Dasiglucagon
A re-engineered glucagon that stays dissolved in water instead of clumping, which allowed the first glucagon rescue injection that needs no mixing — approved in 2021 for severe hypoglycaemia, and discontinued in the United States in 2026.
Dasiglucagon (Zegalogue) is a lab-modified version of glucagon, the hormone that raises blood sugar. Old glucagon rescue kits came as a powder you had to mix during an emergency; dasiglucagon stays liquid, so it comes in a pen you just press. It works about as fast as mixed glucagon once the mixing is done — the gain is that people actually manage to give it in time. Nausea and vomiting are very common afterwards. It was pulled from the US market in 2026.
What is Dasiglucagon?
Dasiglucagon is glucagon redesigned to survive in a syringe. Native human glucagon is a 29-amino-acid hormone that works perfectly well in the body but is chemically miserable in a vial: in water it aggregates into amyloid-like fibrils within hours, which is why every traditional glucagon emergency kit ships as a freeze-dried powder that somebody has to mix with a diluent at the exact moment a person is unconscious or convulsing. Dasiglucagon keeps the 29-residue length and the receptor activity but swaps out the residues responsible for fibril formation, giving a peptide that remains clear, stable and ready to inject in an aqueous solution — supplied as a single-dose autoinjector or prefilled syringe at 0.6 mg, storable at room temperature for up to a year. Developed by Zealand Pharma and approved by the FDA on 22 March 2021 as Zegalogue for severe hypoglycaemia in people with diabetes aged 6 and over, it was licensed globally to Novo Nordisk in September 2022. FDA records now list both presentations as discontinued in the United States.
What Dasiglucagon Is Investigated For
Dasiglucagon's clinical case is almost entirely about formulation rather than pharmacology, and the trials say so quite plainly. Against placebo it is dramatic — median plasma glucose recovery in 10 minutes versus 40. Against reconstituted glucagon it is a tie: 10 minutes against 12, with the comparator's clock starting only after someone had already mixed the powder. The study that actually demonstrates the benefit is a manikin handling study, in which 94% of trained caregivers successfully delivered the dasiglucagon autoinjector within 15 minutes against 56% for a conventional emergency kit. That is the drug: the same rescue, achievable by a frightened bystander. The aqueous stability also opened uses glucagon never had — continuous pump infusion in congenital hyperinsulinism, mini-dose prevention of ordinary hypoglycaemia, and the glucagon channel of a bihormonal artificial pancreas — though each of those is less settled than the headline indication, and the congenital hyperinsulinism programme has twice failed to clear the FDA.
History & Discovery
The problem dasiglucagon solves was recognised long before anyone solved it. Glucagon was isolated in the 1920s as a hyperglycaemic contaminant of insulin extracts, sequenced in the 1950s, and has been available as a rescue injection for severe hypoglycaemia for decades. But glucagon in water is one of the most studied examples of peptide amyloid formation — the molecule self-assembles into fibrils within hours, and a fibrillated solution cannot be injected. Manufacturers therefore shipped lyophilised powder with a separate diluent, and the resulting kit became notorious among diabetes clinicians: multi-step reconstitution, performed rarely, under maximum stress, by someone who is not the patient. Studies of caregiver performance with those kits consistently found failure rates that would be unacceptable in any other emergency medicine. Zealand Pharma, a Danish peptide house, approached it as a chemistry problem. Working from the native 29-residue sequence, the group identified and replaced the residues responsible for intermolecular beta-sheet packing without disturbing the receptor-binding face, producing ZP4207 — later dasiglucagon — a glucagon receptor agonist that stays dissolved. The first clinical demonstration came in 2018 in Diabetes Care, where escalating subcutaneous doses in 58 patients with type 1 diabetes produced the expected glucose response with a peak around 35 minutes and a half-life near 30 minutes, closely matching reconstituted GlucaGen. The phase 3 programme was run three ways — prefilled syringe in 170 adults, autoinjector in 45 adults, and 42 children and adolescents — and all three returned the same median 10-minute recovery. The FDA approved Zegalogue on 22 March 2021 under NDA 214231 for severe hypoglycaemia from age 6, and it launched that June. In September 2022 Zealand signed a global licence and development agreement handing commercialisation to Novo Nordisk, retaining rights to its other dasiglucagon programmes. Those other programmes are where the story gets harder. Aqueous stability made continuous infusion possible, and congenital hyperinsulinism — a rare disease of unregulated insulin secretion causing hypoglycaemia and brain injury in infants — was the obvious target. The phase 3 trial missed its primary endpoint of self-monitored hypoglycaemia episodes, succeeding only on post hoc continuous glucose monitoring measures, and the FDA issued two complete response letters, the second in October 2024, both attributed to inspection problems at a third-party manufacturing facility rather than to the clinical data. Zealand's own reporting has since stated that resubmission depends on that facility's inspection classification being upgraded. The commercial coda arrived in January 2026, when the product was discontinued in the United States. FDA's Drugs@FDA record lists both presentations as discontinued; no public reason has been given, and nothing in the label changed. A drug that demonstrably made glucagon rescue achievable for ordinary bystanders is, for now, not available in the market where that was demonstrated.
