Awiqli (insulin icodec): FDA approval, pivotal trial and safety
Approved
Type
Therapeutic biologic · Solution
FDA-approved use
To improve glycemic control in adults with type 2 diabetes mellitusWording from FDA's list of novel approvals.
FDA review
Standard reviewOrphan drug
Company
Novo Nordisk
Application
BLA 761326
Specialty
Endocrinology
At a glance
Awiqli is the first once-weekly basal insulin approved in the United States, for adults with type 2 diabetes. In ONWARDS 1, in people starting insulin, it lowered HbA1c slightly more than daily glargine (difference -0.19 percentage points) and gave more time in range, with somewhat more clinically significant hypoglycemia that did not reach significance at one year.
What it is and how it works
Insulin icodec is a basal insulin analog that binds strongly but reversibly to albumin, forming a circulating depot from which insulin is released slowly over a week. At the insulin receptor it acts like human insulin. One weekly injection replaces seven daily ones.
Phase 3a, randomized (1:1), open-label, treat-to-target; 52-week main phase plus 26-week extension.
Patients
984 adults with type 2 diabetes not previously treated with insulin, HbA1c 7% to 11%.
Compared with
Insulin glargine U100 once daily.
Primary endpoint
Change in HbA1c from baseline to week 52.
Result
HbA1c fell from 8.50% to 6.93% with icodec (-1.55 points) and from 8.44% to 7.12% with glargine (-1.35): difference -0.19 percentage points (95% CI, -0.36 to -0.03), noninferior (P<0.001) and superior (P=0.02).
Other results
Time in range (70 to 180 mg/dL) in weeks 48 to 52: 71.9% versus 66.9% (difference 4.27 points; 95% CI, 1.92 to 6.62; P<0.001), about an hour more a day.
Safety in the trial
Clinically significant or severe hypoglycemia 0.30 versus 0.16 events per person-year (rate ratio 1.64; 95% CI, 0.98 to 2.75) at week 52; other adverse events similar.
How does Awiqli (insulin icodec-abae) compare with the alternatives (Onswik (insulin efsitora alfa), Insulin glargine U100 or U300, Insulin degludec) for its approved use (to improve glycemic control in adults with type 2 diabetes mellitus)? Summarize head-to-head and indirect evidence, efficacy, safety and where each fits, with citations.
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Safety signals
Hypoglycemia is the main risk, as with any insulin. In ONWARDS 1, clinically significant or severe hypoglycemia occurred at 0.30 versus 0.16 events per person-year with glargine (rate ratio 1.64; 95% CI, 0.98 to 2.75) at 52 weeks. The label warns about mix-ups between insulin products and says never to draw the drug from the pen into a syringe, because overdose and severe hypoglycemia can result. It is not approved for type 1 diabetes, where hypoglycemia was more frequent than with daily degludec in ONWARDS 6.
What it competes with
Weekly basal insulin mainly competes with daily basal insulins, and now with a second weekly insulin, Onswik (efsitora). In type 2 diabetes, GLP-1 receptor agonists are usually tried before or alongside basal insulin.
Onswik (insulin efsitora alfa)The other once-weekly basal insulin, approved September 2026.
Insulin glargine U100 or U300Daily basal insulin; the comparator in ONWARDS 1.
GLP-1 receptor agonistsOften used before or with basal insulin in type 2 diabetes.
Bottom line for clinicians
For adults with type 2 diabetes starting or using basal insulin, Awiqli offers glycemic control at least as good as daily glargine with one injection a week. Teach patients about hypoglycemia and product mix-ups; do not use it in type 1 diabetes.
Dosing, contraindications and full warnings are in the prescribing information.
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Last updated October 27, 2026 by 2 Minute Medicine.
For healthcare professionals. A summary of public FDA documents and published trials, not medical advice. Check the full prescribing information before prescribing.
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