FDA approved 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.

With FDA's decision, Onswik now has approval across four major regulatory regions, positioning it as a global option for patients managing type 2 diabetes. Onswik is designed to deliver steady basal insulin levels over a full seven days, offering an alternative to the daily injections that basal insulin has traditionally required.¹

The approval marks the fourth global regulatory action for Onswik in adults with type 2 diabetes, following clearances from the European Medicines Agency, Mexico's Federal Commission for the Protection against Sanitary Risks, and Japan's Pharmaceuticals and Medical Devices Agency.

"For over a century, Lilly has 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," said Kenneth 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."

What is the approval based on?

FDA approval is based on data from the QWINT Phase III clinical trial program, which evaluated the safety and efficacy of once-weekly Onswik in more than 3,400 adults with type 2 diabetes.² In each QWINT trial, once-weekly Onswik met the primary endpoint of non-inferior A1C reduction from baseline compared with insulin glargine U-100 or insulin degludec U-100. Across the trials, Onswik demonstrated an overall safety profile similar to the daily basal insulins studied.

The QWINT program began in 2022 and enrolled more than 3,400 people with type 2 diabetes across four global registration studies.² QWINT-1 (NCT05662332) randomized 795 insulin-naïve adults across the U.S., Argentina, and Mexico to once-weekly efsitora or daily insulin glargine over 52 weeks, using a fixed-dosage escalation schedule starting at 100 units and rising to 150, 250, and 400 units every four weeks as needed to reach a target fasting blood glucose of 80-130 mg/dL.²

QWINT-2 (NCT05362058) randomized 928 insulin-naïve adults across the U.S., Brazil, Canada, China, Czechia, Germany, Greece, Japan, Korea, Mexico, and Puerto Rico to compare efsitora with insulin degludec over 52 weeks, and was also designed to assess efficacy and safety in patients using and not using GLP-1 receptor agonists.²

QWINT-3 (NCT05275400) randomized 986 adults already on basal insulin across the U.S., Argentina, Hungary, Japan, Korea, Poland, Puerto Rico, Slovakia, Spain, and Taiwan, comparing efsitora with insulin degludec over 78 weeks following a three-week lead-in and a five-week safety follow-up, with a primary objective of non-inferior A1C reduction at week 26.

Finally, QWINT-4 (NCT05462756) randomized 730 adults previously treated with basal insulin and at least two daily mealtime insulin injections across the U.S., Argentina, Germany, India, Italy, Mexico, Puerto Rico, and Spain, comparing weekly efsitora with daily insulin glargine, both administered alongside insulin lispro, over 26 weeks.

Each of the four studies was designed around the same central question: whether a once-weekly basal insulin could match the glycemic control of established daily options without compromising safety.²

What comes next for Onswik?

The Onswik KwikPen is set to be available in the U.S. in the coming months in two concentrations: 500 units/mL, containing 1,500 units total, and 1,000 units/mL, containing 3,000 units total.¹

Sources

1. 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 Eli Lilly and Company September 24, 2026, https://investor.lilly.com/news-releases/news-release-details/us-food-and-drug-administration-fda-approves-lillys-onswiktm
2. Evaluation of Overall Health State, Treatment Burden, and Satisfaction with Insulin Efsitora Alfa (Efsitora) vs. Daily Comparator in Adults with Type 2 Diabetes in the QWINT Clinical Trial Program National Library of Medicine https://pubmed.ncbi.nlm.nih.gov/41591636/