Brand Name
Awiqli
Generic Name
icodec-abae
View Brand Information FDA approval date: March 26, 2026
Form: Injection
What is Awiqli (icodec-abae)?
Awiqli is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Awiqli is a long-acting human insulin analog indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Approved To Treat
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Related Clinical Trials
A Multi-centre, Prospective, Open Label, Non-interventional, Single-armed, 52 Weeks Post-marketing Study to Investigate Safety and Clinical Parameters of Awiqli Once Weekly in Patients With Diabetes Mellitus Under Real-world Clinical Practice Setting in Japan
Summary: The purpose of the study is to investigate the safety and effectiveness of Awiqli in participants with diabetes mellitus under real world clinical practice in Japan. Participants will get Awiqli as prescribed by the study doctor. The study will last for about 1 year.
Evaluation of the Pharmacokinetics and Pharmacodynamics of IBI3035 and Awiqli? (Ecoporin Insulin Injection) in a Randomized, Open-label, Single-dose, Two-formulation, Crossover Design in Healthy Male Subjects in China: A Phase I Clinical Trial.
Summary: This study is a Phase I clinical trial that uses positive glucose clamping technology to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence of IBI3035 with insulin injection (Awiqli?) after a single administration in healthy male subjects
A Trial to Evaluate Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Insulin GZR4 Compared With Insulin Degludec and Insulin Icodec in Participants With Type 2 Diabetes
Summary: In this study, the investigational product will be compared with insulin degludec (Tresiba®) and insulin icodec (Awiqli®). The comparator products are approved for the treatment of T2DM in the European Union.
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Brand Information
Awiqli (Insulin icodec-abae)
1INDICATIONS AND USAGE
Awiqli is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
2DOSAGE FORMS AND STRENGTHS
Injection: 700 units per mL (U-700) available as a clear and colorless solution:
- 3 mL single-patient-use FlexTouch prefilled pen (containing 2,100 units)
- 1.5 mL single-patient-use FlexTouch prefilled pen (containing 1,050 units)
- 1 mL single-patient-use FlexTouch prefilled pen (containing 700 units)
3CONTRAINDICATIONS
Awiqli is contraindicated:
- During episodes of hypoglycemia
- In patients with hypersensitivity to insulin icodec-abae or any of the excipients in Awiqli FlexTouch. Serious hypersensitivity reactions have included anaphylaxis
4ADVERSE REACTIONS
The following adverse reactions are also discussed elsewhere:
- Hypoglycemia Due to Medication Errors and Accidental Overdose
- Hypoglycemia
- Hypersensitivity reactions
- Hypokalemia
4.1Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of Awiqli in patients with type 2 diabetes was evaluated in five clinical trials involving 1,880 adults with type 2 diabetes exposed to Awiqli, with a mean exposure duration of 26 to 52 weeks across the five trials
Common Adverse Reactions
Hypoglycemia
Hypoglycemia is the most commonly observed adverse reaction in patients treated with Awiqli
In clinical trials
In the clinical trials of patients with type 2 diabetes, percentages of adults randomized to Awiqli who experienced at least one episode of severe or clinically significant (level 2) hypoglycemia in clinical trials are shown in
a Level 3 hypoglycemia is an episode associated with severe cognitive impairment requiring external assistance for recovery.
b Level 2 hypoglycemia is hypoglycemia episode with a self-measured blood glucose level below 54 mg/dL with or without associated symptoms.
c In Trial E, Awiqli arm titration was performed via a digital titration app.
d Excludes sulfonylureas and glinides.
e Sulfonulurea and glinide dosage decreased by 50% at the discretion of the investigator.
Insulin Initiation and Intensification of Glucose Control
Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy.
Allergic Reactions
Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including Awiqli and may be life threatening. Hypersensitivity (manifested with urticaria, swelling of face and lips swelling) were reported in 0.4% of patients treated with Awiqli.
In the three clinical trials in type 2 patients with antibody samples collected (Trial B, C, and D), hypersensitivity reactions occurred in 0.6% of Awiqli-treated patients with anti-insulin icodec-abae antibodies and in 0.4% of Awiqli-treated patients who did not develop anti-insulin icodec-abae antibodies
Lipodystrophy
Long-term use of insulin, including Awiqli, can cause lipodystrophy at the site of repeated insulin injections. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue) and may affect insulin absorption
Injection Site Reactions
Patients taking Awiqli may experience injection site reactions, including pruritus, bruising, erythema, pain, injection site hypersensitivity, swelling, urticaria and injection site mass. In the clinical trials, injection site reactions occurred in 1.8% of patients treated with Awiqli.
In the three clinical trials in type 2 patients with antibody samples collected (Trial B, C, and D), injection site reactions occurred in 2.3% of Awiqli-treated patients with anti-insulin icodec-abae antibodies and in 2.4% of Awiqli-treated patients who did not develop anti-insulin icodec-abae antibodies
Weight Gain
Weight gain can occur with insulin therapy, including Awiqli, and has been attributed to the anabolic effects of insulin. In the clinical trials after 26 to 52 weeks of treatment, patients with type 2 diabetes treated with Awiqli gained an average weight of 1.4 to 2.8 kg.
