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Dasiglucagon

Zegalogue

Dasiglucagon is a glucagon analog used to raise blood glucose in a severe hypoglycemia emergency. Its US product, Zegalogue, was supplied as a ready-to-use injection. Its label covers people with diabetes weighing at least 20 kg.

FDA

Severe hypoglycemia requires urgent help. The Zegalogue label describes a 0.6 mg rescue injection and calls for emergency assistance after use, while FDA recorded both US presentations as discontinued.

FDA: Zegalogue (dasiglucagon) prescribing informationFDA: FDA Orange Book: Zegalogue discontinuation changes

By the Peptides Media Editorial TeamEditorial policy3 min read

ClassGlucagon receptor agonist
FDA
Labeled useSevere hypoglycemia rescue
FDA
RouteSubcutaneous injection
FDA
US presentationsDiscontinued
FDA

Overview

Quick answer

FDA approved a weight-based expansion of the Zegalogue indication. FDA's drug product changes also recorded the prefilled syringe and autoinjector as discontinued. A current label does not confirm pharmacy availability.

FDA: FDA approval of the Zegalogue labeling supplementFDA: FDA Orange Book: Zegalogue discontinuation changes

Who is covered by the Zegalogue label?

The label covers adults and children with diabetes who weigh at least 20 kg and have severe hypoglycemia.

FDA

What does the label say to do during an emergency?

Give 0.6 mg under the skin and call for emergency assistance immediately. If there is no response after 15 minutes, another 0.6 mg dose may be given from a new device. After the person responds and can safely swallow, give carbohydrates to help prevent another low.

FDA

What did the adult trial measure?

In adults with type 1 diabetes given insulin to lower glucose under controlled conditions, median time to glucose recovery was 10 minutes with dasiglucagon and 40 minutes with placebo.

PMID 35239971

Evidence

Evidence snapshot

Adult trialControlled hypoglycemia

A randomized trial tested recovery from insulin-induced low glucose in adults with type 1 diabetes.

PMID 35239971
DeviceSingle-dose solution

The label describes a prefilled syringe and an autoinjector, each containing one 0.6 mg dose.

FDA
US product statusPresentations discontinued

The FDA Orange Book recorded both Zegalogue presentations as discontinued.

FDA

Claims

Common claims vs evidence

ClaimHuman evidenceMechanistic evidenceVerdict
Dasiglucagon raises glucose during a severe low.In a controlled study of 170 adults with type 1 diabetes, median time to a defined plasma glucose recovery was 10 minutes with dasiglucagon and 40 minutes with placebo. The drug activates glucagon receptors and depends on liver glycogen to raise blood glucose.The result supports the rescue use described in the label.
PMID 35239971FDA
A person can skip emergency care after receiving glucagon.The prescribing information calls for emergency assistance immediately after the injection.Emergency assessment remains part of the labeled response.
FDA
Glucagon works regardless of the body's stored fuel.The label warns that people with depleted liver glycogen, including some patients with prolonged starvation or adrenal insufficiency, may not respond adequately and may require glucose treatment. A sufficient liver glycogen supply matters.
FDA

Bottom line

Main takeaway

Emergency response

Severe hypoglycemia requires help from another person and prompt emergency assistance.

FDA
Check the rescue plan

FDA recorded both Zegalogue presentations as discontinued, so availability and a replacement plan matter.

FDA
Trial setting

The adult trial induced hypoglycemia under clinical observation and measured a predefined glucose response.

PMID 35239971

Identity

What it is

Dasiglucagon is a modified glucagon peptide that activates glucagon receptors. Its ready-to-use liquid formulation was supplied in a prefilled syringe or an autoinjector.

FDA

Glucagon mobilizes glucose from liver glycogen. The label warns that a person with insufficient liver glycogen may need glucose instead.

FDA

Use context

Routes, doses, and cycle patterns

Zegalogue was designed as a single-dose rescue device. Its label gives a weight threshold, an emergency response sequence, and instructions for a second device if the first dose does not produce a response.

FDA

Human studies and product labels

Zegalogue rescue label

Purpose
Severe hypoglycemia in people with diabetes weighing at least 20 kg
Context
US prescribing label
Route
Subcutaneous injection
Amount
0.6 mg from a single-dose device
Frequency
One dose; another 0.6 mg from a new device may be given after 15 minutes if there is no response
Duration
Emergency rescue treatment

Call for emergency assistance immediately after the injection. Once the person responds and can safely swallow, give carbohydrates. FDA recorded both Zegalogue presentations as discontinued.

