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Mounjaro FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 12, 2024.

FDA Approved: Yes (First approved May 13, 2022)
Brand name: Mounjaro
Generic name: tirzepatide
Dosage form: Injection
Company: Eli Lilly and Company
Treatment for: Type 2 Diabetes

Mounjaro (tirzepatide) is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Development timeline for Mounjaro

DateArticle
Aug 20, 2024Tirzepatide Reduced the Risk of Developing Type 2 Diabetes by 94% in Adults with Pre-Diabetes and Obesity or Overweight
Jul 31, 2023Tirzepatide Demonstrated Significant and Superior Weight Loss Compared to Placebo in Two Pivotal Studies
Apr 27, 2023Lilly's Tirzepatide Achieved up to 15.7% Weight Loss in Adults with Obesity or Overweight and Type 2 Diabetes in SURMOUNT-2
Oct  6, 2022Lilly Receives U.S. FDA Fast Track Designation for Tirzepatide for the Treatment of Adults with Obesity, or Overweight with Weight-Related Comorbidities
May 13, 2022Approval FDA Approves Mounjaro (tirzepatide) Injection for the Treatment of Adults with Type 2 Diabetes
Oct 19, 2021Tirzepatide Results Published in The Lancet Show Superior A1C and Body Weight Reductions Compared to Insulin Glargine in Adults with Type 2 Diabetes with Increased Cardiovascular Risk
Sep 30, 2021Lilly's Tirzepatide Led to Greater Time in Range Compared to Insulin Degludec in Adults with Type 2 Diabetes in SURPASS-3 CGM Sub-Study
Sep 30, 2021Lilly's Tirzepatide Led to Greater Improvements in Liver Fat Content Compared to Insulin Degludec in Adults with Type 2 Diabetes in SURPASS-3 MRI Sub-Study
Jun 26, 2021Lilly's SURPASS-1 Results Published in The Lancet Show Tirzepatide's Superior A1C and Body Weight Reductions Versus Placebo in Adults with Type 2 Diabetes
Jun 25, 2021Lilly's SURPASS-2 Results Published in The New England Journal of Medicine Show Tirzepatide Achieved Superior A1C and Body Weight Reductions Compared to Injectable Semaglutide in Adults with Type 2 diabetes
May 20, 2021Lilly's Tirzepatide Achieves All Primary and Key Secondary Study Outcomes Against Insulin Glargine in Adults with Type 2 Diabetes and Increased Cardiovascular Risk in SURPASS-4 Trial
Mar  4, 2021Tirzepatide Achieved Superior A1C and Body Weight Reductions Across All Three Doses Compared to Injectable Semaglutide in Adults with Type 2 Diabetes
Feb 17, 2021Tirzepatide Significantly Reduced A1C and Body Weight in People with Type 2 Diabetes in Two Phase 3 Trials from Lilly's SURPASS Program
Dec  9, 2020Lilly's Tirzepatide Significantly Reduced A1C and Body Weight in People with Type 2 Diabetes
Jun  9, 2020First Patient Dose Delivered for Lilly's Tirzepatide Cardiovascular Outcomes Trial
Jun  8, 2019Lilly's Tirzepatide Demonstrates Benefits in Data Presented at the American Diabetes Association's® 79ᵗʰ Scientific Sessions

Further information

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