How It Works
Glucagon is insulin's opposite number: when blood sugar falls, the pancreas releases it and the liver responds by breaking down its stored glycogen and pushing glucose into the blood. Dasiglucagon does exactly the same thing at the same receptor — the engineering changes were made to stop the molecule clumping in the vial, not to change what it does in the body. Press the autoinjector, and within about ten minutes the liver has dumped enough glucose to bring someone out of a severe hypoglycaemic episode. The catch is built into the mechanism: if the liver's glycogen is already empty, there is nothing to release and the injection will not work.
Dasiglucagon is a 29-amino-acid glucagon analogue, molecular formula C152H222N38O50 and molecular mass 3,382 g/mol as the anhydrous free base, supplied as the hydrochloride salt. Substitutions relative to native human glucagon were selected to disrupt the intermolecular beta-sheet packing that drives glucagon's rapid fibrillation in aqueous media while leaving the receptor-binding determinants intact, so the molecule is a full glucagon receptor agonist with the physicochemical behaviour of a stable drug product. Pharmacologically it is conventional: dasiglucagon binds the class B G-protein-coupled glucagon receptor, predominantly on hepatocytes, activating Gs and adenylate cyclase and raising intracellular cyclic AMP. Protein kinase A then phosphorylates and activates glycogen phosphorylase while inactivating glycogen synthase, so glycogenolysis dominates and hepatic glucose output rises; gluconeogenesis is stimulated in parallel, and glycolysis suppressed. Because the entire effect is contingent on mobilisable hepatic glycogen, the drug is useless in glycogen-depleted states — a limitation written into the label rather than inferred. Pharmacokinetics are those of a rescue agent: after a 0.6 mg subcutaneous dose, mean peak plasma concentration is 5,110 pg/mL at around 35 minutes, apparent volume of distribution 47 to 57 litres, and terminal half-life approximately 30 minutes, with clearance by the same proteolytic pathways in blood, liver and kidney that degrade native glucagon. In children the peak is lower and earlier — 3,920 pg/mL at around 21 minutes. In the head-to-head pharmacokinetic study the plasma glucose response was comparable to reconstituted glucagon early on, with a somewhat longer-lasting and greater effect, consistent with the slightly extended exposure. Nausea and vomiting follow from high-dose glucagon receptor agonism outside the portal physiology in which the hormone normally operates, and the systemic haemodynamic effects — a transient rise in heart rate and blood pressure — reflect glucagon receptor expression in heart and vasculature.
Evidence Snapshot
Human Clinical Evidence
Strong for the approved indication and unusually consistent. Three phase 3 randomised double-blind trials — 170 adults with the prefilled syringe, 45 adults with the autoinjector, 42 children and adolescents aged 6 to 17 — all showed a median 10-minute recovery from insulin-induced hypoglycaemia, and an integrated analysis across six trials confirmed equivalence to reconstituted glucagon and superiority to placebo. Device-handling, QTc, renal and paediatric pharmacokinetic studies round out the package. Evidence for the non-rescue uses is thinner: one randomised phase 3 trial in congenital hyperinsulinism that missed its primary endpoint, two small crossover trials in post-bariatric hypoglycaemia, and phase 2 work on mini-dosing.
Animal / Preclinical
Limited and largely unnecessary. Glucagon receptor pharmacology has been characterised for decades, and dasiglucagon was developed as a formulation solution to a known hormone rather than as a novel pharmacology, so the preclinical package focused on stability, local tolerance and toxicology rather than on establishing mechanism.
Mechanistic Rationale
Very strong and almost trivially so. The drug is a glucagon receptor agonist used to raise blood glucose in hypoglycaemia; the rationale is the hormone's own physiology. The genuinely novel claim — that an aqueous, ready-to-use presentation changes outcomes — was tested directly in a randomised device-handling study rather than assumed.
Research Gaps & Open Questions
What the current literature has not yet settled about Dasiglucagon:
- 01Whether the handling advantage translates into fewer emergency department visits, hospitalisations or hypoglycaemia-related deaths. The manikin study is persuasive about the proximate step and says nothing about outcomes, and the US discontinuation means the real-world dataset that would have answered this may never be assembled.
