Is dasiglucagon FDA-approved, and what does the research show?

What is dasiglucagon?

Dasiglucagon is an emergency medicine for severe hypoglycemia, the medical term for very low blood sugar, in people with diabetes ¹. The label calls it "a glucagon analog and an antihypoglycemic agent" ¹. Glucagon is a hormone that raises blood sugar, and an analog is a modified copy ², ¹. Like the body's own glucagon, dasiglucagon is a chain of 29 amino acids, the building blocks of proteins ², ¹. Seven of the 29 were changed to keep the molecule stable in water ².

It is not a wellness, weight-loss or performance peptide. The label lists the signs of severe hypoglycemia as "confusion, seizures, unconsciousness, and death" ¹. The label also says the condition "requires the help of others to recover" ¹. Rescue glucagon can be carried by patients or caregivers ².

Older glucagon emergency kits hold a powder that must be mixed with liquid before injection ². The authors of the phase 3 trial, the late-stage study behind the approval, called that step "a known barrier to timely, accurate, and effective administration" ². Dasiglucagon was supplied as a ready-to-use solution in water ², ¹. By 2021, ready-to-use glucagon also existed as an injection in a different solvent and as a nasal powder ².

Is dasiglucagon FDA-approved?

Yes. FDA approved dasiglucagon on March 22, 2021, as the brand Zegalogue, under new drug application (NDA) 214231 ³. Drugs@FDA, the agency's database of approved drugs, names Zealand Pharma as the applicant ³.

The label says Zegalogue is "indicated for the treatment of severe hypoglycemia in adults and pediatric patients with diabetes who weigh at least 20 kg" ¹. The label lists its indication among the sections changed in June 2026 ¹. On June 18, 2026, FDA approved a supplement, a later change to an approved application, that Drugs@FDA classes as "Efficacy" ³. The supplement extended the use to patients who weigh at least 20 kg, on a trial in children under 6 ⁵.

The same record gives both Zegalogue products, a prefilled syringe and an autoinjector, the marketing status "Discontinued" ¹, ³. An autoinjector is a pen-style device that injects when pressed against the skin. That is the status as of November 9, 2026, the date of the record's data ³. The record states no date and no reason for it ³. "Discontinued" is the record's word for marketing status, and the same record still shows the application as approved ³.

A second FDA source reads differently. The National Drug Code (NDC) Directory holds the entries, called listings, that companies file with FDA for their drug products. Its November 9, 2026 data held two Zegalogue listings from Novo Nordisk ⁴. Each shows a marketing start date of June 26, 2023, and a marketing end date of August 31, 2027 ⁴. Neither record says whether any Zegalogue remains in U.S. pharmacies ³, ⁴.

The label gives 0169-1912 as the autoinjector and 0169-1913 as the prefilled syringe ¹. For a product no longer made, FDA recommends in most cases the last lot's expiration date as the end date ⁶.

See the FDA status of every peptide, updated weekly.

How does dasiglucagon work?

The label describes dasiglucagon as "a glucagon receptor agonist," a drug that switches on the receptor glucagon acts on ¹. By "activating hepatic glucagon receptors," the ones in the liver, it stimulates "glycogen breakdown and release of glucose from the liver" ¹. Glycogen is the liver's stored glucose, and glucose is the sugar measured in blood ¹. The label spells out the limit of that mechanism: "Hepatic stores of glycogen are necessary for dasiglucagon to produce an antihypoglycemic effect" ¹.

In adults with type 1 diabetes, mean blood glucose had risen by 168 mg/dL (milligrams per deciliter) 90 minutes after a dose ¹. Blood levels of the drug peaked at around 35 minutes ¹. Its half-life, the time for half of it to leave the blood, was about 30 minutes ¹. The label says it "is cleared like native glucagon," by being broken down in blood, liver and kidney ¹.

What does the research show?

The label describes three trials that it calls "randomized, double-blind, placebo-controlled, multicenter" ¹. In plain words, chance decided who got which injection, and "double-blind" means participants and the staff assessing them were not told which it was. In the phase 3 trial, staff who did know prepared and gave the injections and had no other trial role ². All three enrolled people with type 1 diabetes: two trials in adults and one in children aged 6 to 17 ¹. Each compared dasiglucagon with a placebo at several centers, and the largest trial and the children's trial also had a glucagon group ², ¹.

None of the trials treated a real emergency. Investigators lowered each participant's blood sugar with intravenous insulin, under controlled conditions, and then gave a single injection under the skin ¹. The target was a plasma glucose below 60 mg/dL in the adult trials and below 80 mg/dL in the children's trial ¹. The main outcome was the time to "plasma glucose recovery": a rise of at least 20 mg/dL within 45 minutes, with no other treatment ¹.

The largest trial, Trial A on the label, is the published phase 3 study ², ¹. It randomized 170 adults at five sites in Germany, Austria, the United States and Canada, and 168 received a dose ². Of those, 82 received dasiglucagon, 43 placebo and 43 an older glucagon injection mixed from powder ².

