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Hubálek, F., Cramer, C. N., Helleberg, H., Johansson, E., Nishimura, E., Schluckebier, G., Steensgaard, D. B., Sturis, J., & Kjeldsen, T. B. (2024). Enhanced disulphide bond stability contributes to t

Drug name

Last update: Aug 2026

Insulin icodec

Developer(s)

Novo Nordisk
export_notes

Drug information

Drug's link(s)
Generic name

Insulin icodec

Brand names

Awiqli

Compound type

Biotherapeutic

Drug class/category

Insulin

Summary

Insulin icodec is an ultra long-acting basal insulin analogue. It is a re-engineered version of the ultra long-acting oral basal insulin OI338, with several modifications introduced to significantly extend the half-life. These modifications - which cause increased serum albumin binding and attenuated insulin receptor affinity - result in a mean half-life of approximately 196 hours, allowing for once-weekly administration.

Approval status

Insulin icodec was approved by Health Canada, EMA, Japan, Australia and Switzerland in 2024 for the treatment of adults living with type 1 or 2 diabetes mellitus. It has also been approved in Chine but only for the T2D indication. In July 2024, the US FDA rejected the approval of insulin icodec, citing concerns regarding manufacturing aspects and the indication being sought for type 1 diabetes.

Regulatory authorities

AWIQLI 700 units/1 ml, 1500 units/1.5 ml, & 2100 units/3 mL is approved by several stringent regulatory authorities for management of type 2 diabetes mellitus (and for some, also type 1 diabetes).

Therapeutic area(s)

  • Diabetes
Use case(s)
  • Treatment

Administration route

Subcutaneous

Associated long-acting platforms

Solution

Use of drug

Ease of administration
  • Administered by a community health worker
  • Administered by a nurse
  • Administered by a specialty health worker
  • Self-administered
Frequency of administration
  • Weekly
User acceptance
The reduced injection frequency of once-weekly insulin icodec has been linked to better adherence and acceptance among patients. Studies suggest that the lower injection burden could facilitate greater willingness to initiate or continue insulin therapy, particularly for individuals who find daily injections challenging. In ONWARDS2, T2DM patients using insulin icodec reported significantly higher satisfaction scores compared to those using daily basal insulins. In contrast, patient satisfaction was lower for insulin icodec compared to insulin degludec in type 1 diabetes (ONWARDS 6 trial).

Dosage

Available dose and strength

700 units/1mL; 1050 units/1.5mL & 2100 units/3mL

Maximum dose

700 units per SC administration

Recommended dosing regimen

For Type 1 Diabetes Mellitus—insulin icodec + bolus insulin combination therapy. For Type 2 Diabetes Mellitus —initial dose is 70 units, monotherapy, or combination therapy with sulfonylurea/GLP-1 agonist. For patients transitioning to Awiqli once-weekly insulin, both T1DM & T2DM—the recommended dose depends on their previous total daily dose of once- or twice-daily basal insulin. The dosage regimen is as follows: If the previous daily dose was 10 units, give 110 units of Awiqli in week 1 and 110 units in week 2. If the previous daily dose was 11 units, give 70 units of Awiqli in week 1 and 120 units in week 2. If the previous daily dose was 12 units, give 80 units of Awiqli in week 1 and 130 units in week 2. If the previous daily dose was 14 units, give 90 units of Awiqli in week 1.

Additional comments

The prefilled injection has a dose range of 10-700 units/injection (increase the dose by 10 units) No proprietary device is required to deliver insulin icodec. It is administered subcutaneously using a pre-filled pen injector, which is similar in design and technique to those used for other insulins. The pen contains a high-concentration formulation of 700 units/mL, ensuring that the injection volume remains comparable to once-daily basal insulin injections

Dosage link(s)

Associated compounds, formulations and regimens

Not provided

Associated technologies

Not provided

Additional information

Not provided

Developer(s)

Novo Nordisk
Originator
Denmark

Novo Nordisk

Novo Nordisk is a global healthcare company specializing in diabetes care. Founded in Denmark in 1923, it is renowned for its leadership in insulin production and diabetes treatments. Novo Nordisk's product portfolio includes insulin analogs, GLP-1 receptor agonists, and other pharmaceuticals for managing diabetes and other chronic conditions.

Drug structure

Scale-up and manufacturing prospects

Scale-up prospects

In 2024, Novo Nordisk has invested 4.1 billion to expand the manufacturing capacity and increase the supply of AWQLI. It has five strategic production sites located in Denmark, the USA, France, Brazil, and China.

Tentative equipment list for manufacturing

Peptide synthesizers, mixers, pH meters, and sterile filtration units. No proprietary device is required to deliver insulin icodec. It is administered subcutaneously using a pre-filled pen injector, which is similar in design and technique to those used for other insulins.

Manufacturing

Manufacturing of Insulin icodec (Schedule D) follows ICH G7 guidelines. The manufacturing process includes: 1. Insulin icodec (Awiqli) is made using recombinant DNA technology in S. cerevisiae. 2. Drug substance steps: cell expansion, fermentation, recovery, concentration, and purification (incl. enzymatic/chemical steps). 3. Drug product: solution prep, mixing, pH/volume adjust, sterile filtration, aseptic fill into cartridges. 4. Final: capped, inspected, assembled, labelled, stored at 2–8°C. 5. Processes & controls are validated and acceptable.

Specific analytical instrument required for characterization of formulation

1. High-Performance Liquid Chromatography (HPLC) 2. Mass Spectrometry (MS) and LC-MS (Liquid Chromatography-Mass Spectrometry) 3. Insulin Assay Kits or Immunoassays

Excipients & delivery device(s)

Proprietary excipients used

Not provided

Novel excipients or existing excipients at a concentration above Inactive Ingredient Database (IID) for the specified route of administration

Not provided

Residual solvents used

Not provided

Delivery device(s)

Pen

Safety, Efficacy and Evidence Summary

Safety

Not provided

Efficacy

Not provided

Evidence Summary

Not provided

References and relevant studies

Not provided

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