Dasiglucagon (continuous subcutaneous infusion)
An investigational treatment for Congenital Hyperinsulinism.
The same compound appears under different names depending on the context. Here is how to identify Dasiglucagon (continuous subcutaneous infusion) wherever you encounter it, plus the key facts at a glance.
- Generic name
- Dasiglucagon (continuous subcutaneous infusion)
- Development code
- ZP4207
- Drug class
- Glucagon analog
- Manufacturer
- Zealand Pharma
- How it's taken
- Continuous infusion under the skin by a wearable pump (investigational)
Zealand Pharma's pump-delivered glucagon analog for congenital hyperinsulinism. The FDA issued Complete Response Letters in December 2023 and October 2024, both tied to a third-party manufacturing site rather than the clinical data, and Zealand said in August 2026 that it expects to resubmit in the second half of 2026. Not to be confused with Zegalogue, the single-dose rescue pen approved for severe lows in diabetes.
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Where Dasiglucagon (continuous subcutaneous infusion) fits
Intended for children whose lows are not controlled by diazoxide, somatostatin analogs or surgery, as an add-on that lowers the need for IV dextrose or continuous feeds. If approved it would be the first new FDA-approved HI medicine since diazoxide in 1976.
How Dasiglucagon (continuous subcutaneous infusion) works
Glucagon is the hormone that opposes insulin: it tells the liver to break down stored glycogen and release sugar. Natural glucagon is unstable in solution, which has made long-term pumps unreliable, as the 2024 international guideline notes. Dasiglucagon is a modified glucagon that stays stable in liquid, so it can be infused continuously under the skin with a small wearable pump made by DEKA Research and Development.
The aim is to raise the baseline glucose enough to cut the amount of IV dextrose or tube feeding a child needs, and in some newborns to avoid or delay pancreatectomy.
Mechanism: Stable glucagon analog delivered continuously under the skin by a wearable pump, telling the liver to release stored sugar and counteracting excess insulin
Side effects and safety
Zealand reports that the most frequent adverse events in the 2 Phase 3 trials were skin reactions and gastrointestinal disturbances. In the published home-setting trial, skin and gastrointestinal events were more common with dasiglucagon than with standard care alone. Glucagon products in general can cause nausea and vomiting and, rarely, a skin rash called necrolytic migratory erythema with long infusions, which the guideline mentions for glucagon infusions.
The FDA's October 2024 letter also asked Zealand to justify dosing in the smallest and youngest infants (under 4.1 kg or under 7 days old) and the pump and infusion set's use in very small babies.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Dasiglucagon (continuous subcutaneous infusion)
Continuous infusion under the skin through a wearable pump, at rates of roughly 10 to 70 micrograms per hour in the trials, adjusted to blood sugar. The proposed indication in the NDA was prevention and treatment of hypoglycemia in children 7 days and older with congenital hyperinsulinism, reviewed in 2 parts: up to 3 weeks of dosing (Part 1) and longer use (Part 2). It is not available outside trials.
Availability and cost
Only available as the brand-name product.
An investigational drug and device combination for an ultra-rare pediatric disease; no price exists. Any future price would reflect orphan status and the pump system.
How congenital hyperinsulinism treatments compare
Diazoxide (Proglycem) is the only medicine the FDA has approved for hyperinsulinism. Octreotide is the usual next step but is used off-label, and the 2 investigational drugs shown are not approved for anyone outside a trial. Your HI team chooses based on the gene result, whether diazoxide works, and whether a focal lesion can be removed by surgery.
