FDA approves once-weekly basal insulin efsitora (Onswik) for adults with type 2 diabetes

The U.S. Food and Drug Administration has approved insulin efsitora alfa-gobe (Onswik, Eli Lilly) as a once-weekly injectable basal insulin, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The approval was reported on 24 September 2026. It is the second weekly basal insulin after Novo Nordisk’s insulin icodec (Awiqli), approved in March. Lilly says the product is designed to cut more than 300 injections a year compared with daily basal insulin.

Evidence from phase 3

Support comes from the QWINT phase 3 program, which enrolled more than 3,400 adults across four international trials. Lilly and coverage of the program report noninferior A1c reduction versus daily insulin glargine U-100 and insulin degludec U-100, with a similar safety profile. In QWINT-1, published in the New England Journal of Medicine, fixed-dose efsitora in insulin-naive type 2 diabetes was comparable to daily glargine, with a rate ratio of 0.57 for clinically significant or severe hypoglycemia.

Onswik is expected in the United States in the coming months in prefilled pens at U-500 and U-1000 strengths. Prior approvals include the EMA, Mexico and Japan.

Important limitations

Onswik is not indicated for type 1 diabetes: safety and efficacy have not been established in that population, and there is an increased risk of severe hypoglycemia. The phase 3 program studied adults with type 2 diabetes. This article summarises regulatory and clinical-trial reporting; it is not personal medical advice. Decisions about insulin therapy belong with a clinician who knows the individual patient.

Why it matters

A once-weekly basal option may reduce injection burden for some adults with type 2 diabetes who need basal insulin, but labeling, hypoglycemia risk and individual suitability still require clinical judgment.