Once-Weekly Insulin Awiqli (Icodec) Receives FDA Approval for Type 2 Diabetes

Once-weekly insulin Awiqli (insulin icodec-abae) won FDA approval on March 26, 2026, becoming the first new class of basal insulin in two decades. The U.S. label is restricted to adults with type 2 diabetes.

April 25, 2026 · 3 min read

The Story at a Glance:

Once-weekly insulin Awiqli (insulin icodec-abae) is the first new class of basal insulin to enter U.S. practice in over 20 years.
FDA approval, dated March 26, 2026, is restricted to adults with type 2 diabetes (T2D) — not type 1.
The decision rests on the ONWARDS phase 3a program: four randomized, active-controlled trials enrolling roughly 2,680 adults with uncontrolled T2D.
Hypoglycemia risk concentrates on days 2 to 4 after dosing, when icodec exposure peaks; CGM use and patient selection matter.

What Happened

Once-weekly insulin reached U.S. patients on March 26, 2026, when the FDA approved Awiqli (insulin icodec-abae), Novo Nordisk’s basal analog, as an adjunct to diet and exercise for adults with type 2 diabetes. The drug delivers a single subcutaneous injection per week using the FlexTouch prefilled pen at U-700 concentration — seven times more concentrated than standard U-100 glargine.

The U.S. label is limited to adults with T2D. The FDA declined to extend approval to type 1 diabetes after a May 2024 advisory committee voted 7–4 against icodec in T1D, citing higher rates of clinically significant or severe hypoglycemia versus daily insulin degludec in the ONWARDS 6 trial.

A July 2024 complete response letter prompted Novo Nordisk to resubmit a T2D-only file in late 2025. Awiqli is the first new class of basal insulin to reach U.S. patients in more than two decades.

Why Once-Weekly Insulin Matters

Adherence to daily basal insulin is poor in real-world practice. Cutting injections from seven to one per week could close that gap, particularly for patients already taking once-weekly GLP-1 receptor agonists (glucagon-like peptide-1), where dosing days can be aligned.

The trade-off with once-weekly insulin is pharmacokinetic. Insulin icodec binds reversibly to albumin and is released gradually, with exposure peaking on days 2 to 4 of the dosing cycle. That depot effect, while convenient, lengthens the recovery window from a hypoglycemic event and removes the option of daily titration.

Key Numbers Behind Once-Weekly Insulin

Awiqli was studied in approximately 2,680 adults across four ONWARDS phase 3a trials. Across the program, A1c reductions with once-weekly insulin were non-inferior to once-daily basal insulin, with a small mean weight increase of about 0.6 kg compared with daily comparators.

A1c reduction (ONWARDS 5): −1.6 percentage points with icodec plus dosing-guide app vs −1.4 with daily basal analogs at 52 weeks (estimated treatment difference −0.38; 95% CI −0.66 to −0.09).
Time in range (ONWARDS 4, basal-bolus users): 66.8% with icodec vs 66.5% with daily glargine, weeks 22 to 26.
Day 2–4 hypoglycemia signal (ONWARDS 3): Combined level 2 or 3 hypoglycemia at 0.35 vs 0.12 events per patient-year exposure (icodec vs degludec; P=0.01) — absolute rates remained below one event per patient-year in both arms.
Switch dose (label): Week 1 only — multiply prior total daily basal dose by 7, then by 1.5; from week 2 onward, prior daily basal × 7.
Missed dose: Take within 4 days; if more than 4 days have passed, skip the dose and resume on the next scheduled day.

What Experts Are Saying

Anne Peters, MD, professor of clinical medicine at the Keck School of Medicine, University of Southern California, told Medscape that some patients will be difficult to manage on a fixed weekly dose:

“Their insulin sensitivity and insulin requirements on a day-to-day basis can vary.” — Anne L. Peters, MD, Keck School of Medicine, USC

Peters supports the approval but stresses individualization and continuous glucose monitoring (CGM = continuous glucose monitoring) at initiation. The FDA’s May 2024 advisory committee, which voted 7–4 against icodec for type 1 diabetes, raised no efficacy or safety concerns about the type 2 program reviewed for this approval.

What’s Next

Awiqli will be available in U.S. pharmacies in the coming months, according to Novo Nordisk. List pricing has not been disclosed. Eli Lilly’s competing once-weekly basal analog, efsitora alfa, has reported phase 3 results in T2D but has not been submitted to the FDA.

The 2026 American Diabetes Association Standards of Care, published before this approval, did not address weekly basal insulin. Updated society guidance and post-marketing hypoglycemia surveillance will shape uptake over the next year.

Bottom Line

Identify candidates for once-weekly insulin: adults with stable activity patterns, predictable meals, and documented struggles with daily basal adherence — especially those already on a weekly GLP-1 agonist.
Avoid in patients with high glycemic variability, hypoglycemia unawareness, advanced renal impairment, or no access to continuous glucose monitoring.
When switching from daily basal: dose Week 1 = (prior total daily basal × 7) × 1.5; from Week 2 onward, prior daily basal × 7. Confirm the U-700 pen and never use a syringe to draw from it.
Counsel patients that hypoglycemia risk is highest on days 2 to 4 after injection; a missed dose can be taken within 4 days, otherwise skipped.

Sources

Novo Nordisk. FDA approves Novo Nordisk’s Awiqli, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes. Press release, March 26, 2026. Novo Nordisk press release on Awiqli FDA approval
Novo Nordisk Inc. Awiqli (insulin icodec-abae) injection — Highlights of Prescribing Information. 2026. Awiqli (insulin icodec-abae) U.S. Prescribing Information (PDF)
Rosenstock J, Bain SC, Gowda A, et al. Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin (ONWARDS 1). N Engl J Med, 2023;389:297–308. ONWARDS 1 in NEJM (Rosenstock et al., 2023)
Lingvay I, Asong M, Desouza C, et al. Once-Weekly Insulin Icodec With Dosing Guide App Versus Once-Daily Basal Insulin Analogues in Insulin-Naive Type 2 Diabetes (ONWARDS 5). Ann Intern Med, 2023;176:1476–1485. ONWARDS 5 in Annals of Internal Medicine (Lingvay et al., 2023)
Tucker ME. FDA Approves First Once-Weekly Insulin for Type 2 Diabetes. Medscape Medical News, March 27, 2026. Medscape coverage of Awiqli FDA approval
Campbell P. FDA Approves Insulin Icodec (Awiqli) as First Once-Weekly Basal Insulin for Type 2 Diabetes. HCPLive, March 27, 2026. HCPLive analysis of Awiqli approval and clinical implications
European Medicines Agency. Awiqli (insulin icodec) — Summary of Product Characteristics. EMA, 2024 (updated 2025). EMA Awiqli Product Information (PDF)