Charles Kimball and John Merlin isolated a pancreatic factor that raises blood glucose levels in 1922. This factor is called a "glucose agonist" or simply "glucagon" because it reverses the hypoglycaemic effect of insulin.
Glucagon is a hormone made up of 29-amino acid peptide. It is mainly secreted by pancreatic alpha α-cells and plays critical roles in glucose homeostasis. Recombinant glucagon is clinically used to avoid insulin-induced hypoglycaemia in patients with type 1 diabetes.
Glucagon for Therapeutic Use
Like insulin, therapeutic glucagon is extracted from the pancreatic tissues of porcine and bovine or chemically synthesized. GlucaGen (Injection glucagon, Novo Nordisk) is the first recombinant glucagon derived from Saccharomyces cerevisiae. It was approved by FDA in 1998, then approved by NMPA (China) in 2005, and PMDA (Japan) in 2009.
In addition, the FDA has approved two new glucagon formulations. Among them, a glucagon nasal powder formulation (Baqsimi) has successfully completed Phase III clinical trials for severe hypoglycaemia. Baqsimi is currently approved by FDA and EMA. And it is developed by Lilly and divested to Amphastar Pharmaceuticalsis.
Gvoke (glucagon) is also called G-Pen, is a premixed glucagon formulation that does not require reconstitution before administration. Developed by Xeris Pharmaceuticals, it is the first FDA-approved auto-injector or pre-filled syringe for the treatment of very low blood glucose.
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Glucagon Pipelines
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Generic Name
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Brand Name/Altermative Name
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Expression System
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Indications
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Manufacturer
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R&D Stage
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Glucagon, powder for injection
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GlucaGen
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Yeast (Saccharomyces cerevisiae)
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Severe hypoglycemia; diagnostic aid during gastrointestinal tract radiologic examinations
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Novo Nordisk
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Approval
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|
Glucagon, nasal powder formulation
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Baqsim
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N/A, Chemical synthesis
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Severe hypoglycemia
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Eli Lilly
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Approval
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|
Glucagon, auto-injector and pre-filled syringe
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Gvoke HypoPen
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N/A, Chemical synthesis
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Severe hypoglycemia
|
Xeris Pharmaceuticals
|
Approval
|
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