Eli Lilly and Company announced US FDA approval of Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin indicated alongside diet and exercise to improve glycemic control in adults with type 2 diabetes. Lilly said the weekly formulation is designed to maintain basal insulin coverage for seven days and could reduce the number of injections by more than 300 per year compared with once-daily basal insulin.
The approval was supported by the QWINT Phase III program, which enrolled more than 3,400 adults with type 2 diabetes across four randomized studies — QWINT-1 (NCT05662332), QWINT-2 (NCT05362058), QWINT-3 (NCT05275400), and QWINT-4 (NCT05462756). Across the program, once-weekly efsitora met the primary endpoint of non-inferior A1C reduction compared with once-daily insulin glargine U-100 or insulin degludec U-100, with week 52 assessments in insulin-naïve patients and week 26 assessments in patients already receiving basal insulin. Lilly said the overall safety profile was similar to the daily basal insulins studied, with hypoglycemia among the most common adverse events.
The Onswik KwikPen will be available in the US in two concentrations, 500 units/mL and 1,000 units/mL. The drug should not be used in people with type 1 diabetes because of an increased risk of severe hypoglycemia.
Insulin efsitora alfa-gobe is an engineered Fc-fusion protein that combines a modified single-chain insulin with a human IgG2 Fc domain, producing a prolonged pharmacokinetic profile suitable for once-weekly basal insulin delivery. The EU's Committee for Medicinal Products for Human Use issued a positive opinion in June 2026, and Onswik has also received approvals in Japan and Mexico.