Once-Weekly Insulin Shot for Adults with Type 2 Diabetes

Awiqli is a once-weekly long-acting basal human insulin analogue for subcutaneous injection (700 units/mL, U-700), delivered in a single-patient-use FlexTouch prefilled pen. In the United States the proper name is insulin icodec-abae; elsewhere the INN is insulin icodec. It binds reversibly to albumin and releases slowly so one injection can cover a week of basal need. It is not a mealtime (bolus) insulin, not a GLP-1 receptor agonist, and not a cure for diabetes.

The critical label split is the patient fact that travels with every conversation:

• United States: adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus only. FDA approved 26 March 2026 (BLA 761326/Original 2). Type 1 was not approved; the type 1 BLA original was found deficient on hypoglycemia / benefit-risk.
• European Union, Health Canada, Switzerland, Australia, Japan: treatment of diabetes mellitus in adults (wording varies slightly by label) — which includes type 1 under local caveats, with higher hypoglycemia risk versus daily basal insulin called out on SmPC / Product Monograph.
• China (NMPA): type 2 diabetes adults only (announced Feb 2025).

Do not copy an EU or Canadian type 1 script onto a US prescription. Do not assume a US type 2 carton is the same indication as a European diabetes-mellitus carton.

Where this is taking place

Commercial labelled supply is the door in markets that have authorised it. The ONWARDS Phase 3a programme is completed — it is evidence, not an enrolment path.

United States — FDA-labelled once-weekly basal for type 2 adults only. Endocrinology / diabetes clinic. FlexTouch U-700. Company materials (Mar 2026) described nationwide availability in the coming months / second half of 2026; confirm current pharmacy stock and formulary with the clinic.

Canada — Health Canada-labelled once-weekly basal for adults with diabetes mellitus (full NOC, marketed). Diabetes / endocrinology clinic. Authorized ≠ funded.

European Union — EC marketing authorisation 17 May 2024 (EMEA/H/C/005978). Diabetes mellitus in adults. Type 1: SmPC says start only if a clear benefit of once-weekly dosing is expected; higher hypoglycemia risk vs daily basal; must combine with bolus insulin.

Switzerland — Swissmedic authorised 7 March 2024 (MA 69389) — diabetes mellitus in adults. First marketing authorisation globally (FDA multi-discipline summary).

Australia — TGA AusPMD 17 May 2024 — type 1 and type 2 diabetes in adults. ARTG presentations include 700 U/1 mL, 1,050 U/1.5 mL, and 2,100 U/3 mL pens.

Japan — MHLW / PMDA approval 24 June 2024 — diabetes mellitus where insulin therapy is indicated.

China — NMPA marketing for type 2 adults (public English announcement dated 19 Feb 2025).

United Kingdom — MHRA marketing authorisation for Awiqli not confirmed on public eMC / SmPC sources retrieved for this draft. A paediatric investigation plan waiver (insulin icodec + semaglutide combination, 2022) is not a product licence.

ONWARDS 1–6 — Phase 3a programme, sponsor Novo Nordisk, COMPLETED. Sites included many countries (ONWARDS 6 listed Canada among 12 countries). These trials are finished. They are not a way to start the drug outside labelled commercial supply.

The practical door is the diabetes clinic writing the labelled indication of that country — not importing another regulator’s carton, and not treating a completed Phase 3 listing as an access path.

Approval matrix

Access by country

• United States: Diabetes / endocrinology clinic. FDA-labelled 26 Mar 2026 for type 2 adults only — adjunct to diet and exercise. Inject subcutaneously once weekly same day each week (thigh, upper arm, or abdomen); rotate sites. FlexTouch dials in 10-unit increments up to 700 units per injection. Insulin-naïve start 70 units/week. Switching from daily basal: day after last daily basal; week-1 dose is 1.5 × (daily basal × 7) rounded to nearest 10; week-2 is daily basal × 7 rounded to nearest 10 — per USPI Table 1. Do not transfer from pen into a syringe. Do not use IV, IM, or in a pump. Do not mix with other insulin. Never share pens. Store unused pens refrigerated 2–8 °C; in-use up to 12 weeks room temp below 30 °C or refrigerated. Novo Nordisk Inc. U.S. License 1261; www.awiqli.com / 1-844-668-6463 — medical information, not a formulary guarantee. Prior authorization still applies. Type 1 is not labelled. An EU or Canadian diabetes-mellitus carton is not a substitute for the US type-2 indication.

