FDA Approves Mounjaro to Cut Heart Attack and Stroke Risk in Type 2 Diabetes Patients
The FDA approved Mounjaro (tirzepatide) on August 28, 2026, for a new use: reducing the risk of heart attack, stroke, and cardiovascular death in adults with type 2 diabetes at high cardiovascular risk. The approval was based on the SURPASS-CVOT trial, which involved more than 13,000 participants across 30 countries. Mounjaro is now the first GIP and GLP-1 receptor agonist approved for this indication.
The U.S. Food and Drug Administration approved Mounjaro (tirzepatide) on August 28, 2026, for a new indication: reducing the risk of major cardiovascular events, including heart attack, stroke, and cardiovascular death, in adults with type 2 diabetes who are at high risk for these events.
The approval was based on results from the SURPASS-CVOT trial, described as the largest and longest study of tirzepatide to date. The trial enrolled more than 13,000 participants across 30 countries and ran for approximately five years.
The trial compared Mounjaro against Trulicity (dulaglutide) in patients with type 2 diabetes and established atherosclerotic cardiovascular disease. Over a median follow-up of about four years, the rate of major cardiovascular events was 12.1 percent for Mounjaro patients compared to 13.0 percent for those on Trulicity, an 8 percent lower relative rate.
Mounjaro is now the first GIP and GLP-1 receptor agonist approved to lower the risk of cardiovascular death, heart attack, or stroke in this patient population, in addition to its existing benefits for blood sugar control and weight management.
Medical experts noted that cardiovascular disease is the leading cause of death for people with type 2 diabetes. The new approval gives clinicians an additional tool for addressing that risk.
The safety profile of Mounjaro remained consistent with its previously established profile. Common side effects were primarily gastrointestinal and generally mild to moderate, occurring most often during dose escalation. Existing warnings, including a boxed warning for thyroid C-cell tumors, remain in effect.
Eli Lilly, which manufactures Mounjaro, said the approval reflects the drug's potential to address multiple health risks in a single treatment. The drug is already widely used for blood sugar control and weight loss in people with type 2 diabetes.
