The FDA has approved Awiqli, also called insulin icodec-abae, only as a once-weekly basal insulin used along with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. In the United States, it is not approved for people with type 1 diabetes, it should not be used to treat diabetic ketoacidosis, and it is not known to be safe and effective in children or adolescents.
Quick summary
Awiqli is currently the only basal insulin approved in the United States for once-weekly use in adults with type 2 diabetes. For some people, this may mean one basal insulin injection per week instead of a daily basal injection, but only if the prescribing clinician decides it fits safely. The ONWARDS trials were designed mainly to show that once-weekly Awiqli was not worse than daily basal insulin for A1c lowering, not that it is better for everyone.
Key takeaways
- Awiqli is FDA-approved only as a once-weekly basal insulin, used along with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.
- In the United States, it is not approved for type 1 diabetes or for children or adolescents.
- It is a high-concentration U-700 insulin, meaning 700 units/mL, given once weekly on the same day each week.
- It should not be used with another basal insulin or used to treat diabetic ketoacidosis.
- Switching from daily basal insulin requires close glucose monitoring and clinician-directed dosing.
- The label highlights medication-error risk, hypoglycemia, allergic reactions, hypokalemia, injection-site changes, edema, and weight gain.
- According to Novo Nordisk’s FDA-approval announcement, Awiqli is expected to be available nationwide in the United States in the coming months, but actual access can vary by pharmacy, insurance, and local systems.
Why this matters
Many adults with type 2 diabetes who need basal insulin take an injection every day. A once-weekly option could make treatment feel less burdensome for some people, especially those who struggle with daily injection routines.
Less frequent dosing does not mean less careful treatment. Awiqli has a different dosing schedule and concentration from many insulin products. The label specifically warns about mix-ups, accidental overdose, and severe hypoglycemia if the wrong dose or frequency is used.
What Awiqli is, and what it is not
Awiqli is a long-acting basal insulin. Basal insulin helps cover background insulin needs between meals and overnight. It is not designed to replace rapid-acting insulin used with meals when mealtime insulin is prescribed.
The FDA label says Awiqli is injected under the skin into the thigh, upper arm, or abdomen. Injection sites should be rotated to reduce skin changes such as lipodystrophy or localized cutaneous amyloidosis.
Safety points users should know
- Always check the pen label and dose window before injecting, especially if other insulin or injectable diabetes medicines are used.
- Awiqli is a high-concentration U-700 insulin, or 700 units/mL. Misreading the pen, confusing it with another insulin, or using it more often than prescribed can cause overdose and prolonged low blood sugar.
- The FDA label includes medication-error warnings about not transferring Awiqli from the FlexTouch pen into a syringe, not using it in an insulin pump, not mixing or diluting it, and not injecting it into a vein or muscle.
- Do not transfer Awiqli from the FlexTouch pen into a syringe, because overdose and severe hypoglycemia can result.
- Awiqli is contraindicated during episodes of hypoglycemia, meaning it should not be used during an episode of low blood sugar.
- Do not use Awiqli together with another basal insulin. When switching from another basal insulin, your clinician should tell you exactly when to stop the old basal insulin and when to start Awiqli.
- Awiqli should be injected under the skin only. It should not be injected into a vein or muscle, used in an insulin pump, mixed with other insulins, or diluted.
- Glucose monitoring should increase when starting, switching, missing doses, or changing an insulin regimen.
- Tell the care team about kidney disease, liver disease, hypoglycemia unawareness, heart failure, swelling, pregnancy plans, thiazolidinedione use, or medicines that may affect blood sugar.
- The label includes warnings about hypokalemia, or low potassium, and fluid retention or heart failure risk when insulin is used with thiazolidinediones.
Evidence behind the approval
The FDA approval was supported by the ONWARDS phase 3 program and additional review data in adults with type 2 diabetes. These randomized, active-controlled, treat-to-target trials evaluated once-weekly insulin icodec against once-daily basal insulin comparators in different treatment settings.
