Novo Nordisk reported that its oral semaglutide met the primary endpoint in the PIONEER TEENS phase‑3a trial, a 52‑week study of 132 children and adolescents aged 10‑17 with type 2 diabetes. The trial evaluated once‑daily doses of 3 mg, 7 mg, and 14 mg and found a statistically significant reduction in HbA1c of 0.83 percentage points versus placebo at 26 weeks.
Safety data were consistent with the established profile of oral semaglutide in adults, with no new safety signals identified in the pediatric cohort.
The results represent the first demonstration of an oral GLP‑1 receptor agonist in the pediatric population, addressing a growing unmet need as the prevalence of type 2 diabetes among youth has risen sharply over the past two decades. Oral administration offers a more convenient alternative to injectable therapies, potentially improving adherence.
Novo Nordisk plans to file for regulatory approval of the indication in the United States and European Union in the second half of 2026 and will market the product under the Ozempic Pill brand for diabetes in the U.S. later in 2026.
The trial’s success positions Novo Nordisk to expand its GLP‑1 portfolio into a new patient segment, strengthening its competitive stance against rivals such as Eli Lilly and broadening its market reach.
Chief scientific officer Martin Holst Lange said, “Over the past two decades, the prevalence of type 2 diabetes among children and adolescents has increased substantially, yet treatment options for this population remain limited, underscoring a significant unmet need. Oral semaglutide has already demonstrated clinically meaningful glycaemic efficacy and a well‑established safety profile in adults with type 2 diabetes, alongside proven cardiovascular benefits unique to this molecule. These results from the PIONEER TEENS trial confirm that oral semaglutide is an effective treatment option for children and adolescents with type 2 diabetes who require glycaemic control beyond that provided by the current standard of care.”
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