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Onswik is designed to reduce injections by over 300 per year versus once-daily basal insulin1,2
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With Onswik, Lilly's type 2 diabetes portfolio expands to include a once-weekly basal insulin, alongside existing treatment options across insulins, incretins, oral and injectable medications
INDIANAPOLIS,Sept. 24, 2026/PRNewswire/ --Eli Lilly and Companytoday announced the U.S. Food and Drug Administration (FDA) approval of Onswik™ (insulin efsitora alfa-gobe), a once-weekly basal insulin, indicated along with diet and exercise to control high blood sugar in adults with type 2 diabetes. Onswik is designed to deliver steady basal insulin levels over a full seven days.2
"For over a century,Lillyhas been developing insulins that transformed diabetes care for millions of people worldwide, but delays in initiating treatment and the burden of daily injections can have a real impact on patients' day-to-day experience managing type 2 diabetes," saidKenneth Custer, Ph.D., executive vice president and president,Lilly Cardiometabolic Health. "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."
This is the fourth global approval for Onswik for adults with type 2 diabetes, following regulatory actions from theEuropean Medicines Agency(EMA),Mexico'sFederal Commission for the Protectionagainst Sanitary Risks (COFEPRIS) andJapan'sPharmaceuticals and Medical Devices Agency(PMDA).
TheFDAapproval is based on data from the QWINT Phase 3 clinical trials, which evaluated the safety and efficacy of once-weekly Onswik in over 3,400 adults with type 2 diabetes. In each QWINT trial, once-weekly Onswik met the primary endpoint of non-inferior A1C reduction from baseline that was comparable to insulin glargine U-100 (glargine) or insulin degludec U-100 (degludec).2-6
In these clinical trials, Onswik demonstrated an overall safety profile similar to the daily basal insulins studied.3-6 Onswik should not be used by people who have type 1 diabetes due to increased risk of severe hypoglycemia (low blood sugar). Common side effects of Onswik include low blood sugar, allergic reactions, reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of hands and feet, and weight gain. Please see Indication and Safety Summary below and full Prescribing Information and Patient Information.
Around one in eight Americans live with diabetes, and most of them have type 2 diabetes.7 Globally by 2030, over 510 million people are expected to live with the disease and 38 million of these are expected to use insulin.8 Insulin remains an important treatment option for many people with type 2 diabetes who do not achieve glycemic goals with other therapies.
The Onswik™ KwikPen® will be available in theU.S. in the coming months in two concentrations: 500 units/mL (contains 1,500 units total) and 1,000 units/mL (contains 3,000 units total).
About Onswik (insulin efsitora alfa-gobe)
Onswik (insulin efsitora alfa-gobe) is a once-weekly basal insulin injection,FDAapproved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Its approval is supported by the QWINT clinical trial program, which evaluated its safety and efficacy in over 3,400 adults with type 2 diabetes. Onswik is also approved by theEuropean Medicines Agency(EMA), theFederal Commission for the Protectionagainst Sanitary Risks (COFEPRIS) inMexicoandJapan'sPharmaceuticals and Medical Devices Agency(PMDA) for the treatment of adults with type 2 diabetes mellitus.
About the QWINT clinical trial program
The QWINT Phase 3 global clinical development program for insulin efsitora alfa-gobe (efsitora) in diabetes began in 2022 and enrolled over 3,400 people living with type 2 diabetes across four global registration studies.
QWINT-1 (NCT05662332) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin using a fixed-dosage escalation to daily insulin glargine for 52 weeks in insulin-naïve adults with type 2 diabetes. The trial randomized 795 participants across theU.S.,ArgentinaandMexicoto receive efsitora once weekly or insulin glargine once daily, administered subcutaneously. Participants treated with efsitora received a starting dose of 100 units of insulin, followed by escalation to fixed dosages of 150 units, 250 units and 400 units every four weeks, as needed, until achieving a target fasting blood glucose of 80-130 mg/dL. Participants with fasting blood glucose greater than 130 mg/dL on or after 16 weeks underwent additional weekly dosage adjustments as needed. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 52 with efsitora compared to daily use of insulin glargine.
