FDA

Awiqli approved as the first once-weekly basal insulin for T2DM patients

March 30, 2026

Brand name: Awiqli

Generic name: insulin icodec-abae

Manufacturer: Novo Nordisk

Approval date: March 26, 2026

FDA approved Awiqli (insulin icodec-abae) to improve glycemic control in adults with T2DM, as an adjunct to diet and exercise.

Awiqli binds reversibly to albumin, resulting in a depot in the circulation from which insulin icodec-abae is slowly released. The insulin receptor is activated by insulin icodec-abae leading to a stable glucose-lowering effect over the entire dosing interval of one week.

Efficacy

Approval was based on four randomized, active-controlled, treat-to-target, phase 3 trials in adult patients with T2DM (ONWARDS 1, ONWARDS 2, ONWARDS 3, and ONWARDS 4). All four studies compared once-weekly Awiqli (insulin icodec-abae) to daily insulin (insulin glargine or insulin degludec).

ONWARDS 1 (N=984)

Included insulin naïve T2DM patients inadequately controlled on one or more oral antidiabetic agents (OADs) or glucagon-like peptide-1 (GLP-1) receptor agonist.
Awiqli demonstrated a statistically significant reduction in glycated hemoglobin (HbA1c) at week 52 compared with once-daily insulin glargine U-100 with an estimated treatment difference of -0.18% (95% confidence interval [CI], -0.29%, - 0.08%).

ONWARDS 2 (N=526)

Included T2DM patients treated with once-or twice-daily basal insulin with or without OADs.
Awiqli resulted in a statistically significant reduction in HbA1c at week 26 compared with insulin degludec U-100 with estimated treatment difference of -0.19 (95% CI,-0.32, -0.06).

ONWARDS 3 (N=588)

Included insulin-naïve T2DM patients inadequately controlled on one or more OADs or GLP-1 receptor agonist.
Awiqli showed a statistically significant reduction in HbA1c at week 26 compared to once-daily insulin degludec U-100 with an estimated treatment difference of -0.22 (95% CI, -0.35, - 0.09).

ONWARDS 4 (N=582)

Included T2DM patients inadequately controlled on once-daily basal insulin in combination with mealtime rapid-acting insulin with or without OADs or GLP-1 receptor agonist.
At week 26, the difference in HbA1c reduction from baseline between Awiqli and insulin glargine U-100 was 0.02% (95% CI, -0.11, 0.15) and met the pre-specified non-inferiority margin (0.3%).

Safety

Most common adverse reactions are hypoglycemia, hypersensitivity reactions (e.g., urticaria, swelling face and lips), injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain.

Sources:

(2026, March 26). Novo Nordisk A/S: Awiqli approved in the US, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes. [Press release]. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916521

Awiqli (insulin icodec-abae). [Package insert]. Novo Nordisk. https://www.novo-pi.com/awiqli.pdf. Dated March 2026. Accessed March 27, 2026.