FDA approves Novo Nordisk's Awiqli®, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes

PLAINSBORO, N.J., March 26, 2026 /PRNewswire/ -- Novo Nordisk today 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. 1 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. 1,2

"Awiqli ® is an important new option that meets a real need as the first FDA-approved, once-weekly basal insulin for adult patients with type 2 diabetes. It's helping to reframe what basal insulin care can look like," said Anna Windle, PhD, Group Vice President, Clinical Development, Medical & Regulatory Affairs at Novo Nordisk Inc. "Awiqli ® may address challenges associated with the frequency of daily basal injections, by reducing them from seven to one per week. It is an important advancement for adults with type 2 diabetes who may benefit from an alternative treatment option."

This approval is based on results from the ONWARDS type 2 diabetes phase 3a program for once-weekly Awiqli ® injection which comprises four randomized, active-controlled, treat-to-target trials in approximately 2,680 adults with uncontrolled type 2 diabetes, used in combination with a mealtime insulin or in combination with common oral anti-diabetic agents and/or GLP-1 receptor agonists. The clinical program evaluated once-weekly Awiqli ® vs. daily basal insulin and demonstrated efficacy in the primary endpoint of reduction of A1C across the ONWARDS pivotal clinical trial program for adults with type 2 diabetes. Across these ONWARDS trials, the safety profile of Awiqli ® was overall consistent with the daily basal insulin class. 3-6 Common adverse events include hypoglycemia (low blood sugar), serious allergic reactions (whole body reactions), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of your hands and feet, and weight gain. 1

Please see below for Important Safety Information and please click here for the full Prescribing Information.

"The introduction of daily long-acting basal insulin injections more than 20 years ago, with the concept of "treat-to-target," was a major contribution for adults with type 2 diabetes needing basal insulin therapy. However, some adults living with type 2 diabetes may still find it difficult to begin and stay on this type of daily basal insulin therapy. This underscores the need for new alternative insulin options that may help patients work with their health care providers to determine what treatment works best for them," said Julio Rosenstock, MD, a Principal Investigator for the ONWARDS trial program and Clinical Professor of Medicine at the University of Texas Southwestern Medical Center. "Research supports weekly injectable diabetes medications can be associated with improved patient adherence. Having a weekly basal insulin option like insulin icodec-abae, may reshape insulin management in adults with type 2 diabetes, giving them a routine that feels more manageable as they work toward their blood sugar goals."

Awiqli ® will be available nationwide in the US in the coming months. More information is available at www.awiqli.com.

About Awiqli ®

Awiqli ® (insulin icodec-abae) injection 700 units/mL is a prescription medicine and is the first and only FDA-approved once-weekly basal insulin indicated as an adjunct to diet and exercise for adults with type 2 diabetes. 1 Awiqli ® is designed as an alternative to daily basal insulin and its approval is supported by the ONWARDS clinical program, which evaluated its efficacy and safety across diverse adult populations living with type 2 diabetes. 3-6 Awiqli ® is administered once-weekly on the same day each week using the Awiqli ® FlexTouch ®. 1

Awiqli ® is approved in the US, EU, and 13 additional countries, with market-specific indications for diabetes.

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

Important Safety Information

Do not share your Awiqli ® FlexTouch ® pen or needles with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

Make sure you use the right type and dose of insulin. Always check the label on your insulin pen before each injection to avoid mix-ups with Awiqli ® and other insulin products or injectable medicines used to treat diabetes. If you use another injectable medicine to treat your diabetes, pay close attention to how you select your Awiqli ® dosage. The dosage of Awiqli ® is different from other injectable medicines used to treat diabetes.

Always make sure that you select the correct dosage of your Awiqli ® FlexTouch ® pen as prescribed by your healthcare provider, to avoid dosing errors and accidental overdose. People who are blind or have vision problems should not use this pen without help from a person trained to use the pen.

Do not dial the maximum single dosage (700 units) of your Awiqli ® FlexTouch ® pen, unless prescribed by your healthcare provider.

Do not use a syringe to withdraw Awiqli ® from your pen.

Talk to your healthcare provider if you have any questions about how to correctly dose Awiqli ® FlexTouch ®.

Who should not take Awiqli ®?

Do not take Awiqli ® if you:

Before taking Awiqli ®, tell your healthcare provider about all your medical conditions, including if you are:

Talk to your health care provider about low blood sugar and how to manage it.

How should I take Awiqli ® FlexTouch ®?

What should I avoid while taking Awiqli ®?

What are the possible side effects of Awiqli ®?

Awiqli ® may cause serious side effects that can be life-threatening, including:

Your insulin dose may need to change because of change in level of physical activity or exercise, increased stress, change in diet, weight gain or loss, or illness

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

Get emergency medical help if you have trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion

These are not all the possible side effects of Awiqli ®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Please click here for the full Prescribing Information.

About Novo Nordisk

Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs approximately 10,000 people throughout the country across more than 10 manufacturing, R&D and corporate locations in seven states plus Washington DC. For more information, visit novonordisk-us.com, Facebook, Instagram, and X.

Contacts for further information

Media:

Liz Skrbkova (US)

Ambre James-Brown (Global)

+1 609 917 0632

+45 3079 9289

[email protected]

Investors:

Frederik Taylor Pitter (US)

+1 609 613 0568

[email protected]

References:

Awiqli ® is a registered trademark of Novo Nordisk A/S.

Novo Nordisk is a registered trademark of Novo Nordisk A/S.

SOURCE Novo Nordisk