FDA Approves Novel Weekly Basal Insulin for T2D

The FDA has approved once-weekly insulin icodec-abae (Awiqli; Novo Nordisk) for use in adults with type 2 diabetes (T2D), with a current projected launch in the second half of 2026¹ for the 700-units/mL dose. This novel treatment option is a first-in-its-class therapeutic, freeing patients living with T2D from their strict schedule of daily basal insulin injections and reducing total injections from 7 to 1 for each 7-day period.

Its indication is as an adjunct to diet and exercise for improved glycemic control, as well as for patients also taking mealtime insulin or another common oral antidiabetic agent and/or a glucagon-like peptide-1 receptor agonist. A prescription is required, and administration is with or without food via a prefilled FlexTouch device on the same day each week.

Data from 4 of the trials in the phase 3a ONWARDS program and 2680 adult patients with uncontrolled T2D support this approval; their primary end point of interest was reduction in hemoglobin A_1c. Overall, the ONWARDS program encompasses 6 phase 3a trials and more than 4000 adults with type 1 diabetes (T1D) or T2D.²

Safety and tolerability of insulin icodec-abae were consistent, with data from the ONWARDS 1 study (NCT04460885) demonstrating greater average reduction in hemoglobin A_1c from insulin icodec-abae compared with once-daily insulin glargine U100 at 52 weeks.¹ Data presented at the 2023 American Diabetes Association Scientific Sessions and published in The New England Journal of Medicine first bore out these positive results.³

The estimated between-group difference was –0.19% (95% CI, –0.36% to –0.03%), and individuals receiving insulin icodec-abae saw their hemoglobin A_1c fall from 8.50% to 6.93% compared with 8.44% to 7.12% in those on glargine U100. Following the main 52-week study period, a 26-week extension through week 78 since randomization showed consistent glycemic control, with the cohort receiving insulin icodec-abae coming in at 6.92% and the glargine U100 cohort ending at 7.03%. Insulin icodec-abae also led to longer average time in optimal glycemic range, or 70 to 180 mg/dL, and less time in a hyperglycemic state.

Further, data from the ONWARDS 6 study (NCT04848480) show insulin icodec-abae’s noninferiority to once-daily insulin degludec for individuals who have T1D. For the 564 participants who completed the trial, there were no significant differences between the treated groups regarding fasting plasma glucose change from baseline to week 26, mean weekly insulin dose during the last 2 weeks of treatment, or body weight change from baseline to week 26.⁴

“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, Novo Nordisk, in a statement. “Awiqli may address challenges associated with the frequency of daily basal injections, by reducing them from 7 to 1 per week. It is an important advancement for adults with T2D who may benefit from an alternative treatment option.”⁵

Insulin icodec-abae was approved for T1D and T2D in Canada and Switzerland in May 2024,⁶ but the FDA also rejected it for a T1D indication that same year due to concerns about potential severe or clinically significant hypoglycemia, an overall unfavorable risk-benefit profile, and manufacturing.⁷ It remains unapproved for T1D or for use in children and adolescents.⁵ Contraindications include hypoglycemia and allergies to insulin icodec-abae or any of its ingredients, and consultation with a health care provider is recommended for people with liver or kidney problems; with heart failure or other heart health issues; who are pregnant, planning to become pregnant, or breastfeeding; on other medications, especially thiazolidinediones; and taking new prescription or over-the-counter medications, vitamins, or herbal supplements.

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 30, 2026. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916521
2. Overview of the ONWARDS phase 3 clinical development program for investigational once-weekly insulin icodec. Novo Nordisk. June 2023. Accessed March 30, 2026. https://www.novonordisk-us.com/content/dam/nncorp/us/en_us/images/ONWARDS%20Trial%20U.S.%20Infographic_Final.pdf
3. Monaco K. Once-weekly insulin icodec bests daily insulin options for type 2 diabetes. MedPage Today. June 25, 2023. Accessed March 30, 2026. https://www.medpagetoday.com/meetingcoverage/ada/105183
4. Halpern L. FDA approves insulin icodec-abae, first once-weekly basal insulin for adults with T2D. Pharmacy Times^®. March 27, 2026. Accessed March 30, 2026. https://www.pharmacytimes.com/view/fda-approves-insulin-icodec-abae-first-once-weekly-basal-insulin-for-adults-with-t2d
5. FDA approves Novo Nordisk’s Awiqli, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes. News release. Morningstar. March 26, 2026. Accessed March 30, 2026. https://www.morningstar.com/news/pr-newswire/20260326ny16941/fda-approves-novo-nordisks-awiqli-the-first-and-only-once-weekly-basal-insulin-treatment-for-adults-with-type-2-diabetes
6. Awiqli - world’s first once-weekly basal insulin – now available in Canada. News release. FirstWord Pharma. June 17, 2024. Accessed March 30, 2026. https://firstwordpharma.com/story/5867528
7. Monaco K. First once-weekly basal insulin approved for type 2 diabetes. MedPage Today. March 27, 2026. Accessed March 30, 2026. https://www.medpagetoday.com/endocrinology/diabetes/120534