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

The FDA has approved Mounjaro (tirzepatide) for children 10 years of age and older with type 2 diabetes, extending an indication that had covered only adults ^[1]. The prescribing information's recent-major-changes table dates the pediatric indication to December 2025 ^[1].

Mounjaro is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist ^[1]. It is now indicated as an adjunct to diet and exercise to improve blood sugar control in adults and pediatric patients 10 years of age and older with type 2 diabetes ^[1].

Dosing for children starts the same way as for adults: 2.5 mg injected under the skin once weekly, then 5 mg after four weeks, with further increases of 2.5 mg no sooner than every four weeks if more blood sugar control is needed ^[1][2]. The limit differs. The maximum is 10 mg once weekly for pediatric patients, compared with 15 mg once weekly for adults ^[1][2].

The FDA reviewed the change as a priority supplemental application, NDA 215866/S-039, submitted June 19, 2025, with a goal date of December 19, 2025. The agency's review was completed November 26, 2025, with a recommendation of approval ^[2].

The main evidence came from a trial called SURPASS-PEDS, listed in agency documents as Trial GPGV ^[2][3]. It enrolled 99 patients aged 10 and older with type 2 diabetes who were already taking metformin, basal insulin, or both ^[3]. Participants were randomly assigned to Mounjaro 5 mg weekly, Mounjaro 10 mg weekly, or placebo for 30 weeks ^[3].

Hemoglobin A1c fell by a mean of 2% from baseline across the two Mounjaro doses, a mean difference of 1.8 percentage points compared with placebo ^[3]. BMI fell by a mean of 8.8 kg/m2 from baseline, 8.3 kg/m2 more than with placebo ^[3].

Side effects in children were broadly consistent with those seen in adults, but rates of vomiting, abdominal pain, and hypoglycemia (low blood sugar) appeared to be higher in the pediatric group ^[3]. The label lists nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain as the most common adverse reactions, reported in at least 5% of patients treated with Mounjaro ^[1]. It also warns that using Mounjaro with insulin or an insulin secretagogue such as a sulfonylurea can raise the risk of low blood sugar, including severe episodes, and that reducing the dose of those medicines may be necessary ^[1]. The section on severe gastrointestinal adverse reactions was updated in December 2025 ^[1].

European regulators took the same step. The European Medicines Agency issued an opinion on December 11, 2025, to extend the indication to children and adolescents aged 10 years and older, and the European Commission decision followed on January 22, 2026 ^[5].

Why it matters for patients

Families considering treatment for a child with type 2 diabetes now have a tirzepatide option where the drug was previously approved only for adults ^[1]. Because the pediatric ceiling is 10 mg per week rather than 15 mg, a child's dose cannot be escalated as far as an adult's ^[1][2].

Every participant in the pediatric trial was also taking metformin, basal insulin, or both ^[3]. The label notes that the dose of insulin or an insulin secretagogue may need to be lowered when Mounjaro is added, since that combination carries the highest risk of low blood sugar ^[1].

Gastrointestinal effects were the most frequently reported adverse reactions overall, and vomiting and abdominal pain appeared more often in children than in adults ^[1][3]. The label does not recommend Mounjaro for patients with severe gastroparesis, and it advises monitoring kidney function in patients who have reactions that could cause dehydration ^[1].

Longer-term data in children beyond the 30-week trial period, including effects on growth, puberty, and diabetes complications over time, have not been reported.