- 02Whether dasiglucagon has a confirmed role in congenital hyperinsulinism. The phase 3 trial missed its primary endpoint and succeeded post hoc on continuous glucose monitoring; the regulatory block has been a manufacturing inspection rather than a scientific verdict, so the clinical question remains genuinely open.
- 03The safety of sustained glucagon receptor agonism. Rescue dosing is a single bolus, but infusion protocols expose patients for weeks, and necrolytic migratory erythema has already been reported — the dose, duration and reversibility of that risk are uncharacterised.
- 04Whether low-dose or mini-dose pen glucagon has a place in routine diabetes management. Phase 2 studies show it prevents and treats non-severe hypoglycaemia, but nobody has shown it is better than the carbohydrate people already carry.
- 05Whether a glucagon channel genuinely improves closed-loop insulin delivery. A randomised crossover in adolescents found dual-hormone no better than insulin-only overall, and worse overnight and around exercise, which complicates the main long-term argument for a stable liquid glucagon.
- 06Why the product was withdrawn in the United States, and whether a device or supply arrangement could bring it back. No reason has been published, and the distinction between a commercial withdrawal and a safety withdrawal is not always clear to patients looking at a pharmacy that no longer stocks it.
Forms & Administration
Single-dose subcutaneous injection, 0.6 mg, supplied either as a ready-to-use autoinjector or a prefilled syringe, each in a protective case. There is nothing to mix, measure or reconstitute. The dose is the same — 0.6 mg — for adults and for children aged 6 and over. Injection goes into the lower abdomen, buttock, thigh or outer upper arm; a randomised comparison of buttock versus deltoid found no difference in time to recovery, so site choice is a matter of access rather than pharmacokinetics. Emergency services are called immediately after the injection, and once the person has responded and can swallow safely they are given oral carbohydrate to replenish the glycogen the drug has just spent. If there is no response after 15 minutes a second dose may be given from a new device. Storage is the other practical advantage: refrigerated at 2 to 8 degrees Celsius, or kept at room temperature for up to 12 months, with the removal date recorded on the case and no returning it to the fridge afterwards.
Dosing & Protocols
The ranges below reflect protocols commonly discussed in the literature and by clinicians — not a prescription. Actual dosing for any individual should be determined by a qualified healthcare provider who knows the patient.
Typical Range
0.6 mg as a single subcutaneous dose, identical for adults and for children aged 6 years and over. If there has been no response after 15 minutes, one additional 0.6 mg dose may be given from a new device while waiting for emergency assistance. Investigational continuous subcutaneous infusion in congenital hyperinsulinism used a completely different range — 10 to 70 micrograms per hour.
Frequency
As required for an episode of severe hypoglycaemia. This is a rescue medicine, not a scheduled one.
Timing Considerations
Time of day
Whenever severe hypoglycaemia is recognised — as soon as possible
Relative to meals
Irrelevant at the moment of use; oral carbohydrate follows once the person can swallow safely
Relative to exercise
Not tied to exercise timing.
A second dose may follow 15 minutes after the first if there has been no response, and must come from a new device.
Protocol Notes
There is almost nothing to get wrong, which is the point. The device is single-dose, fixed-dose and ready to use: no vial, no diluent, no reconstitution, no dose calculation and no paediatric dose adjustment above age 6. It goes subcutaneously into the lower abdomen, buttock, thigh or outer upper arm, and the randomised comparison of buttock versus deltoid found no difference in recovery time, so whichever site is reachable through clothing in an emergency is the right one. Three things do need saying in advance, because they are not obvious in the moment. First, call emergency services immediately after injecting — dasiglucagon raises glucose, it does not treat whatever caused the episode. Second, expect nausea and a reasonable chance of vomiting; this happens with glucagon at rescue doses and is not a sign of a problem. Third, once the person is awake and can swallow safely, give oral carbohydrate, because the injection worked by emptying hepatic glycogen and those stores need refilling before the next episode. Storage deserves a note of its own: the device may be kept at room temperature for up to 12 months, but once removed from the fridge it must not go back, and the removal date is written on the protective case for that reason.
Dasiglucagon is a prescription emergency medicine for severe hypoglycaemia in diabetes and has no application outside that setting. Everyone in a household or school where it is kept should be shown how to use it before it is needed. FDA records list both US presentations as discontinued as of 2026, so anyone relying on it should confirm supply and discuss an alternative rescue glucagon with their prescriber.
