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Onswik ™ (insulin efsitora alfa-gobe) injection
500 units/mL (U-500), 1,000 units/mL (U-1,000)
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
When will ONSWIK™ (insulin efsitora alfa-gobe) become available?
The FDA approved efsitora on September 23, 2026, to improve glycemic control in adults with type 2 diabetes. Efsitora is expected to be available in the US in the coming months; Lilly cannot speculate on specific launch dates.
What information is available on the US regulatory status of efsitora?
Insulin efsitora alfa-gobe (efsitora) is a once-weekly basal insulin designed to provide steady basal insulin levels and stable glucose lowering throughout the week, with low peak-to-trough variability, and to reduce the injection burden by more than 300 injections per year compared with once-daily basal insulin therapy.1
On September 23, 2026, the US Food and Drug Administration approved efsitora.2 Efsitora is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.3
The ONSWIK™ KwikPen® is expected to be available in the US in the coming months in 2 concentrations: 500 units/mL (containing 1,500 units per pen) and 1,000 units/mL (containing 3,000 units per pen).2,3
Currently, Lilly does not plan to commercialize efsitora using an alternative delivery device.
Availability of efsitora in the US depends on launch, pricing, and reimbursement processes.4
Efsitora is not recommended for use in patients with type 1 diabetes mellitus due to increased risk of severe hypoglycemia.3 At this time, Lilly has no plans to study efsitora further in people with type 1 diabetes.
Enclosed Prescribing Information
ONSWIK™ (insulin efsitora alfa-gobe) injection, for subcutaneous use, Lilly
References
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
- Bergenstal RM, Philis-Tsimikas A, Wysham C, et al. Once-weekly insulin efsitora alfa: design and rationale for the QWINT phase 3 clinical development programme. Diabetes Obes Metab. 2024;26(8):3020-3030. https://doi.org/10.1111/dom.15604
- 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. Press Release. Eli Lilly and Company; September 24, 2026. Accessed September 24, 2026. https://investor.lilly.com/news-releases/news-release-details/us-food-and-drug-administration-fda-approves-lillys-onswiktm
- ONSWIK [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: September 23, 2026