Peripheral Edema
Awiqli, may cause sodium retention and edema. In the clinical trials, peripheral edema occurred in 1.2% of patients with type 2 diabetes mellitus treated with Awiqli.
5DRUG INTERACTIONS
Table 3 includes clinically significant drug interactions with Awiqli.
Table 3: Clinically Significant Drug Interactions with Awiqli
6OVERDOSAGE
An excess of insulin relative to food intake, energy expenditure, or both may lead to severe and sometimes prolonged and life-threatening hypoglycemia and hypokalemia
7DESCRIPTION
Insulin icodec-abae is a once-weekly basal human insulin analog for subcutaneous injection produced by a process that includes expression of recombinant DNA in
Figure 1: Structural Formula of Insulin icodec-abae
Awiqli (insulin icodec-abae) injection is a sterile, clear and colorless solution available as 700 units/mL (U-700) for subcutaneous use.
Each mL contains 700 units of insulin icodec-abae and glycerin (15 mg), metacresol (1.08 mg), phenol (5.65 mg), sodium chloride (1.17 mg), zinc acetate (101 mcg), and Water for Injection.
Awiqli has a pH of approximately 7.4. Hydrochloric acid or sodium hydroxide may be added to adjust pH.
8HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
Awiqli (insulin icodec-abae) injection is a 700 units/mL (U-700) clear and colorless solution available as follows:
Table 8: Presentations of Awiqli FlexTouch
Awiqli U-700 FlexTouch pen dials in 10 unit increments.
Dispense in this sealed carton with the enclosed Instructions for Use.
Storage and Handling
Dispense in the original sealed carton with the enclosed Instructions for Use.
Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze. Do not use Awiqli if it has been frozen.
The storage conditions are summarized in
Table 9: Storage Conditions for 3 mL, 1.5 mL, and 1 mL Single-patient-use Awiqli FlexTouch Pen
* The total time at room temperature cannot exceed more than 12 Weeks including in-use time.
9PATIENT COUNSELING INFORMATION
Advise the patient and/or caregiver to read the FDA-approved patient labeling (
Hypoglycemia Due to Medication Errors and Accidental Overdose
Advise patients to always check the product label before each injection to confirm they are using Awiqli and not another insulin or injectable antidiabetic medicine. Advise patients using other injectable medications for glycemic control that the dosage selection of Awiqli differs. Instruct patients to visually verify the dialed units on the dose counter of the Awiqli FlexTouch prefilled pen before each injection to avoid dosing errors
Hypoglycemia
Inform patients that hypoglycemia is the most common adverse reaction with insulin. Inform patients of the symptoms of hypoglycemia (e.g., impaired ability to concentrate and react). This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery
Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen
Advise patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia and that changes in insulin regimen should be made under close medical supervision
Hypersensitivity Reactions
Advise patients that hypersensitivity reactions have occurred with Awiqli. Inform patients on the symptoms of hypersensitivity reactions
Never Share an Awiqli FlexTouch Pen or Needle Between Patients
Awiqli FlexTouch disposable prefilled pens should never be shared between patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens
Manufactured by:
Novo Nordisk Inc.
800 Scudders Mill Rd.
Plainsboro, NJ 08536
U.S. License Number 1261
At: Novo Nordisk A/S
Novo Allé
2880 Bagsvaerd
Denmark
www.awiqli.com
For information about Awiqli contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
1-844-668-6463
Novo Nordisk
© 2026 Novo Nordisk
Patent Information: http://novonordisk-us.com/products/product-patents.html
10PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 1 mL Sample Carton
- Awiqli FlexTouch® NDC 0169- 3170 -97
- (insulin icodec-abae) injection List: 317097
- 700 units/mL (U-700) Use Once Weekly
For Single-Patient-Use Only
- For subcutaneous use Pen delivers doses in 10 unit increments only
- Rx only
Dispense in this sealed carton.
Sample not for resale
Contains: 1 x 1 mL Prefilled Pen, 9 disposable needles
11PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 1.5 mL Carton
- Awiqli FlexTouch® NDC 0169- 3105 -11
- (insulin icodec-abae) injection List: 310511
- 700 units/mL (U-700) Use Once Weekly
For Single-Patient-Use Only
- For subcutaneous use Pen delivers doses in 10 unit increments only
- Rx only
Dispense in this sealed carton.
Contains: 1 x 1.5 mL Prefilled Pen, 13 disposable needles
12PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 3 mL Carton
- Awiqli FlexTouch® NDC 0169- 3121 -13
- (insulin icodec-abae) injection List: 312113
- 700 units/mL (U-700) Use Once Weekly
For Single-Patient-Use Only
- For subcutaneous use Pen delivers doses in 10 unit increments only
- Rx only
Dispense in this sealed carton.
Contains: 1 x 3 mL Prefilled Pen, 13 disposable needles
