FDA Approval

FDA Approves Awiqli (Insulin Icodec-Abae) as Once-Weekly Basal Insulin for Adults With Type 2 Diabetes

Edited by:
Anthony Calabro, MA

Key Highlights

  • Awiqli (insulin icodec-abae) has been approved as a once-weekly basal insulin (U-700) for adults with type 2 diabetes.
  • Approval was based on the ONWARDS phase 3a program of 4 randomized, active-controlled trials.
  • There was a demonstrated reduction in A1C as the primary endpoint versus daily basal insulin.
  • The safety profile was consistent with the basal insulin class, including hypoglycemia and injection site reactions.

On March 26, 2026, the US Food and Drug Administration approved Awiqli (insulin icodec-abae) injection 700 units/mL as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Insulin icodec-abae is a long-acting basal insulin administered once weekly and is the first FDA-approved once-weekly basal insulin. It is indicated for use in adults and may be used in combination with mealtime insulin, oral antidiabetic agents, and/or glucagon-like peptide-1 receptor agonists (GLP-1RAs).

The approval was supported by results from the ONWARDS phase 3a clinical program, which included 4 randomized, active-controlled, treat-to-target trials enrolling approximately 2,680 adults with uncontrolled type 2 diabetes. Insulin icodec-abae was evaluated in combination with mealtime insulin or with oral antidiabetic agents and/or GLP-1RAs. Across the program, the primary endpoint was a reduction in glycated hemoglobin (A1C), which was achieved in comparison with daily basal insulin. No additional numerical efficacy outcomes were reported in the announcement.

“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,” Julio Rosenstock, MD, principal investigator for the ONWARDS trial program, said in a press release.

The safety profile of insulin icodec-abae was reported to be consistent with that of the basal insulin class. Common adverse events included hypoglycemia, injection site reactions, lipodystrophy, pruritus, rash, peripheral edema, and weight gain. Serious risks included severe allergic reactions and hypokalemia. Use with thiazolidinediones may increase the risk of heart failure.

Insulin icodec-abae is administered subcutaneously once weekly on the same day each week using a prefilled injection pen. It should not be administered intravenously, intramuscularly, or via infusion pump, and should not be mixed with other insulin products.

Reference
Novo Nordisk. FDA approves Novo Nordisk’s Awiqli® (insulin icodec-abae), the first and only once-weekly basal insulin treatment for adults with type 2 diabetes. Press 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