FDA Approves Awiqli (Insulin Icodec-Abae), the First Once-Weekly Insulin for Adults With Type 2 Diabetes

The FDA has approved Awiqli (insulin icodec-abae) to improve glycemic control in adults with type 2 diabetes mellitus. The approval is listed on the FDA Novel Drug Approvals for 2026 page with an approval date of March 26, 2026.

According to the FDA record, Awiqli was the first once-weekly basal insulin approved in the United States. Insulin is a peptide hormone, and this approval is included in peptide approval tracking for that reason, with the product and its labeled adult population stated exactly as the FDA lists them.

The March 26, 2026 action covered adults only. It did not expand the label to any pediatric population, and any later label change would be recorded as its own separate FDA action with its own date.

As with every FDA approval, the decision applies to the specific product, Awiqli, and the specific indication on its label. It does not extend to compounded formulations, research compounds, or any other use of the molecule.