FDA Approves First Once-Weekly Insulin Shot for Type 2 Diabetes, Offering Major Relief from Daily Injections
The U.S. Food and Drug Administration has approved Awiqli (insulin icodec-abae), the first once-weekly basal insulin for adults with type 2 diabetes. Developed by Novo Nordisk, the long-acting injection represents a significant advance in diabetes care by reducing the typical seven daily basal insulin shots to just one per week. Approved on March 26, 2026, Awiqli became available nationwide in August 2026 at more than 70,000 pharmacies, giving patients a new option that prioritizes convenience without sacrificing glycemic control.
Type 2 diabetes affects more than 36 million people in the United States. A substantial portion of these individuals eventually require basal insulin—the background insulin that keeps blood sugar steady between meals and overnight—when oral medications, lifestyle changes, or other injectables such as GLP-1 receptor agonists are no longer enough. Traditional basal insulins such as insulin glargine or insulin degludec demand daily injections. For many patients, this routine becomes burdensome. Missed doses, injection fatigue, and the psychological weight of needles can undermine adherence and lead to poorer long-term control. Awiqli was designed specifically to address that treatment burden.
Awiqli is a modified human insulin analog engineered for ultra-long action. Three amino acid substitutions and a C20 fatty diacid side chain allow the molecule to bind strongly yet reversibly to albumin in the bloodstream. This creates an inactive circulating depot from which the insulin is slowly and steadily released. The result is a half-life of approximately 196 hours—about eight days—delivering a relatively even glucose-lowering effect across an entire week. Steady-state levels are typically reached after three to four weekly doses. One unit of Awiqli provides glucose-lowering activity comparable to one unit of daily basal insulin, so weekly doses are generally seven times the previous daily amount.
The FDA based its decision on the ONWARDS phase 3a clinical program. Four randomized, treat-to-target trials enrolled roughly 2,680 adults with uncontrolled type 2 diabetes. Participants used Awiqli either with mealtime insulin or in combination with common oral diabetes medications and/or GLP-1 receptor agonists. Across the studies, once-weekly Awiqli met the primary endpoint of non-inferiority in HbA1c reduction compared with daily basal insulins. In several trials it showed statistical superiority.
In the 52-week ONWARDS 1 trial of insulin-naïve patients, Awiqli lowered HbA1c by an average of 1.55 percent versus 1.35 percent with daily insulin glargine U100, an estimated treatment difference of –0.18 to –0.19 percent. Similar advantages appeared in other insulin-naïve and previously insulin-treated cohorts. Continuous glucose monitoring data also favored Awiqli in some studies, with patients spending more time in the target range of 70–180 mg/dL. A meta-analysis of multiple trials found a modest overall advantage of about 0.14–0.17 percent greater HbA1c reduction with the weekly insulin.
Safety findings were generally consistent with the basal insulin class. Hypoglycemia remains the most common adverse reaction. Rates of clinically significant or severe hypoglycemia were low but numerically higher with Awiqli in some trials (for example, 0.30 versus 0.16 events per patient-year in one comparison with glargine). Severe events requiring external assistance were uncommon. Other reported side effects include injection-site reactions, lipodystrophy, hypersensitivity reactions such as rash or swelling, edema, pruritus, and modest weight gain. Because of its long half-life, dose adjustments are generally not recommended during short-term illness or temporary changes in diet or activity; clinicians instead adjust other medications or carbohydrate intake as needed.
Awiqli is supplied in prefilled FlexTouch pens at a concentration of 700 units/mL (U-700). The pens deliver doses in 10-unit increments up to 700 units. For insulin-naïve patients the recommended starting dose is 70 units once weekly. Patients switching from daily basal insulin follow a specific conversion schedule that accounts for the prolonged action, typically beginning with a higher first dose followed by titration based on blood glucose monitoring. Injections are given subcutaneously in the thigh, abdomen, or upper arm on the same day each week, with or without food. The product is not indicated for type 1 diabetes in the United States. An earlier application that included type 1 patients was rejected after an FDA advisory committee raised concerns about higher hypoglycemia risk in that population, along with manufacturing questions. Novo Nordisk later resubmitted data focused solely on type 2 diabetes.
Experts view the weekly option as particularly useful for patients who struggle with daily adherence—those with busy schedules, memory challenges, disabilities, or living situations where frequent nursing visits are difficult. It may also pair conveniently with once-weekly GLP-1 therapies already used by many people with type 2 diabetes. Some clinicians note that the long duration of action requires careful patient education to avoid dose mix-ups or delayed recognition of hypoglycemia. Others describe it as a niche but valuable addition rather than a wholesale replacement for daily insulin.
Affordability programs through NovoCare.com offer eligible commercially insured or Medicare patients costs as low as $35 per month, with options for uninsured individuals as well. The concentration difference from standard U-100 insulins means careful handling is essential to prevent dosing errors when both products are present in a household.
Awiqli is already approved in the European Union, Canada, Japan, Australia, China, and more than a dozen other countries. Its U.S. arrival completes a multi-year regulatory path that began with phase 3 data presentations in 2023. By simplifying one of the most demanding aspects of insulin therapy, the once-weekly basal insulin gives clinicians and patients a practical new tool. For adults with type 2 diabetes who need basal insulin, the ability to replace 365 injections a year with 52 represents a meaningful step toward more manageable, sustainable care. As real-world experience accumulates, its place in treatment algorithms will become clearer, but the core promise is already evident: effective glucose control with far fewer needles.
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