Awiqli Weekly Insulin: 52 Shots a Year for Type 2 Diabetes

Awiqli Weekly Insulin Cuts Basal Injections from 365 to 52 a Year

The FDA approved Awiqli (insulin icodec-abae) injection 700 units/mL on March 26, 2026 — making it the first and only once-weekly, long-acting basal insulin for adults with type 2 diabetes. For anyone who has spent years giving themselves a daily insulin shot, that number is worth sitting with: 52 injections a year instead of 365.

The approval makes insulin icodec the first new class of basal insulin to reach US patients in more than two decades. That alone signals how significant this step is in diabetes care.

What Is Awiqli and How Does It Work?

Awiqli's active ingredient, insulin icodec-abae, loosely attaches to a blood protein called albumin, forming a reservoir that slowly and steadily releases insulin into the bloodstream throughout the week. This mechanism is what separates it from every other basal insulin currently on the market — all of which require daily dosing.

Awiqli comes as a FlexTouch pen containing 700 units of insulin per mL. It delivers doses in 10-unit increments, with a maximum single injection of 700 units; doses requiring more than 700 units must be split into two injections.

One practical detail worth noting: Awiqli is formulated at a concentration of 700 units/mL (U-700) — substantially more concentrated than standard U-100 formulations such as insulin glargine — and this distinction carries meaningful dosing error implications. The prescribing information includes explicit warnings against using a syringe to withdraw insulin from the pen, dialing the maximum single dose of 700 units unless specifically prescribed, and mixing or diluting the product with any other insulin.

[REVIEWER: add clinical insight here — e.g., practical considerations when transitioning a patient from daily basal insulin to Awiqli, including titration guidance and what to monitor in the first few weeks]

What Did the Clinical Trials Show?

The FDA approval rests on the ONWARDS type 2 diabetes phase 3a program — four randomized, active-controlled, treat-to-target trials in approximately 2,680 adults with uncontrolled type 2 diabetes. The trials compared Awiqli head-to-head against leading daily basal insulins.

The results were consistent. In ONWARDS 1, a 78-week trial in 984 insulin-naive adults, Awiqli produced a mean HbA1c reduction of –1.55% versus –1.35% with once-daily insulin glargine U100. In ONWARDS 3, Awiqli achieved a mean HbA1c reduction of –1.57% compared to –1.36% with insulin degludec at week 26. In ONWARDS 4, which evaluated Awiqli in combination with mealtime insulin, it demonstrated noninferiority to insulin glargine U100, with mean HbA1c reductions of –1.16% and –1.18%, respectively.

Pooling data across all five ONWARDS trials, a meta-analysis of 3,764 participants found that once-weekly icodec produced a greater HbA1c reduction compared to other insulin analogues (mean difference –0.17%, p = 0.003), with no significant difference in fasting plasma glucose.

What about low blood sugar? Icodec was associated with a similar incidence but slightly higher rate of clinically significant hypoglycemia, equating to approximately one additional hypoglycemic episode every six years, and fewer severe hypoglycemic episodes versus comparators. That's a meaningful distinction — fewer severe lows, with a modest increase in milder ones.

Hypoglycemia risk concentrates on days 2 to 4 after dosing, when icodec exposure peaks; CGM use and patient selection matter.

Who Is Awiqli For — and Who Is It Not For?

Awiqli's indication is as an adjunct to diet and exercise for improved glycemic control, as well as for patients also taking mealtime insulin or another common oral antidiabetic agent and/or a GLP-1 receptor agonist.

It is not approved for type 1 diabetes. A May 2024 FDA advisory committee voted 7–4 against concluding that the benefits of insulin icodec outweigh its risks in type 1 diabetes; the committee did not evaluate its use for type 2 diabetes.

Awiqli should not be used during episodes of low blood sugar (hypoglycemia) or in those with a known allergy to its ingredients. Use with caution in patients with liver or kidney problems, heart failure, or those taking thiazolidinediones (TZDs), as the combination may worsen heart failure. It is not currently approved for use in children or adolescents.

Common side effects include hypoglycemia, serious allergic reactions, reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of the hands and feet, and weight gain.

[REVIEWER: add clinical insight here — e.g., which patient profiles in your practice are you most likely to consider for Awiqli, and any patient populations where you'd advise extra caution beyond the prescribing label]

Why Does Injection Frequency Matter?

Adherence to daily insulin is a recognized challenge in type 2 diabetes management. Patients skip doses, delay starting insulin therapy, or discontinue it altogether — often because of the daily ritual and the psychological weight it carries. Novo Nordisk notes that some adults with type 2 diabetes find it difficult to begin and stay on daily basal insulin therapy, underscoring the need for alternative insulin options.

Reducing injections from 365 to 52 per year is not a cosmetic change. For many patients, it removes a significant daily friction point. Whether that convenience translates into better long-term glycemic outcomes will depend on real-world adherence data — which won't exist until the drug is in wider use.

According to CDC data, 28.8 million adults have been diagnosed with diabetes, and up to 95% of them have type 2. Even a modest shift in adherence rates across that population carries meaningful public health weight.

When Will Awiqli Be Available?

Awiqli is expected to be available in pharmacies in summer 2026. List pricing has not been disclosed. Novo Nordisk has not announced cost or insurance coverage details ahead of the commercial launch.

For context on the competitive landscape: Eli Lilly's competing once-weekly basal analog, efsitora alfa, has reported phase 3 results in type 2 diabetes but has not been submitted to the FDA. Awiqli enters the market as the only approved product in its class.

FAQ

What is Awiqli used for?
Awiqli is a once-weekly long-acting basal insulin injection approved by the FDA for adults with type 2 diabetes. It helps lower blood sugar levels when used along with a healthy diet and regular exercise. It is not approved for type 1 diabetes.

How is Awiqli different from daily insulin?
Standard basal insulins like glargine or degludec require one injection every day. Awiqli is designed to cover basal insulin requirements for a full week with a single subcutaneous injection, reducing yearly injections from 365 to 52.

What are the main side effects of Awiqli?
Common side effects may include hypoglycemia, injection site reactions, lipodystrophy (skin thickening or pits), itching, rash, swelling of the hands and feet, and weight gain. Talk to your doctor about your individual risk profile before starting.

Is Awiqli approved for type 1 diabetes?
No. Awiqli is specifically indicated for treating adults with type 2 diabetes and is not approved for use in type 1 diabetes. A 2024 FDA advisory panel voted against recommending it for type 1 due to insufficient data on benefit-risk balance in that population.

When will Awiqli be available at pharmacies?
Awiqli is expected to be available in the second half of 2026. Novo Nordisk has not yet announced the list price or detailed insurance coverage plans.