Novo Nordisk has announced positive results from its Phase 3a PIONEER TEENS clinical trial, which examined the impact of oral semaglutide on children and adolescents (aged 10–17) living with type 2 diabetes (T2D). Following these findings, the company plans to seek regulatory approval for oral formulations under the Rybelsus and Ozempic brands for this younger demographic by late 2026.
The study involved 132 participants receiving daily oral doses of 3 mg, 7 mg, or 14 mg alongside existing standard treatments like metformin or basal insulin. At the 26-week mark, the semaglutide group showed a statistically significant reduction in HbA1c levels of 0.83% compared to the placebo group. Medical experts consider any reduction exceeding 0.5% as clinically meaningful for lowering the long-term risk of cardiovascular, kidney, and nerve complications.
Addressing an underserved market, this oral GLP-1 therapy could provide an alternative to traditional treatments. Current options like metformin often fail to meet glucose targets in roughly half of adolescent patients, while insulin carries side effects such as weight gain and hypoglycemia. By introducing a pill version, Novo Nordisk aims to address the global rise in pediatric T2D, which is projected to reach nearly 21 million cases by 2030, while strengthening its competitive edge in the metabolic health sector.
Source: https://pharmaphorum.com/news/novo-says-oral-semaglutide-works-diabetic-kids