The FDA has approved the Wegovy pill, a needle-free weight loss option that may not be effective for everyone, offering an average weight reduction of 16.6%.
The U.S. Food and Drug Administration (FDA) has granted approval for the Wegovy pill, marking the first oral GLP-1 medication designed for weight loss. Developed by Novo Nordisk, this new pill provides a needle-free alternative for individuals seeking to reduce excess body weight, maintain long-term weight loss, and lower the risk of major cardiovascular events.
The approval of the once-daily 25mg semaglutide pill was based on the findings from two significant clinical trials: the OASIS trial program and the SELECT trial. In the OASIS 4 trial, the Wegovy pill demonstrated a mean weight loss of 16.6% among adults who were classified as obese or overweight and had one or more comorbidities. Notably, one in three participants in this trial experienced a weight loss of 20% or more.
According to Novo Nordisk, the weight loss achieved with the Wegovy pill is comparable to that of the injectable version of Wegovy and shares a similar safety profile. Mike Doustdar, president and CEO of Novo Nordisk, expressed optimism about the new treatment option, stating, “With today’s approval of the Wegovy pill, patients will have a convenient, once-daily pill that can help them lose as much weight as the original Wegovy injection.” He emphasized that this oral GLP-1 treatment offers a new, accessible option for individuals dealing with overweight or obesity.
The Wegovy pill is expected to launch in the U.S. in early January 2026. In addition to its approval in the United States, Novo Nordisk has submitted the oral semaglutide for obesity to the European Medicines Agency (EMA) and other regulatory bodies.
Dr. Sue Decotiis, a medical weight-loss specialist based in New York City, confirmed in an interview that studies indicate that oral Wegovy is comparable to the weekly injectable version, minus the need for needles. While the pill may enhance patient compliance and ease of use, Decotiis cautioned that some individuals might not absorb the medication through the gastrointestinal tract as effectively as with the injectable form. This variability can be attributed to individual differences in body chemistry.
Decotiis noted that most side effects associated with the Wegovy pill are expected to be gastrointestinal in nature, similar to those experienced with the injectable version. These may include nausea, vomiting, and constipation.
In her practice, Decotiis has observed that tirzepatide, marketed as Mounjaro and Zepbound, tends to yield greater weight loss and fat loss compared to semaglutide, often by about 20%. This trend has been supported by various studies, which suggest that tirzepatide may also come with fewer side effects.
Looking ahead, Decotiis indicated that more oral GLP-1 medications could be on the horizon in 2026. This includes an Orforglipron application by Lilly and a new combination drug from Novo Nordisk that is pending approval. She expressed optimism about the future of weight loss medications, stating, “There will be more new drugs available in the future that will be more effective for patients who are more insulin-resistant and have not responded as well to semaglutide and/or tirzepatide.” This development is promising, as novel drugs targeting multiple receptors could lead to better long-term outcomes for a broader range of patients.
As these medications become more affordable and accessible, Decotiis stressed the importance of maintaining healthy lifestyle habits. This includes proper nutrition, sufficient protein and fiber intake, and increased hydration, all of which are crucial for achieving lasting weight loss results. “If not, patients will regain weight and could lose muscle and not enough body fat,” she warned.
Fox News Digital reached out to Novo Nordisk for further comments regarding the Wegovy pill.
According to Fox News, the introduction of the Wegovy pill represents a significant advancement in the field of weight management, offering a new option for those struggling with obesity.