The US Food and Drug Administration (FDA) has granted approval for the use of the type 2 diabetes drug tirzepatide in chronic weight management. This move formalizes the usage of a medication that has been widely prescribed off-label for weight loss. The diabetes drug, originally known as Mounjaro, will now be marketed as Zepbound for weight loss, as confirmed by the FDA in a recent news release. Manufactured by Eli Lilly, tirzepatide belongs to a new class of drugs that includes semaglutide, known as Ozempic for diabetes and Wegovy for weight loss, both of which have gained significant popularity in recent years.
Clinical trials have demonstrated that Zepbound can lead to an average weight loss of over 20% on higher doses over a 72-week period, surpassing the results of other approved medications. The FDA has cleared its use for individuals with obesity or those categorized as overweight with at least one weight-related health condition, such as high blood pressure or heart disease—this aligns with the indications for Wegovy. Similar to other drugs in its class, Zepbound is administered through a weekly self-administered injection, and it is recommended in conjunction with a reduced-calorie diet and increased physical activity.
Dr. John Sharretts, the FDA’s Director of the Division of Diabetes, Lipid Disorders, and Obesity, highlighted the seriousness of obesity and overweight conditions, which are associated with leading causes of death like heart disease, stroke, and diabetes. The FDA’s decision addresses an unmet medical need, especially considering the rising rates of obesity and overweight individuals in the United States.