Novo Nordisk’s oral semaglutide pill has shown it can lower blood sugar in children and adolescents with type 2 diabetes, according to results from a late-stage clinical trial released Thursday.
The trial tested 132 patients between the ages of 10 and 17 over 26 weeks. Patients taking the pill reduced their average blood sugar levels by 0.83 percentage points more than those on a placebo.
The company called the result statistically significant and said it met the trial’s main goal.
This is the first time an oral GLP-1 drug has been tested in children and adolescents. Currently, no oral GLP-1 therapy is approved for use in that age group.
The pill is already sold under the brand names Rybelsus and Ozempic pill for adult patients. An Ozempic pill version is expected to become available in the U.S. in the second quarter of 2026.
Type 2 diabetes was once largely an adult condition. That has changed. Around 364,000 children and adolescents under 20 in the U.S. are currently living with diagnosed diabetes, per CDC data.
Doctors treating younger patients have few tools available. Metformin is the standard first option, but it fails to control blood sugar in roughly half of adolescent patients.
Insulin is the other main option, but it carries risks including low blood sugar episodes and weight gain. A well-tolerated oral option would fill a clear gap in care.
Martin Holst Lange, Novo Nordisk’s chief scientific officer, said the prevalence of type 2 diabetes in young people has grown substantially over the past two decades.
“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,” Lange said.
Novo Nordisk said it plans to file for regulatory approval to expand the label for both Rybelsus and Ozempic pill to include children and adolescents in the U.S. and EU in the second half of 2026.
If approved, it would make semaglutide the first oral GLP-1 therapy cleared for pediatric use.
The trial’s safety profile was described as consistent with results seen in other semaglutide trials across adult populations.
A successful approval would also extend Novo’s semaglutide franchise into a new patient population, giving the Danish drugmaker a potential edge over rival Eli Lilly (LLY) in the diabetes and weight-loss space.
Novo Nordisk is expected to submit regulatory filings in both markets before the end of the year.
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