FDA approves Onswik, second once-weekly insulin for type 2 diabetes

FDA has approved Onswik (insulin efsitora alfa-gobe) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). The long-acting basal insulin is administered once weekly and is the second once-weekly insulin approved for adults with T2DM, offering an alternative to traditional daily basal insulin regimens[JS2] .

Approval was supported by the phase 3 QWINT global clinical trial program, which enrolled more than 3,400 adults with T2DM in four studies (QWINT-1, QWINT-2, QWINT-3, QWINT-4). Across the trials, once-weekly Onswik lowered hemoglobin A1c (HbA1c) to a similar extent as once-daily insulin glargine or insulin degludec, providing a less frequently administered basal insulin option without compromising glycemic control.

In the QWINT studies, Onswik demonstrated an overall safety profile similar to that of the daily basal insulins used as comparators. The most common adverse reactions included hypoglycemia, hypersensitivity reactions, injection-site reactions, lipodystrophy, pruritus, rash, edema, and weight gain.

“Onswik offers a new once-weekly basal insulin option for patients and reflects our continued commitment to deliver innovative treatment options that expand choice and provide greater flexibility in how people manage type 2 diabetes,” said Kenneth Custer, Ph.D., executive vice president and president, Lilly Cardiometabolic Health.

Sources: FDA. (2026 Sep 24). FDA approves once-weekly insulin for type 2 diabetes mellitus; Eli Lilly and Company; Lilly. (2026 Sep 24). U.S. Food and Drug Administration (FDA) approves Lilly's Onswik™ (insulin efsitora alfa-gobe), a once-weekly basal insulin injection treatment for adults living with type 2 diabetes