The weekly insulin Onswik will now be available to U.S. patients after initial approvals in Europe, Mexico and Japan.
Eli Lilly’s weekly insulin, which offers a chance for patients with type 2 diabetes to receive more than 300 fewer injections per year, has been approved in the U.S. The FDA nod sets up yet another market battle between Lilly and obesity rival Novo.
Insulin efsitora alfa-gobe will now be known as Onswik after the FDA approval, Lilly said in a Thursday press release.
The FDA nod marks the fourth global approval for Onswik, which has already been cleared for use in Europe, Mexico and Japan.
Onswik was tested in 3,400 adults in the Phase 3 QWINT clinical trials, which showed non-inferiority to standard once-daily options: insulin glargine, variations of which are sold by several Big Pharmas, or insulin degludec, marketed by Novo as Tresiba.
In the QWINT-2 trial, Onswik lowered A1C, a measure of average blood sugar levels, by 1.34%, compared with a 1.26% reduction in patients that took degludec. These results were presented by Lilly at the Annual Meeting of European Association for the Study of Diabetes in September 2024
Lilly promised that Onswik will be made available in the U.S. “in the coming months.”
With the approval, Lilly has added another product to compete with Novo, which received FDA clearance for the once-weekly insulin Awiqli in March. The regulatory greenlight followed two FDA rejections in 2024, with the agency objecting to Novo’s request for approval in type 1 diabetes while also raising concerns about the manufacturing process for the drug.
Novo refiled the application in September 2025 seeking a type 2 indication. With its approval earlier this year, the drug became the first once-weekly insulin medicine available in the U.S.
On Onswik’s new label, Lilly stated that the drug should not be used in patients with type 1 diabetes due to an increased risk of low blood sugar. Awiqli’s label has warnings about using the drug with low blood sugar.
