You are now leaving the Lilly Medical website
The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Lilly USA, LLC does not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Lilly USA, LLC. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. We encourage you to read the privacy policy of every website you visit.
Click "Continue" to proceed or "Return" to return to Lilly Medical
If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)
Insulin Efsitora Alfa
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling.
When will insulin efsitora alfa become available?
Efsitora is currently under review by regulatory authorities for type 2 diabetes. It is not approved for clinical use, and Lilly cannot speculate on potential approval or launch dates at this time.
What Information Is Available on the Regulatory Status of Efsitora?
Insulin efsitora alfa is a once-weekly basal insulin currently being investigated for the treatment of patients with diabetes, and is not approved for clinical use.1
Eli Lilly and Company has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for efsitora for type 2 diabetes (T2D).2
At this time, the application is still under review by the FDA,2and Lilly cannot currently speculate on potential approval or launch dates.
Lilly plans to submit efsitora to additional global regulatory agencies for the treatment of adults with T2D.2
Lilly has concluded that the benefit-risk of efsitora differs in people with T2D compared to people with type 1 diabetes (T1D). At this time, Lilly has no plans to study efsitora further in people with T1D.
Lilly’s autoinjector was used to administer fixed doses of efsitora in QWINT-1. Throughout the QWINT trials, efsitora was also administered using the KwikPen®, and we will continue to assess device options for commercialization. Lilly is excited about the potential to simplify insulin treatment for people with T2D through a fixed-dose regimen similar to the well-established and accepted method of starting and titrating weekly incretin products.
Date of Last Review: 12-November-2025
References
1Bergenstal 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
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: November 12, 2025