Zegalogue, a rescue glucagon made by Zealand Pharmaceuticals, was released today in the United States. Zegalogue is the third shelf stable glucagon product to enter the US market over the past three years. But what distinguishes Zegalogue is that it may have the potential to move glucagon from an emergency treatment for hypoglycemia to a part of a regular super-treatment for people with T1D, and perhaps a component of a future Practical Cure.
This report will review the history of glucagon rescue kits and provide an overview of the options currently available to people with T1D. While it is much less talked about than its hormonal counterpart insulin, the production of glucagon is also impaired by the T1D autoimmune attack. The role of glucagon in the body is to prevent severe hypoglycemia; its absence is debilitating and life-threating to people with T1D. As a result, a T1D Practical Cure will have to eliminate the threat of hypoglycemia that currently hangs over people living with the disease.
If you’re new to glucagon, the link at the bottom of the page offers insight about what glucagon is and how to use it. Please note that JDCA does not give medical advice: we are illustrating a few key differences between the available products as a service to the T1D community, but readers should choose the glucagon that suits them based on conversations with their health care team.
The first rescue glucagon was approved in the US in 1960; it remained the standard of care for treating severe hypoglycemia until 2019.
Glucagon 1.0 is different from glucagon 2.0 in two important ways. First, because glucagon 1.0 is not shelf stable in a liquid state, it has to be mixed with sterile water just before it is injected. Second, glucagon 1.0 is injected directly into the muscle of the unresponsive person, a challenging ask for anyone who is untrained.
In 2019, Eli Lily’s nasal powder glucagon, BAQSIMI, was approved by the FDA. This was the first rescue glucagon that did not need to be mixed and injected intramuscularly. One year ago, Xeris Pharmaceuticals released its Gvoke Hypopen and Autoinjector Syringe, the first ready-to-use premixed liquid glucagons. Just this morning, Zealand Pharma released Zegalogue, the second shelf-stable liquid glucagon available in the US to people with T1D.
Glucagon For Non-Emergency Treatment?
Current iterations of glucagon are only approved by the FDA for treating severe hypoglycemia in emergency situations. However, in a functional pancreas, glucagon prevents hypoglycemia by releasing caches of sugar into the bloodstream when glucose levels drop too low.
There is some indication that the next generation of glucagon will not just be for emergency use— it will aim to eliminate the threat of “going low” entirely. Zealand Pharma is on the cutting edge of this research: Zealand’s glucagon is being tested in the iLet dual hormone artificial pancreas. This product, which is under development by Beta Bionics, aims to automatically dose insulin to treat high blood glucose and glucagon to treat lows, mimicking a natural pancreas.
Beta Bionics has published results from a human trial of this device, and announced in April that it expects to receive FDA approval in 2023. We will provide updates on the commercialization timeline as they become available.
For more information about rescue glucagon, check out this Beyond T1D page: