Novo Nordisk Wins FDA Approval for First Oral GLP-1 Wegovy Pill in Obesity Treatment

The FDA approved Novo Nordisk's Wegovy pill (once-daily oral semaglutide 25 mg) on December 22, 2025, as the first oral GLP-1 receptor agonist for chronic weight management in adults with obesity or overweight and at least one weight-related condition.123

In the OASIS 4 trial, it demonstrated 16.6% mean weight loss with treatment adherence.1

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

The approval is also supported by the SELECT trial for cardiovascular risk reduction and other trial programs.1

No other current oral GLP-1 matches the weight loss efficacy of the Wegovy pill, per Novo Nordisk's CEO.1

Sources:

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

2. https://www.pharmaceuticalcommerce.com/view/fda-approves-novo-nordisk-wegovy-pill

3. https://www.fiercepharma.com/pharma/novo-nordisk-wins-fda-approval-wegovy-pill-introducing-first-oral-glp-1-option-obesity