Plainsboro, New Jersey, August,11, 2026
Novo Nordisk has announced the nationwide U.S. launch of Awiqli® (insulin icodec-abae) injection 700 units/mL, the first and only FDA-approved once-weekly basal insulin for adults with type 2 diabetes. The launch follows the U.S. Food and Drug Administration approval earlier in 2026 and makes Awiqli available through retail pharmacies across the country. The once-weekly insulin is designed to provide an alternative to daily basal insulin injections, reducing the frequency of basal insulin administration from seven injections per week to one.
Awiqli Introduces Once-Weekly Basal Insulin
Awiqli is a long-acting U-700 insulin indicated as an adjunct to diet and exercise to improve glycemic control in adults living with type 2 diabetes. It is administered once a week on the same day each week using the prefilled Awiqli FlexTouch pen. By offering a weekly dosing schedule, the treatment provides an alternative to conventional daily basal insulin routines, which can be challenging for some people managing long-term diabetes care. Novo Nordisk said the reduced injection frequency may help make basal insulin therapy more manageable for appropriate patients.
The company said Awiqli will be available at more than 70,000 pharmacies nationwide. Novo Nordisk also highlighted affordability and patient-support programs through NovoCare, with eligible patients potentially paying as little as $35 per month. These access initiatives are intended to support adults with type 2 diabetes who may benefit from the newly available weekly insulin option.
Phase 3 ONWARDS Program Supported FDA Approval
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The FDA approval of Awiqli was supported by the ONWARDS type 2 diabetes Phase 3a clinical development program, which evaluated once-weekly insulin icodec in adults with type 2 diabetes across multiple randomized, active-controlled studies. Participants received Awiqli in combination with mealtime insulin or commonly used oral antidiabetic medicines and/or GLP-1 receptor agonists, depending on the individual trial. Across the pivotal ONWARDS program, once-weekly Awiqli demonstrated non-inferiority in mean HbA1c change compared with daily basal insulin at the end of the trials.
The clinical program included diverse adult populations with type 2 diabetes and examined the efficacy and safety of once-weekly insulin administration compared with daily basal insulin. Novo Nordisk reported that across five ONWARDS trials, the overall safety profile of Awiqli was consistent with the daily basal insulin classes used in the respective studies. Reported adverse events included hypoglycemia, injection-site reactions, allergic reactions, lipodystrophy, itching, rash, swelling and weight gain.
Expanding Treatment Options for Type 2 Diabetes
The U.S. launch of Awiqli represents an important development in diabetes treatment and insulin delivery, particularly for adults who may find daily basal insulin administration difficult to maintain. The availability of a once-weekly option could simplify the frequency of injections while retaining basal insulin therapy as part of diabetes management. Novo Nordisk said clinical evidence supports efforts to simplify complex insulin regimens when appropriate, potentially helping address treatment barriers associated with daily injections.
Awiqli is already approved in the United States, European Union and 13 additional countries, with market-specific indications for diabetes. The U.S. launch expands access to the medicine following its regulatory approval and represents a major commercial milestone for Novo Nordisk’s diabetes portfolio. As the first once-weekly basal insulin approved in the United States, Awiqli adds a new dosing option for adults with type 2 diabetes and reflects continued innovation in long-acting insulin therapy. Its nationwide availability brings the results of the ONWARDS clinical development program into routine U.S. treatment settings, while providing clinicians and eligible patients with an alternative to daily basal insulin injections.
Source: Novo Nordisk press release
