The Food and Drug Administration on Thursday, Sept. 24, 2026, approved Eli Lilly and Company’s Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection used with diet and exercise to improve blood-sugar control in adults with type 2 diabetes, according to Lilly’s PR Newswire release and corroborating coverage from NY Post, Pharmaceutical Executive (opens in new tab), and BioSpace (opens in new tab).
Approval rests on the QWINT Phase 3 program in more than 3,400 adults with type 2 diabetes. Lilly said once-weekly Onswik met primary endpoints of non-inferior A1C reduction versus daily basal comparators insulin glargine U-100 or insulin degludec U-100 across the trials, with an overall safety profile similar to those daily basals in the studied settings.
Lilly’s labeling summary states Onswik should not be used by people with type 1 diabetes because of increased severe hypoglycemia risk, and that it is not known to be safe and effective in children. Common side effects listed include low blood sugar, allergic and injection-site reactions, lipodystrophy, itching, rash, swelling of hands and feet, and weight gain.
The company said Onswik KwikPen will be available in the United States in the coming months in 500 units/mL and 1,000 units/mL concentrations. The Event Log treats the FDA approval announcement as confirmed across company wire and trade/consumer reports.