FDA Approves Lilly's Onswik (Insulin Efsitora Alfa-Gobe), a Once-Weekly Basal Insulin for Adults With Type 2 Diabetes
Eli Lilly announced on Thursday, September 24, 2026 that the FDA approved Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin used with diet and exercise to control blood sugar in adults with type 2 diabetes; it is not for type 1 diabetes because of an increased risk of severe hypoglycemia. Approval rests on four Phase 3 QWINT trials in more than 3,400 adults, in which efsitora met non-inferiority for A1C reduction against daily insulin glargine (QWINT-1, n=795; QWINT-4, n=730) and insulin degludec (QWINT-2, n=928; QWINT-3, n=986). Onswik will come in U-500 and U-1,000 prefilled pens delivering up to 400 and 800 units per injection, and Lilly expects U.S. availability in the coming months. It is already approved in the European Union, Mexico, and Japan.