• Canada (zoom): Authorized (full NOC) 12 Mar 2024. Marketed. Ask the diabetes clinician for a once-weekly Awiqli prescription under the Canadian indication (adults with diabetes mellitus). Authorized ≠ funded. CDA-AMC SR0790 (final rec Jun 2024) recommended public-plan reimbursement with conditions for type 2 adults (A1C 7.0–11.0% inclusive; price not exceeding least costly long-acting basal). That is HTA, not Health Canada’s broader indication, and not a provincial listing. Provincial / territorial / NIHB listings: unknown. SAP is the wrong door for labelled DINs. Product Monograph (Novo Nordisk Canada): type 1 must be basal-bolus; higher hypoglycemia risk language; not recommended in hypoglycemia unawareness. Store refrigerated when unused. Do not mail-order a US-only carton as if it answered a Canadian type 1 question — the US label does not include type 1.

• European Union: EC licence 17 May 2024. Diabetes mellitus in adults. Physician experienced in diabetes. Type 1: bolus insulin required; SmPC 4.4 — higher hypoglycemia risk vs daily basal; start only if clear once-weekly benefit expected. Member-state reimbursement is not the EC licence — reimbursement outside local HTA is unknown. Educational materials address daily-to-weekly dose mix-ups.

• Switzerland: In-country commercial after Swissmedic 7 Mar 2024. Diabetes mellitus in adults. Reimbursement unknown.

• Australia: TGA-labelled 17 May 2024, adults with type 1 or type 2 diabetes. PBS listing unknown. Specialist + local pathway if not yet funded.

• Japan: MHLW-approved 24 Jun 2024 for diabetes mellitus where insulin is indicated. In-country commercial (company materials described Jan 2025 launch in Japan).

• China: NMPA-labelled for type 2 adults. Not the broader EU/Canada diabetes-mellitus line.

• United Kingdom / other regulators not listed: Marketing authorisation not confirmed here. Do not import on your own.

If your regulator has not authorised it for your diabetes type: do not import on your own. US type 2 ≠ EU/Canada type 1 eligibility.

Who is eligible (from the labels — they are not the same)

This is a basal insulin conversation. Mealtime coverage still needs a separate plan when the regimen requires it.

United States (USPI / DailyMed) — type 2 only:

• Adult.
• Type 2 diabetes mellitus.
• Adjunct to diet and exercise to improve glycemic control.
• Once-weekly subcutaneous FlexTouch U-700.
• May be used with mealtime insulin or with common oral agents and/or GLP-1 receptor agonists (as studied).
• Pediatric use not established.
• Contraindications: during hypoglycemia; hypersensitivity to insulin icodec-abae or excipients.
• Not labelled for type 1 diabetes.

Canada (Product Monograph / RDS / SBD) — diabetes mellitus adults:

• Adult.
• Diabetes mellitus to improve glycemic control (once-weekly) — broader than US.
• Type 1: must be part of a basal-bolus regimen; no trial experience in newly diagnosed insulin-naïve type 1; higher hypoglycemia risk language; not recommended in hypoglycemia unawareness.
• Type 2: may be used alone or with oral agents, GLP-1 RAs, and/or bolus insulin per monograph.
• Pediatrics not authorised.
• NOC is full authorisation. Funding is separate. CDA-AMC reimbursement recommendation is T2DM-conditional, not the full HC indication.

