Mounjaro approved for children 10 and older with type 2 diabetes

The FDA has approved Mounjaro (tirzepatide) as an add-on to diet and exercise to improve blood sugar control in children 10 years of age and older with type 2 diabetes. The prescribing information now lists the indication as covering "adults and pediatric patients 10 years of age and older," and the label's Recent Major Changes table dates the pediatric indication to 12/2025 ^[1][4].

The approval came through a supplemental new drug application, NDA 215866/S-039, that Eli Lilly submitted on June 19, 2025. The FDA granted it priority review, set a PDUFA goal date of December 19, 2025, and completed its review on November 26, 2025, recommending approval of the indication and dosing regimen as proposed ^[2].

What the label says about dosing

The starting dose is the same for everyone: 2.5 mg injected under the skin once weekly, increased to 5 mg after four weeks, then in 2.5 mg steps after at least four weeks on the current dose if more glucose control is needed ^[1]. The ceiling is where children and adults differ. The maximum is 15 mg once weekly in adults but 10 mg once weekly in pediatric patients ^[1][4]. The label also notes that the 2.5 mg dose is for starting treatment and is not intended for glycemic control ^[1].

A later version of the label adds that the MOUNJARO KwikPen, a single-patient-use multi-dose pen, is not recommended for self-administration by pediatric patients ^[4]. That same later label also reflects an August 2026 addition of a cardiovascular indication for adults, which is separate from the pediatric change ^[4].

The trial behind the decision

The approval rests on SURPASS-PEDS, a randomized, double-blind, placebo-controlled phase 3 trial published in The Lancet ^[3]. According to a summary from the Pediatric Endocrine Society's Drugs and Therapeutics Committee, the trial enrolled 99 patients aged 10 and older with type 2 diabetes who were already taking metformin, basal insulin, or both. Participants were randomized to tirzepatide 5 mg weekly, tirzepatide 10 mg weekly, or placebo for 30 weeks ^[3].

Pooled across both tirzepatide doses, A1C fell by a mean of 2 percentage points from baseline, a mean difference of –1.8 percentage points versus placebo ^[3]. BMI also dropped significantly from baseline, reported as a mean reduction of 8.8 kg/m2 and a mean difference of –8.3 kg/m2 versus placebo ^[3]. The FDA review lists the same endpoints — change in A1C at week 30, the share of patients reaching an A1C of 6.5% or lower, change in BMI and BMI standard deviation score, and change in fasting serum glucose — but the numeric tables were not included in the text available here ^[2].

On safety, side effects in children were broadly consistent with what has been seen in adults, but rates of vomiting, abdominal pain and hypoglycemia appeared higher in the pediatric group ^[3]. The label's boxed warning about thyroid C-cell tumors in rats, and the contraindication for anyone with a personal or family history of medullary thyroid carcinoma or MEN 2, apply to all ages ^[1]. The label also warns that using tirzepatide with insulin or an insulin secretagogue can raise the risk of hypoglycemia, including severe hypoglycemia, and that the dose of those other drugs may need to be reduced ^[1].

Why it matters for patients

Until now, families of children with type 2 diabetes had a short list of approved drug options; the FDA review includes an appendix cataloging approved antihyperglycemics for pediatric type 2 diabetes ^[2]. This change adds a once-weekly injection to that list, with a defined 10 mg pediatric ceiling written into the label rather than left to case-by-case judgment.

The evidence base is small — 99 patients over 30 weeks ^[3]. Longer-term effects in children, insurance coverage, cost, and how many pediatric clinicians will prescribe it are not addressed in these documents. The GI and hypoglycemia signals appearing more often in children than adults is the practical safety point families and clinicians will be weighing ^[3].

What happens next

In Europe, the EMA accepted an extension of the Mounjaro indication to children and adolescents aged 10 years and older based on the same SURPASS-PEDS study, with an opinion issued 11/12/2025 and a European Commission decision dated 22/01/2026 ^[5]. The US label continues to be revised for unrelated reasons, including updates dated 01/2026 and 08/2026 ^[4].