FDA Approves Wegovy Weight-Loss Pill, First Oral GLP-1

On December 22, 2025, the U.S. Food and Drug Administration (FDA) formally approved Wegovy® pills, marking a major milestone in obesity treatment. The new medication from Novo Nordisk is designed as a once-daily oral semaglutide pill — the first oral glucagon-like peptide-1 (GLP-1) receptor agonist approved in the U.S. for weight loss and long-term weight management in adults with obesity or overweight and weight-related medical conditions.

What Changed: An Oral Pill for Weight Loss

This approval follows highly positive results from the Phase III OASIS 4 clinical trial, in which participants taking the oral Wegovy pill once daily lost an average of about 16.6 percent of their body weight over 64 weeks compared to placebo, and a significant number achieved 20 percent or more weight loss.

How the Pill Works

Like existing weight-loss treatments in the GLP-1 class, such as injectable Wegovy and Ozempic, the Wegovy pill uses semaglutide, a compound that mimics a hormone involved in appetite control and blood-sugar regulation. GLP-1 drugs help reduce hunger, increase feelings of fullness, and improve glycemic control.

The oral formulation gives patients a needle-free option, appealing to people who prefer taking medication by mouth or who have avoided regular injections. Because oral semaglutide must be taken on an empty stomach with water and then followed by a waiting period before food, patients are advised to follow dosing instructions for optimal effectiveness.

Despite generational differences in administration, early data suggest the effectiveness of the oral pill approaches that of weekly injectables, making it an important alternative in clinical practice.

Expected Availability and Launch

Novo Nordisk plans to begin selling the Wegovy pill in the United States in early January 2026, with manufacturing already underway. The company expects broad distribution through pharmacies, alongside programs aimed at improving patient access.

The approval places Wegovy ahead of competing oral GLP-1 treatments under review — including orforglipron, a rival oral drug from Eli Lilly that has shown promising results but has not yet received FDA clearance.

Potential Impact on Obesity Treatment

The FDA’s approval of an oral GLP-1 weight-loss medication is a major development in the ongoing battle against obesity — a chronic condition affecting a significant portion of the U.S. population. Obesity is linked to higher risks of cardiovascular disease, diabetes, and other serious chronic conditions, making effective treatments a public health priority.

Healthcare experts say that the arrival of an oral option could make weight-loss medications more accessible and acceptable for people who struggle with injections, potentially expanding the pool of patients willing to pursue pharmacologic treatment. It may also influence broader treatment strategies, diet and lifestyle interventions, and long-term management of weight-related health issues.

You might also want to read: Ozempic Shows It Can Reduce Alcohol Cravings