Timeline of Effects
Onset
Fast and tightly characterised. Plasma glucose rises by 20 mg/dL within 9 to 14 minutes and crosses 70 mg/dL within 6 to 10 minutes in the dose-ranging study; median time to the trial definition of recovery was 10 minutes across adults, children and both device presentations. Peak plasma drug concentration occurs at about 35 minutes in adults and about 21 minutes in children. Nausea tends to arrive on roughly the same schedule as the glucose rise.
Peak Effect
The glucose effect peaks within the first half hour and is somewhat larger and longer-lasting than an equivalent dose of reconstituted glucagon, which matters mainly in that it reduces the chance of an immediate relapse before carbohydrate can be taken by mouth. There is no accumulation and no second phase; the drug has a half-life of about 30 minutes and is gone.
After Discontinuation
The concept barely applies to a single rescue dose — the drug clears within a couple of hours and leaves no residual effect. What does persist is the metabolic consequence: hepatic glycogen has been spent, so a person is more vulnerable to a further hypoglycaemic episode until those stores are replenished by eating. For the investigational continuous infusion protocols, stopping returns the patient to their underlying disease, and in congenital hyperinsulinism that means a prompt return of hypoglycaemia and glucose dependence.
Monitoring & Measurement
Bloodwork & Labs
- •Capillary or continuous glucose immediately and repeatedly after a rescue dose, until the person is reliably above the hypoglycaemic threshold and has taken oral carbohydrate
- •Continuous glucose monitoring data, which is the measure that detected benefit in the congenital hyperinsulinism programme after self-monitored readings did not
- •Blood pressure and heart rate after dosing in people taking beta-blockers, in whom a transient rise is expected
- •INR in people on warfarin, since glucagon may increase the anticoagulant effect
Functional & Performance Tests
- •Periodic caregiver demonstration of device technique — not a laboratory test, but the one that the comparative handling study suggests has the largest effect on whether the drug works at all
- •Review of hypoglycaemia frequency, severity and awareness at each diabetes appointment, which determines whether a rescue glucagon should be prescribed in the first place
- •Inspection of infusion sites for necrolytic migratory erythema in anyone receiving prolonged continuous subcutaneous dasiglucagon in a research setting
When to Test
No scheduled laboratory monitoring is required for a rescue medicine. Glucose is measured at the moment of use and until recovery is secure. Device expiry and the room-temperature 12-month clock should be checked at each clinical review, along with whether the people most likely to have to use it still know how.
Interpretation & Notes
The monitoring that matters for dasiglucagon is logistical rather than biochemical. The device has two clocks — the printed expiry date and a 12-month limit once it leaves the refrigerator, whichever comes first — and the removal date is written on the case precisely because people forget. After a rescue dose, the sequence is injection, emergency call, glucose measurement, and oral carbohydrate once swallowing is safe; skipping the carbohydrate leaves the liver depleted and the person exposed to a second episode. The one genuine interpretive subtlety in the whole dataset concerns the congenital hyperinsulinism trial, where self-monitored fingerstick readings showed no benefit and blinded continuous glucose monitoring showed a 43% reduction. The most likely explanation is that intermittent self-monitoring is simply too insensitive to detect the events that matter in an infant, which is an argument about measurement rather than about the drug, and it is why continuous monitoring has become the standard endpoint in this population.
Common Questions
Why did glucagon need redesigning at all?
Because of a formulation problem, not a biological one. Glucagon's 29-amino-acid sequence is prone to self-assembly into amyloid fibrils in aqueous solution — the peptide is literally a textbook model for studying amyloid formation. A solution that gels or turns cloudy cannot be injected, so manufacturers freeze-dried it and shipped a vial of powder plus a syringe of diluent. That works in a pharmacy and fails in a kitchen at 3 a.m.: the person who needs glucagon is by definition unable to help, and the person giving it has to reconstitute a drug under extreme stress, often having been trained once, years ago. Dasiglucagon substitutes the residues that drive aggregation while preserving glucagon receptor agonism, so the finished product is a clear solution in a device that requires one action.
Is dasiglucagon faster than regular glucagon?
Not once the regular glucagon is already in the syringe. In the 170-patient pivotal trial, median time to plasma glucose recovery was 10 minutes for dasiglucagon and 12 minutes for 1 mg reconstituted glucagon — a difference with no clinical meaning — against 40 minutes for placebo. The integrated analysis of six trials reproduced exactly those figures. Crucially, the published recovery times for the comparator do not include the minutes spent reconstituting it. The real-world difference shows up in the handling study rather than the glucose curve: 94% of trained caregivers got the autoinjector in within 15 minutes versus 56% with the conventional kit, and significantly more managed it inside 2 minutes.
