FDA approves once-weekly insulin icodec for pediatric T2D

Children and adolescents 10 years and older with type 2 diabetes (T2D) who require basal insulin now have a once-weekly option. The US Food and Drug Administration (FDA) has approved insulin icodec-abae (Awiqli; Novo Nordisk) injection 700 units/mL as an adjunct to diet and exercise to improve glycemic control in this population, reducing basal injections from 7 per week to 1.¹ The decision extends an adult T2D indication granted in March 2026.²

"Children with type 2 diabetes face an aggressive disease trajectory," said Eda Cengiz, MD, MHS, professor of pediatrics at the University of California, San Francisco, in the company's announcement. She added that many young patients struggle to sustain a daily basal insulin routine and that a weekly injection may ease administration barriers.¹

How the FDA evaluated insulin icodec in pediatric T2D

The pediatric approval rests on extrapolation rather than a dedicated pediatric efficacy trial. It is supported by adequate and well-controlled studies in adults and a single-dose pharmacokinetic (PK) study in patients aged 10 to younger than 18 years.¹ The adult ONWARDS phase 3a program comprised 4 randomized, active-controlled, treat-to-target trials in approximately 2680 adults with uncontrolled T2D.²

In the open-label pediatric study (NCT05790681), conducted at 7 US sites, 18 insulin-treated participants (mean age, 14.4 years; mean body mass index, 38.5; mean HbA1c, 7.5%) received a single subcutaneous icodec dose of 5.6 U/kg, with PK sampling through 35 days.³ That dose corresponds to roughly 2.8 U/kg weekly, or 0.4 U/kg daily, at steady state.³

Modeled steady-state profiles indicated that icodec exposure covered the full 1-week dosing interval, and the shape of the concentration curve closely resembled that seen in adults.³ Total exposure was modestly higher in youth (geometric mean area under the curve, 819 vs 682 × 10⁵ pmol·h/L in adults), which investigators attributed in part to pubertal insulin resistance and higher body mass index. They judged the difference of limited clinical relevance because insulin is individually titrated.³

Six mild adverse events occurred in 2 participants, along with 1 level 1 hypoglycemic episode; there were no serious adverse events, hypersensitivity reactions, or injection-site reactions.³ Labeled adverse reactions include hypoglycemia, injection-site reactions, lipodystrophy, pruritus, rash, peripheral edema, and weight gain, with warnings for hypokalemia and heart failure when combined with thiazolidinediones.¹

Burden of youth-onset T2D and basal insulin adherence

Projections estimate that 30,000 to 84,000 US youths could be living with T2D by 2050.³ Youth-onset disease progresses rapidly; in TODAY study follow-up, most participants developed diabetes-related complications by young adulthood.³

Metformin and insulin were long the only approved pharmacologic options, now joined by glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose cotransporter-2 inhibitors.³ Yet adherence to diabetes medication declines over time in youth with T2D and remains suboptimal among insulin-treated young adults with youth-onset disease, a gap that less frequent dosing is intended to address.³

Insulin icodec mechanism and adult ONWARDS efficacy

After absorption, icodec binds albumin, forming a largely inactive circulating depot that slowly equilibrates with a small active fraction; low insulin receptor affinity further slows clearance.³ In insulin-naive adults, weekly icodec produced superior HbA1c reductions vs daily glargine U100 at 52 weeks and vs degludec at 26 weeks, with low rates of level 2 or 3 hypoglycemia.³ Icodec is given on the same day each week via the FlexTouch pen; a missed dose may be taken within 4 days.¹

Limitations of pediatric insulin icodec evidence

The pediatric data are limited to 18 patients receiving a single fixed dose, and pharmacodynamics were not assessed because a week-long glucose clamp was not feasible in this population.³ All participants were already insulin-treated and had obesity, so findings may not generalize to insulin-naive youth or those with other characteristics.³ The PK study was funded by Novo Nordisk, and several authors are company employees.³

Safety and efficacy have not been established in children younger than 10 years, and the indication does not include type 1 diabetes.¹ Because icodec is a U-700 product with dosing that differs from other injectable diabetes therapies, the label emphasizes careful dose selection and pen-label checks to prevent errors.¹ Long-term pediatric outcomes await postmarketing data.

References

1. Novo's Awiqli receives FDA approval as the first and only once-weekly insulin for children 10 years of age and older with type 2 diabetes. News release. Novo Nordisk. October 23, 2026. Accessed October 23, 2026. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=918803

2. Awiqli approved in the US, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes. News release. Novo Nordisk. March 27, 2026. Accessed October 23, 2026. https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=916521

3. Van Name M, Ásbjörnsdóttir B, Murphy Gomes M, et al. Pharmacokinetic properties of once-weekly insulin icodec in children and adolescents with type 2 diabetes. Pediatr Diabetes. 2025;2025:5514927. doi:10.1155/pedi/5514927