Novo Nordisk Launches First FDA-Approved Weekly Basal Insulin

Novo Nordisk has announced that the US FDA has approved its once-weekly long-acting basal insulin. The insulin, with a concentration of 700 units/mL, has received FDA approval.

President and CEO Mike Doustdar explained that the product is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes.

“The FDA approval of this once-weekly basal insulin offers a new treatment option for diabetes patients who previously relied on daily basal insulin,” Doustdar stated on Monday, 25 May 2026.

The FDA approval is based on results from the ONWARDS phase 3a programme for once-weekly injection in type 2 diabetes, which comprised four randomised clinical trials. These included active-controlled, treat-to-target studies involving approximately 2,680 adults with uncontrolled type 2 diabetes, using the insulin in combination with meal-time insulin or oral anti-diabetic agents and/or GLP-1 receptor agonists.

The clinical trials compared the weekly basal insulin with daily insulin, showing similar reductions in HbA1c levels among adults with type 2 diabetes. Additionally, the safety profile of the weekly basal insulin was consistent with that of daily basal insulin.

“Novo Nordisk’s provision of once-weekly basal insulin reflects our ongoing commitment to advancing healthcare innovation and supporting people with diabetes,” Doustdar said.

“While some pharmaceutical companies are stepping back from insulin, we are reaffirming our commitment to supporting innovation, access, and supply for millions of patients who depend on insulin daily,” he added.

In Indonesia, over 20 million adults live with diabetes. However, awareness and medication adherence remain challenges. A study found that 43.4% of type 2 diabetes patients cited feeling burdened by daily injections as a barrier to adherence, while 28.4% admitted to frequently forgetting their treatment.