Why does it cause so much nausea?
Because that is what glucagon does. In the placebo-controlled trials nausea occurred in 57% of adults and vomiting in 25%, against 4% and 2% on placebo, and the integrated analysis across six trials put the causally related rates at 56.5% and 24.6%. Dasiglucagon's rates are not worse than reconstituted glucagon's — the earlier pharmacokinetic study found nausea in 44% to 56% of patients on both drugs. High-dose glucagon slows gastric emptying and stimulates the area postrema, and a rescue dose is a large pharmacological bolus rather than a physiological one. Patients and caregivers should expect it: it is a sign the drug has been delivered, not a sign something has gone wrong, and oral carbohydrate is given once the person can safely swallow.
When will dasiglucagon not work?
When there is no glycogen left to mobilise. Glucagon raises blood glucose by telling the liver to break down stored glycogen, so its effect depends entirely on those stores existing. The label is explicit that people in states of starvation, with adrenal insufficiency, or with chronic hypoglycaemia may not have adequate hepatic glycogen, and should be treated with glucose rather than glucagon. The same logic rules it out after prolonged fasting or heavy alcohol use. It is also contraindicated in phaeochromocytoma, where it can trigger catecholamine release and a dangerous rise in blood pressure, and in insulinoma, where it can provoke exaggerated insulin secretion and a rebound hypoglycaemia worse than the one being treated.
Is dasiglucagon still available?
Not in the United States. FDA's Drugs@FDA record now lists both the 0.6 mg prefilled syringe and the 0.6 mg autoinjector under NDA 214231 as discontinued, and drug-information services recorded a US discontinuation in January 2026, with Novo Nordisk as the marketer following its September 2022 global licence from Zealand Pharma. The National Drug Code listing has not yet lapsed, which is why some references still describe the product as marketed. No reason for the withdrawal has been published, and a discontinuation is a commercial decision rather than a safety action — nothing in the label changed. Anyone who relied on a Zegalogue prescription needs an alternative rescue glucagon, of which several remain available.
Who Dasiglucagon Is NOT For
- •Phaeochromocytoma. Glucagon products can stimulate catecholamine release from the tumour and cause a substantial rise in blood pressure; the label notes intravenous phentolamine as the management if a previously undiagnosed phaeochromocytoma is suspected after a dose.
- •Insulinoma. An initial rise in blood glucose may be followed by exaggerated insulin secretion from the tumour and a rebound hypoglycaemia worse than the episode being treated.
- •Known hypersensitivity to dasiglucagon or any excipient. Allergic reactions to glucagon products, including anaphylaxis with hypotension and respiratory compromise, have been reported.
- •States of glycogen depletion — starvation, prolonged fasting, adrenal insufficiency, chronic hypoglycaemia — where the drug will not work because there is no hepatic glycogen to mobilise. These patients require glucose, and reaching for glucagon instead wastes time that matters.
- •Children under 6 years of age, in whom safety and efficacy for the rescue indication have not been established; the paediatric trial enrolled from age 6.
- •Latex allergy warrants care rather than outright avoidance: the autoinjector's grey cap and the prefilled syringe's needle cover both contain dry natural rubber.
Drug & Supplement Interactions
Three interactions appear in the label and one of them can defeat the drug. Indomethacin is the important one: in patients taking it, glucagon may lose its ability to raise blood glucose, and may even produce hypoglycaemia instead — an interaction worth knowing about in anyone on chronic non-steroidal therapy who carries a rescue injection. Beta-blockers produce a transient increase in pulse and blood pressure when glucagon is given, which is usually self-limiting but can be uncomfortable or clinically relevant in someone with cardiovascular disease; it is a reason to monitor rather than to withhold rescue treatment. Warfarin's anticoagulant effect may be increased by glucagon, a classical interaction with a well-documented mechanism involving reduced clotting factor synthesis. Beyond the label, the interaction that defines the drug's use is physiological rather than pharmacological: dasiglucagon works by spending hepatic glycogen, so anything that has already depleted those stores — alcohol, prolonged fasting, repeated recent hypoglycaemic episodes — blunts or abolishes the response. Dasiglucagon is cleared by proteolysis in blood, liver and kidney rather than by cytochrome P450 enzymes, so metabolic drug interactions of the conventional kind are not expected, and renal impairment does not require dose adjustment for a single rescue dose.
Safety Profile
Common Side Effects
Cautions
- • Contraindicated in phaeochromocytoma, because glucagon can stimulate catecholamine release from the tumour and cause a substantial blood pressure rise; the label notes that intravenous phentolamine has been used to manage this.
