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

The Food and Drug Administration approved Mounjaro (tirzepatide) for children and adolescents 10 years of age and older with type 2 diabetes, according to an approval letter dated December 19, 2025 ^[1]. The action expands an indication that previously covered only adults ^[1][4].

The approval came through supplement S-039 to New Drug Application 215866, which Eli Lilly submitted on June 20, 2025 ^[1]. The FDA approved it effective the date of the letter and concluded that the submission fulfilled postmarketing requirement PMR 4271-1, a pediatric study the agency had requested in Mounjaro's May 13, 2022, approval letter ^[1]. Drugs@FDA lists the supplement with an action date of December 19, 2025, classified as "Efficacy-New Patient Population" ^[3][5]. Some secondary coverage has dated the approval to February 2026, but both the FDA approval letter and the agency's own submission record show December 19, 2025 ^[1][3].

The pediatric study, identified in the letter as trial I8F-MC-GPGV, was a randomized, double-blind, placebo-controlled Phase 3 trial in pediatric and adolescent patients with type 2 diabetes that was not adequately controlled with metformin, basal insulin, or both ^[1]. PMR 4271-1 specified a 30-week randomized trial in patients ages 10 to 17, followed by a 22-week open-label extension ^[1]. The approval letter does not report the trial's results, such as changes in blood sugar or weight ^[1].

The label sets a different ceiling for children than for adults. Adults can be escalated to a maximum of 15 mg injected once weekly; for pediatric patients 10 and older, the maximum is 10 mg once weekly ^[1][2][4]. Both groups begin at 2.5 mg once weekly, can move to 5 mg after four weeks, and can then increase by 2.5 mg increments after at least four weeks at the current dose ^[2][4].

The approval also updated three safety sections of the label — acute pancreatitis, acute kidney injury due to volume depletion, and severe gastrointestinal adverse reactions — to align Mounjaro with recent labeling changes for other GLP-1 receptor agonists ^[1]. The boxed warning is unchanged: tirzepatide caused thyroid C-cell tumors in rats, and it is unknown whether it causes such tumors, including medullary thyroid carcinoma, in humans ^[2][4]. Mounjaro is contraindicated in people with a personal or family history of that cancer or with Multiple Endocrine Neoplasia syndrome type 2 ^[2][4]. The most common side effects, reported in at least 5% of patients, are nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia and abdominal pain ^[2][4].

Why it matters for patients

For families managing type 2 diabetes in a child, the change means the drug is now part of the FDA-labeled options for that age group, a status that often shapes prescribing, pharmacy dispensing and insurance review ^[1][2]. The labeled pediatric maximum is lower than the adult maximum, so a child's regimen is not simply an adult's regimen scaled down ^[1][2][4].

The evidence behind the approval covers roughly a year of treatment — 30 weeks of randomized treatment plus a 22-week extension ^[1]. Safety and effectiveness beyond that period in children have not been reported ^[1]. The label also advises females of reproductive potential who use oral contraceptives to switch to a non-oral method or add a barrier method for four weeks after starting the drug and after each dose increase ^[2][4].

What happens next

Within 14 days of the letter, Lilly must submit the label content in structured product labeling format through the FDA's drug registration and listing system ^[1]. Other postmarketing requirements listed in the May 13, 2022, approval letter and in a November 29, 2024, letter remain open, the agency said ^[1]. Whether insurers will cover Mounjaro for pediatric patients, and how the drug will be priced for that group, has not been disclosed ^[1].