USFDA Approves First Weight-Loss Pill Version of Wegovy
23rd Dec. 2025
The US Food and Drug Administration has approved a pill version of Wegovy. It marked a major milestone for the organization in the rapidly expanding market for weight-loss medicines. Developed by Danish pharmaceutical group Novo Nordisk, the drug becomes the first oral weight-loss treatment of its kind to receive clearance from the regulator.
The approval signals a shift in how obesity may be treated. Patients will no longer need injections to access one of the most effective weight-loss medications that is currently available. Novo Nordisk said the once-daily tablet would offer the same benefits as the injections. Previously, injections were also authorized by the FDA specifically for weight management.
Tablet has strong weight-loss outcome: Clinical Trials
According to Novo Nordisk, clinical trials demonstrated that patients who take the pill will lose an average of 16.6% of their body weight. In addition, around one-third of the 1,300 participants recorded weight loss of 20% or more during the study period. The company emphasised that the oral drug is designed to match the performance of the original Wegovy injection.
“Patients will have a convenient, once-daily pill that can help them lose as much weight as the original Wegovy injection,” said Mike Doustdar, the firm’s chief executive. Drugs such as Ozempic have become widely known for their weight-loss effects. Initially, they were approved to treat Type 2 diabetes, rather than obesity itself. By contrast, Wegovy was cleared specifically for weight loss, that strengthen its position in the growing market.
What is the reaction of the market after Wegovy approval?
The pill is expected to be launched in the United States in early January 2026, once final commercial preparation is complete. Meanwhile, the news sources have contacted the FDA for further comment following the announcement. The approval could provide a timely boost for Novo Nordisk. In the present year, they had faced a difficult situation amid profit warnings and intensifying competition from rivals, including US-based drugmaker Eli Lilly.
As a result, investors reacted positively to the news, with Novo Nordisk shares rising by nearly 10% in after-hours trading in New York. More broadly, analysts say the decision reflects increasing demand for accessible obesity treatments. At the same time, regulators and healthcare systems are also responding to rising global rates of weight-related illness. Consequently, the arrival of an effective pill may widen access for patients reluctant or unable to use injections.
The other side of Wegovy weight-loss pills
Despite the enthusiasm surrounding the approval, experts caution that the pill version of Wegovy is not without limitations. Like its injectable counterpart, the oral drug may cause side effects. The patients may face nausea, vomiting, diarrhea, and abdominal discomfort, which were also reported during clinical trials.
In addition, specialists warn that long-term safety data for the pill remains limited. While the trial results are promising, researchers say further real-world evidence will be needed to assess how patients respond over extended periods. Doctors also continuously stress that such medications are not a substitute for lifestyle changes. Instead, they are most effective when combined with diet, exercise, and medical supervision, particularly for patients with obesity-related health conditions.
Web Resources on the US Approving Wegovy Tablets
1. ABCNews.go.com: US regulators approve Wegovy pill for weight loss
2. Reuters.com: Novo Nordisk wins US approval for weight-loss pill
3. WSJ.com: Pill Version of Wegovy Is Approved for Use in the U.S.