Tirzepatide approved for kids

Mounjaro, Eli Lilly’s tirzepatide shot, is now cleared for children ages 10 and older with type 2 diabetes in the U.S. and U.K. (accessdata.fda.gov) (pharmaceutical-journal.com) The U.S. label was updated in December 2025, adding “pediatric patients 10 years of age and older” to the indication for improving glycemic control with diet and exercise. The prescribing information sets a maximum weekly dose of 10 mg for pediatric patients, versus 15 mg for adults. (accessdata.fda.gov) In Europe, the European Medicines Agency’s drug committee issued a positive opinion on December 11, 2025 for Mounjaro in adults, adolescents and children age 10 and up with insufficiently controlled type 2 diabetes. The U.K.’s updated product information was published on April 9, 2026, according to The Pharmaceutical Journal. (ema.europa.eu) (pharmaceutical-journal.com) Tirzepatide works by mimicking two gut hormones, GIP and GLP-1, that help the body release insulin and reduce appetite. Mounjaro is approved for diabetes, while the same drug is sold separately as Zepbound for obesity in adults in the U.S. (accessdata.fda.gov) (ema.europa.eu) The pediatric diabetes approval does not mean tirzepatide is approved for obesity in children. A separate phase 3 obesity study in adolescents, SURMOUNT-ADOLESCENTS-2, is still recruiting and lists primary completion in October 2027. (clinicaltrials.gov) The pediatric diabetes decision was based on SURPASS-PEDS, a phase 3 trial in patients ages 10 to under 18 whose diabetes was not adequately controlled with metformin, basal insulin, or both. Lilly said in September 2025 that tirzepatide reduced hemoglobin A1c by an average of 2.2 percentage points in that study. (investor.lilly.com) (thelancet.com) The safety picture in children looked similar to what doctors already see in adults, with gastrointestinal side effects such as nausea, vomiting and diarrhea featuring prominently in the label and trial reports. The drug also carries a boxed warning about thyroid C-cell tumors seen in rats and is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. (accessdata.fda.gov) (medical.lilly.com) For families and pediatric endocrinologists, the immediate change is narrower than the headlines suggest: tirzepatide can now be prescribed for type 2 diabetes starting at age 10, but pediatric obesity use remains under study. (accessdata.fda.gov) (clinicaltrials.gov)