Dasiglucagon: evidence, FDA status and research

A ready-to-use emergency injection for dangerously low blood sugar in people with diabetes. In 170 adults it raised blood sugar in about 10 minutes, as fast as older kits.

Sold for

Dasiglucagon has no wellness market; the pitch is practical, a glucagon rescue pen that does not need mixing and works as fast as the powder-and-syringe kits it replaces.

Studies say

A 170-person randomized trial showed glucose recovered within 10 minutes in half the participants and within 15 minutes in 99%, matching conventional glucagon, which supports an A for the approved rescue use.

Why grade A. Approval rested on randomized double-blind trials in which hypoglycemia was induced with insulin under supervision and the time to blood-glucose recovery was measured. The adult trial in the citations randomized 170 people with type 1 diabetes and found a median recovery time of 10 minutes with dasiglucagon against 40 minutes with placebo and 12 minutes with reconstituted glucagon. ¹²

FDA. Dasiglucagon is FDA-approved as Zegalogue, approved in March 2021 for severe hypoglycemia in people with diabetes. The June 2026 label replaced the original age cutoff of six years with a weight cutoff, so it now covers adults and children who weigh at least 20 kg. It comes as an autoinjector and a prefilled syringe. ²

Written from 2 cited sources. Fact-checked 2026-10-27: 14 claims checked, 1 corrected. Last refreshed 2026-10-27. Not physician reviewed.

What this means for you

What people take it for: Treating very low blood sugar in diabetes.
Can a US doctor prescribe it?: Yes, FDA approved for very low blood sugar in people with diabetes.
Properly tested in people?: Yes, in large controlled trials: a 170-adult trial.

Evidence checklist

Randomised controlled trial Double-blind, placebo and glucagon controlledyes
Human study over 100 people Adult trial of 170 peopleyes
More than one research group Sponsor-run trials; no independent group citedno information
Clinical outcomes, not surrogate markers Glucose recovery time, not outcomesno
Human safety data beyond case reports Trial and label safety datayes

Drawn from the cited studies below. A dash means the sources give no information.

What it is

Dasiglucagon is an analog of human glucagon, the pancreatic hormone that raises blood sugar, with seven amino-acid substitutions that keep it stable and soluble in water. Native glucagon clumps into fibrils in solution within hours, which is why older rescue kits ship as a powder to be mixed at the moment of use; dasiglucagon stays in solution for years, so it can be sold ready to inject. Zealand Pharma developed it, and Novo Nordisk now markets it. ²¹

The approved product, Zegalogue, is for emergency treatment of severe hypoglycemia, the kind where a person is confused or unconscious and cannot safely swallow sugar. ²

How it works

Dasiglucagon binds the glucagon receptor on liver cells and triggers glycogenolysis, the breakdown of stored glycogen into glucose that is released into the blood. The effect depends on the liver having glycogen in store, so the drug works less well in people who have fasted for a long time, drunk heavily or have adrenal insufficiency, a limitation it shares with every glucagon product. ²

What human research shows

Pieber and colleagues ran a phase 3 double-blind trial in 170 adults with type 1 diabetes. Hypoglycemia was induced with intravenous insulin under medical supervision, and participants were randomized to dasiglucagon, placebo or reconstituted glucagon. The primary endpoint was time to plasma-glucose recovery, defined as a rise of at least 20 mg/dL from baseline without rescue intravenous glucose. Median recovery was 10 minutes with dasiglucagon, 40 minutes with placebo and 12 minutes with glucagon, and 99% of dasiglucagon recipients recovered within 15 minutes. ¹

A parallel pediatric trial in 42 children aged 6 to 17 weighing at least 20 kg gave similar results and supported the original pediatric approval. The 2026 label change to a weight threshold rests on that weight-based enrollment plus pharmacokinetic and safety data from children younger than 6. ²

Study	Model	Finding
Pieber 2021, phase 3 adult trial	Humans, n=170 adults with type 1 diabetes, randomized double-blind, insulin-induced hypoglycemia	Median time to glucose recovery 10 minutes versus 40 with placebo and 12 with reconstituted glucagon; 99% recovered within 15 minutes. ¹
Zegalogue FDA label, 2026	Regulatory summary including a pediatric trial in 42 children aged 6 to 17 weighing at least 20 kg	Indication now defined by a 20 kg weight threshold rather than age. ²

Safety

The common adverse effects in the trials were nausea, vomiting, headache, diarrhoea and injection-site pain, which are the expected effects of glucagon and of the glucose swing itself. The label warns that dasiglucagon can release catecholamines from a pheochromocytoma (an adrenal tumour) and cause a hypertensive crisis, that it can trigger insulin release from an insulinoma and worsen hypoglycemia, and that hypersensitivity reactions have occurred with glucagon products. ¹²

Because the drug is used once in an emergency, there are no long-term exposure questions. Data in children under 20 kg are not included in the label. ²

Questions for your clinician

How does dasiglucagon compare with the glucagon kit I already have?
Do I have a tumour or condition that makes it unsafe?
Who around me should know how to give it?

Questions people ask

Is dasiglucagon FDA-approved?

Yes, as Zegalogue, approved in 2021 for severe hypoglycemia in people with diabetes. The 2026 label covers adults and children who weigh at least 20 kg. ²

How is it different from a regular glucagon kit?

It is chemically modified so it stays dissolved and can be sold as a ready-to-use pen or syringe. Older kits are a powder that has to be mixed with liquid at the moment of use, a step that caregivers often get wrong in a panic. In the trial it worked as fast as freshly mixed glucagon. ¹²

How fast does it work?

In the adult trial half of participants had a glucose rise of at least 20 mg/dL within 10 minutes and 99% within 15 minutes, compared with 40 minutes for placebo. ¹

Which adverse reactions are most likely?

Mostly nausea, vomiting and headache. It can cause a dangerous blood-pressure spike in people with an undiagnosed adrenal tumour and can worsen low blood sugar in people with an insulin-secreting tumour, both rare. ²

Citations

Pieber 2021, Diabetes Care: dasiglucagon for severe hypoglycemia, phase 3 randomized double-blind trial doi.org
FDA label, June 2026: Zegalogue (dasiglucagon) injection accessdata.fda.gov