FDA Approves First Weekly Basal Insulin for Adults With Type 2 Diabetes

The FDA approved insulin icodec-abae (Awiqli), marking the arrival of the first and only once-weekly basal insulin for adults living with type 2 diabetes (T2D). Developed by Novo Nordisk, this long-acting injection represents a significant shift in the treatment landscape, potentially reducing the burden of basal insulin administration from 365 injections a year to just 52.¹

The approval also offers a new treatment solution designed to fit diverse patient routines and preferences, providing an alternative to the daily injections that have long been a standard of care.

“As the first FDA-approved, once-weekly basal insulin for adults with type 2 diabetes, it offers an important new treatment option. At a time when parts of the industry are stepping back from insulin, we are reaffirming our commitment—continuing to invest in innovation, access, and supply for the millions of patients who rely on insulin every day,” Mike Doustdar, president and CEO of Novo Nordisk, said in a news release.

The FDA's decision was based on the results of the extensive ONWARDS phase 3a clinical program, which comprised 4 randomized, active-controlled, treat-to-target trials involving approximately 2680 adults with uncontrolled T2D. Across these trials, insulin icodec-abae demonstrated efficacy in its primary end point of hemoglobin A_1c reduction, proving noninferior and, in certain studies like ONWARDS 3 (NCT04795531), statistically superior to daily basal insulins such as insulin degludec and insulin glargine U100.^1,2

For pharmacists, this approval introduces a medication that addresses the primary barriers to insulin therapy, including injection fatigue and complex dosing schedules that often hinder patient adherence.³

From a pharmacological perspective, insulin icodec-abae extended duration of action is derived from its unique molecular structure, which includes a C20 fatty diacid side chain that facilitates strong but reversible binding to albumin. This binding creates an inactive albumin-bound depot from which active insulin is progressively and slowly released into the bloodstream, resulting in a half-life of approximately 196 hours.³

Pharmacists should be aware that because of this long half-life, the medication takes about 1 month to reach a steady-state concentration. Clinical data suggests that an initial loading dose may be beneficial when transitioning patients from a daily basal insulin to this once-weekly regimen to prevent a temporary impairment of glycemic control during the first few weeks of therapy.³

In addition to A_1c reduction, clinical evidence indicates that patients on insulin icodec-abae may experience a significantly higher percentage of time in range (TIR) compared with those on daily glargine. Although the safety profile of insulin icodec-abae is generally consistent with the daily basal insulin class, some specific outcomes require pharmacist vigilance.³

For instance, in insulin-naive populations, trials showed a higher rate of combined level 2 or 3 hypoglycemia compared with insulin degludec, though the overall rates remained low at less than 1 event per patient-year. Furthermore, a modest increase in body weight was observed in several studies, a factor that may necessitate proactive counseling for patients already concerned about metabolic complications.^2,3

Insulin icodec-abae will be administered via the FlexTouch pen device at a concentration of 700 units/mL. Patients are instructed to deliver their dose on the same day each week, an approach intended to simplify therapy and reduce the clinical inertia often associated with initiating insulin.¹

Novo Nordisk has indicated that they expect to launch insulin icodec-abae nationwide in the United States in the second half of 2026. As this novel therapy enters the market, pharmacists will be essential in educating both patients and providers on the nuances of once-weekly dosing, monitoring for safety, and helping to integrate this innovation into long-term diabetes management strategies.¹

READ MORE: Insulin Management Resource Center

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REFERENCES

1. Novo Nordisk A/S: Awiqli approved in the US, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes. News release. Novo Nordisk. March 26, 2026. Accessed March 27, 2026. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916521

2. 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

3. Ashraf T, Kumar A, Tara A, et al. Once-weekly insulin icodec vs. daily insulin glargine in type 2 diabetes: a meta-analysis with longitudinal insights. Ann Med Surg (Lond). 2025;87(7):4452-4466. Published 2025 Jun 10. doi:10.1097/MS9.0000000000003392