Lilly Announces New Heart-Risk Approval for Mounjaro in Type 2 Diabetes
Updated 23 September 2026
What Is Happening
Eli Lilly announced that the U.S. Food and Drug Administration had approved an additional use for Mounjaro, the weekly tirzepatide injection made by Lilly. The new use is to reduce the risk of heart attack, stroke or cardiovascular death in adults with type 2 diabetes who are at high risk of these events.
The FDA is the regulator deciding which uses may be included in the medicine’s approval. Lilly develops and sells Mounjaro. The decision expands what the existing medicine is approved to treat, rather than introducing a new drug.
Mounjaro was already approved to help control blood sugar. Type 2 diabetes impairs the body’s ability to use insulin effectively and can raise the risk of heart and circulation problems.
Lilly said the approval drew on a study of more than 13,000 people comparing Mounjaro with Trulicity, another diabetes medicine with established heart benefits. Mounjaro met the trial’s test for comparable protection. The study did not establish that Mounjaro prevented these events better than Trulicity.
Sources (1)
Companies Involved
Eli Lilly
Eli Lilly develops and manufactures medicines for diabetes, obesity, cancer and other diseases.
Mentioned In
GLP-1 Market Monitor
Active companies
