FDA approves Mounjaro for type 2 diabetes in children 10 and older
Mounjaro is now FDA-approved for type 2 diabetes in children 10 and older, a change that moves pediatric use inside the drug's label and closes a 2022 study requirement.
Eli Lilly's supplemental new drug application for Mounjaro (tirzepatide) injection has been approved, expanding the drug's type 2 diabetes indication to include children aged 10 years and older [1]. The FDA received the supplement, NDA 215866/S-039, on June 20, 2025, and the approval letter was signed December 19, 2025 [1].
The supplement updates Mounjaro's Prescribing Information and Medication Guide based on results from a trial called I8F-MC-GPGV [1]. The letter describes that study as a randomized, double-blind, placebo-controlled Phase 3 trial with an open-label extension, assessing the efficacy, safety, and pharmacokinetics/pharmacodynamics of tirzepatide in pediatric and adolescent participants with type 2 diabetes that was inadequately controlled with metformin, or basal insulin, or both [1].
How many patients were enrolled, what the trial found, and how much blood sugar control changed are not reported in the approval letter. Those results have not been disclosed there.
The study was run to satisfy a postmarketing requirement, PMR 4271-1, attached to Mounjaro's May 13, 2022, approval [1]. That requirement asked Lilly to conduct a 30-week, randomized, double-blind, placebo-controlled, multicenter, parallel-arm study of tirzepatide's safety and efficacy in pediatric patients ages 10 to 17 with type 2 diabetes, followed by a 22-week open-label extension [1]. The FDA concluded the requirement "has been fulfilled" [1]. Postmarketing requirements listed in the 2022 approval letter and in a November 29, 2024, new postmarketing requirement letter remain open, the agency said [1].
The supplement adds pediatric information under both the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act [1]. The letter was signed by John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA's Center for Drug Evaluation and Research [1].
The labeling change was not limited to the pediatric indication. The letter says three Warnings and Precautions sections were updated to align with recent changes to the labeling of other glucagon-like peptide-1 receptor agonists: acute pancreatitis (section 5.2), acute kidney injury due to volume depletion (5.5), and severe gastrointestinal adverse reactions (5.6) [1].
Mounjaro contains tirzepatide, the same active ingredient sold under the brand name Zepbound. The approved dose for children, and how it compares with the adult dose, is not described in the approval letter [1].
Why it matters for patients
The FDA action puts pediatric use of Mounjaro inside the drug's approved labeling for the first time, for patients 10 and older with type 2 diabetes [1]. Before this supplement, the indication covered adults; pediatric prescribing would have been an off-label decision by a clinician. Whether insurers and pharmacy benefit managers will change coverage or prior authorization criteria for children is not addressed in the approval letter.
The revised warnings apply to everyone taking Mounjaro, not only children. The Medication Guide and Prescribing Information now carry updated language on pancreatitis, kidney injury from volume depletion, and severe gastrointestinal reactions [1]. Families reading those documents may notice wording aligned with other GLP-1 receptor agonist labels rather than language specific to this drug.
Two important questions are unanswered in the approval letter: the size of the trial and what it showed. A reader cannot tell from the letter how many children received tirzepatide, how many received placebo, what the average change in blood sugar was, or what side effects occurred. Those details would normally appear in the trial publication or the full prescribing information, which the letter refers to as an enclosure but does not summarize [1].
The FDA also noted that other postmarketing requirements for Mounjaro, listed in the 2022 approval letter and a November 2024 letter, are still open [1].
What happens next
Within 14 days of the letter, Lilly must submit the content of labeling in structured product labeling format and amend any pending supplements that include labeling changes for this application [1]. Within 30 days of approval, the company must submit patent information for listing in the Orange Book [1]. Final promotional materials and the Prescribing Information must be filed with the FDA on Form FDA 2253 at the time of first publication [1]. The open postmarketing requirements from 2022 and 2024 remain outstanding [1].
Sources
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