European Union (SmPC 4.1) — diabetes mellitus adults:

• Treatment of diabetes mellitus in adults.
• Type 1: combine with bolus insulin; higher hypoglycemia risk vs insulin degludec; treat only if a clear benefit from once-weekly dosing is expected; newly diagnosed insulin-naïve type 1 not established.
• Type 2: alone or with other diabetes medicines including bolus insulin.
• Pediatrics: waiver / not authorised for under 18 on the SmPC paediatric line retrieved.
• Contraindication: hypersensitivity (and hypoglycemia-related restrictions per SmPC).

Switzerland / Australia / Japan: Diabetes mellitus in adults (AU explicitly type 1 and type 2; JP “where insulin therapy is indicated”). Local hypo caveats apply — read the country label. Not the US type-2-only line.

China: Type 2 adults only.

Not labelled (illustrative):

• Type 1 on a US script — FDA did not approve the T1 original.
• Children / adolescents (every major adult-only line above).
• Using Awiqli as mealtime insulin or in an insulin pump.
• Treating diabetic ketoacidosis with Awiqli.
• Assuming CADTH/CDA conditions equal Health Canada’s indication.

What the pivotal studies showed (ONWARDS Phase 3a)

Sponsor: Novo Nordisk. Six Phase 3a treat-to-target trials. US labelling Section 14 describes four T2D trials (A–D) supporting the US type 2 indication. EU / Canada also include ONWARDS 6 (type 1) in the diabetes-mellitus assessment — with the hypoglycemia difference that drove the US T1 non-approval.

Use the label of the country that will prescribe. The FDA did not approve Awiqli for type 1. ONWARDS 6 studied type 1; that does not create a US type-1 label. EU and Canada SmPC/monograph caveats still apply for type 1: higher hypoglycemia risk; clear-benefit language (EU); basal-bolus only (Canada).

Safety — hypoglycemia and other labelled risks

Hypoglycemia is the most common adverse reaction on every label.

Type 2 (USPI Table 2, adults exposed to Awiqli): proportion with ≥1 level 2 episode ranged roughly 9–14% in basal-only / insulin-naïve settings and about 51% in the basal-bolus trial; level 3 (severe) was uncommon (0–1.4% across those USPI columns). Long half-life (~1 week) may delay recovery from hypoglycemia versus shorter-acting basal insulins.

Type 1 (ONWARDS 6 / EMA SmPC / HC PM): combined clinically significant or severe hypoglycemia rate roughly doubled versus degludec (~19.9 vs ~10.4 events per patient-year). EMA: treat type 1 only if clear benefit of weekly dosing expected. Health Canada: higher risk language; reconsider if recurrent hypoglycemia; not recommended in hypoglycemia unawareness. FDA: type 1 not approved.

Medication errors: mix-ups with daily basal insulin or other once-weekly injectables (e.g. GLP-1 RAs) can cause severe hypoglycemia. Always check the pen label. Never withdraw Awiqli from the FlexTouch into a syringe. Dose selection for weekly U-700 differs from daily basal and from other weekly diabetes injectables.

Other labelled risks (USPI / SmPC / PM): hypersensitivity / anaphylaxis; hypokalemia; lipodystrophy / cutaneous amyloidosis at injection sites; peripheral edema; weight gain (~1.4–2.8 kg in T2D trials); fluid retention / heart failure risk when combined with thiazolidinediones; never share pens.

Missed dose (USPI): if ≤4 days late, take missed dose ASAP and resume weekly schedule from that day; if >4 days, skip and take next on the regular day — with increased glucose monitoring.

How to talk to a doctor

Bring the label of the country you are in. The indication is not interchangeable.

