Is Mounjaro Approved for Children?
No, Mounjaro (tirzepatide) is not approved for use in children or adolescents under 18 years of age. The medication is currently approved only for adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control 1, 2.
Current FDA Approval Status
- Tirzepatide received its first FDA approval in May 2022 exclusively for adults with type 2 diabetes mellitus 2.
- The approval is specifically limited to adult populations, with no pediatric indication included in the initial or subsequent approvals 1, 2.
- All phase III SURPASS clinical trials that led to FDA approval enrolled only adult patients, providing no safety or efficacy data for pediatric populations 1, 3.
Absence of Pediatric Data
- No clinical trials have been conducted in children or adolescents to establish the safety, efficacy, or appropriate dosing of tirzepatide in pediatric populations 1, 3.
- The mechanism of action involves dual GIP/GLP-1 receptor agonism, which has not been studied in developing pediatric patients 4.
- Unlike some other diabetes medications that have established pediatric dosing (such as metformin for children ≥10 years or lamivudine for children ≥3 years), tirzepatide has no such pediatric formulations or dosing guidelines 5.
Clinical Implications
- Tirzepatide should not be prescribed to patients under 18 years of age, as there is no evidence supporting its use in this population and it falls outside FDA-approved indications 1, 2.
- For pediatric type 2 diabetes management, established first-line options include lifestyle modifications followed by metformin, which has been studied and approved for use in children 5.
- The lack of pediatric approval contrasts with some other antiviral and metabolic medications that have specific pediatric formulations and age-based dosing (such as oseltamivir approved for children ≥1 year or entecavir for children ≥2 years) 5.
Future Considerations
- Eli Lilly is developing tirzepatide for multiple indications including obesity, but current development programs have not included pediatric populations 2.
- Until dedicated pediatric clinical trials are conducted demonstrating safety and efficacy, and regulatory approval is obtained for pediatric use, tirzepatide remains contraindicated in children 1, 2.