Once-weekly insulin icodec (Awiqli)
Novo Nordisk
What it is
A once-weekly basal insulin for adults. In ONWARDS 6, 582 adults with type 1 diabetes had similar HbA1c reductions to daily degludec at 26 weeks, but more level 2 or 3 hypoglycemia. Some jurisdictions permit adult type 1 use with precautions; the US indication covers adult type 2 diabetes only.
Editorial review: .
Most recent recorded citation date: 2023-10-17. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence behind this assessment
Key evidence notes. Study results, product eligibility and access answer different questions.
- Who was studied?
- Study populations and analysis groups vary. Product age limits alone do not describe who was studied.See the linked studies and their populations →
- Benefit or performance
- Consistency: In ONWARDS 6, level 2 or 3 hypoglycemia occurred at 19.93 versus 10.37 events per patient-year with icodec and degludec over 26 weeks. The separate severe-event rate estimate was imprecise; this does not establish equal severe-hypoglycemia risk.[1]
- Important harms and treatment burden
- Read the safety discussion and original sources. A missing summary does not establish safety.
- Approval and country access
- Adult type 1 labeling checked for the EU, Canada, Australia and Japan; the US label is type 2 only. Canada lists a marketed product. Other local supply and reimbursement were not confirmed.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
- Follow-up and remaining uncertainty
- Read the full discussion and original sources for follow-up duration and study limitations.
Editorial score: calculation and evidence
A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.
Score limitations. Scores are retained editorial judgments, not validated clinical measurements or probabilities. Weekly flatness estimates come from a type 2 diabetes model and do not establish comparative type 1 safety. The access score is not a country-specific coverage assessment.
Default calculation: 50 × 20 + 80 × 25 + 58 × 15 + 56 × 20 + 30 × 10 + 45 × 10 = 5740; divide by total weight 100. Unrounded weighted result: 57.4.
Basal-role convention: albumin binding and reduced receptor affinity prolong exposure. This explains a weekly regimen but does not provide a validated numerical onset grade or establish a type 1 safety advantage.[4]
Basal-role convention (less variation is preferred): a model in 32 people with type 2 diabetes allocated 12.0–16.3% of weekly glucose lowering to each day. This was modeled from clamp data, not a directly observed seven-day profile or proof of peakless action in type 1 diabetes.[4]
The EU label describes an approximately one-week half-life and warns that prolonged action may delay recovery from hypoglycemia. Long exposure supports weekly dosing but limits short-term flexibility; it is not evidence of universally forgiving coverage.[1]
In ONWARDS 6, level 2 or 3 hypoglycemia occurred at 19.93 versus 10.37 events per patient-year with icodec and degludec over 26 weeks. The separate severe-event rate estimate was imprecise; this does not establish equal severe-hypoglycemia risk.[1]
The EU label advises against changing the weekly dose for short-term activity changes or acute illness and directs patients to their clinician for other adjustments. Prolonged action may delay recovery from hypoglycemia; no comparative exercise-benefit claim follows.[1]
The EU indication includes adult type 1 diabetes, with initiation restricted to situations where a weekly regimen offers clear benefits. This regulatory indication does not establish current supply or individual reimbursement; other jurisdictions are discussed below.[1]
Insulins are scored relative to their role peers (see tags: rapid, ultra-rapid, basal, inhaled). A basal insulin's onset score compares it to other basals, not to mealtime insulins.
The full picture
Insulin icodec (Awiqli) is a once-weekly basal insulin given by subcutaneous injection from a prefilled pen. In type 1 diabetes it must be combined with separate mealtime insulin. The EU formulation is 700 units/mL; it is not for use in insulin pumps. Starting or switching requires a clinician-directed regimen and close glucose monitoring; no conversion formula is provided here.1
Why it lasts a week. The molecule combines a 20-carbon fatty-diacid side chain with three amino-acid substitutions (A14E, B16H and B25H). Strong reversible albumin binding and reduced insulin-receptor affinity prolong its exposure. The original molecular and pharmacology work was funded by Novo Nordisk, and its authors were current or former company employees. These mechanistic findings explain the design; they do not by themselves demonstrate clinical benefit in type 1 diabetes.4
Measured exposure versus modeled flatness. An early study in 38 people with type 2 diabetes reported a geometric mean half-life of about 196 hours, a median time to peak concentration of 16 hours and modeled clinical steady state after about 3–4 weeks. The reported 12.0–16.3% daily share of weekly glucose lowering was a model using data from 32 participants, based on two 24-hour clamps during week 5. It was not a continuous seven-day measurement in people with type 1 diabetes. Current Canadian labeling says the effect is highest on days 2–4, and the EU label notes that most hypoglycemic episodes across ONWARDS trials occurred on days 2–4.451
ONWARDS 6: benefit and harm at 26 weeks. This open-label trial randomized 582 adults with type 1 diabetes to weekly icodec (290) or daily degludec (292), both with mealtime insulin. HbA1c changed by −0.47 versus −0.51 percentage points; the estimated difference was 0.05 (95% CI −0.13 to 0.23), meeting the prespecified 0.3-point noninferiority margin. Level 2 or 3 hypoglycemia rates were 19.93 versus 10.37 events per patient-year, with a rate ratio of 1.89 (95% CI 1.54–2.33). Level 2 means glucose below 54 mg/dL (3.0 mmol/L); level 3 means severe impairment requiring help. This is not evidence of equivalent safety.18