1. "In the United States, is Awiqli labelled for my type 2 diabetes as once-weekly basal? (Type 1 is not on the US label.)"
2. "In Canada / EU / Switzerland / Australia / Japan, is Awiqli labelled for diabetes mellitus in adults, and if I have type 1, what does the local SmPC / monograph say about hypoglycemia and ‘clear benefit’?"
3. "Please do not copy an EU type 1 regimen onto a US script, or assume a US type 2 carton answers a Canadian type 1 funding question."
4. "Show me the FlexTouch: 10-unit steps, max 700 per injection, once weekly same day. How do we switch from my current daily basal (week-1 one-time additional dose rules differ by label and by type 1 vs type 2)?"
5. "What is my hypoglycemia plan — especially days 2–4 after the weekly dose (Canadian PM notes increased risk then) — and what if I use CGM?"
6. "I also take a GLP-1 RA / SGLT2i / mealtime insulin — how do we avoid mix-ups between weekly pens?"
7. "Canada: This is a full NOC, marketed DINs. SAP is the wrong door. What is actually funded in this province after CDA-AMC SR0790 (T2-only conditional recommendation)?"
8. "US: Prior authorization started? Is the pharmacy stocking the 1.5 mL or 3 mL trade pen?"
9. "If I travel between a T2-only country and a diabetes-mellitus country, who rewrites the plan — both clinicians, not airport customs."

Canada zoom: authorized, not funded-by-default

Health Canada has already authorised Awiqli with a full NOC (12 Mar 2024) for adults with diabetes mellitus, and it is marketed. That is broader than the US type-2-only FDA line. The remaining Canadian questions are who pays (CDA-AMC SR0790 conditions for T2DM are not a formulary listing; provincial status unknown) and type 1 safety monitoring under the Canadian monograph. Do not call the clinic asking for SAP. Do not assume every labelled type 1 patient is publicly funded. The US label remains type-2-only — the Canadian diabetes-mellitus indication does not travel onto a US prescription.

Bottom line

Awiqli is the first labelled once-weekly basal insulin (U-700 FlexTouch). FDA (26 Mar 2026) — type 2 adults only. Health Canada (12 Mar 2024), EU (17 May 2024), Switzerland (7 Mar 2024), Australia, and Japan — diabetes mellitus in adults, with type 1 hypoglycemia caveats on those labels. China — type 2 only. ONWARDS 1–5 support type 2 efficacy versus daily basal insulin; ONWARDS 6 showed higher hypoglycemia rates in type 1 and underpins why the US did not approve type 1. Authorized is not funded. The door is a diabetes clinic writing the labelled indication of that country.

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Primary sources

1. DailyMed AWIQLI (insulin icodec-abae) injection, setid 5162b93e-5775-4581-a5e9-e8783ae0acd7, revised Mar 2026 / effective 20260326 — https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5162b93e-5775-4581-a5e9-e8783ae0acd7
2. FDA Prescribing Information / label PDF, BLA 761326, 26 Mar 2026 — https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761326Orig2s000lbl.pdf
3. Novo Nordisk USPI host copy — https://www.novo-pi.com/awiqli.pdf
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19. Novo Nordisk Pharma Japan approval announcement PDF, 24 Jun 2024 — https://www.novonordisk.co.jp/content/dam/nncorp/jp/ja/news/media/2024/06/24-16.pdf
20. CDA-AMC / CADTH Reimbursement Recommendation SR0790 (Insulin Icodec / Awiqli), Jun 2024 — https://www.cda-amc.ca/sites/default/files/DRR/2024/SR0790REC-Awiqli.pdf
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25. ClinicalTrials.gov ONWARDS 5 NCT04760626 — https://clinicaltrials.gov/study/NCT04760626
26. ClinicalTrials.gov ONWARDS 6 NCT04848480 — https://clinicaltrials.gov/study/NCT04848480
27. Rosenstock J, et al. Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin. N Engl J Med. 2023 (ONWARDS 1). DOI 10.1056/NEJMoa2303208. NCT04460885 (journal; not the label)
28. Russell-Jones D, et al. Once-weekly insulin icodec versus once-daily insulin degludec … type 1 diabetes (ONWARDS 6). Lancet. 2023;402:1636-1647. DOI 10.1016/S0140-6736(23)02179-7. NCT04848480 (journal; not the label)