Mounjaro (tirzepatide) has been on the market since May 13, 2022, when it was approved by the Food and Drug Administration.
It was first approved to help adults with type 2 diabetes manage their blood sugar levels along with diet and exercise. Tirzepatide was the first glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist approved for this use.
In November 2023, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) approved Mounjaro for weight loss and weight management in the United Kingdom. However, the FDA did not approve it for this use in the United States. Instead, they approved Zepbound, a drug containing the same active ingredient as Mounjaro (tirzepatide), for weight management in the U.S.
In December 2025, the FDA updated Mounjaro’s prescribing rules in the U.S. Now, doctors can prescribe the drug for type 2 diabetes to children ages 10 and older.
Mounjaro’s Approval Timeline
- May 13, 2022: The FDA approves Mounjaro for adults with type 2 diabetes in the U.S.
- November 8, 2023: The UK’s MHRA authorizes the drug for weight management and weight loss.
- December 2025: The FDA expands Mounjaro’s use to include children ages 10 years and older with type 2 diabetes.
Despite its relatively short time on the market, Mounjaro has established itself as a powerful tool for treating type 2 diabetes and obesity.
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