The recent launch of Novo Nordisk’s Wegoby pill has opened up the oral GLP-1 market for obesity, and the company announced positive results that could trigger the first expanded diabetes indication for semaglutide.
In Novo’s Phase 3a Pioneer Teens trial, oral semaglutide demonstrated better blood sugar reduction than placebo at 26 weeks in children and adolescents ages 10 to 17 years. The drug’s safety and tolerability profile was comparable to semaglutide’s performance in other studies, the company announced Thursday.
Oral semaglutide has already been approved for diabetes and obesity in adults, under the respective brand names Rybelsus and Wegovy tablets. Injectable versions of the drug, Ozempic and Wegoby, are approved for similar indications, but only Wegoby currently has the green light to treat obesity in adolescents.
Novo touts the Pioneer Teens Study as the first study of oral GLP-1 in the 10- to 17-year-old age group. With the results in hand, the Danish drugmaker plans to apply for a label extension for oral semaglutide for type 2 diabetes in the United States and European Union in the second half of 2026, the company said in a release.
In the U.S., Novo plans to reintroduce oral semaglutide to diabetic patients under the name Ozempic Pill in “late second quarter 2026,” according to a Thursday release. When Novo revealed the brand change in a company statement in February, it said the change was “aimed to make it easier for patients and healthcare professionals to be aware of available treatment options for type 2 diabetes, including the semaglutide molecule.” The active ingredients of the drug remain unchanged.
Back in 2019, Novo’s Libersus became the first oral GLP-1 approved for the treatment of type 2 diabetes.
“Over the past two decades, the prevalence of type 2 diabetes in children and adolescents has increased significantly, but treatment options for this population remain limited, highlighting a significant unmet need,” Martin Horst Lange, Novo’s chief scientific officer, said in a statement Thursday.
He added: “Oral semaglutide has already demonstrated clinically meaningful glycemic effects and a well-established safety profile in adults with type 2 diabetes, along with proven cardiovascular benefits unique to this molecule.”
Formerly known as adult-onset diabetes, approximately 14.6 million young people worldwide had type 2 diabetes in 2021, and according to Novo, that number is expected to reach 20.9 million by the end of the decade.
Basic therapies such as metformin and insulin are recommended as first-line treatments for symptoms in children and teens, but metformin is associated with failure to control blood sugar in about half of adolescents, and insulin is associated with hypoglycemia and weight gain, the company said.
Novo’s Phase 3a study evaluated oral semaglutide over a one-year period in 132 children and adolescents with type 2 diabetes who were receiving background treatment with metformin, basal insulin, or both. The primary endpoint looked at the change in patients’ blood glucose levels from baseline at week 26. This study evaluated oral semaglutide at doses of 3, 7, and 14 mg once daily.
Novo’s efforts to advance oral semaglutide for diabetes could give the company an advantage as it competes with Eli Lilly in the oral GLP-1 market for obesity, which was recently pioneered by the launch of the two companies’ respective products, the Wegovy pill and Foundayo.
Lilly’s Foundayo received 1,390 prescriptions in its first week of launch on April 6, according to IQVIA data referenced in a recent note by Jefferies analysts. By comparison, Wegovy’s pill attracted just over 3,000 prescriptions during its launch week in January.
