FDA Greenlights Wegovy: The First Oral GLP-1 Weight Loss Pill
In a landmark move for obesity treatment, the U.S. Food and Drug Administration (FDA) has approved the first-ever oral GLP-1 medication for weight loss. This approval, granted on December 22, 2025, marks a significant shift in the accessibility of revolutionary weight management therapies. The pill, known as Wegovy, is a product of Novo Nordisk.
The daily pill contains 25 milligrams of semaglutide, the same active ingredient found in the injectable version of Wegovy. Clinical trials have shown impressive results, with participants losing an average of 16.6% of their body weight over 64 weeks when adhering to the treatment. This efficacy is nearly identical to that of the injectable form.
Novo Nordisk plans to launch the pill in early January 2026. The starting dose of 1.5 milligrams will be available for $149 per month for cash-paying patients. This approval gives the Danish pharmaceutical giant a significant edge over its rival, Eli Lilly, whose competing oral drug, orforglipron, is still under FDA review. A decision is expected by spring.
The pill must be taken on an empty stomach with water in the morning, followed by a 30-minute wait before eating or drinking. Despite this requirement, health experts believe the oral option will appeal to patients who are needle-averse or those who have not sought treatment due to concerns about injectable medications. Currently, about 1 in 8 U.S. adults use GLP-1 drugs, but the new pill format could dramatically expand access.
Following the announcement, Novo Nordisk’s stock surged 9.2%, marking what analysts called a “redemption” for investors after a challenging year that saw shares lose nearly 50% of their value amid competition concerns.
Source: CNBC