FDA Approval Status of Mounjaro (Tirzepatide)
Yes, Mounjaro (tirzepatide) is FDA-approved for the treatment of type 2 diabetes mellitus in adults as an adjunct to diet and exercise to improve glycemic control. 1
Approval Details
- Tirzepatide was approved by the FDA in 2022 for type 2 diabetes management, making it the first dual GIP/GLP-1 receptor co-agonist available for clinical use 2, 1
- The approval covers use as monotherapy or combination therapy across a broad spectrum of patients with type 2 diabetes 1
- Available doses are 5 mg, 10 mg, and 15 mg administered once weekly via subcutaneous injection 1
Clinical Efficacy Supporting Approval
The FDA approval was based on the robust SURPASS 1-5 clinical trial program demonstrating:
- Unprecedented HbA1c reductions of 1.87% to 2.59% (20 to 28 mmol/mol), with 23.0% to 62.4% of patients achieving normoglycemia (HbA1c <5.7%) 2
- Substantial weight loss of 6.2 to 12.9 kg, with 20.7% to 68.4% of patients losing more than 10% of baseline body weight 2
- Superior efficacy compared to semaglutide 1.0 mg (a GLP-1 receptor agonist) and titrated basal insulin in head-to-head trials 2, 1
Safety Profile
- Cardiovascular safety was established with MACE-4 events showing hazard ratios <1.0 versus pooled comparators, with upper confidence interval bounds <1.3 2
- Gastrointestinal side effects (nausea, vomiting, diarrhea, constipation) are the most common adverse events, similar to the GLP-1 receptor agonist class 2, 1
- Low risk of hypoglycemia when used without insulin or insulin secretagogues 1
Current Guideline Recommendations
The American Diabetes Association (2024) includes tirzepatide as a treatment option for type 2 diabetes, noting:
- Tirzepatide has the highest weight loss efficacy among agents approved for glycemic management 3
- Tirzepatide probably reduces severe hypoglycemia compared with insulin (RR 0.21, moderate certainty of evidence) 3
- It should be considered when weight management is a distinct treatment goal alongside glycemic control 3
Important Caveats
- While approved for type 2 diabetes, tirzepatide is also under investigation for chronic weight management, cardiovascular outcomes, heart failure with preserved ejection fraction, and NASH 1, 4
- Not approved for type 1 diabetes, though preliminary observational data suggest potential benefit 5
- The drug's mechanism through dual GIP/GLP-1 receptor agonism represents a novel approach, though questions remain about the specific contribution of GIP receptor activation to its clinical effects 2