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

The FDA approved insulin efsitora alfa-gobe, sold as Onswik, on September 24, 2026 as a once-weekly basal insulin for adults with type 2 diabetes. The approval rests on four Phase 3 QWINT trials that met their non-inferiority or superiority endpoints against daily insulins. It is not indicated for type 1 diabetes because of severe hypoglycemia risk.

• Once-weekly basal insulin for adults with type 2 diabetes, used with diet and exercise
• Based on four Phase 3 QWINT trials
• Safety profile similar to insulin glargine and insulin degludec
• Not for type 1 diabetes due to hypoglycemia risk