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

The U.S. Food and Drug Administration has approved a new indication for Mounjaro (tirzepatide), Eli Lilly's widely prescribed diabetes drug, clearing it to reduce the risk of heart attack, stroke, and cardiovascular death in certain adults with type 2 diabetes.

Lilly announced the approval on August 28, 2026. Mounjaro was originally approved in May 2022 as an add-on to diet and exercise to improve blood sugar control in adults and children 10 and older with type 2 diabetes, working by activating the body's GIP and GLP-1 incretin hormone receptors. The FDA added the cardiovascular indication based on the SURPASS-CVOT trial. Mounjaro remains one of Lilly's leading brand-name diabetes treatments, and the same active ingredient is sold as Zepbound for chronic weight management.

Clinical backing

The approval rests on SURPASS-CVOT, described by Lilly as the first head-to-head cardiovascular outcomes trial comparing two incretin therapies rather than testing a drug against placebo. The trial randomized 13,299 adults with type 2 diabetes and established cardiovascular disease to either Mounjaro, dosed up to 15 mg weekly, or Trulicity (dulaglutide) 1.5 mg weekly, and followed patients for a median of about four years.

Cardiovascular death, non-fatal heart attack, or non-fatal stroke occurred in 12.1% of Mounjaro patients versus 13.0% of those on dulaglutide — an 8% relative reduction that proved the drugs were comparable ("non-inferior"), though not that Mounjaro was outright superior. Death from any cause occurred in 8.5% of the Mounjaro group compared with 10.1% of the dulaglutide group, though that was an exploratory finding, not a primary endpoint. Lilly also reported that Mounjaro slowed decline in kidney function versus Trulicity among patients at high risk of chronic kidney disease.

The competitive landscape and market share

Mounjaro's new indication puts it in a small group of type 2 diabetes drugs also approved to cut cardiovascular risk. Market-share figures vary depending on how analysts define the market — combined GLP-1 category versus individual diabetes-drug sales — so the numbers below should be read as approximate:

• Ozempic (semaglutide), Novo Nordisk — The category leader by revenue. One market analysis put Ozempic's share of the global GLP-1 diabetes-drug market at roughly 32% as of 2024, with 2026 global sales estimated near $24.5 billion. Novo Nordisk's full semaglutide portfolio (Ozempic, Wegovy, Rybelsus, and Saxenda) has been estimated at more than half of the total GLP-1 market. Ozempic gained its own cardiovascular indication in 2020, based on the SUSTAIN 6 trial, which showed a 26% relative risk reduction versus placebo.

• Mounjaro / tirzepatide franchise, Eli Lilly — Mounjaro and its sister drug Zepbound have been projected to generate more than $45 billion combined in global sales in 2026, which analysts say could make tirzepatide the best-selling drug in the world this year. Mounjaro's revenue growth has significantly outpaced Ozempic's in percentage terms, even though Ozempic still holds the larger current dollar share.

• Trulicity (dulaglutide), Eli Lilly — Once the top-selling diabetes drug by revenue, Trulicity generated roughly $7 billion in sales in 2023, though its U.S. revenue has been declining as prescribers shift toward Mounjaro. It was approved for cardiovascular risk reduction in 2020 and served as the comparator drug in Mounjaro's SURPASS-CVOT trial.

• Jardiance (empagliflozin), Boehringer Ingelheim/Eli Lilly, Farxiga (dapagliflozin), AstraZeneca, and Invokana (canagliflozin), Johnson & Johnson — These SGLT2 inhibitors compete more on kidney- and heart-failure-related indications than head-to-head with GLP-1s. Jardiance has captured a substantial share of nephrology prescribing for diabetic kidney disease, and Farxiga has continued to expand into heart-failure indications, though precise, consistently defined market-share figures for this group are harder to pin down than for the GLP-1 drugs.

Side effects and safety

The most commonly reported adverse events were gastrointestinal — nausea, diarrhea, and vomiting — generally mild-to-moderate and occurring during dose increases. About 13.3% of Mounjaro patients discontinued treatment due to side effects, compared with 10.2% on Trulicity.

Mounjaro carries a boxed warning for thyroid C-cell tumors; people with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 should not take it. Other serious risks include pancreatitis, severe gastrointestinal events, low blood sugar, and kidney and gallbladder problems, along with an increased aspiration risk during surgery or sedation due to delayed stomach emptying.

Lilly says patients already on Mounjaro don't need to do anything differently — the new approval doesn't change existing prescriptions or dosing, but it may shape how physicians choose among these competing drugs and how insurers structure coverage going forward.