FDA Approves Novo Nordisk Once-Weekly Insulin Icodec-abae for Type 2 Diabetes Patients Aged 10 and Older

The adult development of insulin icodec was supported by two phase 3 registered studies. NCT04760626 compared insulin icodec with DoseGuide against once-daily basal insulin analogues, with a planned or actual enrollment of 1,085 people and change in HbA1c from week 0 to week 52 as the primary endpoint; the study began on March 1, 2021, and was primarily completed on August 12, 2022, with Novo Nordisk A/S as the sponsor . The other study, NCT06340854, compared insulin icodec with insulin glargine U100 in adults with type 2 diabetes, with a planned or actual enrollment of 412 people and change in HbA1c from week 0 to week 26 as the primary endpoint; it was primarily completed on May 8, 2025 . Its adult indication had previously been approved by the U.S. FDA in March 2026, bringing once-weekly basal insulin into adult type 2 diabetes use (needs verification).

On October 23, 2026, the U.S. FDA approved a new indication for Novo Nordisk’s insulin icodec-abae once-weekly insulin: as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes aged 10 years and older. FDA regulatory information described the approval as a once-weekly insulin approval for pediatric patients with type 2 diabetes and showed that the product received BLA 761326/Original 2 approval on March 26, 2026 [Regulatory Document·C] [Regulatory Document·D]. This pediatric indication makes insulin icodec a once-weekly subcutaneous basal insulin approved for children and adolescents with type 2 diabetes, adding a weekly dosing option for this age group (needs verification).

The expansion extends the eligible population for insulin icodec from adults to patients with type 2 diabetes aged 10 years and older. Industry media reported that the regulatory decision was based on adult ONWARDS data and a pediatric single-dose pharmacokinetic study [Industry Media·F]. Peer-reviewed material noted preliminary data from a phase 1 trial of insulin icodec in an insulin-experienced pediatric population under 18 years with type 2 diabetes, identified as NCT05790681 [Peer-Reviewed·E]. Together, the adult clinical program and a dedicated pediatric pharmacokinetic study formed the evidence base for the expansion, although the specific pediatric study design, sample size, pharmacokinetic parameters, and data were not disclosed in the materials.

Information still to be confirmed includes the complete prescribing information, clinical trial registration number, primary and secondary endpoint results, specific efficacy magnitude, safety results, and prescribing-information revisions for the pediatric indication. Commercial arrangements, product pricing, and launch or supply timing were also not disclosed. The full FDA approval documents, prescribing information, and pediatric study data will be important for assessing the actual benefit-risk profile of the once-weekly regimen in this population.