These trials compared once-weekly Awiqli with once-daily basal insulin comparators and were mainly designed to show that once-weekly dosing was no worse, or noninferior, for lowering A1c. For example, ONWARDS 1 reported a mean A1c change from 8.50% to 6.93% with insulin icodec and from 8.44% to 7.12% with daily glargine U100 at 52 weeks. ONWARDS 3 reported A1c changes from 8.6% to 7.0% with icodec and from 8.5% to 7.2% with daily degludec at 26 weeks. These were modest differences in treat-to-target studies, not proof that once-weekly insulin is better for everyone.
The benefit-risk picture is balanced. Awiqli may lower injection burden, but some people may have more episodes of low blood sugar than with daily basal insulin. ONWARDS 1 and ONWARDS 3 reported higher rates of clinically significant or severe hypoglycemia with icodec than with the daily comparators, while ONWARDS 4 reported similar rates in people already using basal-bolus insulin. Regulatory reviews outside the United States, including Health Canada and NCBI clinical reviews, describe higher hypoglycemia rates particularly on days 2 to 4 after the weekly dose. This timing detail comes from those reviews rather than being a central focus of the US FDA label, although hypoglycemia risk is clearly warned in the US label.
Practical takeaway
Awiqli may be an important new option for some adults with type 2 diabetes who need basal insulin, but it is not a simple one-for-one swap. The weekly schedule, U-700 concentration, switching instructions, missed-dose rules, and low-blood-sugar plan should be reviewed carefully with the prescribing clinician. When switching from a daily basal insulin, the FDA label includes specific conversion formulas, including a one-time higher first weekly dose and later maintenance dosing. The label describes calculations such as 1.5 x 7 x the prior total daily basal dose for the first weekly dose and 7 x the prior daily basal dose for later weekly dosing, with rounding and adjustment rules that must be handled by the clinician. Do not calculate this yourself. Because Awiqli is taken once weekly, late or missed-dose instructions are different from daily insulin, so follow the FDA prescribing information’s specific timing instructions as explained by your clinician. Do not guess, catch up, stack extra doses, or apply daily-insulin rules on your own. Day-to-day dose changes between weekly injections are not recommended unless your clinician specifically directs them.
Safety note
This article is not a substitute for medical care. Do not start, stop, or switch insulin without medical guidance. Seek urgent care for severe low blood sugar, seizure, confusion, loss of consciousness, serious allergic reaction, chest pain, severe weakness, or symptoms that feel unsafe. Awiqli should not be used to treat diabetic ketoacidosis. Seek urgent care for possible ketoacidosis symptoms such as nausea, vomiting, abdominal pain, rapid breathing, confusion, or severe illness.
What to ask your care team
- Am I a candidate for once-weekly basal insulin, or is daily basal insulin safer for me?
- How would my current basal insulin dose be converted, and how often should I check glucose during the switch?
- What should I do if I miss a dose?
- How should I prevent mix-ups with mealtime insulin, GLP-1 medicines, or other injectable treatments?
- Do any of my medicines, including thiazolidinediones or potassium-affecting medicines, change my safety plan?
- What low-blood-sugar symptoms should prompt urgent action?
Source summary
- BLA Approval Letter for Awiqli, U.S. Food and Drug Administration. Approval letter. Accessed June 4, 2026. Source
- Awiqli Prescribing Information, U.S. Food and Drug Administration. Prescribing information. Accessed June 4, 2026. Source
- Awiqli Prescribing Information, Novo Nordisk. Prescribing information. Accessed June 4, 2026. Source
- FDA Approves Novo Nordisk’s Awiqli, Novo Nordisk via PR Newswire. Company announcement. Accessed June 4, 2026. Source
- Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin, New England Journal of Medicine via PubMed. ONWARDS 1 randomized trial. Accessed June 4, 2026. Source
- Once-Weekly Insulin Icodec vs Once-Daily Insulin Degludec in Adults With Insulin-Naive Type 2 Diabetes, JAMA via PubMed. ONWARDS 3 randomized trial. Accessed June 4, 2026. Source
- Switching to Once-Weekly Insulin Icodec versus Once-Daily Insulin Glargine U100, Lancet via PubMed. ONWARDS 4 randomized trial. Accessed June 4, 2026. Source
- Insulin Icodec Clinical Review, NCBI Bookshelf. Independent clinical review. Accessed June 4, 2026. Source
- Summary Basis of Decision for Awiqli, Health Canada. Regulatory review. Accessed June 4, 2026. Source