Novo Nordisk has launched insulin icodec-abae (Awiqli), the first once-weekly basal insulin approved as an adjunct to diet and exercise for glycemic control in adults with type 2 diabetes (T2D), at pharmacies nationwide.1
The once-weekly formulation replaces 7 daily basal insulin injections with a single weekly dose delivered through the prefilled Awiqli FlexTouch pen. The launch follows FDA approval earlier in 2026 and completion of the ONWARDS phase 3a program.1
“Awiqli represents meaningful progress in the options available for basal insulin therapy for the millions of adults with type 2 diabetes,” Tom Scales, senior vice president of Market Access and Public Affairs and Patient Support Solutions at Novo Nordisk, said in a statement. “As the only once-weekly basal insulin available in the US, Awiqli reduces the frequency of daily basal insulin injections from 7 to 1 per week.”2
Frequently Asked Questions
What is insulin icodec-abae approved for?
Insulin icodec-abae (Awiqli) is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, dosed once weekly.
How does insulin icodec-abae differ from daily basal insulin?
It uses a longer-acting formulation that allows once-weekly dosing via a prefilled FlexTouch pen, replacing seven daily basal injections with one weekly injection.
What did the ONWARDS program show?
Across the phase 3a program, once-weekly icodec-abae met the primary endpoint of noninferiority for HbA1c reduction compared with daily basal insulin comparators, with a safety profile reported as consistent with the daily basal insulin class.
Daily basal insulin regimens remain a common barrier to sustained use among adults with T2D, according to expert consensus cited by Novo Nordisk. Icodec-abae is now the only FDA-approved once-weekly basal insulin on the US market, positioning it as an alternative within a treatment class dominated by daily injectable options. The product also carries approval in the European Union and 13 additional countries, with market-specific indications.1,2
The FDA approval rests on the ONWARDS T2D phase 3a program, which evaluated once-weekly icodec-abae against daily basal insulin comparators. The program enrolled adults with T2D across 4 randomized, active-controlled, treat-to-target trials, 3 conducted open-label and 1 conducted double-blind. Patients received icodec-abae in combination with mealtime insulin or with oral anti-diabetic agents and/or a glucagon-like peptide-1 receptor agonist, depending on trial design.1
Across the program, once-weekly icodec-abae met the primary endpoint of noninferiority for mean change in hemoglobin A1c from baseline to trial end compared with daily basal insulin. Individual trial publications, including ONWARDS 2 and ONWARDS 3, confirmed the noninferiority finding in separate T2D populations.1,3,4
Insulin icodec-abae safety profile and dosing
Across the ONWARDS trials, the safety profile of icodec-abae was reported as consistent with the daily basal insulin comparators used in each study. Novo Nordisk attributed this characterization to the pooled trial program rather than to an independently verified analysis.1
Common adverse events included hypoglycemia, serious allergic reactions, injection-site reactions, lipodystrophy, itching, rash, swelling of the hands and feet, and weight gain. Icodec-abae is administered once weekly via the prefilled FlexTouch pen, injected into the thigh, upper arm, or abdomen on the same day each week. Patients who miss a dose may take it within 4 days of the scheduled day and resume the weekly schedule, or skip the dose entirely once >4 days have passed.1
Icodec-abae carries approval in the US, the European Union, and 13 additional countries, with market-specific indications for diabetes. Novo Nordisk is distributing the product through more than 70,000 US pharmacies and offers affordability support through NovoCare.com, where eligible patients may pay as little as $35 per month. The company also operates a Patient Education Center through the same platform, offering educational resources for adults starting basal insulin therapy.1
References
Awiqli® (insulin icodec-abae) [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2026.
Jude E, Malecki M, Huelgas R, et al. Expert panel guidance and narrative review of treatment simplification of complex insulin regimens to improve outcomes in type 2 diabetes. Diabetes Ther. 2022;13:619-634. https://doi.org/10.1007/s13300-022-01222-2
Philis-Tsimikas A, Asong M, Franek E, et al. Switching to once-weekly insulin icodec versus once-daily insulin degludec in individuals with basal insulin-treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open-label, multicentre, treat-to-target trial. Lancet Diabetes Endocrinol. 2023. https://doi.org/10.1016/S2213-8587(23)00093-1
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. https://doi.org/10.1001/jama.2023.11313
