Eli Lilly gains FDA approval for Onswik once-weekly insulin in US diabetes market

USA—Eli Lilly and Company has secured US Food and Drug Administration (FDA) approval for Onswik, a once-weekly basal insulin for adults with type 2 diabetes (T2D), expanding treatment options while reducing insulin injection frequency.

The FDA approved Onswik on September 23 for use alongside diet and exercise to improve glycemic control.

Clinical evidence supports approval

The approval is based on Lilly’s QWINT Phase III clinical programme, which evaluated insulin efsitora alfa-gobe in more than 3,400 adults with T2D across four registration studies.

According to Lilly, Onswik met the primary endpoint in each trial by achieving non-inferior reductions in glycated haemoglobin (A1C) compared with daily insulin glargine U-100 or insulin degludec U-100.

The programme included people starting basal insulin for the first time as well as those already receiving basal insulin.

QWINT-1 enrolled 795 participants in Argentina, Mexico and the US, while QWINT-2 included 928 participants across 11 countries and territories.

QWINT-3 enrolled 986 participants across 10 countries and territories, and QWINT-4 included 730 participants in eight countries and territories.

QWINT-1 compared once-weekly efsitora with insulin glargine in insulin-naive adults, while QWINT-2 and QWINT-3 compared it with insulin degludec in different patient populations.

QWINT-4 evaluated efsitora against insulin glargine in people already receiving basal and mealtime insulin, with both treatment groups also using insulin lispro.

Lilly reported that the overall safety profile observed in the trials was similar to that of the daily basal insulins used as comparators.

Reported common adverse effects include hypoglycaemia, allergic reactions, injection-site reactions, lipodystrophy, itching, rash, swelling of the hands and feet, and weight gain.

Weekly dosing expands insulin options

Onswik is designed to provide basal insulin coverage over seven days.

The FDA states that it should not be used in people with type 1 diabetes because of the risk of severe hypoglycaemia. It is administered subcutaneously once a week on the same day each week.

Kenneth Custer, executive vice-president and president of Lilly Cardiometabolic Health, said the burden associated with daily insulin injections can affect patients’ experience of managing T2D.

He said Onswik provides another once-weekly basal insulin option and greater flexibility in treatment schedules.

Lilly plans to introduce the Onswik KwikPen in the US in the coming months. The product will be available in 500-unit/mL pens containing 1,500 units and 1,000-unit/mL pens containing 3,000 units.

Broader diabetes portfolio

The US approval represents Onswik’s fourth regulatory approval for adults with T2D, following actions by the European Medicines Agency, Mexico’s Federal Commission for the Protection against Sanitary Risks, and Japan’s Pharmaceuticals and Medical Devices Agency.

The approval also adds a once-weekly basal insulin to Lilly’s broader diabetes portfolio, which includes insulin, incretin-based medicines, and oral therapies.

The FDA describes Onswik as the second once-weekly insulin approved for adults with T2D.

The development comes as Lilly continues to expand its cardiometabolic pipeline.

The company is preparing to present additional data on its diabetes and obesity portfolio at the 2026 European Association for the Study of Diabetes meeting, including studies of retatrutide, Foundayo, and eloraTZP.

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