FDA Clears Lilly’s Weekly Insulin Onswik, Challenging Novo’s Awiqli

The FDA approved Eli Lilly’s Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin for adults with type 2 diabetes, on September 24, 2026.

Onswik is intended to be used with diet and exercise to improve blood-sugar control and offers an alternative to daily long-acting insulin injections.

Lilly plans to launch a prefilled Onswik KwikPen in the U.S. in the coming months, in 500 units/mL and 1,000 units/mL concentrations.

The decision was supported by the Phase 3 QWINT program, which included more than 3,400 adults with type 2 diabetes. The trials found the drug non-inferior to daily basal-insulin comparators for glucose control.

The approval intensifies competition with Novo Nordisk, whose once-weekly insulin Awiqli (insulin icodec) was cleared by the FDA in March 2026 and was the first weekly basal insulin available in the U.S.

The products extend the Lilly–Novo rivalry beyond GLP-1 diabetes and obesity medicines into the basal-insulin market. Weekly dosing could reduce the burden of injections substantially—roughly 52 a year rather than daily injections—though treatment selection will still depend on clinical suitability, safety, access, and price.