The U.S. Food and Drug Administration (FDA) has approved Mounjaro (tirzepatide), a new drug to treat type 2 diabetes. The announcement, issued May 13, said that the new drug would be authorized for adults with type 2 diabetes as a supplement to diet and exercise.

According to the FDA, despite the high number of diabetes medications on the market, many patients struggle to achieve safe blood sugar levels. The agency approved Mounjaro as a first of its class treatment to try to help meet those blood sugar goals. 

Mounjaro is taken by injection once a week and functions by activating receptors for two hormones: Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Both of these hormones help control blood sugar levels in the body, helping keep people with type 2 diabetes in safe blood sugar ranges.

The FDA stated that Mounjaro was more effective than the other diabetes therapies that it was compared to during its clinical trials. These five trials evaluated three dosages of Mounjaro, 5 milligrams, 10 milligrams, and 15 milligrams, as stand-alone therapies or supplements to other treatment methods including a placebo, an approved GLP-1 receptor, and two long-lasting insulin analog drugs. 

In the trials, Mounjaro improved on the performance of its competitors by a factor ranging from 0.5% to 1.6% for lowering the blood sugar-measuring chemical hemoglobin A1c. 

“Given the challenges many patients experience in achieving their target blood sugar goals, today’s approval of Mounjaro is an important advance in the treatment of type 2 diabetes,” said Dr. Patrick Archdeacon, M.D., associate director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research.

Type 2 diabetes is the most common form of diabetes. Of the over 37 million adults with diabetes in the United States, approximately 29 million of them have type 2 diabetes, according to the U.S. Center for Disease Control and Prevention (CDC). Type 2 diabetes is a chronic health condition that occurs when the body does not produce or utilize insulin normally. This leads to elevated levels of sugar in the blood, which can lead to a number of dangerous complications if untreated.