Congenital Hyperinsulinism has 1 FDA-approved treatment: Proglycem (and generics) (diazoxide, approved 1976). Also compared, not FDA-approved for congenital hyperinsulinism: Sandostatin (off-label) (octreotide, Off-label (approved 1988 for acromegaly)); Ersodetug (investigational) (ersodetug (RZ358), Phase 3 missed primary endpoint (Dec 2025); FDA recommended a pre-BLA meeting (Oct 2026)); Dasiglucagon pump (investigational) (dasiglucagon, Complete Response Letters Dec 2023 and Oct 2024; resubmission expected H2 2026). Proglycem (and generics) is typically used as first-line for every confirmed diagnosis; works in roughly half of children, mostly those without 2 recessive katp gene changes.
| Drug | How it works | How it’s given | How often | Where you get it | Typical use | FDA status |
|---|---|---|---|---|---|---|
Proglycem (and generics) diazoxide | KATP channel opener: props open the beta cell's potassium gate so it cannot fire and release insulin | Oral suspension by dropper or syringe | Twice or 3 times a day | Home, after a hospital start with close glucose checks | First-line for every confirmed diagnosis; works in roughly half of children, mostly those without 2 recessive KATP gene changes | 1976 |
Sandostatin (off-label) octreotide | Somatostatin analog: dampens insulin release even when the KATP gate is broken | Injection under the skin or continuous pump; monthly octreotide LAR or lanreotide once stable | Several times a day or continuous; monthly for long-acting forms | Home injections or pump after hospital training; clinic for monthly depot shots | Second-line when diazoxide fails or is not tolerated, usually with feeds, while focal versus diffuse disease is sorted out | Off-label (approved 1988 for acromegaly) |
Ersodetug (investigational) ersodetug (RZ358) | Insulin receptor antibody: lets insulin be released but blocks its effect on the body's cells | Infusion (intravenous in the Phase 2 study) | Every 2 weeks at first, then every 4 weeks in the Phase 3 trial | Trial sites only | Studied as an add-on for children and adults with lows despite standard care; could work regardless of gene | Phase 3 missed primary endpoint (Dec 2025); FDA recommended a pre-BLA meeting (Oct 2026) |
Dasiglucagon pump (investigational) dasiglucagon You are here | Stable glucagon analog: tells the liver to release stored sugar to offset the extra insulin | Continuous infusion under the skin from a wearable pump | Around the clock | Trial sites only; designed for hospital start then home | Studied to cut IV dextrose in newborns and to reduce lows in children not controlled by medicines or surgery | Complete Response Letters Dec 2023 and Oct 2024; resubmission expected H2 2026 |
This chart is for understanding, not medical advice. Only diazoxide is FDA-approved for hyperinsulinism; octreotide is prescribed off-label by HI specialists, and ersodetug and dasiglucagon are investigational and available only in clinical studies. Feeds, IV dextrose, emergency glucagon and surgery are also central to HI care and are not shown here. Always discuss options with a hyperinsulinism center.
Clinical trial results
Two Phase 3 trials and an extension. In the hospital trial of newborns and infants aged 7 days to 12 months who depended on IV glucose (NCT04172441, 12 infants, published in JCEM 2025), dasiglucagon met its primary endpoint, lowering the glucose infusion rate to 4.3 mg/kg/min against 9.5 on placebo in the last 12 hours of each 48-hour crossover period (P = .004); in the 21-day open-label part Zealand reports IV glucose was reduced or stopped in 10 of 12 infants.
In the home trial of 32 children aged 3 months to 12 years with lows despite surgery or maximal medicine (NCT03777176, published in JCEM 2024), the primary endpoint, the weekly rate of finger-stick hypoglycemia, was not met (rate ratio 0.85, P = .50), while post hoc blinded CGM analysis showed 43% fewer CGM-detected lows (rate ratio 0.57, P = .003).
Those CGM data are what the FDA asked Zealand to analyze further for Part 2. Forty-two of the 44 children joined the long-term extension (NCT03941236), which ClinicalTrials.gov lists as completed in May 2026.
Development history
Zealand submitted the CHI NDA on June 30, 2023; the FDA granted priority review for the up-to-3-weeks part with a December 30, 2023 target date. On December 23, 2023 Zealand received a Complete Response Letter citing deficiencies at a third-party contract manufacturing facility that it said were not specific to dasiglucagon, with no clinical or safety concerns raised.
