FDA Clears First Weight-Loss Pill of Its Kind
The US Food and Drug Administration (FDA) has approved a pill version of the popular weight-loss drug Wegovy, according to its maker, Novo Nordisk. The approval marks the first time a pill-based version of a GLP-1 weight-loss drug has received regulatory clearance in the United States.
The decision signals a major shift in how weight-loss treatments could be delivered in the future.
Alternative to Injectable Wegovy
Novo Nordisk said the once-daily pill offers a more convenient option compared with the injectable form of Wegovy. The Danish drugmaker added that the pill delivers the same level of weight loss as the weekly injection.
Wegovy was previously approved by the FDA specifically for weight loss. By contrast, similar drugs such as Ozempic were initially cleared to treat Type 2 diabetes, even though many users experienced weight loss.
The BBC has contacted the FDA for comment.
Strong Results in Clinical Trials
According to Novo Nordisk, the pill version of Wegovy produced strong results during clinical trials. The company said participants achieved an average weight loss of 16.6%.
In addition, around one-third of the 1,300 trial participants lost 20% or more of their body weight. These results matched the effectiveness seen with the injectable form of the drug, the company said.
US Launch Expected in Early 2026
Novo Nordisk expects to launch the Wegovy pill in the US in early January 2026. The company believes the oral version could attract more patients who prefer pills over injections.
“Patients will have a convenient, once-daily pill that can help them lose as much weight as the original Wegovy injection,” said Mike Doustdar, Novo Nordisk’s chief executive.
Boost for Novo Nordisk After Tough Year
The approval could help boost Novo Nordisk’s sales after a difficult year. The company’s shares had fallen earlier after it warned investors about pressure on profits.
At the same time, Novo Nordisk has faced growing competition in the weight-loss drug market. Rivals such as Eli Lilly have launched or developed similar treatments, increasing pressure on pricing and market share.
Shares Jump After Announcement
Following the announcement, Novo Nordisk’s shares rose by nearly 10% in after-hours trading in New York. Investors reacted positively to the approval, viewing the pill as a potential growth driver for the company.
As demand for weight-loss treatments continues to rise, analysts expect the FDA’s decision to reshape competition in the rapidly expanding market.
