FDA Approves Once Weekly Insulin Icodec for Type 2 Diabetes

The US Food and Drug Administration has approved insulin icodec (Awiqli), developed by Novo Nordisk, as the first once-weekly long-acting basal insulin for glycemic control in adults with Type 2 Diabetes. However, it is not approved for Type 1 Diabetes, as the FDA had previously rejected its use for this indication in 2024.

Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Awiqli® (insulin icodec-abae) injection 700 units/mL, the first and only once-weekly, long-acting basal insulin, indicated as an adjunct to diet and exercise to improve glycemic control (blood sugar) in adults living with type 2 diabetes.1 This new approval offers the only once‑weekly basal insulin option, recognizing the importance of personalized care and the need for treatments that fit different patient routines and preferences for adults living with type 2 diabetes.1,2

"Awiqli® is an important new option that meets a real need as the first FDA-approved, once-weekly basal insulin for adult patients with type 2 diabetes. It's helping to reframe what basal insulin care can look like," said Anna Windle, PhD, Group Vice President, Clinical Development, Medical & Regulatory Affairs at Novo Nordisk Inc. "Awiqli® may address challenges associated with the frequency of daily basal injections, by reducing them from seven to one per week. It is an important advancement for adults with type 2 diabetes who may benefit from an alternative treatment option."

This approval is based on results from the ONWARDS type 2 diabetes phase 3a program for once-weekly Awiqli® injection which comprises four randomized, active-controlled, treat-to-target trials in approximately 2,680 adults with uncontrolled type 2 diabetes, used in combination with a mealtime insulin or in combination with common oral anti-diabetic agents and/or GLP-1 receptor agonists.

The clinical program evaluated once-weekly Awiqli® vs. daily basal insulin and demonstrated efficacy in the primary endpoint of reduction of A1C across the ONWARDS pivotal clinical trial program for adults with type 2 diabetes. Across these ONWARDS trials, the safety profile of Awiqli® was overall consistent with the daily basal insulin class.3-6 Common adverse events include hypoglycemia (low blood sugar), serious allergic reactions (whole body reactions), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain.1

Please see below for Important Safety Information and please click here for the full Prescribing Information.

"The introduction of daily long-acting basal insulin injections more than 20 years ago, with the concept of "treat-to-target," was a major contribution for adults with type 2 diabetes needing basal insulin therapy. However, some adults living with type 2 diabetes may still find it difficult to begin and stay on this type of daily basal insulin therapy. This underscores the need for new alternative insulin options that may help patients work with their health care providers to determine what treatment works best for them," said Julio Rosenstock, MD, a Principal Investigator for the ONWARDS trial program and Clinical Professor of Medicine at the University of Texas Southwestern Medical Center. "Research supports weekly injectable diabetes medications can be associated with improved patient adherence. Having a weekly basal insulin option like insulin icodec-abae, may reshape insulin management in adults with type 2 diabetes, giving them a routine that feels more manageable as they work toward their blood sugar goals."

Awiqli® will be available nationwide in the US in the coming months. More information is available at www.awiqli.com.

References: Awiqli® (insulin icodec-abae) [package insert]. Plainsboro, NJ: Novo Nordisk Inc.

American Diabetes Association Professional Practice Committee for Diabetes*; Facilitating positive health behaviors and well-being to improve health outcomes: Standards of care in diabetes—2026. Diabetes Care 1 January 2026; 49(suppl 1-5):S89–S131. https://doi.org/10.2337/dc26-S005

Rosenstock J, Gowda A, Liang B. Weekly icodec versus daily glargine U100 in type 2 diabetes without previous insulin. N Engl J Med. 2023 2023;389(16):1533. doi:10.1056/NEJMc2310221

Philis-Tsimikas A, Asong M, Franek E, et al. Switching to once-weekly insulin icodec versus once-daily insulin degludec in individuals with basal insulin-treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open label, multicentre, treat-to-target trial. Lancet Diabetes Endocrinol. 2023 https://doi.org/10.1016/S2213-8587(23)00093-1

Lingvay I, Asong M, Desouza C, et al. Once-weekly insulin icodec vs once-daily insulin degludec in adults with insulin-naive type 2 diabetes: the ONWARDS 3 randomized clinical trial. JAMA. 2023;330(3):228–237. doi:10.1001/jama.2023.11313

Mathieu C, Ásbjörnsdóttir B, Bajaj H, et al. Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial. 2023 https://doi.org/10.1016/S0140-6736(23)00520-