Onswik (insulin efsitora alfa-gobe)

Sept. 24, 2026: Eli Lilly and Company announced FDA approval of Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin indicated with diet and exercise to improve glycemic control in adults with type 2 diabetes. The approval was based on the Phase 3 QWINT program, which enrolled more than 3,400 adults across four registration studies.

Across QWINT-1, -2, -3, and -4, once-weekly efsitora met the primary endpoint of non-inferior A1C reduction versus once-daily insulin glargine U-100 or insulin degludec U-100; Lilly said the overall safety profile was similar to the daily basal insulins studied. QWINT-1 and QWINT-2 were 52-week trials in insulin-naïve adults; QWINT-3 studied adults already on basal insulin and assessed A1C non-inferiority at week 26; QWINT-4 evaluated adults previously treated with basal plus mealtime insulin and also assessed A1C non-inferiority at week 26.

Lilly said this is the fourth global approval for Onswik, following regulatory actions from the EMA, Mexico’s COFEPRIS, and Japan’s PMDA. The Onswik KwikPen will be available in the U.S. in the coming months in U-500 and U-1,000 concentrations.