"The FDA has approved the first once-weekly basal analog insulin, Novo Nordisk’s icodec-abae (Awiqli injection 700 units/mL), for adults with type 2 diabetes (T2D).

"The product is already approved in the EU and 13 other countries, including Canada, Australia, and Japan. In the US, the FDA issued the company a “complete response letter” in July 2024 to its first biologic license application for icodec for use in people with both major diabetes types, in part because of concerns regarding hypoglycemia risk in type 1 diabetes (T1D). In May 2024, an FDA advisory panel voted against its use in T1D while expressing no safety concerns about its use in T2D.

"“Novo Nordisk finally agreed with the FDA to focus on T2D where it had the best data,” independent industry consultant Charles Alexander, MD, told Medscape Medical News, adding, “It definitely adds a convenient regimen for those with T2D who need insulin, especially for those who are also taking a once-weekly GLP-1 or dual [receptor agonist].”

"Awiqli (insulin icodec) is an FDA-approved, once-weekly long-acting basal insulin for adults with type 2 diabetes. It replaces the need for daily, 7-day-a-week insulin shots with just a single weekly injection. Awiqli is injected under the skin (subcutaneously) using the FlexTouch prefilled pen on the same day every week. (AI Overview)

Key Details About Awiqli Injections

• How It Works: Basal insulin is a background, long-lasting insulin that keeps blood sugar steady between meals and overnight. Awiqli uses a modified molecular structure that binds to a protein in your blood (albumin) and releases insulin slowly throughout the entire week.
• Injection Sites: You can inject Awiqli into your stomach (at least 2 inches away from your belly button), upper arm, or thigh. Be sure to rotate the exact spot you use each week to prevent skin lumps.
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• FlexTouch Pen: The pen is designed to deliver doses in 10-unit increments. Your healthcare provider must show you how to use it before your first dose.
• Dosing: Do not mix Awiqli with other insulins in the same syringe, and never inject it directly into a vein or muscle.

Important Safety Information

• Low Blood Sugar (Hypoglycemia): The most common side effect is low blood sugar. This risk is higher if you also take other medications like insulin or sulfonylureas.
• Side Effects: Other possible side effects include injection site reactions, allergic reactions, itching, rash, swelling, and weight gain. [1, 2]

Note: Awiqli is not recommended for children or adolescents.

"The first once-weekly basal insulin analog is insulin icodec-abae (brand name Awiqli). Approved by the U.S. Food and Drug Administration (FDA) and other global agencies, this once-weekly injection drastically reduces the traditional 365 daily basal shots down to just 52 injections per year for adults with Type 2 diabetes.

How It Works and What It Does

Basal insulin is a "background" insulin that keeps blood sugar steady throughout the day and night. Historically, patients took daily shots to maintain this balance.

Insulin icodec-abae achieves a weekly duration through a molecular modification.

"The FDA has approved Novo Nordisk’s Awiqli (insulin icodec-abae), making it the first once-weekly basal insulin available in the U.S. for adults with type 2. This follows previous approvals from the European Union, Canada, Australia, India, Japan, China, and eight other countries," the Dia Tribe Learn says.

The insulin is to be injected using a prefilled pen on the same day each week.  The prescribing information notes that when switching from daily basal insulin, glucose levels need to be monitored closely because dosing is different with Awiqli's long-lasting action, and hypoglycemia remains the most common side effect.

Weekly dosing comes with its own learning curve, and the label makes clear that dose mix-ups and low blood sugar are important concerns. But for anyone with type 2 who has delayed starting basal insulin, struggles to consistently take a daily shot, or just wants a simpler routine, once-weekly insulin could be a better fit.

"Awiqli (insulin icodec) is the first and only once-weekly, long-acting basal insulin for adults with type 2 diabetes. By taking one injection a week instead of every day, it reduces yearly injections from 365 to 52, making it easier for people to manage their blood sugar.



Awiqli works by slowly releasing insulin over seven days. Because the insulin sticks to a normal body protein in your blood (called albumin), it stays in your body much longer than daily insulin.

"What is Awiqli^® (insulin icodec-abae) injection 700 units/mL?

• Prescription Awiqli^® is a long-acting insulin (U-700) that is used to control high blood sugar in adults with type 2 diabetes mellitus
• It is not known if Awiqli^® is safe and effective in children and adolescents
• Awiqli^® is available in 1 concentration: U-700  (Source: Awiqli)

PLAINSBORO, N.J. -- Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved Awiqli^® (insulin icodec-abae) injection 700 units/mL, the first and only once-weekly, long-acting basal insulin, indicated as an adjunct to diet and exercise to improve glycemic control (blood sugar) in adults living with type 2 diabetes," Novo Nordisk says.

This new approval offers the only once‑weekly basal insulin option, recognizing the importance of personalized care and the need for treatments that fit different patient routines and preferences for adults living with type 2 diabetes.¹

• Awiqli^® (insulin icodec-abae) injection is the first-ever once-weekly basal insulin approved by the FDA¹
• Awiqli^® offers adults with type 2 diabetes an alternative to daily basal insulin injections, reducing these injections from seven to one per week¹
• The Awiqli^® approval reflects Novo Nordisk's ongoing efforts to advance healthcare innovation and strengthen support for people living with diabetes.