Eli Lilly receives FDA approval for weekly basal insulin

• Eli Lilly (NYSE:LLY) received U.S. FDA approval for Onswik, a once-weekly basal insulin for adults with type 2 diabetes.
• The approval was supported by four Phase 3 QWINT trials involving more than 3,400 adults.
• Onswik is designed to reduce injection frequency compared with once-daily basal insulin therapies.

Eli Lilly (NYSE:LLY) received U.S. Food and Drug Administration approval on September 24, 2026, for Onswik, a once-weekly basal insulin treatment for adults with type 2 diabetes.

The therapy is approved for use alongside diet and exercise to help control elevated blood sugar levels.

Eli Lilly said the once-weekly dosing schedule is designed to reduce injections by more than 300 per year compared with once-daily basal insulin treatments.

The comparison relates to dosing frequency and does not indicate differences in safety or effectiveness.

The approval was supported by four Phase 3 QWINT clinical trials involving more than 3,400 adults with type 2 diabetes.

Each trial met its primary endpoint, demonstrating non-inferior A1C reduction compared with daily insulin glargine U-100 or insulin degludec U-100.

A1C is a measurement used to estimate average blood glucose levels over time.

The Onswik KwikPen is expected to become available in the United States in the coming months in 500 units/mL and 1,000 units/mL formulations.

Eli Lilly noted that Onswik should not be used in people with type 1 diabetes due to an increased risk of severe hypoglycemia. Reported common side effects include low blood sugar and weight gain.