FDA approves Novo Nordisk’s Awiqli (insulin icodec-abae), the first once-weekly basal insulin for adults with type 2 diabetes, supported by results from the ONWARDS phase 3 program.
Written By: Anand Sathappan, BPharm
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration (FDA) has approved Awiqli (insulin icodec-abae) injection 700 units/mL, a once-weekly long-acting basal insulin developed by Novo Nordisk for adults living with Type 2 Diabetes. The therapy is indicated as an adjunct to diet and exercise to improve glycaemic control and represents the first once-weekly basal insulin approved in the United States.
The approval introduces a new insulin dosing approach intended to reduce the burden of daily basal insulin injections for many patients managing type 2 diabetes.
Regulatory clearance was supported by results from the ONWARDS phase 3a clinical programme, which included four randomized, active-controlled, treat-to-target trials involving approximately 2,680 adults with uncontrolled type 2 diabetes. In these studies, once-weekly Awiqli was evaluated in combination with mealtime insulin or alongside commonly used oral anti-diabetic agents and/or GLP-1 receptor agonists.
Across the ONWARDS trials, Awiqli achieved the primary endpoint of HbA1c reduction, demonstrating glycaemic control comparable to daily basal insulin therapy. The overall safety findings were consistent with the established safety profile of the basal insulin class.
Commenting on the approval, Mike Doustdar, president and CEO of Novo Nordisk, said the milestone reflects the company’s continued focus on diabetes innovation and patient access to insulin therapies. He noted that while parts of the industry are scaling back insulin investments, Novo Nordisk remains committed to advancing treatment options and ensuring supply for people who rely on insulin every day.
Novo Nordisk plans to launch Awiqli in the United States in the second half of 2026, with the therapy delivered through the FlexTouch injection device. The product has also been approved in the United States, the European Union, and 13 additional countries, with indications varying by market.
Awiqli (insulin icodec-abae) is administered once weekly on the same day each week, providing a long-acting basal insulin option designed as an alternative to traditional daily dosing.
Reference
FDA approves Novo Nordisk’s Awiqli (insulin icodec-abae), the first once-weekly basal insulin for adults with type 2 diabetes, supported by results from the ONWARDS phase 3 program, 27 March 2026, News Details
About the Writer
Anand Sathappan is a pharmacy graduate with interests in pharmaceutical sciences, pharmacology, and medical writing. He also holds certification in medical coding and has familiarity with pharmacology and healthcare documentation. He has completed the Medical Writing Skills for Beginners program offered by the International Medical Writers Association (IMWA). His work focuses on exploring developments in pharmaceuticals and presenting scientific information in a clear and structured manner.