Mounjaro FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 9, 2022.
FDA Approved: Yes (First approved May 13, 2022)
Brand name: Mounjaro
Generic name: tirzepatide
Dosage form: Injection
Company: Eli Lilly and Company
Treatment for: Diabetes, Type 2
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.
- Mounjaro works by activating the body's receptors for GIP and GLP-1, which are natural incretin hormones.
- Mounjaro is administered via subcutaneous injection once weekly.
- Warnings and precautions associated with Mounjaro include pancreatitis; hypoglycemia with concomitant use of insulin secretagogues or insulin; hypersensitivity reactions; acute kidney injury; severe gastrointestinal disease; diabetic retinopathy complications in patients with a history of diabetic retinopathy; and acute gallbladder disease.
- Common adverse reactions include nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.
Development timeline for Mounjaro
|Jul 31, 2023||Tirzepatide demonstrated significant and superior weight loss compared to placebo in two pivotal studies|
|Apr 27, 2023||Lilly's Tirzepatide Achieved up to 15.7% Weight Loss in Adults with Obesity or Overweight and Type 2 Diabetes in SURMOUNT-2|
|Oct 6, 2022||Lilly Receives U.S. FDA Fast Track Designation for Tirzepatide for the Treatment of Adults with Obesity, or Overweight with Weight-Related Comorbidities|
|May 13, 2022||Approval FDA Approves Mounjaro (tirzepatide) Injection for the Treatment of Adults with Type 2 Diabetes|
|Oct 19, 2021||Tirzepatide 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, 2021||Lilly'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, 2021||Lilly'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, 2021||Lilly'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, 2021||Lilly'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, 2021||Lilly'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, 2021||Tirzepatide Achieved Superior A1C and Body Weight Reductions Across All Three Doses Compared to Injectable Semaglutide in Adults with Type 2 Diabetes|
|Feb 17, 2021||Tirzepatide Significantly Reduced A1C and Body Weight in People with Type 2 Diabetes in Two Phase 3 Trials from Lilly's SURPASS Program|
|Dec 9, 2020||Lilly's Tirzepatide Significantly Reduced A1C and Body Weight in People with Type 2 Diabetes|
|Jun 9, 2020||First Patient Dose Delivered for Lilly's Tirzepatide Cardiovascular Outcomes Trial|
|Jun 8, 2019||Lilly's Tirzepatide Demonstrates Benefits in Data Presented at the American Diabetes Association's® 79ᵗʰ Scientific Sessions|
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