With the recent launch of Novo Nordisk’s Wegovy pill opening the oral GLP-1 market for obesity, the company has now unveiled positive results that could tee up an expansion in semaglutide’s inaugural diabetes indication.
In Novo’s phase 3a Pioneer Teens trial, oral semaglutide helped kids and adolescents aged 10 - 17 years chart a superior reduction in blood sugar over placebo at 26 weeks. The med's safety and tolerability profile remained on par with semaglutide's performance in other studies, the company said Thursday.
Oral semaglutide already boasts approvals for diabetes and obesity in adults, under the brand names Rybelsus and Wegovy. The injectable versions of the drugs—Ozempic and Wegovy—are cleared in similar indications, but only Wegovy currently carries a green light to treat obesity in adolescents.
Novo is touting the Pioneer Teens study as the first for an oral GLP-1 in the 10 to 17-year-old age bracket. With results in hand, the Danish drugmaker plans to file for a label expansion for oral semaglutide in Type 2 diabetes in the U.S. and European Union during the second half of 2026, the company said in a release.
In the U.S., Novo plans to reintroduce oral semaglutide for diabetes under the Ozempic Pill moniker “later in Q2 2026,” according to Thursday’s release. When it revealed the rebrand in a company statement in February, Novo said the change was “intended to help patients and health care professionals more easily recognize the available treatment options for type 2 diabetes that contain the semaglutide molecule.” The drug’s active ingredient will remain the same.
Back in 2019, Novo’s Rybelsus became the first oral GLP-1 approved to treat Type 2 diabetes.
“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,” Martin Holst Lange, Novo’s chief scientific officer, said in a statement Thursday.
He continued, “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.”
Once known as adult-onset diabetes, there were some 14.6 million adolescents globally living with Type 2 diabetes in 2021, with that number projected to reach 20.9 million by the end of the decade, according to Novo.
Cornerstone therapies like metformin and insulin are recommended as first-line treatments for the condition in kids and teens, although metformin is associated with failure in glycemic control in roughly half of adolescents, and insulin is linked to hypoglycemia and weight gain, per the company.
Novo’s phase 3a study assessed oral semaglutide in 132 kids and adolescents with Type 2 diabetes over a year, with patients receiving background treatment with metformin, basal insulin or both. The primary endpoint looked at the change in patients’ blood glucose levels from baseline at 26 weeks. The trial evaluated oral semaglutide at 3-, 7- and 14-mg doses once per day.
Novo’s efforts to advance oral semaglutide for diabetes could give the company an edge as it dukes it out with Eli Lilly in the oral GLP-1 market for obesity, recently opened by the launches of the companies’ respective products, the Wegovy pill and Foundayo.
In its first week on the market, Lilly’s Foundayo—starting from April 6—drew 1,390 prescriptions, according to IQVIA data referenced in a recent note from Jefferies analysts. By comparison, the Wegovy pill garnered a little over 3,000 prescriptions during its launch week in January.