- • Contraindicated in insulinoma, where an initial rise in glucose may be followed by exaggerated insulin release and worse hypoglycaemia.
- • Ineffective without hepatic glycogen. People in starvation states, with adrenal insufficiency, or with chronic hypoglycaemia should receive glucose instead.
- • Allergic reactions, including generalised rash and in some cases anaphylactic shock with breathing difficulty and hypotension, have been reported with glucagon products as a class.
- • Emergency services should be called immediately after any dose; dasiglucagon buys time and does not treat the underlying cause.
- • A second dose from a new device may be given after 15 minutes if there has been no response, but the device is strictly single-use and cannot be re-primed.
- • The cap of the autoinjector and the needle cover of the prefilled syringe contain dry natural rubber, a latex derivative — relevant for people with latex allergy.
- • Prolonged continuous subcutaneous infusion, used investigationally in congenital hyperinsulinism rather than for rescue, has produced necrolytic migratory erythema, the rash otherwise seen in glucagonoma syndrome.
What We Don't Know
For its approved indication the uncertainty is low: the dose is single and fixed, the exposure is measured in minutes, the half-life is about half an hour, and six trials with several hundred patients found no serious adverse events or withdrawals attributable to the drug. A dedicated study found no clinically relevant QTc effect across escalating doses. The open questions sit around the uses the formulation makes possible. Repeated or continuous dosing is a different pharmacological proposition from a one-off rescue, and the necrolytic migratory erythema case report is a reminder that sustained glucagon receptor agonism recapitulates a paraneoplastic syndrome. The congenital hyperinsulinism programme missed its primary endpoint and rests on post hoc continuous-glucose-monitoring analyses. Mini-dose and closed-loop applications are supported by small physiological studies rather than outcome trials. And because the product has been withdrawn in its largest market, the long-term real-world safety dataset that would ordinarily accumulate after approval may simply never exist.
Legal Status
United States
Approved by the FDA on 22 March 2021 under NDA 214231 to Zealand Pharma as Zegalogue, for the treatment of severe hypoglycaemia in paediatric and adult patients with diabetes aged 6 years and above, in both a 0.6 mg prefilled syringe and a 0.6 mg autoinjector. Global commercialisation was licensed to Novo Nordisk in September 2022. FDA's Drugs@FDA record now lists both presentations as discontinued, and drug-information services recorded a US discontinuation in January 2026; the National Drug Code listing has not lapsed, which is why some sources still describe it as marketed. A separate application for congenital hyperinsulinism received two complete response letters, the second in October 2024, attributed to third-party manufacturing inspection issues rather than to the clinical data. Dasiglucagon is not a controlled substance and is not available from compounding pharmacies.
International
Marketing has been limited outside the United States. Approval in the US preceded the Novo Nordisk licence, under which Zealand retained responsibility for certain regulatory, development and manufacturing activities supporting approval in other territories. Where Zegalogue is unavailable, reconstituted glucagon kits and nasal glucagon remain the standard rescue options.
Sports & Competition
Not prohibited. Neither glucagon nor dasiglucagon appears anywhere on the WADA Prohibited List. Insulin and insulin-mimetics are prohibited under class S4.4.2, but a hormone whose action is to raise blood glucose in an emergency is in a different category entirely, and there is no plausible performance rationale for a drug that reliably produces nausea and vomiting. An athlete with diabetes may carry and use it without restriction or therapeutic use exemption.
Regulatory status changes over time. Verify current local rules with a qualified professional.
Myths & Misconceptions
Myth
Dasiglucagon is a faster-acting glucagon.
Reality
It is not. Median time to glucose recovery was 10 minutes for dasiglucagon and 12 for reconstituted glucagon in the pivotal trial, and the pooled analysis of six trials reproduced those exact numbers. The pharmacology is equivalent. What differs is that the glucagon kit's 12 minutes begins after someone has already mixed it, and in a randomised handling study only 56% of trained caregivers managed to do that within 15 minutes.
Myth
Nausea and vomiting mean the injection was given wrongly.
Reality
They mean it was given. Nausea affected 57% and vomiting 25% of adults in the placebo-controlled trials, and the dose-ranging study found 44% to 56% nausea with both dasiglucagon and conventional glucagon. This is ordinary high-dose glucagon pharmacology. Caregivers should be warned in advance, and should position the person to protect the airway if they are not yet fully alert.
Myth
Glucagon rescue works in anyone with low blood sugar.
Reality
Only if there is glycogen in the liver to release. The label specifically names starvation, adrenal insufficiency and chronic hypoglycaemia as states in which there may not be enough, and the same applies after prolonged fasting or heavy alcohol use. In those situations glucose, not glucagon, is the treatment, and reaching for the autoinjector first costs time.
