In a major development for diabetes care, the FDA has approved Awiqli®, the first and only once‑weekly basal insulin for adults with type 2 diabetes. This marks a meaningful shift in treatment options for people who currently rely on daily basal insulin injections.
According to Novo Nordisk, Awiqli® (insulin icodec‑abae) is designed to help improve blood sugar control when used alongside diet and exercise. What makes it stand out is its dosing schedule: instead of seven injections per week, adults with type 2 diabetes can now take just one. For many, this could make insulin therapy less burdensome and easier to maintain.
The FDA’s decision is based on results from Novo Nordisk’s ONWARDS clinical trial program, which included about 2,680 adults with type 2 diabetes. These studies compared once‑weekly Awiqli® with standard daily basal insulin. Across the trials, Awiqli® showed effective reductions in HbA1c — a key measure of long‑term blood sugar control — and its safety profile was described as consistent with existing basal insulin options.
Novo Nordisk says it plans to launch Awiqli® in the United States in the second half of 2026, using its FlexTouch® injection device. The medicine has already been approved in the European Union and more than a dozen other countries.
This approval comes at a time when parts of the industry are scaling back insulin development. Novo Nordisk emphasized that it remains committed to innovation and access for people who rely on insulin every day.
For more details, you can read the full press release from Novo Nordisk:
https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=916521#
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