GLP-1 Receptor Agonists: New Frontiers and Challenges

Obesity and diabetes have been two of the greatest public health challenges for decades. Many different diets and fads have promised the public a quick fix and a path to losing excess weight or resolving their diabetic issues.

Recently, a new class of drugs, based on GLP-1, are revolutionizing medicine and the treatment of patients with diabetes, obesity, and other disorders associated with obesity. GLP-1 is a short-acting hormone that is released after eating. This hormone helps regulate glucose levels in the body by causing the pancreas to release insulin, which lowers sugar levels in the blood. Furthermore, the hormone causes individuals to feel full by both causing the gut to reduce how quickly it processes food and acting on different parts of the brain which control hunger and satiety.

GLP-1 receptor agonists are a new class of drugs which mimic the activity of GLP-1 and maintain the benefits of the GLP-1 hormone in patients. The U.S. Food & Drug Administration (FDA) has approved many drugs in this class over the past couple of years including Ozempic, Wegovy, Mounjaro, and Zepbound to name a few. These drugs are approved to treat different conditions, including obesity and type 2 diabetes, and are now being tested for treatments far beyond obesity and diabetes. Studies to treat cardiovascular disease, addictive behavior, and rheumatologic diseases are just a few of the ongoing trials. Together, this new class of drugs could lead to sales in the tens of billions of dollars in the upcoming years.

The rapid expansion of this area of technology raises many business and legal questions. We will explore many of these throughout the upcoming articles in this series. These topics include:

1. Issues related to deals and licensing for GLP-1 therapeutics
2. Patent/IP challenges to consider for GLP-1 therapeutics
3. Clinical trial issues for GLP-1 therapeutics
4. FDA/regulatory issues for GLP-1 therapeutics
5. Litigation issues for GLP-1 therapeutics

For additional resources on GLP-1 Drugs and how they will change the health care & life sciences and technology industries, click here to read the other articles in our series.

Foley is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, our Health Care & Life Sciences Sector, or to our Innovative Technology Sector with any questions.