Novo Nordisk Resubmits Insulin Icodec Injection to FDA for Potential First Once-Weekly Basal Insulin Therapy for T2D

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Novo Nordisk has resubmitted its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for insulin icodec (Awiqli) injection, a once-weekly basal insulin for adults with type 2 diabetes, the company announced September 29, 2025. If approved, it would become the first once-weekly basal insulin available in the US.¹

The application is supported by results from the ONWARDS phase 3a program, which included 5 randomized, active-controlled, treat-to-target clinical trials enrolling approximately 4 000 adults with type 2 diabetes. The primary endpoint across the program was change in HbA_1C from baseline, comparing once-weekly insulin icodec with standard daily basal insulin.¹

Findings from ONWARDS 2, a 26-week study of 526 participants, demonstrated noninferiority of once-weekly insulin icodec compared with daily insulin degludec in reducing HbA_1C. From a baseline HbA_1C of 8.13%, participants receiving insulin icodec achieved a superior reduction of 0.93% compared with 0.71% for insulin degludec, with an estimated treatment difference of −0.22%. Rates of hypoglycemia did not differ significantly between groups, and no severe hypoglycemia events were reported in the icodec cohort. Severe or clinically significant hypoglycemia events occurred at a rate of 0.73 per patient-year with icodec versus 0.27 per patient-year with degludec. Overall, insulin icodec was well tolerated.³

"With this resubmission, we're closer to offering a new insulin treatment option for people living with type 2 diabetes that, if approved, could reduce their yearly basal insulin injections from 365 to 52," Anna Windle, PhD, Senior Vice President, Clinical Development, Medical and Regulatory Affairs at Novo Nordisk, said in a statement.¹ "It is critical that we continue to build upon our 100-year legacy in diabetes and long-standing mission to advance science and the ONWARDS clinical program supports our hope that [insulin icodec] can help streamline the basal insulin injection regimen for people living with type 2 diabetes."

Insulin icodec is a novel once-weekly basal insulin analog designed to meet basal insulin requirements for a full week with a single subcutaneous injection. The current resubmission addresses issues outlined in the FDA’s complete response letter received in the third quarter of 2024.²

Awiqli has already received approval in the European Union and 12 other countries. Regulatory filings have been completed in several additional markets, with decisions expected in 2025.¹

References:

1. Novo Nordisk. Novo Nordisk resubmits Awiqli to the FDA with potential to be the first once-weekly basal insulin treatment for adults with type 2 diabetes. Press release. September 29, 2025. Accessed September 29, 2025. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=916432
2. Halsey G. FDA Issues CRL to Novo Nordisk for Once-Weekly Insulin Icodec. Patient Care Online. July 11, 2024. Accessed September 29, 2025. https://www.patientcareonline.com/view/fda-issues-crl-to-novo-nordisk-for-once-weekly-insulin-icodec
3. Jennings S. Novel Once-Weekly Insulin Icodec Found Superior vs Insulin Degludec in Reducing HbA1c in Type 2 Diabetes. Patient Care Online. April 29, 2022. Accessed September 29, 2025. https://www.patientcareonline.com/view/novel-once-weekly-insulin-icodec-found-superior-vs-insulin-degludec-in-reducing-hba1c-in-type-2-diabetes