FDA approves Lilly's once-weekly basal insulin Onswik for adults with type 2 diabetes

Eli Lilly said on September 24 that the FDA had approved Onswik, or insulin efsitora alfa-gobe, as an adjunct to diet and exercise for glycaemic control in adults with type 2 diabetes. It is a long-acting basal insulin designed for one injection every seven days.

Lilly said the approval was based on four phase-three QWINT studies involving more than 3,400 adults with type 2 diabetes. Onswik's reductions in A1C were non-inferior to once-daily insulin glargine or insulin degludec in each study. Lilly funded the programme; individual risks still require the full prescribing information and clinical assessment.

The company says Onswik should not be used in type 1 diabetes because of an increased risk of severe hypoglycaemia. Common adverse effects include hypoglycaemia, allergic and injection-site reactions, lipodystrophy, itching, rash, swelling and weight gain. People already taking insulin should not switch products or doses without medical guidance.

Onswik KwikPen is expected to become available in the United States in the coming months in 500-unit/mL and 1,000-unit/mL concentrations. Lilly says weekly dosing could eliminate more than 300 injections a year compared with once-daily basal insulin. Onswik had already been approved in Europe, Japan and Mexico.

This is not the first weekly basal insulin approved in the United States: the FDA approved Novo Nordisk's Awiqli in March 2026. Onswik therefore adds another weekly option for U.S. adults with type 2 diabetes.

Verification status: confirmed by Lilly's formal FDA-approval announcement and independent Reuters reporting; the European Medicines Agency was used to cross-check product background. News value: B. Origin region: United States. Primary section: Health. Related region: Worldwide. Source time: September 24, 2026, 11:27 UTC. N Globe report time: September 24, 2026, 13:24 UTC.