FDA approves Lilly's once-weekly insulin Onswik

Eli Lilly secured US Food and Drug Administration approval for Onswik (insulin efsitora alfa-gobe). The once-weekly basal insulin is indicated for adults with type 2 diabetes alongside diet and exercise to help manage blood sugar levels. It is not approved for type 1 diabetes due to risks of severe hypoglycemia.

The approval reduces basal insulin injections from around 365 to 52 per year. This clearance marks Onswik's fourth global authorization, following prior approvals in the European Union, Mexico and Japan. Lilly expects to launch the Onswik KwikPen in the United States in the coming months in two strengths: U-500 (500 units/mL) and U-1,000 (1,000 units/mL).

The regulatory decision was supported by the phase 3 QWINT clinical program. In those trials, Onswik met its primary endpoint by demonstrating non-inferior A1C reductions and a safety profile comparable to daily insulin glargine U-100 or insulin degludec U-100. In the US market, Onswik will compete with Novo Nordisk's Awiqli, which gained FDA approval in March 2026.

Year to date, Eli Lilly shares are up 10.5%, compared with a 13.7% gain for the broader industry.