QWINT-2 (NCT05362058) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin to insulin degludec for 52 weeks in insulin-naïve adults with type 2 diabetes. The trial randomized 928 participants across theU.S.,Brazil,Canada,China, Czechia (Czech Republic),Germany,Greece,Japan,Korea,MexicoandPuerto Ricoto receive efsitora once weekly or insulin degludec once daily administered subcutaneously. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 52 with efsitora compared to insulin degludec. The trial was also designed to assess efficacy and safety for patients using and not using GLP-1 receptor agonists.
QWINT-3 (NCT05275400) was a multicenter, randomized, parallel-design, open-label trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin to insulin degludec for 78 weeks after a three-week lead-in followed by a five-week safety follow up period, in adults with type 2 diabetes who are currently treated with basal insulin. The trial randomized 986 participants across the U.S.,Argentina,Hungary,Japan,Korea,Poland,Puerto Rico,Slovakia,SpainandTaiwanto receive efsitora once weekly or insulin degludec once daily, administered subcutaneously. The primary objective of the study was to demonstrate non-inferiority in reducing A1C at week 26 with efsitora compared to insulin degludec.
QWINT-4 (NCT05462756) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a weekly basal insulin to insulin glargine for 26 weeks in adults with type 2 diabetes who have previously been treated with basal insulin and at least two injections per day of mealtime insulin. The trial randomized 730 participants across theU.S.,Argentina,Germany,India,Italy,Mexico, Puerto Rico andSpainto receive efsitora once weekly or insulin glargine once daily, both of which were administered subcutaneously along with insulin lispro. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 26 with efsitora compared to insulin glargine.
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable.
Endnotes and References
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Based on approximate number of injections per year for Onswik (52 injections) vs a once-daily basal insulin (365 injections). This information is not intended to make a comparison of safety or efficacy.
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Onswik. Prescribing Information.Lilly USA, LLC.
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Rosenstock J, Bailey T, Connery L, et al. Weekly fixed-dose insulin efsitora in type 2 diabetes without previous insulin therapy. N Engl J Med. 2025;393(4)(Incl suppl append):325-335. doi:10.1056/NEJMoa2502796
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Wysham C, Bajaj HS, Del Prato S, et al. Insulin efsitora versus degludec in type 2 diabetes without previous insulin treatment. N Engl J Med. 2024;391(23)(Incl suppl mat):2201-2211. doi:10.1056/NEJMoa2403953
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Philis-Tsimikas A, Bergenstal RM, Bailey TS, et al. Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 2 diabetes currently treated with basal insulin (QWINT-3): a phase 3, randomised, non-inferiority trial.Lancet. 2025;405(10497)(Incl suppl mat):2279-2289. doi:10.1016/S0140-6736(25)01044-X
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Blevins T, Dahl D, Pérez Manghi FC, et al. Once-weekly insulin efsitora alfa versus once-daily insulin glargine U100 in adults with type 2 diabetes treated with basal and prandial insulin (QWINT-4): a phase 3, randomised, non-inferiority trial.
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Lancet. 2025;405(10497):2290-2301. doi:10.1016/S0140-6736(25)01069-4 Centers for Disease Control and Prevention. About type 2 diabetes. CDC. AccessedAugust 10, 2026. https://www.cdc.gov/diabetes/about/about-type-2-diabetes.html
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Basu S, Yudkin JS, Kehlenbrink S, et al. Estimation of global insulin use for type 2 diabetes, 2018–30: a microsimulation analysis. Lancet Diabetes Endocrinol. 2019;7(1):25-33. doi:10.1016/S2213-8587(18)30303-6. Available from: https://www.thelancet.com/journals/landia/article/PIIS2213-8587%2818%2930303-6/abstract