Adults with type 2 diabetes who rely on daily long-acting insulin know the routine well: seven injections per week, year after year. Since March 26, 2026, there is an alternative. The FDA approved Awiqli on that date, the world's first once-weekly basal insulin. Instead of 365 injections per year, patients now need only 52.
Two Decades Without a New Insulin Class
Awiqli (active ingredient: Insulin Icodec) is not merely a new formulation but a new drug class. The last fundamentally new basal insulin introduced to the U.S. market was approved more than 20 years ago. Until now, insulins such as glargine or degludec, with a half-life of around 25 hours, have been the long-acting standard. Insulin Icodec has a half-life of more than eight days: the compound binds reversibly to serum albumin circulating in the blood, forming a natural depot from which it is released steadily over seven days.
Awiqli was developed by Novo Nordisk, the Danish pharmaceutical company that also makes Ozempic and Wegovy. The U.S. commercial launch is planned for the second half of 2026. In the European Union, Insulin Icodec is already approved under the brand name Awiqli, as it is in 13 other countries.
What the Trials Show
The approval is based on four Phase 3 trials in the ONWARDS program, enrolling a total of 2,680 adults whose blood sugar was not adequately controlled with existing treatments. The trials compared once-weekly insulin with daily basal insulins across various combination therapies: mealtime insulin, GLP-1 receptor agonists, and oral glucose-lowering agents. In all four trials, Insulin Icodec demonstrated non-inferiority to the daily comparator for blood sugar control as measured by HbA1c. In some trial arms Awiqli performed better.
One important caveat: in the trials, low blood sugar episodes occurred more frequently on days two through four after the weekly injection compared with daily dosing. This is explained by the drug's action profile — insulin concentrations are highest in the days immediately after injection. Patients and physicians need to account for this when adjusting doses.
Why Adherence Matters
Type 2 diabetes affects an estimated 537 million people worldwide according to the International Diabetes Federation (IDF). Many patients who need insulin do not keep up with their therapy consistently. Studies show that injection frequency is a key reason. Fewer injections can increase willingness to maintain treatment over the long term, with direct effects on complications such as kidney damage, vision loss, or amputation.
Novo Nordisk puts the difference in concrete terms: with Awiqli, 52 injections per year are needed versus 365 with daily insulin. For patients that means less planning, fewer supplies, and fewer injections in an already demanding daily life with a chronic condition.
Limitations
Critics in diabetology point out that a lower injection frequency is no guarantee of better blood sugar control. Patients who are already well-managed with daily insulin may benefit less than those who struggle with the daily routine. Awiqli is also approved exclusively for adults with type 2 diabetes, not for people with type 1. In type 1 diabetes, the absence of any endogenous insulin production would require a more stable weekly profile than Insulin Icodec provides.
Outlook
Novo Nordisk expects the U.S. commercial launch in the second half of 2026; a specific date has not been announced. In Germany and other EU countries Awiqli is already available, with reimbursement by public health insurers depending on each country's assessment process. A decision by Germany's Institute for Quality and Efficiency in Health Care (IQWiG) is expected before the end of this year.