The FDA has approved Novo Nordisk’s Wegovy pill (oral semaglutide 25 mg), the first daily oral GLP-1 therapy for long-term weight management and the reduction of major cardiovascular risks.

Based on the OASIS 4 and SELECT trials, the pill achieved a 16.6% mean weight loss—performance comparable to the 2.4 mg Wegovy injection. Additionally, one-third of trial participants lost 20% or more of their body weight, while maintaining a safety profile consistent with existing semaglutide treatments.

“The pill is here. 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,” said Mike Doustdar, president and CEO of Novo Nordisk.

“As the first oral GLP-1 treatment for people living with overweight or obesity, the Wegovy pill provides patients with a new, convenient treatment option that can help patients start or continue their weight loss journey. 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”. 

Novo Nordisk expects to launch the Wegovy pill in the US in early January 2026. Novo Nordisk has submitted oral semaglutide 25 mg once-daily for obesity to the European Medicines Agency (EMA) and other regulatory authorities during the second half of 2025.