Novo Nordisk’s Awiqli Wins FDA Approval as First Once-Weekly Insulin

The FDA has approved Awiqli (insulin icodec), Novo Nordisk’s once-weekly basal insulin, offering a new treatment option for adults with type 2 diabetes. 

The therapy is the first and only insulin of its kind, reducing the need for daily injections to just one per week.

The approval represents a significant milestone, introducing the first new class of basal insulin in more than two decades and a shift toward more patient-friendly dosing regimens.

Basal insulin, sometimes called “background” insulin, helps regulate blood glucose levels throughout the day. Traditionally, patients with type 2 diabetes who require insulin must inject it once daily, creating a routine that can be difficult to maintain over time.

Awiqli changes that paradigm. By extending insulin’s duration of action to a full week, the therapy reduces injections from seven per week to just one, a shift that could improve adherence and quality of life for many patients.

Missed doses remain a persistent challenge in diabetes care. Studies suggest that patients often skip multiple injections per week, which can lead to poorer glycemic control. A once-weekly option may help address this gap by simplifying treatment schedules.

Awiqli is an ultra-long-acting insulin analogue engineered to remain active in the body for more than a week. Its extended half-life, over eight days, is achieved through molecular modifications that allow it to bind to albumin and release slowly into circulation.

This prolonged action enables steady glucose control with a single weekly injection, rather than the peaks and troughs associated with shorter-acting insulins.

Awiqli is administered using Novo Nordisk’s FlexTouch pen.

The FDA’s decision is supported by results from Novo Nordisk’s ONWARDS Phase III clinical program, which evaluated once-weekly insulin icodec in adults with type 2 diabetes.

In one key trial involving insulin-naïve patients, Awiqli demonstrated greater reductions in HbA1c compared to once-daily insulin glargine, a widely used standard-of-care therapy.

Across multiple studies involving thousands of patients, the therapy showed effective blood glucose lowering, a safety profile comparable to daily basal insulin, and consistent performance across different treatment settings.

“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 at Novo Nordisk, in a company news release. 

“Awiqli may address challenges associated with the frequency of daily basal injections, by reducing them from seven to one per week. It is an important advancement for adults with type 2 diabetes who may benefit from an alternative treatment option.”

The approval is currently only extended to adults with type 2 diabetes.

Earlier regulatory discussions raised concerns about the risk of hypoglycemia in people with type 1 diabetes, and the therapy has not yet been approved for that population.

Novo Nordisk’s approval positions the company at the forefront of a new diabetes category. Other pharmaceutical companies, namely fierce GLP-1 competitor Eli Lilly, are developing their own once-weekly insulin candidates. 

Last June, Lilly reported that its once-weekly insulin efsitora alfa led to A1C reduction and a safety profile consistent with daily insulin in several Phase III trials. 

Novo Nordisk expects to launch Awiqli in the US in the second half of 2026, with the product already approved in Europe and other markets.