FDA Approves Once-Weekly Basal Insulin for Adults With Type 2 Diabetes

The US Food and Drug Administration (FDA) has approved insulin icodec-abae (Awiqli®) injection 700 units/mL, a once-weekly, long-acting basal insulin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2D), manufacturer Novo Nordisk announced March 26, 2026.¹

The approval marks the first once-weekly basal insulin to receive FDA authorization, offering an alternative to daily basal insulin injections for eligible adults with T2D.¹

Clinical Trial Data

The FDA approval is based on the ONWARDS phase 3a clinical program, which comprised 4 randomized, active-controlled, treat-to-target trials enrolling approximately 2680 adults with uncontrolled T2D. Trials evaluated insulin icodec administered once weekly against daily basal insulin, used either in combination with mealtime insulin or with oral antidiabetic agents and/or glucagon-like peptide-1 (GLP-1) receptor agonists.^2-5

The primary endpoint across the ONWARDS trials was reduction in hemoglobin A_1C (HbA_1c). The clinical program demonstrated efficacy in meeting this endpoint. The safety profile of insulin icodec was reported to be consistent with that of the daily basal insulin drug class.^2-5

Insulin icodec is a U-700 formulation administered subcutaneously once weekly on the same day each week, using the Awiqli® FlexTouch® pen device. It is available in a single concentration of U-700. The drug is not approved for use in children or adolescents, and its safety and efficacy in pediatric populations have not been established.¹

Common adverse events reported in the ONWARDS trials include hypoglycemia, serious allergic reactions, injection site reactions, lipodystrophy (skin thickening or pits at the injection site), pruritus, rash, peripheral edema, and weight gain.^2-5

"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," Julio Rosenstock, MD, principal investigator for the ONWARDS trial program and clinical professor of medicine at the University of Texas Southwestern Medical Center, said in a press release. "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. Research supports weekly injectable diabetes medications can be associated with improved patient adherence."¹

Anna Windle, PhD, Group Vice President, Clinical Development, Medical & Regulatory Affairs at Novo Nordisk Inc., noted that the approval "may address challenges associated with the frequency of daily basal injections, by reducing them from seven to one per week."¹

Insulin icodec-abae is expected to be available nationwide in the US in the coming months. The drug has received approval in the US, the European Union (EU), and 13 additional countries, with market-specific indications for diabetes.¹

1. Novo Nordisk. FDA approves Novo Nordisk's Awiqli®, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes. News release. March 26, 2026. Accessed March 27, 2026. https://www.prnewswire.com/news-releases/fda-approves-novo-nordisks-awiqli-the-first-and-only-once-weekly-basal-insulin-treatment-for-adults-with-type-2-diabetes-302726839.html
2. 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
3. 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
4. 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
5. 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-