FDA: Zegalogue (dasiglucagon) prescribing informationFDA: FDA Orange Book: Zegalogue discontinuation changes

Adult phase 3 trial

Purpose
Recovery from controlled insulin-induced hypoglycemia
Context
Randomized trial in adults with type 1 diabetes
Route
Subcutaneous injection
Amount
A single 0.6 mg dose, placebo, or 1 mg reconstituted glucagon
Frequency
Single administration in the study
Duration
Recovery assessed in minutes

The primary comparison was with placebo; the reconstituted glucagon arm was a reference.

PMID 35239971

What varies

  • Weight: the label applies to people with diabetes weighing at least 20 kg.
    FDA
  • Device: a second dose requires a new single-dose device.
    FDA
  • Availability: FDA recorded the syringe and autoinjector as discontinued.
    FDA

Research

Research evidence

The adult trial measured glucose recovery during insulin-induced hypoglycemia in a controlled setting. Pediatric data and the additional weight-based indication are described in the FDA label and approval letter.

PMID 35239971FDA: Zegalogue (dasiglucagon) prescribing informationFDA: FDA approval of the Zegalogue labeling supplement
Study / evidence areaPopulationDesignProduct contextMain outcomeLimitationsWeight
Adult dasiglucagon phase 3 trial
PMID 35239971
170 adults with type 1 diabetesRandomized, double-blind, placebo-controlled trialSingle subcutaneous dose during controlled insulin-induced hypoglycemiaMedian glucose recovery time was 10 minutes with dasiglucagon and 40 minutes with placebo.The low glucose episode was induced and observed in a clinical setting.Strong for the measured response
FDA label and pediatric supplement
FDA: Zegalogue (dasiglucagon) prescribing informationFDA: FDA approval of the Zegalogue labeling supplementFDA: FDA Orange Book: Zegalogue discontinuation changes
People with diabetes weighing at least 20 kgPrescribing information and FDA approval letterZegalogue prefilled syringe or autoinjectorThe indication uses a weight threshold and the label specifies 0.6 mg per dose.FDA recorded the two product presentations as discontinued.Strong for labeled use

Cautions

Safety and unknowns

  • Zegalogue is contraindicated in people with pheochromocytoma or insulinoma. The label warns about a substantial rise in blood pressure in the first condition and a recurrence of low blood glucose in the second.
    FDA
  • Nausea and vomiting are common. Serious allergic reactions have been reported with glucagon products. Carbohydrates are given after the person responds and can safely swallow.
    FDA
  • Glucagon needs sufficient liver glycogen. The label identifies starvation, adrenal insufficiency, and chronic hypoglycemia as situations where glycogen may be too low for an adequate response.
    FDA

Mechanism

How it is proposed to work

Dasiglucagon signals the liver to release stored glucose, raising blood glucose during a severe low.

FDA
01

The effect depends on available hepatic glycogen, and the drug is given as a ready-to-use solution under the skin.

FDA

Details

Technical details

Dasiglucagon technical details
Active ingredient
Dasiglucagon
FDA
Class
Glucagon receptor agonist
FDA
Labeled route
Subcutaneous injection
FDA
Device dose
0.6 mg in a single-dose device
FDA
US product status
Prefilled syringe and autoinjector recorded as discontinued
FDA

Sources

References

  1. 1.

    FDA. Zegalogue (dasiglucagon) prescribing information

    US label for severe hypoglycemia in people with diabetes weighing at least 20 kg.

  2. 2.

    FDA. FDA approval of the Zegalogue labeling supplement

    FDA approved a weight-based expansion of the severe-hypoglycemia indication.

  3. 3.

    FDA. FDA Orange Book: Zegalogue discontinuation changes

    FDA recorded the prefilled syringe and autoinjector as discontinued presentations.

  4. 5.

    PubMed. Dasiglucagon for treatment of severe hypoglycemia: randomized phase 3 trial

    doi:10.2337/dc20-2995 PMID:35239971 NCT03378635

    Adult type 1 diabetes trial using controlled insulin-induced hypoglycemia.