 6, 2021.

FDA Approved: Yes (First approved March 22, 2021)
Brand name: Zegalogue
Generic name: dasiglucagon
Dosage form: Injection
Company: Zealand Pharma A/S
Treatment for: Hypoglycemia

Zegalogue (dasiglucagon) is a glucagon analog antihypoglycemic agent for the treatment of severe hypoglycemia in diabetes patients aged 6 years and older.

  • Severe hypoglycemia is an acute, life-threatening condition resulting from a critical drop in blood glucose levels. It is associated primarily with insulin therapy. Dasiglucagon works by increasing blood glucose concentration through activation of hepatic glucagon receptors, thereby stimulating glycogen breakdown, and release of glucose from the liver.
  • Zegalogue is available as a single-dose autoinjector and a single-dose prefilled syringe. Zegalogue is administered via subcutaneous injection into the lower abdomen, buttocks, thigh, or outer upper arm. Caregivers should call for emergency assistance immediately after administering the dose.
  • Common adverse reactions in adults include nausea, vomiting, headache, diarrhea and injection site pain. Common adverse reactions in children include nausea, vomiting, headache and injection site pain.

Development Timeline for Zegalogue

Mar 22, 2021Approval  FDA Approves Zegalogue (dasiglucagon) Injection for the Treatment of Severe Hypoglycemia in People with Diabetes
May 22, 2020Zealand Pharma Announces FDA acceptance of New Drug Application for the Dasiglucagon HypoPal® Rescue Pen for Treatment of Severe Hypoglycemia
Sep 24, 2019Zealand Pharma Achieves Primary and All Key Secondary Endpoints in Pediatric Phase 3 Trial with Dasiglucagon for Severe Hypoglycemia
Jul  3, 2017Zealand Initiates First Phase 3 Trial with Dasiglucagon for the Treatment of Severe Hypoglycemia in Diabetes

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.