Dasiglucagon

Dasiglucagon is a glucagon receptor agonist, which increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating glycogen breakdown and release of glucose from the liver. Hepatic stores of glycogen are necessary for dasiglucagon to produce an antihypoglycemic effect.

• ZEGALOGUE ® is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above. ZEGALOGUE is an antihypoglycemic agent indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.

• ZEGALOGUE is contraindicated in patients with: • Pheochromocytoma because of the risk of substantial increase in blood pressure [see Warnings and Precautions (5.1) ] • Insulinoma because of the risk of hypoglycemia [see Warnings and Precautions (5.2) ] Pheochromocytoma ( 4 ) Insulinoma ( 4 )contraindicated

• ZEGALOGUE autoinjector and prefilled syringe are for subcutaneous injection only. ( 2.1 ) • The dose in adults and pediatric patients aged 6 years and older is 0.6 mg. ( 2.2 ) • Administer ZEGALOGUE according to the printed instructions on the protective case label and the Instructions For Use. ( 2.1 ) • Visually inspect ZEGALOGUE prior to administration. The solution should appear clear, colorless, and free from particles. If the solution is discolored or contains particulate matter, do not use. ( 2.1 ) • Administer the injection into the lower abdomen, buttocks, thigh, or outer upper arm. ( 2.1 ) • Call for emergency assistance immediately after administering the dose. ( 2.1 ) • If there has been no response after 15 minutes, an additional dose of ZEGALOGUE from a new device may be administered while waiting for emergency assistance. ( 2.1 ) • When the patient has responded to treatment, give oral carbohydrates. ( 2.1 ) • Do not attempt to reuse ZEGALOGUE. Each device contains a single dose of dasiglucagon and cannot be reused. ( 2.1 ) 2.1 Administration Instructions ZEGALOGUE autoinjector and prefilled syringe are for subcutaneous injection only. Instruct patients and their caregivers on the signs and symptoms of severe hypoglycemia. Because severe hypoglycemia requires the help of others to recover, instruct the patient to inform those around them about ZEGALOGUE and its Instructions For Use. Administer ZEGALOGUE as soon as possible when severe hypoglycemia is recognized.

• Substantial Increase in Blood Pressure in Patients with Pheochromocytoma: Contraindicated in patients with pheochromocytoma because ZEGALOGUE may stimulate the release of catecholamines from the tumor. ( 4 , 5.1 ) • Hypoglycemia in Patients with Insulinoma: In patients with insulinoma, administration may produce an initial increase in blood glucose, but ZEGALOGUE may stimulate exaggerated insulin release from an insulinoma and cause subsequent hypoglycemia. If a patient develops symptoms of hypoglycemia after a dose of ZEGALOGUE, give glucose orally or intravenously. ( 4 , 5.2 ) • Hypersensitivity and Allergic Reactions: Allergic reactions have been reported with glucagon products and may include generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. ( 5.3 ) • Lack of Efficacy in Patients with Decreased Hepatic Glycogen: ZEGALOGUE is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for ZEGALOGUE to be effective. Patients with these conditions should be treated with glucose. ( 5.4 ) 5.1 Substantial Increase in Blood Pressure in Patients with Pheochromocytoma ZEGALOGUE is contraindicated in patients with pheochromocytoma because glucagon products may stimulate the release of catecholamines from the tumor [see Contraindications (4) ] .

The following important adverse reactions are described elsewhere in the labeling: • Hypersensitivity and Allergic Reactions [see Warnings and Precautions (5.3) ] Most common adverse reactions (≥2%) associated with ZEGALOGUE are: Adults: nausea, vomiting, headache, diarrhea, and injection site pain Pediatrics: nausea, vomiting, headache, and injection site pain ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc., at 1-800-727-6500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of ZEGALOGUE cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, 316 adult patients with type 1 diabetes and 20 pediatric patients with type 1 diabetes were exposed to ZEGALOGUE. The data in Table 1 reflect exposure of 116 adult patients to ZEGALOGUE in 2 placebo-controlled trials (mean age 40 years). Table 2 reflects exposure of 20 pediatric patients exposed to ZEGALOGUE in a placebo-controlled trial. Eight patients were 7 to 11 years old, and 12 were 12 to 17 years old [see Clinical Studies (14) ] . Table 1.

8.1 Pregnancy Risk Summary There are no available data on dasiglucagon use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Untreated hypoglycemia in pregnancy can cause complications and may be fatal. In animal reproduction studies, daily subcutaneous administration of dasiglucagon to pregnant rabbits and rats during the period of organogenesis did not cause adverse developmental effects at exposures 7 and 709 times the human dose of 0.6 mg based on AUC, respectively (see Data ) . Data Animal Data In an embryo-fetal development study, pregnant rats were treated daily with subcutaneous doses of 2, 10, and 24 mg/kg/day during the period of organogenesis (gestation day 6 to 17). Maternal toxicity, in terms of decreased body weight gain, lower fetal body weight, and delayed bone ossification, was observed at ≥10 mg/kg/day (≥475 times the human dose, based on AUC). In an embryo-fetal development study, pregnant rabbits were treated daily with subcutaneous doses of 0.1, 0.3, and 1 mg/kg/day during the period of organogenesis (gestation day 6 to 19). Lower fetal body weight and delayed bone ossification were observed at 1 mg/kg/day (100 times the human dose, based on AUC), a dose that also induced maternal toxicity in terms of decreased body weight gain.

