FDA Approves Awiqli, the First Once-Weekly Basal Insulin for Type 2 Diabetes

The US FDA has approved Awiqli (insulin icodec-abae) injection 700 units/mL, developed by Novo Nordisk, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The decision makes Awiqli the first and only once-weekly basal insulin approved by the US FDA, reducing the injection frequency from seven times per week to one. It is also the first change to basal insulin dosing frequency in more than two decades, since the introduction of once-daily long-acting analogs such as insulin glargine around the year 2000. Awiqli is already approved in the EU and 13 additional countries.

The approval covers use of the weekly insulin in combination with mealtime insulin or with common oral anti-diabetic agents and GLP-1 receptor agonists. It is administered via the Awiqli FlexTouch pen on the same day each week. The product is not approved for use in children or adolescents. Novo Nordisk said Awiqli will be available nationwide in the US in the coming months.

The insulin icodec FDA approval is supported by the ONWARDS Phase IIIa clinical program, which comprised four randomized, active-controlled, treat-to-target trials enrolling approximately 2,680 adults with uncontrolled type 2 diabetes. These trials evaluated once-weekly Awiqli against daily basal insulins, including insulin glargine U-100 (ONWARDS 1) and insulin degludec (ONWARDS 2, ONWARDS 3), across both insulin-naive patients and those switching from daily basal or basal-bolus regimens (ONWARDS 4). The primary endpoint across the program was reduction of HbA1c, and the company reported that Awiqli demonstrated efficacy on this measure. The safety profile was described as consistent with the daily basal insulin class. Common adverse events included hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, itching, rash, peripheral edema, and weight gain.

The approval of Novo Nordisk insulin icodec addresses a long-recognized gap in type 2 diabetes management. Despite the availability of effective daily basal insulins, adherence remains a persistent challenge. Injection fatigue, missed doses, and what clinicians term "psychological insulin resistance" — reluctance among patients and providers to initiate insulin therapy — contribute to suboptimal glycemic control in a substantial proportion of the estimated 37 million Americans living with type 2 diabetes. Research has indicated that weekly injectable diabetes medications may be associated with improved adherence, and Awiqli's once-weekly dosing is designed to reduce the burden that daily injections impose.

The weekly insulin for type 2 diabetes enters a treatment landscape that has been reshaped in recent years by the arrival of GLP-1 receptor agonists such as semaglutide and dual GIP/GLP-1 agonists such as tirzepatide, both of which offer HbA1c reduction alongside weight loss and cardiovascular benefits. Awiqli occupies a distinct niche as a basal insulin rather than an incretin-based therapy, targeting patients who require insulin but may benefit from a less frequent dosing schedule. Eli Lilly is developing insulin efsitora alfa, another once-weekly basal insulin currently in late-stage clinical development, which would make this a directly competitive space if approved. For Novo Nordisk, securing the first-mover position with Awiqli adds to a diabetes portfolio that already includes insulin degludec (Tresiba), insulin aspart (NovoLog), and the combination product Xultophy.

The approval does not resolve all unmet needs in basal insulin therapy. Hypoglycemia risk remains present, weight gain is listed among common side effects, and the program did not include patients with type 1 diabetes. Whether the reduction in injection frequency translates into measurable improvements in real-world adherence and long-term glycemic outcomes will require post-marketing data. Nonetheless, the availability of a once-weekly basal insulin option represents a structural shift in how insulin therapy can be delivered to the large population of adults with type 2 diabetes who need it.

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