FDA Approves Novo Nordisk’s Wegovy Pill as First Oral GLP-1 for Weight Management

The US FDA approved the Wegovy® pill (once-daily oral semaglutide 25 mg) on December 22, 2025, as the first oral GLP-1 receptor agonist for reducing excess body weight and maintaining weight loss long-term, plus reducing major cardiovascular event risks.1

In the OASIS 4 trial, the Wegovy pill achieved a mean weight loss of 16.6% in adults with obesity or overweight with comorbidities, similar to the injectable version, with one in three participants losing 20% or more.1

Novo Nordisk plans to launch the Wegovy pill in the US in early January 2026.1

The approval is based on the OASIS trial program and SELECT trial, confirming a safety profile comparable to prior semaglutide studies.1

Sources:

1. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916472