Metabolism

Absorption ZEGALOGUE absorption following subcutaneous injection of 0.6 mg resulted in a mean peak plasma concentration of 5110 pg/mL (1510 pmol/L) at around 35 minutes. Distribution The mean apparent volume of distribution was 47 L to 57 L following subcutaneous administration.

If overdosage occurs, the patient may experience nausea, vomiting, inhibition of GI tract motility, and/or increases in blood pressure and heart rate. In case of suspected overdosing, serum potassium may decrease and should be monitored and corrected if needed. If the patient develops a marked increase in blood pressure, phentolamine mesylate has been shown to be effective in lowering blood pressure for the short time that control would be needed. Appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.

• Mar 22, 2021NDANDA214231Zealand Pharma

1. 1Death1533%
2. 2Disability24.3%
3. 3Memory Impairment24.3%
4. 4Staphylococcal Infection24.3%
5. 5Abdominal Pain12.2%
6. 6Amino Acid Level Decreased12.2%
7. 7Arthritis12.2%
8. 8Back Pain12.2%
9. 9Blood Glucagon Decreased12.2%
10. 10Blood Glucose Fluctuation12.2%
11. 11Burning Sensation12.2%
12. 12Cardiac Disorder12.2%
13. 13Cerebrovascular Accident12.2%
14. 14Constipation12.2%
15. 15Covid-1912.2%

The 10 most recently updated of 21 ClinicalTrials.gov registrations naming Dasiglucagon as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism
  Active not recruiting · Phase 3 · Interventional · 42 enrolled · Zealand Pharma
  NCT03941236updated 2026-01-20
• Research Study in Japan to Compare Dasiglucagon With Glucagon in Treating Very Low Levels of Blood Sugar in Asian Adults With Type 1 Diabetes and Testing of Dasiglucagon for the Same Condition in Japanese Adolescents
  Completed · Phase 1 · Interventional · 38 enrolled · Novo Nordisk A/S
  NCT06588504updated 2025-12-05
• A Study to Inv. Safety, Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children <6 Years With T1D
  Completed · Phase 3 · Interventional · 8 enrolled · Zealand Pharma
  NCT05378672updated 2025-07-20
• Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
  Completed · Phase 2 · Phase 3 · Interventional · 12 enrolled · Zealand Pharma
  NCT04172441updated 2025-03-14
• A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System
  Withdrawn · Phase 2 · Interventional · 0 enrolled · Inreda Diabetic B.V.
  NCT05454709updated 2024-01-03
• A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
  Completed · Phase 3 · Interventional · 32 enrolled · Zealand Pharma
  NCT03777176updated 2023-12-13
• Micro Glucagon During Exercise in Type 1 Diabetes
  Withdrawn · Early phase 1 · Interventional · 0 enrolled · Insel Gruppe AG, University Hospital Bern
  NCT04192019updated 2023-09-01
• Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults
  Withdrawn · Phase 2 · Interventional · 0 enrolled · Zealand Pharma
  NCT04824872updated 2023-02-21
• A Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With T1DM
  Completed · Phase 3 · Interventional · 92 enrolled · Zealand Pharma
  NCT03895697updated 2023-02-21
• Treatment of Post-bariatric Hypoglycaemia
  Completed · Phase 2 · Interventional · 24 enrolled · Filip Krag Knop
  NCT04836273updated 2023-02-02

Frequently asked questions

How does Dasiglucagon work?

Dasiglucagon is a glucagon receptor agonist, which increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating glycogen breakdown and release of glucose from the liver. Hepatic stores of glycogen are necessary for dasiglucagon to produce an antihypoglycemic effect.

What is Dasiglucagon used for?

According to FDA labeling, Dasiglucagon carries indications including: ZEGALOGUE ® is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above. ZEGALOGUE is an antihypoglycemic agent indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Dasiglucagon?

Dasiglucagon is classified as Glycogenolytic hormones, Antihypoglycemic Agent, Glucagon Receptor Agonists, Increased Glucagon Secretion, Increased Glycogenolysis.

What are the brand names for Dasiglucagon?

Dasiglucagon is marketed under brand names including Zegalogue.

What are the contraindications for Dasiglucagon?

Dasiglucagon labeling lists contraindications including: ZEGALOGUE is contraindicated in patients with: • Pheochromocytoma because of the risk of substantial increase in blood pressure [see Warnings and Precautions (5.1) ] • Insulinoma because of the risk of hypoglycemia [see Warnings and Precautions (5.2) ] Pheochromocytoma ( 4 ) Insulinoma ( 4 ). Always consult the full prescribing information and a clinician.