Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library · Trial & Regulatory Tracker →
Dasiglucagon (Zegalogue): what the evidence says
At a glance
What it is: a ready-to-use, water-stable glucagon analogue from Zealand Pharma. FDA approved Zegalogue (NDA 214231) in 2021 for severe hypoglycemia. R1 A June 2026 label update covers diabetes patients weighing at least 20 kg. R2
What the evidence says: in phase 3, blood sugar recovered within 15 minutes in 99% with dasiglucagon vs 2% with placebo, similar to standard glucagon. R3 In children with congenital hyperinsulinism, it cut low readings on a glucose monitor by 43%, but the main endpoint was missed. R4
Biggest risks: nausea and vomiting; dangerous in pheochromocytoma and insulinoma. R3, R2
Rating
| Human Human evidence | Strong: phase 3 rescue trials R3; moderate for congenital hyperinsulinism R4, R5 |
| Animal Animal / lab evidence | Mouse carcinogenicity study (on label) R2 |
| Regulatory | FDA-approved (NDA 214231) R1, R2 · not approved for congenital hyperinsulinism R6 · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page R7, R8, R9 · not named by WADA R10 |
| Established human dose | Yes, label dose (emergency use) |
Evidence verdict: Severe hypoglycemia rescue in diabetes: Strong (FDA-approved) · Congenital hyperinsulinism: Moderate (phase 3, not approved for this) · Other uses: No human data
This page reports what studies used. It is not dosing advice.
Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source
About the evidence: the rescue data are strong. For congenital hyperinsulinism the primary endpoint was not met, and the hypoglycemia benefit was a post hoc analysis. R4
What is it?
Related pages: Pramlintide, Semaglutide, Survodutide.
Does it work?
- Human Severe hypoglycemia (type 1 diabetes): median recovery about 10 minutes. R3 UNVERIFIED the exact median, which is from the full text.
- Human Congenital hyperinsulinism: fewer monitor-detected lows (post hoc). R4, R5, R11 FDA has not approved this use. R6 UNVERIFIED reports of FDA letters in Dec 2023 and Oct 2024 tied to a contract manufacturer.
Is it safe?
- Human Nausea and vomiting are the most common side effects. R3 Skin and stomach events were more frequent in the hyperinsulinism trial. R4
- Human Contraindicated in pheochromocytoma and insulinoma. R2
Gray-market vials: extra risks
A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.
Is it legal?
- US: FDA-approved prescription drug. R1 UNVERIFIED openFDA lists both Zegalogue products as "Discontinued" while FDA approved a label update in 2026; current US availability is unclear.
- Compounding: not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. R7, R8, R9
- Sport: not named on WADA's 2026 Prohibited List. R10
Study details
Study details
These are amounts researchers used, not recommendations.
| Study | People / model | Route | Amount used | Follow-up | Reported | Citation |
|---|---|---|---|---|---|---|
| Phase 3 rescue 2021 | Adults with T1D | SC single | 0.6 mg | 30 to 45 minutes | 99% recovered in 15 min | PMID 35239971 |
| CHI phase 3 2024 | Children 3 months to 12 years | SC infusion | Per protocol | 4 weeks + | CGM lows −43% (post hoc) | PMID 37930757 |
Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 26, 2026)
- R1 Drugs@FDA, Zegalogue (dasiglucagon), application NDA 214231 (openFDA drugsfda record checked Oct 26, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA 214231
- R2 FDA, Zegalogue prescribing information and approval letter, NDA 214231/S-004 (indication: diabetes patients weighing at least 20 kg), 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214231s004lbl.pdf
- R3 Pieber TR, et al. Diabetes Care. 2021. PMID 35239971
- R4 Thornton PS, et al. J Clin Endocrinol Metab. 2024. PMID 37930757
- R5 De Leon DD, et al. J Clin Endocrinol Metab. 2025. PMID 39584500
- R6 FDA Orphan Drug Designations, dasiglucagon for congenital hyperinsulinism (designated Aug 10, 2017; not approved for orphan indication), checked Oct 26, 2026. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=569416
- R7 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
- R8 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
- R9 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- R10 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
- R11 ClinicalTrials.gov NCT04172441, dasiglucagon phase 2/3 in congenital hyperinsulinism (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT04172441
Disclaimer
This page is for education and harm reduction, not medical advice or a recommendation to use Dasiglucagon (Zegalogue). This is a prescription medicine. Use it only under the care of a licensed clinician; do not buy it from research-chemical or gray-market sellers. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).