The U.S. Food and Drug Administration (FDA) has granted approval for the Wegovy pill, marking a significant milestone as the first oral GLP-1 medication for weight loss. Developed by the Danish pharmaceutical company Novo Nordisk, this once-daily pill is intended to help individuals reduce excess body weight, maintain long-term weight reduction, and lower the risk of major cardiovascular events.
The approval of the 25 mg semaglutide pill was based on the results from two pivotal clinical trial programs: the OASIS trial and the SELECT trial. In the OASIS 4 trial, participants who were classified as obese or overweight and had one or more comorbidities achieved a mean weight loss of 16.6%. Remarkably, one in three participants reported a weight loss of 20% or greater.
Comparative Effectiveness and Safety Profile
Novo Nordisk has asserted that the weight loss outcomes associated with the Wegovy pill are comparable to those of the injectable version of Wegovy, with a similar safety profile. Mike Doustdar, president and CEO of Novo Nordisk, stated, “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.”
The oral formulation is expected to be available in the U.S. market by early January 2026. Moreover, Novo Nordisk has submitted oral semaglutide for obesity treatment to the European Medicines Agency (EMA) and other regulatory bodies around the world.
Despite the anticipated advantages of ease and convenience, Dr. Sue Decotiis, a weight loss physician in New York City, cautioned that the absorption of the medication may vary among individuals. “Some patients may not absorb the medication through the gastrointestinal tract as effectively as with the injectable version,” she noted. Side effects, primarily gastrointestinal in nature, are expected to be similar to those seen with the injectable version, including nausea, vomiting, and constipation.
The Future of Weight Loss Medication
Dr. Decotiis also highlighted that in her experience, the weight loss associated with tirzepatide—another medication—has been more pronounced compared to semaglutide, showing approximately 20% greater fat loss. “This has been shown in studies, often with fewer side effects,” she explained.
Looking ahead, the landscape of oral GLP-1 medications is set to expand. Dr. Decotiis mentioned the anticipated launch of additional options like Orforglipron by Lilly and a new combination drug from Novo Nordisk, which is pending approval for release later in 2026. “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,” she said.
As these innovative treatments become more accessible, Dr. Decotiis emphasized the importance of maintaining healthy lifestyle habits. Proper nutrition, including adequate protein and fiber intake, along with increased hydration, is essential for achieving sustainable weight loss. “If not, patients will regain weight and could lose muscle and not enough body fat,” she cautioned.
As the Wegovy pill prepares for its market debut, it raises important questions about the evolving landscape of weight loss medications and their potential impact on public health.
