FDA Approves Mounjaro (Tirzepatide) to Reduce Cardiovascular Risk in Adults With Type 2 Diabetes

On August 28, 2026, Eli Lilly announced that the FDA had approved Mounjaro (tirzepatide) to lower the risk of major adverse cardiovascular events in adults with type 2 diabetes who are at high risk for these events. Lilly defined those events as cardiovascular death, non-fatal heart attack, or non-fatal stroke. Reuters reported the approval on the same day.

No FDA press announcement for this label expansion was found in the research record. The account, therefore, rests on the sponsor announcement and on Reuters reporting, and it is presented that way here.

Lilly said the approval was based on the SURPASS-CVOT cardiovascular outcomes trial. In that trial, tirzepatide was non-inferior to dulaglutide. Non-inferiority is the result Lilly reported, and this post does not claim superiority over dulaglutide.

This was a label expansion of an already approved product, not a new drug approval. On the same calendar date, August 28, 2026, the FDA also approved MIMRYLO (rusfertide), which is covered in a separate post. The two actions are different decisions for different products and must not be merged.

As with every FDA approval, the decision applies to the specific product, Mounjaro, and the specific indication on its label. It does not extend to compounded formulations, research compounds, or any other use of tirzepatide.