Longer follow-up and severe events. The EU product information reports 52-week HbA1c reductions of 0.37 points with icodec and 0.54 with degludec: the estimated difference was +0.17 (95% CI 0.02–0.31), favouring degludec. At 26 weeks, the separate severe-hypoglycemia rates were 0.33 versus 0.12 events per patient-year, with a rate ratio of 2.08 (95% CI 0.39–10.96). That wide interval leaves substantial uncertainty; a statistically inconclusive comparison does not establish no added risk.1
Other trial safety reporting. The original ONWARDS 6 abstract reports 39 serious adverse events in 24 icodec participants and 25 events in 20 degludec participants. One icodec participant died; investigators judged the death unlikely to be due to the trial product. Novo Nordisk funded the trial. The full publication was not accessible in this pass, so these statements remain limited to its abstract; they do not establish a difference in mortality or serious-event risk.8
Activity, illness and medication errors. The EU label advises against adjusting the weekly dose for acute illness or short-term changes in activity or diet; those situations require guidance about other management adjustments. Prolonged action may delay recovery from hypoglycemia. The label also warns about errors involving weekly versus daily administration or other insulins, and about drawing concentrated insulin from the pen into a syringe. These restrictions make weekly dosing a different management approach from daily basal insulin, rather than an automatic convenience improvement.1
Country indications and access. Adult type 1 diabetes is included in the EU and Australian indications. The EU label says to start it in type 1 only when a weekly regimen offers clear benefits because hypoglycemia is more frequent than with daily basal insulin; use in newly diagnosed insulin-naive type 1 diabetes has not been established. The US indication is adult type 2 diabetes only. Canadian labeling includes adult type 1 use with mealtime insulin, and its public database lists a marketed product. Japan’s April 2026 label includes adult insulin-requiring diabetes and specifically urges caution in type 1 because of recurrent hypoglycemia, including consideration of daily basal alternatives. Approval, actual supply and reimbursement remain separate: this review did not confirm local stock or individual funding. UK authorization was not confirmed from a current primary source in this pass.123567
Sources
- [1]Awiqli — EU product information · Regulatory decision — Current SmPC sections 4.1–4.4 and 5.1, Table 6 and extension results. At 52 weeks, HbA1c fell by 0.37 percentage points with icodec versus 0.54 with degludec; estimated difference +0.17 (95% CI 0.02–0.31). Read 17 September 2026.
European Medicines Agency. Awiqli product information, sections 4.1–4.4, 4.8 and 5.1 (Table 6 and extension results).
- [2]Awiqli — Australian prescription medicine decision summary · Regulatory decision — Decision 17 May 2024; registration 28 June 2024. Explicitly includes adult type 1 and type 2 diabetes. Regulatory scope, not evidence of stock or subsidy.
Therapeutic Goods Administration. Awiqli decision summary, approved indication.
- [3]Awiqli — US prescribing information (2026) · Regulatory decision — Section 1: adults with type 2 diabetes only. Does not establish a US type 1 indication.
FDA. Awiqli US prescribing information, section 1.
- [4]Nishimura et al. Molecular and pharmacological characterization of insulin icodec · Peer-reviewed study — Original full article. Clinical PK in 38 people with type 2 diabetes; modeled weekly glucose-lowering distribution in 32. Geometric mean half-life 196 hours; modeled steady state after 3–4 weeks. Novo Nordisk funded the work; authors were current or former employees.
Nishimura et al. Original molecular/pharmacology study, clinical Methods/Results and Figure 2.
- [5]Health Canada: Awiqli product monograph, authorized 12 December 2025 · Regulatory decision — Sections 1 and 4.1: adult diabetes indication including type 1 with mealtime insulin; highest effect on days 2–4 and hypoglycemia precautions. No pediatric indication. Labeling does not establish individual coverage.
Health Canada. Awiqli product monograph, sections 1 and 4.1.
- [6]Health Canada Drug Product Database: Awiqli, DIN 02546205 · Regulatory decision — Product listed as Marketed, with status date 13 June 2024. Database status does not guarantee pharmacy stock or reimbursement.
Health Canada. Awiqli Drug Product Database record, marketed status.
- [7]PMDA: Awiqli FlexTouch Japanese prescribing information, April 2026 revision · Regulatory decision — Sections 4–7: adult weekly dosing for diabetes requiring insulin, with specific caution about repeated hypoglycemia in type 1 diabetes and consideration of daily basal alternatives. This review checks indication scope, not local stock or funding.
PMDA. Awiqli FlexTouch prescribing information, April 2026 revision, sections 4–7.
- [8]Russell-Jones et al. ONWARDS 6 randomized phase 3a trial · Peer-reviewed study · 2023-10-17 — Original published abstract personally read; full publisher article could not be retrieved in this pass. 582 randomized adults, open-label 26-week main phase and 26-week extension; Novo Nordisk funded. Detailed estimates on this page use the original regulatory table when available.
Russell-Jones et al. ONWARDS 6 original published abstract, Methods/Findings/Funding. Full publisher text was not retrieved in this pass.