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EMA-approvedaka Awiqli

Insulin icodec — Complete Research Guide (2026)

Last updated 2026-06-30

TL;DR

Insulin icodec (also known as Awiqli) is a peptide catalogued under Hormones & Metabolic (Once-weekly basal insulin). It is described as: Insulin receptor agonist. Documented context: Type 2 diabetes. Neutral reference entry; EU status: EU-approved prescription medicine.

What is Insulin icodec?

Insulin icodec (brand name Awiqli) is a once-weekly basal insulin analogue engineered to bind reversibly to circulating albumin, creating a large, slowly-released depot that covers basal insulin needs for a full seven days from a single injection.

It is approved in the European Union (2024), Canada, China, Australia, Japan and Switzerland for diabetes mellitus; in the United States the FDA issued a Complete Response Letter in 2024 and it was not FDA-approved at that time, so US availability should be checked before relying on it.

Evidence level is high: efficacy and safety come from the phase 3a ONWARDS 1-6 randomised controlled trial programme in both type 2 and type 1 diabetes.

How does Insulin icodec work?

Icodec is a modified human insulin analogue whose fatty-acid side chain drives strong, reversible albumin binding, giving a half-life of roughly one week so that one weekly dose maintains near-steady basal insulin receptor activation.

Like all insulins it lowers blood glucose by activating the insulin receptor, promoting glucose uptake and suppressing hepatic glucose output.

What does the research say about Insulin icodec?

  • In insulin-naive type 2 diabetes, once-weekly icodec lowered HbA1c at least as effectively as once-daily glargine U100 over the ONWARDS 1 trial. [1]
  • In insulin-naive type 2 diabetes, once-weekly icodec produced a slightly greater HbA1c reduction than once-daily degludec at 26 weeks in ONWARDS 3. [3]
  • Once-weekly dosing cuts basal injections from about 365 to 52 per year and was associated with improved reported treatment satisfaction versus once-daily basal insulin. [8]

Clinical research & studies

The references below are the primary sources cited throughout this guide. Each links directly to PubMed or the regulator. Where evidence is preclinical (animal or in-vitro), that is stated rather than implied.

  • [1] Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin — Rosenstock J et al., The New England Journal of Medicine 2023. (Phase 3a RCT (ONWARDS 1))
  • [2] 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 — Philis-Tsimikas A et al., The Lancet Diabetes and Endocrinology 2023. (Phase 3a RCT (ONWARDS 2))
  • [3] Once-Weekly Insulin Icodec vs Once-Daily Insulin Degludec in Adults With Insulin-Naive Type 2 Diabetes: The ONWARDS 3 Randomized Clinical Trial — Lingvay I et al., JAMA 2023. (Phase 3a RCT (ONWARDS 3))
  • [4] 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 — Mathieu C et al., Lancet 2023. (Phase 3a RCT (ONWARDS 4))
  • [5] Once-Weekly Insulin Icodec With Dosing Guide App Versus Once-Daily Basal Insulin Analogues in Insulin-Naive Type 2 Diabetes (ONWARDS 5): A Randomized Trial — Bajaj HS et al., Annals of Internal Medicine 2023. (Phase 3a RCT (ONWARDS 5))
  • [6] Once-weekly insulin icodec versus once-daily insulin degludec as part of a basal-bolus regimen in individuals with type 1 diabetes (ONWARDS 6): a phase 3a, randomised, open-label, treat-to-target trial — Russell-Jones D et al., Lancet 2023. (Phase 3a RCT (ONWARDS 6))
  • [7] Rationale and design of the phase 3a development programme (ONWARDS 1-6 trials) investigating once-weekly insulin icodec in diabetes — Philis-Tsimikas A et al., Diabetes, Obesity and Metabolism 2023. (Trial-programme design review)
  • [8] Improved treatment satisfaction with once-weekly insulin icodec compared with once-daily basal insulin analogues — Polonsky W et al., Diabetes Research and Clinical Practice 2024. (Patient-reported-outcome analysis)

Dosing context

This is not medical advice or a usage recommendation. Dosing figures are reported research context only, cited from the published literature.

Reported trial regimens used a once-weekly subcutaneous injection with a defined loading approach when switching from daily basal insulin, individualised and adjusted by weekly titration.

All dosing is set by a prescribing clinician for the specific patient; this entry describes trial context only and is not dosing guidance.

