FDA approves Mounjaro for children and adolescents 10 and older with type 2 diabetes

The FDA approved a labeling supplement for Mounjaro (tirzepatide) that expands its type 2 diabetes indication to include pediatric patients 10 years of age and older. The approval letter to Eli Lilly and Company is dated December 19, 2025, and covers supplement S-039 to new drug application 215866 ^[1][3].

Mounjaro's indication now reads that the drug is "indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus" ^[4]. Drugs@FDA categorizes the December 19, 2025 action as "Efficacy-New Patient Population" ^[3].

What the approval was based on

Lilly submitted the supplement on June 20, 2025 ^[1]. It rests on trial I8F-MC-GPGV, described by the FDA as "A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study With an Open-Label Extension Assessing the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of Tirzepatide in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, or Basal Insulin, or Both" ^[1].

That study was run to satisfy a postmarketing requirement, PMR 4271-1, that FDA imposed when Mounjaro was first approved on May 13, 2022. The requirement called for a 30-week randomized, double-blind, placebo-controlled study in patients ages 10 to 17, followed by a 22-week open-label extension ^[1]. FDA says the final report was submitted and the requirement "has been fulfilled," while noting that other postmarketing requirements from the 2022 approval letter and a November 29, 2024 letter remain open ^[1]. The specific A1C and other trial results are not included in the source documents reviewed here; the label adds a new clinical studies section (14.5) covering pediatric use with metformin or basal insulin, or both ^[4].

The pediatric dose ceiling is lower

The dosing section now lists two different maximums. Adults can go up to 15 mg subcutaneously once weekly. Pediatric patients 10 years of age and older top out at 10 mg once weekly ^[2][4]. The starting dosage is the same for both groups: 2.5 mg once weekly, increasing to 5 mg after four weeks, with further increases in 2.5 mg steps after at least four weeks on the current dose if more glycemic control is needed. The label states the 2.5 mg dosage is for treatment initiation and is not intended for glycemic control ^[4].

The same supplement also updated three safety sections to match recent changes made to other GLP-1 receptor agonist labels: Acute Pancreatitis (5.2), Acute Kidney Injury Due to Volume Depletion (5.5), and Severe Gastrointestinal Adverse Reactions (5.6) ^[1]. Section 5.6 now says Mounjaro is not recommended in patients with severe gastroparesis ^[4]. The boxed warning about thyroid C-cell tumors seen in rats, and the contraindication for people with a personal or family history of medullary thyroid carcinoma or MEN 2, remain unchanged ^[4].

A date discrepancy worth noting

Some secondary coverage has dated this pediatric approval to February 2026. The FDA's own approval letter is signed December 19, 2025, at 4:52 p.m., and the Drugs@FDA action date for SUPPL-39 is 12/19/2025 ^[1][3]. Where accounts differ, the agency's letter is the primary record.

Why it matters for patients

Before this, Mounjaro's label covered adults only. Families whose children were prescribed tirzepatide were relying on off-label use, which can complicate insurance coverage. An on-label pediatric indication gives prescribers and payers an FDA-reviewed basis for use in 10- to 17-year-olds with type 2 diabetes. Whether individual insurers or Medicaid programs change their coverage rules is not addressed in these documents.

The 10 mg pediatric ceiling is a concrete difference from adult care. A teenager on Mounjaro cannot be titrated to 12.5 mg or 15 mg within the label, even though those strengths exist as single-dose pens and vials ^[3][4].

This approval applies to Mounjaro for type 2 diabetes, not to Zepbound, which is the same molecule marketed for weight management. Nothing in these documents extends a pediatric weight-management indication.

What happens next

Later supplements have continued to change the label. On January 20, 2026, FDA approved labeling and Medication Guide updates (SUPPL-9), and on August 27, 2026, it approved supplements 44 and 45, which added an adult indication to reduce the risk of major adverse cardiovascular events and revised the recommended dosage section ^[2][3][5]. The current DailyMed label was updated August 27, 2026 ^[2].