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Onswik ™ (insulin efsitora alfa-gobe) injection
500 units/mL (U-500), 1,000 units/mL (U-1,000)
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Was ONSWIK™ (insulin efsitora alfa-gobe) studied in pediatric patients?
No data is available on the use of efsitora in pediatric patients as participants were required to be over 18 years of age to be considered for the phase 3 efsitora clinical trial program.
Pediatric use in the prescribing information
Safety and effectiveness of insulin efsitora alfa-gobe have not been established in pediatric patients.1
Insulin efsitora alfa-gobe is not recommended for use in pediatric patients with type 1 diabetes mellitus due to increased risk of severe hypoglycemia.1
Clinical Trial Information
There is no data on the use of efsitora in pediatric patients as they were excluded from all phase 3 QWINT studies which assessed the efficacy and safety of efsitora as treatment for patients with diabetes.2-6
The inclusion criteria for the QWINT studies required participants to be 18 years or older.2-6
Enclosed Prescribing Information
ONSWIK™ (insulin efsitora alfa-gobe) injection, for subcutaneous use, Lilly
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
- ONSWIK [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
- Rosenstock J, Bailey T, Connery L, et al; QWINT-1 Trial Investigators. Weekly fixed-dose insulin efsitora in type 2 diabetes without previous insulin therapy. N Engl J Med. 2025;393(4):325-335. https://doi.org/10.1056/NEJMoa2502796
- Wysham C, Bajaj HS, Del Prato S, et al; QWINT-2 Investigators. Insulin efsitora versus degludec in type 2 diabetes without previous insulin treatment. N Engl J Med. 2024;391(23):2201-2211. https://www.nejm.org/doi/full/10.1056/NEJMoa2403953
- Philis-Tsimikas A, Bergenstl RM, Bailey TS, et al. Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 2 diabetes currently treated with basal insulin (QWINT-3): a phase 3, randomised, non-inferiority trial. Lancet. 2025;405(10497):2279-2289. https://doi.org/10.1016/S0140-6736(25)01044-X
- Blevins T, Dahl D, Pérez Manghi FC, et al. Once-weekly insulin efsitora alfa versus once-daily insulin glargine U100 in adults with type 2 diabetes treated with basal and prandial insulin (QWINT-4): a phase 3, randomised, non-inferiority trial. Lancet. 2025;405(10497):2290-2301. https://doi.org/10.1016/S0140-6736(25)01069-4
- Bergenstal RM, Weinstock RS, Mathieu C, et al. Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 1 diabetes (QWINT-5): a phase 3 randomised non-inferiority trial. Lancet. 2024;404(10458):1132-1142. https://doi.org/10.1016/S0140-6736(24)01804-X
Date of Last Review: January 08, 2026