After resubmission the new target date was October 8, 2024, and on that day a second letter arrived. The FDA's published letter lists unresolved facility findings on a Form 483, a need to resubmit the prescribing information, a paused proprietary name review and a required safety update, plus questions about dosing in infants under 4.1 kg or under 7 days old and in kidney impairment.
Zealand said the site had been reinspected in August and September 2024 with the classification pending. Through 2025 its quarterly reports said resubmission waited on that inspection upgrade and that an alternative supplier was being qualified. The 2025 annual report (February 2026) and the first-half 2026 report (August 13, 2026) say Zealand expects to resubmit both parts in the second half of 2026.
Nothing had been announced as of October 13, 2026; the next scheduled update is the third-quarter report on November 12, 2026. Separately, Zealand's license with Novo Nordisk for the Zegalogue diabetes rescue pen ended on January 9, 2026 and Novo stopped US sales; Zealand kept the NDA and is looking for a partner.
Explore Congenital Hyperinsulinism trials
Other Congenital Hyperinsulinism treatments
Where to access Dasiglucagon (continuous subcutaneous infusion)
Investigational: available only through clinical trial enrollment
Dasiglucagon (continuous subcutaneous infusion) has not been approved by the FDA and is not available by prescription. The only way for a patient to receive Dasiglucagon (continuous subcutaneous infusion) today is by enrolling in an active clinical trial and meeting that trial's eligibility criteria. Decisions about trial participation should be made with the specialist who manages the patient's condition and knows their current treatment.
Primary active trial
ClinicalTrials.gov record NCT03941236
View full trial record on ClinicalTrials.gov →Trial status, site list, and eligibility are pulled from ClinicalTrials.gov. Confirm current recruitment status and nearest site directly with the study team before traveling.
Common questions about Dasiglucagon (continuous subcutaneous infusion)
▸What is Dasiglucagon (continuous subcutaneous infusion)?
Zealand Pharma's pump-delivered glucagon analog for congenital hyperinsulinism. The FDA issued Complete Response Letters in December 2023 and October 2024, both tied to a third-party manufacturing site rather than the clinical data, and Zealand said in August 2026 that it expects to resubmit in the second half of 2026. Not to be confused with Zegalogue, the single-dose rescue pen approved for severe lows in diabetes.
▸How does Dasiglucagon (continuous subcutaneous infusion) work?
Glucagon is the hormone that opposes insulin: it tells the liver to break down stored glycogen and release sugar. Natural glucagon is unstable in solution, which has made long-term pumps unreliable, as the 2024 international guideline notes. Dasiglucagon is a modified glucagon that stays stable in liquid, so it can be infused continuously under the skin with a small wearable pump made by DEKA Research and Development. The aim is to raise the baseline glucose enough to cut the amount of IV dextrose or tube feeding a child needs, and in some newborns to avoid or delay pancreatectomy.
▸What are the side effects of Dasiglucagon (continuous subcutaneous infusion)?
Zealand reports that the most frequent adverse events in the 2 Phase 3 trials were skin reactions and gastrointestinal disturbances. In the published home-setting trial, skin and gastrointestinal events were more common with dasiglucagon than with standard care alone. Glucagon products in general can cause nausea and vomiting and, rarely, a skin rash called necrolytic migratory erythema with long infusions, which the guideline mentions for glucagon infusions. The FDA's October 2024 letter also asked Zealand to justify dosing in the smallest and youngest infants (under 4.1 kg or under 7 days old) and the pump and infusion set's use in very small babies.
▸How is Dasiglucagon (continuous subcutaneous infusion) taken?
Continuous infusion under the skin through a wearable pump, at rates of roughly 10 to 70 micrograms per hour in the trials, adjusted to blood sugar. The proposed indication in the NDA was prevention and treatment of hypoglycemia in children 7 days and older with congenital hyperinsulinism, reviewed in 2 parts: up to 3 weeks of dosing (Part 1) and longer use (Part 2). It is not available outside trials.
