Dasiglucagon

Also known as: Zegalogue

Approved, discontinued

Last verified: October 30, 2026

At a glance

FDA approval Approved, discontinued 1 application
Randomized controlled trials 13 of 48 publications on PubMed
Registered clinical trials 21 0 active
Adverse event reports 53 34 classified as serious
  • Dasiglucagon was approved by the FDA (Zegalogue, March 22, 2021), but the products are no longer marketed.
  • PubMed lists 48 publications mentioning it, including 13 randomized controlled trials and 1 animal-only study.
  • ClinicalTrials.gov lists 21 registered studies testing it (0 active).
  • FDA's adverse event system (FAERS) holds 53 reports mentioning it; 34 classified as serious. Reports do not prove causation.

Research topics

  • Hypoglycemia 28
  • Blood Glucose 23
  • Diabetes Mellitus, Type 1 21
  • Hypoglycemic Agents 14
  • Insulin 14
  • Cross-Over Studies 6
  • Blood Glucose Self-Monitoring 4
  • Congenital Hyperinsulinism 3
  • Diabetes Mellitus, Type 2 3
  • Gastric Bypass 3

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

Application Product Status First approval Sponsor
NDA214231 ZEGALOGUE, ZEGALOGUE (AUTOINJECTOR) Approved, discontinued March 22, 2021 ZEALAND PHARMA

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 48
  • Human (MeSH) 33
  • Animal only 1
  • Clinical trials 13
  • Randomized controlled trials 13
  • Systematic reviews & meta-analyses 2
  • Case reports 1
  • Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
21
Active
0
With posted results
9

Conditions studied

  • Hypoglycemia 11
  • Diabetes Mellitus, Type 1 7
  • Type 1 Diabetes 4
  • Congenital Hyperinsulinism 3
  • Hyperinsulinemic Hypoglycemia 2
  • Postprandial Hypoglycemia 2
  • Glucose Metabolism Disorders 1
  • Type 1 Diabetes Mellitus 1
  • Diabetes Mellitus Type 1 1
Study Status Phase Start
Research Study in Japan to Compare Dasiglucagon With Glucagon in Treating Very Low Levels of Blood Sugar in Asian Adults With Type 1 Diabetes and Testing of Dasiglucagon for the Same Condition in Japanese Adolescents
NCT06588504 Novo Nordisk A/S
Completed Phase 1 September 10, 2024
A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System
NCT05454709 Inreda Diabetic B.V.
Withdrawn Phase 2 December 29, 2023
A Study to Inv. Safety, Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children <6 Years With T1D
NCT05378672 Zealand Pharma Results posted
Completed Phase 3 May 9, 2023
Micro Glucagon During Exercise in Type 1 Diabetes
NCT04192019 Insel Gruppe AG, University Hospital Bern
Withdrawn Early phase 1 Apr 2023
Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults
NCT04824872 Zealand Pharma
Withdrawn Phase 2 Feb 2023
Treatment of Post-bariatric Hypoglycaemia
NCT04836273 Filip Krag Knop
Completed Phase 2 August 20, 2021
Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People With Type 1 Diabetes
NCT04764968 Steno Diabetes Center Copenhagen
Completed Phase 2 April 27, 2021
Low-dose Dasiglucagon for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes
NCT04449692 Steno Diabetes Center Copenhagen
Completed Phase 2 July 2, 2020
Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
NCT04172441 Zealand Pharma Results posted
Completed Phase 2, Phase 3 June 19, 2020
Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass
NCT03984370 University Hospital, Gentofte, Copenhagen
Completed Phase 2 September 18, 2019
Show 11 more studies
Study Status Phase Start
The Bihormonal iLet Bionic Pancreas Feasibility Study
NCT03840278 Massachusetts General Hospital Results posted
Completed Phase 2, Phase 3 May 15, 2019
Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism
NCT03941236 Zealand Pharma
Completed Phase 3 May 2, 2019
A Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With T1DM
NCT03895697 Zealand Pharma
Completed Phase 3 March 26, 2019
A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
NCT03777176 Zealand Pharma Results posted
Completed Phase 3 February 7, 2019
Evaluation of the Safety, Tolerability and Bioavailability of Dasiglucagon Following Subcutaneous (SC) Compared to IV Administration
NCT03735225 Zealand Pharma
Completed Phase 1 November 7, 2018
Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM
NCT03688711 Zealand Pharma Results posted
Completed Phase 3 November 1, 2018
Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children
NCT03667053 Zealand Pharma Results posted
Completed Phase 3 September 28, 2018
A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects
NCT03378635 Zealand Pharma Results posted
Completed Phase 3 December 7, 2017
A Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen in Patients With Type 1 Diabetes Mellitus
NCT03216226 Zealand Pharma Results posted
Completed Phase 3 June 28, 2017
ZP4207(Dasiglucagon) Administered to T1D Patients to Assess the PK and PD Compared to Marketed Glucagon
NCT02916251 Zealand Pharma
Completed Phase 2 December 1, 2016
Feasibility Trial Testing the Bionic Pancreas With ZP4207
NCT02971228 Zealand Pharma Results posted
Completed Phase 2 Nov 2016

All 21 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
53
Serious
34
With death outcome
15

Most reported reactions

  • Death 15
  • Hyperglycaemia 3
  • Arthritis 2
  • Disability 2
  • Feeling abnormal 2
  • Memory impairment 2
  • Nausea 2
  • Off label use 2
  • Staphylococcal infection 2
  • Abdominal pain 1
  • Amino acid level decreased 1
  • Back pain 1

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

FDA prescribing information

Official US prescribing information. Dosing sections are intentionally not shown.

  • Zegalogue HUMAN PRESCRIPTION DRUG Novo Nordisk January 1, 2023

Source: DailyMed / openFDA

Change history

No changes since monitoring began on October 30, 2026.