FDA has approved insulin efsitora alfa-gobe (Onswik), Eli Lilly and Company's (Lilly’s) once-weekly basal insulin, on September 24, 2026, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.¹ The approval is based on the QWINT phase 3 clinical trial program, which enrolled more than 3400 adults with type 2 diabetes across 4 global registration studies.¹
Key facts
- Drug: insulin efsitora alfa-gobe (Onswik; Eli Lilly and Company)
Class: Once-weekly basal insulin
Indication: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
- Trial: QWINT phase 3 program (QWINT-1 through QWINT-4); more than 3400 participants
- Primary endpoint met: Non-inferior A1C reduction vs. insulin glargine U-100 or insulin degludec U-100
- Safety: Profile similar to daily basal insulins studied; not indicated for type 1 diabetes
- Regulatory status: FDA approved September 24, 2026; fourth global approval after the EMA, COFEPRIS (Mexico), and PMDA (Japan)
- Dosing: Once weekly; KwikPen in U-500 and U-1000 concentrations, available in the coming months
- Current approval: US, EU, Mexico, and Japan for adults with type 2 diabetes
"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, PhD, executive vice president and president, Lilly Cardiometabolic Health, in a company press release.¹ "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 Onswik and how does it work?
Onswik is designed to deliver steady basal insulin levels over a full seven days and is intended to reduce injections by more than 300 per year compared with a once-daily basal insulin, roughly 52 injections annually versus 365.¹ The Onswik KwikPen will be available in the United States in the coming months in 2 concentrations: a 500 units/mL pen containing 1500 units total and a 1000 units/mL pen containing 3000 units total.
What clinical evidence supports the approval?
Across the QWINT trials, once-weekly efsitora met its primary endpoint of non-inferior A1C reduction from baseline compared with insulin glargine U-100 or insulin degludec U-100. QWINT-1 (NCT05662332) randomized 795 insulin-naive adults to efsitora or glargine over 52 weeks,¹,² while QWINT-3 randomized 986 adults already on basal insulin to efsitora or degludec, meeting its primary A1C endpoint at week 26.¹,³ QWINT-2 randomized 928 insulin-naive adults to efsitora or degludec and also assessed outcomes in patients using and not using glucagon-like peptide-1 receptor agonists.¹ QWINT-4 randomized 730 adults already using basal and mealtime insulin to efsitora or glargine, both given alongside mealtime insulin lispro, with non-inferior A1C reduction at week 26.¹
What are the safety considerations?
Onswik demonstrated an overall safety profile similar to the daily basal insulins studied in the QWINT trials.¹ Lilly stated that It should not be used by people with type 1 diabetes because of an increased risk of severe hypoglycemia.¹ Common side effects include low blood sugar, allergic reactions, injection-site reactions, lipodystrophy, itching, rash, swelling of the hands and feet, and weight gain.¹
