Overview
- Eli Lilly’s once‑weekly basal insulin Onswik (insulin efsitora alfa‑gobe) won FDA approval on Thursday, Sept. 24, 2026, for use with diet and exercise in adults with type 2 diabetes.
- The approval rests on the QWINT phase 3 program of more than 3,400 participants that showed noninferior reductions in A1C versus once‑daily glargine and degludec.
- In the QWINT‑1 study published in the New England Journal of Medicine, insulin‑naive patients on the fixed once‑weekly dose had similar glucose control and a lower rate of clinically significant or severe hypoglycemia.
- Lilly says Onswik will be offered in prefilled KwikPens in two high concentrations, U‑500 and U‑1000, with U.S. availability expected in the coming months and specified maximum units per injection.
- The clearance makes Onswik the second once‑weekly basal insulin approved in the U.S., sets up direct competition with Novo Nordisk’s Awiqli, prompted an immediate positive market reaction, and could change how people who need basal insulin manage injections and clinic workflows.