Digestive & weight Glucagon analog
Dasiglucagon
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Dasiglucagon (sold as Zegalogue) is a stable glucagon analog formulated as a ready-to-use injection for the emergency treatment of severe low blood sugar. Because it stays stable in solution, it comes premixed in an autoinjector or prefilled syringe, with no reconstitution needed. It has been FDA-approved in the U.S. since 2021 and is now approved for adults and children with diabetes who weigh at least 20 kg.
At a glance
- What it is
- A glucagon analog peptide engineered for stability in a ready-to-use liquid
- Approved for
- Severe hypoglycemia in adults and children with diabetes who weigh at least 20 kg (about 44 pounds)
- Key fact
- In a phase 3 trial, median time to blood-sugar recovery was 10 minutes versus 40 minutes with placebo
- Route
- Subcutaneous injection (autoinjector or prefilled syringe)
- Evidence strength
- FDA approved
Summary
Dasiglucagon is an FDA-approved, ready-to-use glucagon analog for severe low blood sugar. Learn how it works, what it is used for, and its side effects.
What is dasiglucagon?
Dasiglucagon, sold under the brand Zegalogue, is a modified version of glucagon designed to remain stable in a water-based solution. Native glucagon is unstable once dissolved, which is why traditional emergency kits require mixing a powder with liquid at the moment of a crisis; dasiglucagon's amino-acid changes let it be supplied premixed and ready to use. It is an emergency rescue treatment for severe hypoglycemia. It was developed under the codes ZP4207 and ZP-GA-1 and approved in the United States in 2021.
How does dasiglucagon work?
Dasiglucagon activates the same liver glucagon receptor as native glucagon, triggering glycogenolysis and gluconeogenesis so the liver releases glucose and blood sugar rises quickly. Its structural changes do not alter what it does at the receptor; they make the molecule stable enough to be stored as a ready-to-use liquid, which matters in an emergency where every step of mixing and preparation costs time.
That practical advantage is the point of the drug. In its phase 3 trial in adults with type 1 diabetes, dasiglucagon produced a median time to plasma-glucose recovery of 10 minutes versus 40 minutes with placebo, with nearly all patients recovering within 15 minutes. A separate pediatric trial supported its use in children.
Is it FDA-approved?
Editor’s note
Status: Yes. Dasiglucagon (Zegalogue) is FDA-approved, and its label has changed since approval: Date | FDA action | Who it covers 2021 | Approved for severe hypoglycemia in people with diabetes | Ages 6 and up June 2026 | Label replaced the age limit with a weight limit | Adults and children who weigh at least 20 kg (about 44 pounds) It is available as an autoinjector and a prefilled syringe.
Category: FDA-approved · Primary body area: Digestive & weight
Yes. Dasiglucagon (Zegalogue) is FDA-approved, and its label has changed since approval:
| Date | FDA action | Who it covers |
|---|---|---|
| 2021 | Approved for severe hypoglycemia in people with diabetes | Ages 6 and up |
| June 2026 | Label replaced the age limit with a weight limit | Adults and children who weigh at least 20 kg (about 44 pounds) |
It is available as an autoinjector and a prefilled syringe.
What is dasiglucagon prescribed for?
Dasiglucagon is prescribed as emergency treatment for severe hypoglycemia in adults and children with diabetes who weigh at least 20 kg, typically administered by a caregiver. As with glucagon, it is contraindicated in pheochromocytoma and insulinoma.
What are the side effects?
According to the prescribing information, common side effects include:
- Nausea and vomiting
- Headache
- Diarrhea (in adults)
- Injection-site pain
More serious considerations include:
- A rise in blood pressure in people with pheochromocytoma
- Low blood sugar rebound in people with insulinoma
- Serious allergic reactions
Sources: FDA prescribing information for Zegalogue; the phase 3 dasiglucagon trial (Pieber et al., Diabetes Care, 2021, DOI: 10.2337/dc20-2995), indexed on PubMed. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
Approved (PDF)
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