FDA approves Lilly’s Onswik, the second once-weekly insulin

The FDA has approved Eli Lilly’s once-weekly basal insulin, Onswik (insulin efsitora alfa-gobe), to improve glycemic control in adults with Type 2 diabetes. The Onswik KwikPen will be available in the United States in the coming months in two concentrations: 500 units/mL and 1,000 units/mL, according to a Lilly press release. No information is available on the list price of Onswik.

About 40 million Americans have diabetes, and about 90% to 95% have Type 2 diabetes, according to the CDC. In Type 2 diabetes, cells don’t respond normally to insulin. This can lead to heart disease, vision loss, and kidney disease. Risk factors for diabetes include being over the age of 45 and being overweight. African American, Hispanic or Latino, American Indian, or Alaska Native person. Some Pacific Islander people are at a higher risk.

“Onswik offers a new once-weekly basal insulin option for patients and reflects our continued commitment to deliver innovative treatment options that expand choice and provide greater flexibility in how people manage type 2 diabetes,” Kenneth Custer, Ph.D., executive vice president and president, Lilly Cardiometabolic Health, said in a news release.

The approval of Onswik is based on data from four phase 3 trials, which enrolled a total of more than 3,400 adults with Type 2 diabetes. In each QWINT trial, once-weekly Onswik met the primary endpoint of non-inferior A1C reduction from baseline that was comparable to insulin glargine or insulin degludec.

Common side effects of Onswik include low blood sugar, allergic reactions, reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of hands and feet, and weight gain.

This is the fourth global approval for Onswik for adults with Type 2 diabetes. It is approved in Europe, Mexico and Japan.

Onswik is not recommended for use in patients with Type 1 diabetes because of an increased risk of severe hypoglycemia. Lilly had been studying Onswik for use in patients who have Type 1 diabetes.

Data published in The Lancet in September 2024 found that in the QWINT-5 trial, efsitora met the primary endpoint of noninferior A1C reduction at week 26, reducing A1C by 0.53% compared with 0.59% for insulin degludec. But severe hypoglycemic events were higher in the efsitora arm compared with the insulin degludec arm. About 10% of patients in the efsitoria arm experienced severe hypoglycemia compared with 3% in the degludec arm.

The first once-weekly insulin basal

Related: Novo Nordisk launches Awiqli, a once-weekly basal insulin.

Onswik is the second once-daily insulin to be approved, after Novo’s Awiqli (insulin icodec-abae) was launched early in August 2026.

Awiqli is available as a prefilled FlexTouch pen. It has a list price of $99 per package, a company spokesperson told Managed Healthcare Executive at the time. For those with commercial insurance or considering a self-pay option through NovoCare.com, Awiqli is available for $35 a month for patients with Medicare or commercial insurance or $55 a month for those who are uninsured.