Myth
Because glucagon raises blood sugar, dasiglucagon must be a weight-loss drug.
Reality
Glucagon receptor agonism does appear in metabolic drug design — dual and triple agonists pair it with GLP-1 to increase energy expenditure — but dasiglucagon is not one of those molecules. It is a short-acting, single-dose rescue agent with a 30-minute half-life, indicated for emergency hypoglycaemia. Its sibling programmes, not dasiglucagon itself, are where the metabolic story lives.
Myth
The US discontinuation means a safety problem was found.
Reality
Nothing in the label changed and no safety action was announced. FDA's Drugs@FDA record lists both presentations as discontinued and drug-information services dated the US withdrawal to January 2026, but discontinuations of this kind are commercial decisions. The separate congenital hyperinsulinism application was blocked by two complete response letters that were explicitly attributed to a third-party manufacturing facility inspection and not to the drug's clinical data.
Published Research
29 studiesManaging post-bariatric hypoglycemia: a systematic review of pharmacological therapies
Necrolytic migratory erythema following prolonged continuous subcutaneous dasiglucagon administration: a rare dermatologic adverse event
A reminder that chronic glucagon receptor agonism is not the same drug as a single rescue dose. Prolonged continuous subcutaneous infusion produced necrolytic migratory erythema — the characteristic rash of glucagonoma syndrome, in which a tumour secretes glucagon continuously. Nothing like this is expected from a one-off 0.6 mg injection, and it is directly relevant to the investigational infusion protocols in congenital hyperinsulinism.
Dasiglucagon in Children With Congenital Hyperinsulinism Up to 1 Year of Age: Results From a Randomized Clinical Trial
Dasiglucagon: A New Hope for Diazoxide-unresponsive, Nonfocal Congenital Hyperinsulinism?
Dasiglucagon for the Treatment of Congenital Hyperinsulinism: A Randomized Phase 3 Trial in Infants and Children
Thirty-two children aged 0.6 to 10.9 years randomised to standard of care with or without continuous subcutaneous dasiglucagon at 10 to 70 micrograms an hour. The primary endpoint — self-monitored hypoglycaemia episodes per week — was not met, with an event rate ratio of 0.85 and a P value of 0.50. A post hoc analysis of blinded continuous glucose monitoring found a 43% reduction, and reductions of 37% to 61% across the other CGM measures. The positive result in this trial is the secondary, post hoc one, and that distinction matters when reading the regulatory history.
Dasiglucagon Treatment for Postprandial Hypoglycemia After Gastric Bypass: A Randomized, Double-Blind, Placebo-Controlled Trial
Dasiglucagon for the Treatment of Insulin-induced Hypoglycemia in Patients with Type 1 Diabetes Mellitus: A Meta-analysis
Evaluating Ease of Use and Patient Safety of Dasiglucagon Hypo Pal Autoinjector for the Management of Hypoglycemia
Pen-administered low-dose dasiglucagon vs usual care for prevention and treatment of non-severe hypoglycaemia in people with type 1 diabetes during free-living conditions
Performance of a dual-hormone closed-loop system versus insulin-only closed-loop system in adolescents with type 1 diabetes. A single-blind, randomized, controlled, crossover trial
The sobering counterweight to closed-loop enthusiasm. Eleven adolescents crossed over between insulin-plus-glucagon and insulin-only configurations of the same artificial pancreas across 26 hours including meals and exercise. Time below range, time in range and rescue carbohydrate were statistically indistinguishable, and overnight and around exercise the insulin-only system performed better. Adding a glucagon channel is not automatically an improvement.
Integrated safety and efficacy analysis of dasiglucagon for the treatment of severe hypoglycaemia in individuals with type 1 diabetes
Pooled six trials in adults. Median recovery was 10.0 minutes for dasiglucagon and 12.0 for reconstituted glucagon, both far better than 40.0 for placebo, and consistent across every demographic subgroup. No serious adverse events, withdrawals or deaths occurred in the placebo-controlled datasets; the commonest causally related events were nausea at 56.5% and vomiting at 24.6%. The clearest single statement of what this drug does and does not improve.