Side effects & safety profile

The dominant risk is hypoglycaemia, which can be severe or fatal; because a weekly depot cannot be rapidly withdrawn, a low dose or an intercurrent event (reduced food intake, exercise, illness) can produce prolonged low glucose that is harder to reverse than with daily insulin.

Hypoglycaemia risk was notably higher in type 1 diabetes: in ONWARDS 6 weekly icodec showed more hypoglycaemic events than daily degludec, so once-weekly basal insulin changes how hypoglycaemia must be anticipated and managed.

As with all insulins, weight gain and injection-site reactions can occur, and insulin products are not interchangeable unit-for-unit.

Stacking & combinations

In type 1 and many type 2 regimens icodec is combined with mealtime (bolus) insulin and/or other glucose-lowering agents under clinician supervision, not used as a standalone.

Finding Insulin icodec vendors

Finding Insulin icodec vendors

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Frequently asked questions

It is a once-weekly basal insulin analogue (brand Awiqli) that binds albumin to release insulin slowly over about seven days, so a single weekly injection covers background insulin needs.

References

  1. [1] Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin — Rosenstock J et al., The New England Journal of Medicine 2023. PMID: 37356066. View sourceStudy: Phase 3a RCT (ONWARDS 1)Once-weekly icodec was non-inferior to once-daily glargine U100 for HbA1c reduction in insulin-naive type 2 diabetes.
  2. [2] 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 — Philis-Tsimikas A et al., The Lancet Diabetes and Endocrinology 2023. PMID: 37148899. View sourceStudy: Phase 3a RCT (ONWARDS 2)Switching basal-insulin-treated type 2 patients to weekly icodec gave superior HbA1c control versus daily degludec.
  3. [3] Once-Weekly Insulin Icodec vs Once-Daily Insulin Degludec in Adults With Insulin-Naive Type 2 Diabetes: The ONWARDS 3 Randomized Clinical Trial — Lingvay I et al., JAMA 2023. PMID: 37354562. View sourceStudy: Phase 3a RCT (ONWARDS 3)Weekly icodec produced a greater HbA1c reduction than daily degludec in insulin-naive type 2 diabetes.
  4. [4] 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 — Mathieu C et al., Lancet 2023. PMID: 37156252. View sourceStudy: Phase 3a RCT (ONWARDS 4)Within a basal-bolus regimen, weekly icodec was non-inferior to daily glargine U100 for HbA1c.
  5. [5] Once-Weekly Insulin Icodec With Dosing Guide App Versus Once-Daily Basal Insulin Analogues in Insulin-Naive Type 2 Diabetes (ONWARDS 5): A Randomized Trial — Bajaj HS et al., Annals of Internal Medicine 2023. PMID: 37748181. View sourceStudy: Phase 3a RCT (ONWARDS 5)Weekly icodec with a dosing-guide app safely lowered HbA1c versus daily basal analogues at 52 weeks.
  6. [6] Once-weekly insulin icodec versus once-daily insulin degludec as part of a basal-bolus regimen in individuals with type 1 diabetes (ONWARDS 6): a phase 3a, randomised, open-label, treat-to-target trial — Russell-Jones D et al., Lancet 2023. PMID: 37863084. View sourceStudy: Phase 3a RCT (ONWARDS 6)In type 1 diabetes, weekly icodec met HbA1c non-inferiority but was associated with more hypoglycaemia than daily degludec.
  7. [7] Rationale and design of the phase 3a development programme (ONWARDS 1-6 trials) investigating once-weekly insulin icodec in diabetes — Philis-Tsimikas A et al., Diabetes, Obesity and Metabolism 2023. PMID: 36106652. View sourceStudy: Trial-programme design reviewDescribes the design of the six pivotal ONWARDS trials underpinning icodec's approvals.
  8. [8] Improved treatment satisfaction with once-weekly insulin icodec compared with once-daily basal insulin analogues — Polonsky W et al., Diabetes Research and Clinical Practice 2024. PMID: 39368488. View sourceStudy: Patient-reported-outcome analysisOnce-weekly icodec was associated with improved reported treatment satisfaction versus once-daily basal insulin.
This article is for educational and research purposes only. Peptides discussed here are not approved for human consumption by the FDA, EMA, or equivalent regulators outside of specific clinical contexts. Always consult a licensed medical professional before any therapeutic use.