HEADLINE SCIENCE
[Sept 14, 2026] - On August 28, 2026, the FDA expanded the indication for Mounjaro (tirzepatide), approving the dual GIP/GLP-1 receptor agonist to reduce the risk of major adverse cardiovascular events—including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke—in adults with type 2 diabetes at high cardiovascular risk. The decision makes tirzepatide the first dual GIP/GLP-1 receptor agonist with an FDA-approved cardiovascular risk-reduction indication.
The approval is supported by results from the SURPASS-CVOT trial, which enrolled more than 13,000 adults across 30 countries and followed participants for more than four years. Tirzepatide demonstrated noninferiority to the GLP-1 receptor agonist dulaglutide (Trulicity), with an 8% lower rate of major cardiovascular events. Importantly, superiority to dulaglutide for MACE was not established. The expanded indication further shifts the clinical role of incretin-based therapies beyond glucose control and weight management toward broader cardiometabolic risk reduction.
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For further details, please refer to: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215866Orig1s044%2C215866Orig1s045ltr.pdf
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