FDA Expands Mounjaro (Tirzepatide) Approval to Children 10 Years and Older With Type 2 Diabetes

The FDA has approved a supplemental application expanding Mounjaro (tirzepatide) for pediatric patients 10 years of age and older with type 2 diabetes mellitus. The FDA pediatric labeling record lists the Mounjaro pediatric change on December 19, 2025, and the agency approval letter for the supplement documents the action.

Mounjaro is a dual GIP and GLP-1 receptor agonist that was already approved before this action. The December 19, 2025 decision was, therefore, a label expansion of an existing peptide drug, not a new drug approval, and the revised label reflects the expanded patient population stated above.

The record for this expansion rests on the FDA pediatric labeling list and the FDA approval letter. The indication is reported here only as a regulatory fact: the product name, the labeled population, and the approval date, as the FDA record states them.

As with every FDA approval, the decision applies to the specific product, Mounjaro, and the specific indication on its label. It does not extend to compounded formulations, research compounds, or any other use of the molecule, and the approval of one product never approves the molecule in general.