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FDA Clears Awiqli, First Once-Weekly Basal Insulin for Type 2 Diabetes

Weekly dosing could help patients stick with therapy, with doctors urging close glucose monitoring to reduce low-blood-sugar risks.

The clinical trials assessed once-weekly Awiqli with mealtime insulin, oral anti-diabetic agents, and GLP-1 receptor agonists. Credit: Andrzej Rostek / Shutterstock.com.
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Overview

  • Awiqli, which the FDA cleared Monday, is the first long-acting insulin taken once a week for adults with type 2 diabetes.
  • The drug is indicated as an add-on to diet and exercise to improve blood sugar control, with Novo Nordisk planning a U.S. launch in the second half of 2026 using its FlexTouch pen at 700 units per milliliter.
  • Approval rests on four ONWARDS Phase III trials in about 2,680 adults that showed A1c reductions comparable to or better than daily basal insulin regimens.
  • Safety data showed a numerical uptick in clinically significant or severe hypoglycemia in some studies, including ONWARDS 1, and a 2024 FDA panel opposed use in type 1 diabetes over low-blood-sugar concerns.
  • Endocrinologists recommend careful patient selection and, ideally, continuous glucose monitoring because a weekly dose is hard to adjust if activity or health status changes, and some warn that insurance hurdles could limit access.