▸Is Dasiglucagon (continuous subcutaneous infusion) FDA approved?
Dasiglucagon (continuous subcutaneous infusion) is currently in crl clinical trials for Congenital Hyperinsulinism. It has not yet received FDA approval.
▸Is dasiglucagon approved for congenital hyperinsulinism?
No. The FDA has twice declined to approve the pump version for CHI, in December 2023 and October 2024, each time over a third-party manufacturing site rather than the trial results. Zealand said in August 2026 it expects to resubmit in the second half of 2026. The approved product Zegalogue is a one-time rescue injection for severe lows in people with diabetes who weigh at least 20 kg, and its label does not cover CHI.
▸Why did the FDA reject the dasiglucagon CHI application?
Zealand said both letters concerned deficiencies found when the FDA inspected a contract manufacturing facility, not the clinical data. The FDA's own October 2024 letter, now public, lists the facility findings, a need to resubmit the label and a safety update, and asks for justification of dosing in the smallest infants and in kidney impairment.
▸Can I still buy Zegalogue for my child with diabetes?
Zealand's 2025 annual report says Novo Nordisk stopped all US sales and distribution of Zegalogue when their license ended on January 9, 2026, and Drugs@FDA now lists the products as discontinued. Zealand says it is looking for a new commercial partner. Ask your pharmacist about other glucagon rescue products.
▸What did the dasiglucagon CHI trials show?
In 12 IV-dependent infants it cut the glucose infusion rate by more than half compared with placebo and met its primary endpoint. In 32 older children at home it did not meet its primary endpoint on finger-stick lows, but blinded CGM showed about 43% fewer lows. Skin reactions and stomach upset were the most frequent side effects.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Zealand Pharma via GlobeNewswire · 2023-12-23. Zealand Pharma announces Complete Response Letter from the U.S. FDA for dasiglucagon in congenital hyperinsulinism. https://www.globenewswire.com/news-release/2023/12/23/2800891/0/en/a.html
- Zealand Pharma via GlobeNewswire · 2024-10-08. Zealand Pharma provides U.S. regulatory update on dasiglucagon in congenital hyperinsulinism. https://www.globenewswire.com/news-release/2024/10/08/2960183/0/en/Zealand-Pharma-provides-U-S-regulatory-update-on-dasiglucagon-in-congenital-hyperinsulinism.html
- U.S. Food and Drug Administration, openFDA CRL database · 2024-10-08. Complete Response Letter, NDA 217724 (dasiglucagon), October 8, 2024. https://api.fda.gov/transparency/crl.json?search=dasiglucagon
- Zealand Pharma · 2026-02-19. Zealand Pharma Annual Report 2025. https://www.zealandpharma.com/media/2oeew4jl/zealand-pharma-annual-report-2025.pdf
- Zealand Pharma · 2026-08-13. Zealand Pharma interim report for the first half of 2026. https://www.zealandpharma.com/media/gfdbqawp/zealand-pharma-h1-2026-interim-report.pdf
- Zealand Pharma. Dasiglucagon: Continuous infusion. https://www.zealandpharma.com/pipeline/dasiglucagon-continuous-infusion/
- Journal of Clinical Endocrinology and Metabolism, PubMed 39584500 · 2025. Dasiglucagon in infants with congenital hyperinsulinism dependent on intravenous glucose (trial 17103). https://pubmed.ncbi.nlm.nih.gov/39584500/
- Journal of Clinical Endocrinology and Metabolism, PubMed 37930757 · 2024. Dasiglucagon for the treatment of congenital hyperinsulinism in children 3 months to 12 years (trial 17109). https://pubmed.ncbi.nlm.nih.gov/37930757/
- U.S. Food and Drug Administration · 2026-06-18. ZEGALOGUE (dasiglucagon) injection prescribing information, revised 06/2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214231s004lbl.pdf