Median time to recovery, the middle value of each group, was 10 minutes with dasiglucagon and 40 minutes with placebo ², ¹. A difference that size was unlikely to arise by chance (P < 0.001) ², ¹. The glucagon group's median was 12 minutes, which the label calls "numerically similar"; it adds that there was "no formal hypothesis test" against glucagon ¹. Within 15 minutes, 99 percent of the dasiglucagon group had recovered, against 2 percent on placebo and 95 percent on glucagon ². Seven of the 43 on placebo (16 percent) needed rescue glucose through a vein, and no one in the other two groups did ².

The two smaller trials reported similar medians. Trial B randomized 45 adults: the median was 10 minutes in the 34 treated with dasiglucagon and 35 minutes in the 10 on placebo ¹. Trial C randomized 42 children aged 6 to 17 who weighed at least 20 kg ¹. Its median was 10 minutes in the 20 treated with dasiglucagon, 30 minutes in the 11 on placebo, and 10 minutes with glucagon ¹.

For children under 6, the label cites an open-label trial, one in which everyone knew what was given, in type 1 diabetes ¹. It supplied what the label calls "additional pharmacokinetic and safety data," pharmacokinetics being how the body takes up and clears a drug ¹. The label gives no count of that trial's participants ¹.

Zealand Pharma sponsored the phase 3 trial and took part in its design, conduct and analysis ². Three of the paper's eight authors were its employees ². The authors wrote that the inpatient research setting "may not fully reflect real-world settings" ².

Neither the label nor the phase 3 paper reports a weight outcome ², ¹. The label says safety and effectiveness "have not been established in pediatric patients who weigh less than 20 kg" ¹. It adds that the studies "included too few patients 65 years of age and older" to tell whether they respond differently ¹.

What are the side effects?

Nausea and vomiting were the most common side effects in the label's trials ¹. The label's adult figures cover the 12 hours after a dose in the two adult trials: 116 people given dasiglucagon and 53 given placebo ¹. Nausea was reported by 57 percent against 4 percent, vomiting by 25 against 2, and headache by 11 against 4 ¹. Diarrhea was reported by 5 percent and injection site pain by 2 percent, against none on placebo ¹.

In the children's trial, 20 received dasiglucagon and 11 placebo ¹. Nausea was reported by 65 percent, vomiting by 50 percent, headache by 10 percent and injection site pain by 5 percent, against none on placebo ¹.

In the phase 3 trial, drug-related nausea was reported by 55 percent on dasiglucagon, 53 percent on glucagon and 2 percent on placebo ². Vomiting was reported by 23, 21 and 2 percent ². Nausea generally began 1 to 3 hours after the dose and lasted under 3 hours in most cases ². No serious or fatal adverse events occurred in that trial ².

The label also lists "hypertension, hypotension, bradycardia, presyncope, palpitations, and orthostatic intolerance" ¹. The label lists them "in patients treated with dasiglucagon" within 12 hours of treatment ¹. In plain terms those are high and low blood pressure, a slow heartbeat, near-fainting, a pounding heartbeat and dizziness on standing. In clinical studies, 4 of 506 people given the drug developed antibodies, immune proteins that can bind to a drug, against it ¹.

The label has two contraindications, conditions in which a drug is not to be used ¹. One is pheochromocytoma, a tumor of the adrenal gland, "because of the risk of substantial increase in blood pressure" ¹. The other is insulinoma, a tumor of the pancreas, "because of the risk of hypoglycemia" ¹.

The label warns that allergic reactions "have been reported with glucagon products; these include generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension" ¹. The gray cap of the autoinjector contains dry natural rubber, "which may cause allergic reactions in people with latex allergy" ¹. The drug "is effective in treating hypoglycemia only if sufficient hepatic glycogen is present" ¹. People "in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen," and the label says they "should be treated with glucose" ¹.

The label names three drug interactions ¹. People taking beta-blockers, a class of heart and blood pressure drugs, "may have a transient increase in pulse and blood pressure" ¹. With indomethacin, an anti-inflammatory painkiller, the drug "may lose its ability to raise blood glucose or may even produce hypoglycemia" ¹. It "may increase the anticoagulant effect of warfarin," a blood thinner ¹.

On pregnancy, the label says there are "no available data on dasiglucagon use in pregnant women" ¹. It adds: "Untreated hypoglycemia in pregnancy can cause complications and may be fatal" ¹.

In sport

Dasiglucagon is not named on the 2026 Prohibited List of WADA, the World Anti-Doping Agency ⁷. Glucagon, the hormone it copies, is not named there either ⁷. Neither appears in section S2, headed "Peptide Hormones, Growth Factors, Related Substances, and Mimetics," or in any other section ⁷.

Section S0 of the list reads: "Any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use (e.g. drugs under pre-clinical or clinical development or discontinued, designer drugs, substances approved only for veterinary use) is prohibited at all times" ⁷. Drugs@FDA lists both Zegalogue products "Discontinued" ³.

What JumpstartMD offers

JumpstartMD does not prescribe dasiglucagon. Our peptide library covers it so you have the facts on its FDA status and the evidence, current as of November 10, 2026.

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Compounded medications are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they are marketed. A licensed clinician decides after an evaluation whether a peptide is appropriate for you, and not every patient will qualify.