Is Dasiglucagon approved by the US FDA?

Drugs@FDA lists 2 application product lines for Dasiglucagon, including ZEGALOGUE (Discontinued); ZEGALOGUE (AUTOINJECTOR) (Discontinued).

Is Dasiglucagon authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Dasiglucagon: Zegalogue.

Are there safety signals or safety updates for Dasiglucagon?

US FDA: 2 entries (latest 2026-06-18).

Active substance

Dasiglucagon

US FDA 2
EMA 1
US price lines 4
Safety 2

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ZEGALOGUE	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	solution · subcutaneous	ZEALAND PHARMA	Discontinued	22 Mar 2021
ZEGALOGUE (AUTOINJECTOR)	EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)	solution · subcutaneous	ZEALAND PHARMA	Discontinued	22 Mar 2021

EMA European Union — centrally authorised medicines

Zegalogue Zealand Pharma A/S · Authorised · authorised 24 Jul 2024 · ATC H04AA02

Therapeutic indication (EMA)

Zegalogue is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 6 years and over with diabetes mellitus.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ZEGALOGUE 0.6 MG/0.6 ML AUTOINJ	$493.89598	per ML	21 Jan 2026
US NADAC	ZEGALOGUE 0.6 MG/0.6 ML AUTOINJ	$492.83148	per ML	21 Jan 2026
US NADAC	ZEGALOGUE 0.6 MG/0.6 ML SYRING	$494.05208	per ML	21 Jan 2026
US NADAC	ZEGALOGUE 0.6 MG/0.6 ML SYRING	$495.0225	per ML	21 Jan 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 18 Jun 2026 ZEGALOGUE — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 18 Jun 2026 ZEGALOGUE (AUTOINJECTOR) — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for dasiglucagon →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.