Novo Nordisk said April 23 it plans to seek expanded FDA approval for its Ozempic pill in the second half of 2026, which would make the drug the first oral GLP-1 approved for children and adolescents with Type 2 diabetes.
Currently, the Denmark-based drugmaker has FDA approval for the injectable form of Ozempic, which is indicated for adults with Type 2 diabetes, as well as diabetes-related cardiovascular disease and chronic kidney disease. The FDA approved the oral presentation of Ozempic in February, and Novo Nordisk said it would launch the pill in the U.S. in the second quarter of 2026.
The world’s two largest manufacturers of brand-name GLP-1s, Novo Nordisk and Eli Lilly, already produce FDA-approved GLP-1 pills for obesity. Novo Nordisk also offers Rybelsus, an oral GLP-1 for Type 2 diabetes, which the FDA approved in 2017.
The latest announcement comes alongside positive phase 3 trial results evaluating oral semaglutide (Ozempic) among Type 2 diabetes patients ages 10-17 years old. The 52-week study found “superior blood glucose lowering versus multiple comparators, together with consistent weight reduction, reduction in cardiometabolic risk factors and reduction in major adverse cardiovascular events,” Novo Nordisk said.
“Pending regulatory approvals, oral semaglutide has the potential to be the first and only oral GLP-1 RA to demonstrate superior glycemic efficacy versus placebo in children and adolescents with Type 2 diabetes, while maintaining the well-established safety profile seen across the semaglutide portfolio,” the drugmaker said.
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