Novo Nordisk (NYSE:NVO) shares rose nearly 8% after the US Food and Drug Administration approved its Wegovy pill, the first oral GLP-1 treatment for weight management.
Currently, GLP-1 treatments for weight-loss and diabetes are given by injection, with Denmark-based Novo first to market with its Wegovy and Ozempic drugs, before being overtaken by Eli Lilly, whose injectable Mounjaro and Zepbound control around 58% of total prescriptions versus Novo’s 42%.
Novo said its new once-daily 25 mg semaglutide pill demonstrated 16.6% average weight loss in its OASIS 4 clinical trial, with one in three participants losing at least 20% of their body weight. The safety and tolerability profile was consistent with previous semaglutide studies.
Novo Nordisk expects to launch the product in the US in early January 2026.
Regulatory submissions have also been made to the European Medicines Agency and other authorities.
“The pill is here,” said Mike Doustdar, president and CEO of Novo Nordisk. “With today's approval of the Wegovy pill, patients will have a convenient, once-daily pill that can help them lose as much weight as the original Wegovy injection.
“No other current oral GLP-1 treatment can match the weight loss delivered by the Wegovy pill, and we are very excited for what this will mean for patients in the US.”
Eli Lilly's oral GLP‑1 pill, orforglipron, is currently under FDA review and expected to be approved as early as March 2026, according to reports from the company.