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

• 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

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?

• 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 

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:

• are having an episode of low blood sugar (hypoglycemia)
• have an allergy to Awiqli^® or any of the ingredients in Awiqli^®. See the full Patient Information for a complete listing of ingredients in Awiqli^®

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

• have liver or kidney problems
• take other medicines, especially ones called TZDs (thiazolidinediones)
• have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Awiqli^®
• pregnant, planning to become pregnant, or are breastfeeding
• taking new prescription or over-the-counter medicines, vitamins, or herbal supplements

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

How should I take Awiqli^® FlexTouch^®?

• Read the Instructions for Use that come with your Awiqli^® FlexTouch^® pen
• Your healthcare provider should show you how to use Awiqli^® FlexTouch^® pen before you use it for the first time
• Take Awiqli^® exactly as your healthcare provider tells you to. Do not do any conversion of your dose. The dose counter always shows the selected dose in units. Awiqli^® FlexTouch^® pens are made to deliver your insulin dose in units
• Know the type and strength of insulin you take. Do not change the type of insulin you take unless your health care provider tells you to. The amount of insulin and best time for you to take your insulin may need to change if you take different types of insulin
• Inject Awiqli^® FlexTouch^® 1 time each week on any day of the week on the same day each week
• If you need to change the day of the week, you may do so if your last dose has been at least 4 days
• If you have missed your dose, take your missed dose as soon as possible as long as it has been 4 days or less. Then continue the 1 time each week schedule 1 week from the day your missed dose was taken
• If more than 4 days has passed, skip the missed dose and take your next Awiqli^® dose on your regularly scheduled day.
• Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them
• Never inject Awiqli^® FlexTouch^® into a vein or muscle or use Awiqli^® in an infusion pump
• Never use a syringe to remove Awiqli^® from the FlexTouch^® pen
• Do not dilute or mix Awiqli^® with any other insulin or solution
• Awiqli^® FlexTouch^® can be injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen)
• Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
  • Do not use the exact same spot for each injection
  • Do not inject where the skin has pits, is thickened, or has lumps
  • Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin
• Keep Awiqli and all medicines out of the reach of children.

What should I avoid while taking Awiqli^®?

• Do not drive or operate heavy machinery, until you know how Awiqli^® affects you
• Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol

What are the possible side effects of Awiqli^®?

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

• Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include: dizziness or light-headedness, sweating, confusion, fast heartbeat, blurred vision, slurred speech, shakiness, anxiety, irritability, mood changes, hunger and headache
• Severe allergic reactions (whole body reaction). Stop using Awiqli and get medical help right away, if you have any of these signs or symptoms of a severe allergic reaction: a rash over you whole body, trouble breathing, a fast heartbeat or sweating
• Low potassium in your blood (hypokalemia)
• Heart failure in some people if taken with thiazolidinediones (TZDs). This can happen even if you have never had heart failure or heart problems. If you already have heart failure, it may get worse while you take TZDs with Awiqli^®. Tell your health care provider if you have any new or worse symptoms of heart failure including shortness of breath, tiredness, swelling of your ankles or feet, and sudden weight gain

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.

References:

1. Awiqli® (insulin icodec-abae) [package insert]. Plainsboro, NJ: Novo Nordisk Inc.
2. American Diabetes Association Professional Practice Committee for Diabetes*; Facilitating positive health behaviors and well-being to improve health outcomes: Standards of care in diabetes—2026. Diabetes Care 1 January 2026; 49(suppl 1-5):S89–S131. https://doi.org/10.2337/dc26-S005
3. Rosenstock J, Gowda A, Liang B. Weekly icodec versus daily glargine U100 in type 2 diabetes without previous insulin. N Engl J Med. 2023 2023;389(16):1533. doi:10.1056/NEJMc2310221
4. Philis-Tsimikas A, Asong M, Franek E, et al. Switching to once-weekly insulin icodec versus once-daily insulin degludec in individuals with basal insulin-treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open label, multicentre, treat-to-target trial. Lancet Diabetes Endocrinol. 2023 https://doi.org/10.1016/S2213-8587(23)00093-1
5. Lingvay I, Asong M, Desouza C, et al. Once-weekly insulin icodec vs once-daily insulin degludec in adults with insulin-naive type 2 diabetes: the ONWARDS 3 randomized clinical trial. JAMA. 2023;330(3):228–237. doi:10.1001/jama.2023.11313
6. Mathieu C, Ásbjörnsdóttir B, Bajaj H, et al. Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial. 2023 https://doi.org/10.1016/S0140-6736(23)00520-

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