FDA Approves Insulin Icodec-abae, First Once-Weekly Basal Insulin for Adults With T2D

The FDA has approved insulin icodec (Awiqli; Novo Nordisk) injection 700 U/mL as an adjunct to diet and exercise to improve glycemic control in adults living with type 2 diabetes (T2D). The news was announced in a release from Novo Nordisk.¹

Positive results from the phase 3a ONWARDS (NCT04848480) program, comprising 4 randomized, active-controlled, treat-to-target trials with 2680 adults with uncontrolled T2D, bolstered insulin icodec toward its approval. Weekly insulin icodec was compared with daily basal insulin; the weekly injection demonstrated significant efficacy in hemoglobin A_1c (HbA_1c) reduction across the clinical trial program, with a consistent and tolerable safety profile.^1-3

Further, findings published in JAMA Network Open determine that, among 564 participants who completed the trial, mean HbA_1c level decreased from 8.6% (observed) to 7.0% (estimated) at 26 weeks in the icodec insulin group, and from 8.5% (observed) to 7.2% (estimated) in the degludec insulin group (estimated treatment difference [ETD]: −0.2 percentage points [95% CI, −0.3 to −0.1]), confirming noninferiority (P < .001) and superiority (P = .002). Additionally, there were no significant differences observed between the different groups for fasting plasma glucose change from baseline to week 26 (ETD: 0 mg/dL [95% CI, −6 to 5]; P = .90), mean weekly insulin dose during the last 2 weeks of treatment, or body weight change from baseline to week 26 (2.8 kg vs 2.3 kg, respectively; ETD: 0.46 kg [95% CI, −0.19 to 1.10]; P = .17).³

Further, combined level 2 or 3 hypoglycemia rates were numerically higher in the icodec group than the degludec group from week 0 to 31 (0.31 vs 0.15 events per patient-year exposure; P = .11) and statistically higher in the icodec group from week 0 to 26 (0.35 vs 0.12 events per patient-year exposure; P = .01).³

Insulin icodec injection is a prescription medicine and is the first and only FDA-approved once-weekly basal insulin indicated as an adjunct to diet and exercise for adults with T2D. The injection is administered once per week on the same day, using the manufacturer’s accompanying FlexTouch device.¹

Insulin icodec was designed as an alternative to daily basal insulin, and with comparable efficacy and safety, it stands to offer adults with uncontrolled T2D a more convenient and tolerable option for glycemic control.¹ Pharmacists will now have a new treatment option in their armory, allowing for more personalized and tailored patient care.

“[This] approval reflects Novo Nordisk’s ongoing efforts to advance health care innovation and strengthen support for people living with diabetes. As the first FDA-approved, once-weekly basal insulin for adults with T2D, it offers an important new treatment option,” Mike Doustdar, president and CEO of Novo Nordisk, said in the news release announcing the approval. “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.”¹

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. 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. doi:10.1097/MS9.0000000000003392

3. 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