Clinical efficacy and safety of dasiglucagon in severe hypoglycemia associated with patients of type 1 diabetes mellitus: a systematic review and meta-analysis
Dasiglucagon: A Novel Ready-to-Use Treatment for Severe Hypoglycemia
Dasiglucagon for treating severe hypoglycemia in patients with diabetes
Low-Dose Dasiglucagon Versus Oral Glucose for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes: A Phase 2, Randomized, Three-Arm Crossover Study
Dasiglucagon Effects on QTc in Healthy Volunteers: A Randomized, Placebo-Controlled, Dose-Escalation, Double-Blind Study
Dasiglucagon Effectively Mitigates Postbariatric Postprandial Hypoglycemia: A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial
Extends the drug beyond diabetes. In people with disabling postprandial hypoglycaemia after bariatric surgery — a condition with no approved treatment — a single low dose of dasiglucagon given at symptom onset prevented the glucose nadir. A follow-up randomised trial in gastric bypass patients the next year reproduced the effect.
Dasiglucagon-A Next-Generation Glucagon Analog for Rapid and Effective Treatment of Severe Hypoglycemia: Results of Phase 3 Randomized Double-Blind Clinical Trial
The pivotal trial: 170 adults with type 1 diabetes randomised 2:1:1 to dasiglucagon 0.6 mg, placebo, or 1 mg reconstituted glucagon during controlled insulin-induced hypoglycaemia. Median time to plasma glucose recovery was 10 minutes for dasiglucagon, 40 for placebo and 12 for reconstituted glucagon; 99% of dasiglucagon patients recovered within 15 minutes against 2% on placebo and 95% on glucagon. Read carefully, the trial shows dasiglucagon matching glucagon pharmacologically — the comparator's clock began after someone had already mixed it.
A Comparative Study of Dasiglucagon Ready-to-Use Autoinjector and Glucagon Emergency Kit During Rescue from Simulated Severe Hypoglycemia
The study that actually justifies the drug. Fifty-four trained caregivers and untrained bystanders treated manikins in a simulated emergency with either the dasiglucagon autoinjector or a conventional glucagon emergency kit. 94% of trained caregivers succeeded within 15 minutes with the autoinjector against 56% with the kit, significantly more succeeded within 2 minutes, and 94% preferred the autoinjector. Three authors are Zealand Pharma employees and shareholders, which is worth knowing and does not undo a 94%-versus-56% gap.
Dasiglucagon (Zegalogue) for severe hypoglycemia
Dual-hormone artificial pancreas for management of type 1 diabetes: Recent progress and future directions
Dasiglucagon: an effective medicine for severe hypoglycemia
Dasiglucagon, a next-generation glucagon analogue, for treatment of severe hypoglycaemia via an autoinjector device: Results of a phase 3, randomized, double-blind trial
Confirmed the result in the autoinjector presentation across 45 adults: median recovery 10.0 minutes versus 35.0 on placebo, with 88% recovering inside 15 minutes against none on placebo. Injection site — buttock or deltoid — made no difference to time to recovery, which is why the label allows four sites without preference.
Dasiglucagon: First Approval
Dasiglucagon, a next-generation ready-to-use glucagon analog, for treatment of severe hypoglycemia in children and adolescents with type 1 diabetes: Results of a phase 3, randomized controlled trial
Forty-two children and adolescents aged 6 to 17, randomised to dasiglucagon, placebo or reconstituted glucagon. Median recovery was 10 minutes versus 30 on placebo, and every child on dasiglucagon or glucagon recovered within 20 minutes against 2 of 11 on placebo. This trial is the basis for the label's lower age limit of 6 years.
Evaluating dasiglucagon as a treatment option for hypoglycemia in diabetes
Low doses of dasiglucagon consistently increase plasma glucose levels from hypoglycaemia and euglycaemia in people with type 1 diabetes mellitus
Stable Liquid Glucagon: Beyond Emergency Hypoglycemia Rescue
Pharmacokinetic and Pharmacodynamic Characteristics of Dasiglucagon, a Novel Soluble and Stable Glucagon Analog
The dose-finding study in 58 patients with type 1 diabetes, comparing 0.1 to 1.0 mg dasiglucagon with 0.5 and 1.0 mg GlucaGen. Peak concentrations arrived around 35 minutes with a half-life near 0.5 hours, glucose rose by 20 mg/dL within 9 to 14 minutes, and the early response matched GlucaGen with a somewhat longer-lasting and larger effect. Nausea occurred at a similar rate — 44% to 56% — on both drugs, which disposes of any suggestion that the analogue is better tolerated than the hormone.
Quick Facts
- Class
- Glucagon Receptor Agonist (Glucagon Analogue)
- Tier
- B
- Evidence
- Strong
- Safety
- Well-Studied
- Updated
- Oct 2026
- Citations
- 29PubMed
Also known as
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Evidence Score
Clinical Trials
View Clinical TrialsLinks to ClinicalTrials.gov for reference. Listing does not imply endorsement.