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Dasiglucagon: First Approval

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Abstract

Dasiglucagon (Zegalogue®) is an antihypoglycaemic agent being developed by Zealand Pharma for the treatment of hypoglycaemia, type 1 diabetes mellitus (T1DM) management and congenital hyperinsulinism. In March 2021, dasiglucagon received its first approval in the USA for the treatment of severe hypoglycaemia in paediatric and adult patients with diabetes aged 6 years and above. Dasiglucagon, a glucagon analogue, is available as a single-dose autoinjector or prefilled syringe for subcutaneous injection. This article summarizes the milestones in the development of dasiglucagon leading to this first approval for hypoglycaemia.

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References

  1. Li S, Hu Y, Tan X, et al. Evaluating dasiglucagon as a treatment option for hypoglycemia in diabetes. Expert Opin Pharmacother. 2020;21(11):1311–8.

    Article  CAS  Google Scholar 

  2. Thieu VT, Mitchell BD, Varnado OJ, et al. Treatment and prevention of severe hypoglycaemia in people with diabetes: current and new formulations of glucagon. Diabetes Obes Metab. 2020;22(4):469–79.

    Article  Google Scholar 

  3. Zealand Pharma. ZEGALOGUE (dasiglucagon) injection, for subcutaneous use: US prescribing information. 2021. https://www.accessdata.fda.gov/. Accessed 28 Apr 2021.

  4. Zealand Pharma. Zealand Pharma announces FDA approval of Zegalogue® (dasiglucagon) injection, for the treatment of severe hypoglycemia in people with diabetes [media release]. 2021. http://www.zealandpharma.com. Accessed 22 Mar 2021.

  5. Zealand Pharma. Zealand Pharma initiates second phase 3 trial with dasiglucagon for the treatment of congenital hyperinsulinism [media release]. 2019. http://www.zealandpharma.com. Accessed 4 Dec 2019.

  6. Zealand Pharma. Zealand and Beta Bionics to collaborate on the development of a first-in-class dual-hormonal bionic pancreas system for treatment of people with type 1 diabetes [media release]. 2016. http://www.zealandpharma.com. Accessed 10 Jun 2016.

  7. Zealand Pharma. Zealand Pharma boosts collaboration with Beta Bionics to advance development of its dasiglucagon in the iLetTM [media release]. 2017. http://www.zealandpharma.com. Accessed 21 Dec 2017.

  8. Zealand Pharma. Zealand Pharma completes equity investment in strategic partner Beta Bionics [media release]. 2019. http://www.zealandpharma.com. Accessed 4 Jan 2019.

  9. Macchi F, Wenander C. Dasiglucagon is a novel stable glucagon analogue with fast glucose response following subcutaneous injection in hypoglycaemic rats [abstract no. 512]. Diabetologia. 2020;63(Suppl. 1):S247.

  10. Castle J, Elander M, O'Halloran S. Long-term safety and tolerability of dasiglucagon, a stable-in-solution glucagon analog [abstract no. ATTD19-0111]. Diabetes Technol Ther. 2019;21(Suppl. 1):A49.

  11. Ahlkvist L, Omar B, Valeur A, et al. Defective insulin secretion by chronic glucagon receptor activation in glucose intolerant mice. J Endocrinol. 2016;228(3):171–8.

    Article  CAS  Google Scholar 

  12. Hovelmann U, Bysted BV, Mouritzen U, et al. Pharmacokinetic and pharmacodynamic characteristics of dasiglucagon, a novel soluble and stable glucagon analog. Diabetes Care. 2018;41(3):531–7.

    Article  Google Scholar 

  13. Hovelmann U, Olsen MB, Mouritzen U, et al. Low doses of dasiglucagon consistently increase plasma glucose levels from hypoglycaemia and euglycaemia in people with type 1 diabetes mellitus. Diabetes Obes Metab. 2019;21(3):601–10.

    Article  Google Scholar 

  14. Pieber TR, Aronson R, Hovelmann U, et al. Dasiglucagon: a next-generation glucagon analog for rapid and effective treatment of severe hypoglycemia results of phase 3 randomized double-blind clinical trial. Diabetes Care. 2021. https://doi.org/10.2337/DC20-2995.

  15. Bailey TS, Willard J, Klaff LJ, et al. Dasiglucagon hypopal autoinjector as a fast and effective treatment for severe hypoglycemia: results of a phase 3 trial [abstract no. 1053-P plus poster]. Diabetes. 2020;69(Suppl. 1).

  16. Battelino T, Tehranchi R, Melgaard AE, et al. Dasiglucagon as a fast and effective treatment for severe hypoglycemia in children with diabetes [abstract no. 180-OR]. Diabetes. 2020;69(Suppl. 1).

  17. Nielsen CK, Ohrstrom CC, Kielgast UL, et al. Dasiglucagon ameliorates postprandial hypoglycaemia after Roux-En-Y gastric bypass [abstract no. 737]. Diabetologia. 2020;63(Suppl. 1):S356–7.

  18. Bionics B, Zealand Pharma. Beta Bionics and Zealand Pharma announce superior glycemic control in phase 2 home-use clinical trial testing the iLetTM bionic pancreas using dasiglucagion [media release]. 2019. http://www.betabionics.com. Accessed 5 Jun 2019.

  19. Sherwood JS, Balliro CA, Jafri RZ, et al. Individual response of automated glycaemic control with the iLet bionic pancreas in the insulin-only vs bihormonal configuration with a stable glucagon analogue, dasiglucagon [abstract no. 172]. Diabetologia. 2020;63(Suppl. 1):S87.

  20. Jafri R, Maheno M, Balliro C, et al. The stable glucagon analog dasiglucagon is well-tolerated and as effective as recombinant human glucagon when delivered by the bionic pancreas in response to insulin excess [abstract]. Diabetes Technol Ther. 2018;20(Suppl. 1):A13.

    Google Scholar 

  21. Zealand Pharma. Phase 2a trial results support development of dasiglucagon in the iLet pump system for type 1 diabetes [media release]. 2017. http://www.zealandpharma.com. Accessed 22 Jun 2017.

  22. Zealand Pharma. Zealand Pharma announces data from the first phase 3-trial with dasiglucagon in congenital hyperinsulinism (CHI) [media release]. 2020. http://www.zealandpharma.com. Accessed 15 Dec 2020.

  23. Pieber T, Ajala B, Alassad H, et al. Immunogenicity and other safety parameters following multiple SC doses of dasiglucagon [abstract no. 738 + oral presentation]. Diabetologia. 2020;63(Suppl. 1):S357.

  24. US National Institutes of Health. http://www.clinicaltrials.gov. Accessed 5 May 2021.

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  1. Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand

    Hannah A. Blair

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  1. Hannah A. Blair
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Correspondence to Hannah A. Blair.

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The preparation of this review was not supported by any external funding.

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During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Hannah Blair is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Blair, H.A. Dasiglucagon: First Approval. Drugs 81, 1115–1120 (2021). https://doi.org/10.1007/s40265-021-01531-z

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