The U.S. Food and Drug Administration (FDA) has approved the first oral medication for weight loss, the Wegovy pill, developed by Danish pharmaceutical company Novo Nordisk. This significant advancement allows individuals seeking to manage their weight to do so without the need for injections. The Wegovy pill is designed to reduce excess body weight, support long-term weight maintenance, and lower the risk of major cardiovascular events.
The approval comes after promising results from two pivotal clinical trials: the OASIS trial program and the SELECT trial. In the OASIS 4 trial, participants who were overweight or obese and had at least one comorbidity experienced an average weight loss of 16.6%. Notably, one-third of the participants achieved a weight loss of 20% or more.
Mike Doustdar, president and CEO of Novo Nordisk, highlighted the convenience of the new pill, 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.” The company reports that the weight loss effectiveness and safety profile of the oral version are comparable to that of its injectable counterpart.
Launch and Expert Insights
The Wegovy pill is expected to be available in the U.S. starting in early January 2026. Novo Nordisk is also pursuing approval for the oral semaglutide in Europe through the European Medicines Agency (EMA).
Dr. Sue Decotiis, a weight loss physician based in New York City, confirmed that studies show the oral version of Wegovy is comparable to the weekly injectable. She noted that while the new format may enhance patient compliance due to its ease of use, individual absorption variability could affect its efficacy.
“Most side effects will be GI-related and should be similar to the injectable, such as nausea, vomiting, and constipation,” Dr. Decotiis explained. She further remarked on the comparative effectiveness of other medications, stating, “In my practice, I have found tirzepatide (Mounjaro and Zepbound) to yield more weight loss and fat loss than semaglutide by about 20%.”
Future Developments in Weight Loss Medications
Looking ahead, experts anticipate the introduction of more oral GLP-1 medications in 2026. Dr. Decotiis mentioned potential developments, including an application for Orforglipron by Lilly and a new combination therapy from Novo Nordisk awaiting approval.
“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 stated. “This is great news, as novel drugs affecting more receptors mean better long-term results in more patients.”
As these medications become more accessible and affordable, Dr. Decotiis emphasized the importance of maintaining a healthy lifestyle. Proper nutrition, sufficient protein and fiber intake, and adequate hydration are vital for achieving sustainable weight loss.
“If not, patients will regain weight and could lose muscle and not enough body fat,” she cautioned.
With the arrival of the Wegovy pill, patients will soon have a new option in their arsenal for weight management, aiming to improve both their health and quality of life.
