The FDA has expanded the US label for Eli Lilly’s Mounjaro (tirzepatide) to include reducing cardiovascular risk in adults with type 2 diabetes — a milestone for the drug and for its dual GIP/GLP-1 mechanism.
The expansion is backed by the SURPASS-CVOT trial, in which Mounjaro reduced the combined risk of cardiovascular death, heart attack, or stroke by 8% compared with Trulicity (dulaglutide), an established GLP-1 drug. It is the first GIP/GLP-1-targeting therapy approved for this cardiovascular indication in the US.
A blockbuster gets bigger
Mounjaro recently became the world’s top-selling prescription medicine, with Q2 2026 sales of $9.9 billion (up 91% year over year). Adding a cardiovascular claim strengthens its case with physicians and payers in type 2 diabetes, where heart disease is the leading cause of death. Novo Nordisk’s Wegovy (a GLP-1-only drug) won a similar approval in 2024.
Why it matters
“Mitigating cardiovascular risk is essential and can be overlooked” in type 2 diabetes, said Duke endocrinologist David D’Alessio. A label that pairs strong glucose and weight effects with proven heart benefit makes the drug harder to displace — in a GLP-1 market projected to top $125 billion by 2033.