Overview
Dasiglucagon is a glucagon analog that acts to increase blood sugar levels. It consists of 29 amino acids similar to endogenous glucagon; however, it contains seven substituted amino acids for improved physical and chemical stability in its drug formulation. In March 2021, the FDA approved dasiglucagon to treat severe hypoglycemia in patients six years and older with diabetes. It is available as a subcutaneous injection marketed as ZEGALOGUE. Severe hypoglycemia is an acute, life-threatening medical condition resulting from a profound drop in blood glucose levels. It is characterized by neurological impairment, with manifestations like loss of consciousness and seizure. Hypoglycemia is a common side effect of antidiabetic treatments, most notably insulin and sulfonylureas. Although it tends to be more common in type 1 diabetes mellitus, occurring in about 22% to 46% of patients annually, about 7% to 25% of patients with type 2 diabetes mellitus treated with insulin experience severe hypoglycemia a year. Even with close monitoring of blood glucose levels, it is not always possible to prevent severe hypoglycemic events in patients with diabetes, and children are particularly at risk for experiencing severe hypoglycemia. Treatments for severe hypoglycemia have mostly been limited to intravenous dextrose and different glucagon formulations. The approval of dasiglucagon marks the first glucagon analog approved for severe hypoglycemia treatment that does not require administration by a healthcare professional.
Background
Dasiglucagon is a glucagon analog that acts to increase blood sugar levels. It consists of 29 amino acids similar to endogenous glucagon; however, it contains seven substituted amino acids for improved physical and chemical stability in its drug formulation. In March 2021, the FDA approved dasiglucagon to treat severe hypoglycemia in patients six years and older with diabetes. It is available as a subcutaneous injection marketed as ZEGALOGUE. Severe hypoglycemia is an acute, life-threatening medical condition resulting from a profound drop in blood glucose levels. It is characterized by neurological impairment, with manifestations like loss of consciousness and seizure. Hypoglycemia is a common side effect of antidiabetic treatments, most notably insulin and sulfonylureas. Although it tends to be more common in type 1 diabetes mellitus, occurring in about 22% to 46% of patients annually, about 7% to 25% of patients with type 2 diabetes mellitus treated with insulin experience severe hypoglycemia a year. Even with close monitoring of blood glucose levels, it is not always possible to prevent severe hypoglycemic events in patients with diabetes, and children are particularly at risk for experiencing severe hypoglycemia. Treatments for severe hypoglycemia have mostly been limited to intravenous dextrose and different glucagon formulations. The approval of dasiglucagon marks the first glucagon analog approved for severe hypoglycemia treatment that does not require administration by a healthcare professional.
Indication
Dasiglucagon is an antihypoglycemic agent indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.
Associated Conditions
- Severe Hypoglycemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/09/19 | Phase 1 | Recruiting | |||
2022/07/12 | Phase 2 | Withdrawn | |||
2022/05/18 | Phase 3 | Recruiting | |||
2021/04/08 | Phase 2 | Completed | Filip Krag Knop | ||
2021/04/01 | Phase 2 | Withdrawn | |||
2021/02/21 | Phase 2 | Completed | |||
2020/06/29 | Phase 2 | Completed | |||
2019/11/21 | Phase 2 | Completed | |||
2019/06/13 | Phase 2 | Completed | University Hospital, Gentofte, Copenhagen | ||
2019/05/07 | Phase 3 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Novo Nordisk | 0169-1912 | SUBCUTANEOUS | 0.6 mg in 0.6 mL | 1/1/2023 | |
| Zealand Pharma US, Inc | 80644-0013 | SUBCUTANEOUS | 0.6 mg in 0.6 mL | 10/4/2023 | |
| Novo Nordisk | 0169-1913 | SUBCUTANEOUS | 0.6 mg in 0.6 mL | 1/1/2023 | |
| Zealand Pharma US, Inc | 80644-0012 | SUBCUTANEOUS | 0.6 mg in 0.6 mL | 10/4/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||