FDA Approves First Oral GLP-1 Medication for Weight Loss

The Food and Drug Administration has approved the first oral GLP-1 medication for weight loss in the United States. Novo Nordisk’s Wegovy pill, a once-daily 25mg semaglutide tablet, has been cleared to reduce excess body weight, maintain long-term weight reduction, and lower the risk of major cardiovascular events.

The approval follows successful results from two clinical trials—the OASIS trial program and the SELECT trial. In the OASIS 4 trial, the oral medication demonstrated a mean weight loss of 16.6% among adults who were obese or overweight with at least one additional medical condition. Notably, one in three participants experienced 20% or greater weight loss.

According to Novo Nordisk, the pill delivers weight loss results comparable to injectable Wegovy, with a similar safety profile. “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,” said Mike Doustdar, president and CEO of Novo Nordisk, in a press release.

The new oral formulation is expected to launch in the United States in early January 2026. Novo Nordisk has also submitted applications for regulatory approval to the European Medicines Agency and other regulatory authorities around the world.

Dr. Sue Decotiis, a medical weight-loss specialist in New York City, confirmed that studies show the oral version is comparable to the weekly injectable version, with the obvious advantage of eliminating needles. However, she cautioned that individual differences in gastrointestinal absorption might mean some patients respond better to injectable formulations.

“Most side effects will be GI-related and should be similar to the injectable, such as nausea, vomiting and constipation,” Dr. Decotiis noted.

The approval marks a significant milestone in the rapidly evolving weight loss medication market. GLP-1 (glucagon-like peptide-1) medications work by mimicking hormones that regulate appetite and blood sugar, helping patients feel fuller longer and reducing food intake.

Dr. Decotiis shared her clinical experience comparing different weight loss medications: “In my practice, I have found tirzepatide (Mounjaro and Zepbound) to yield more weight loss and fat loss than semaglutide by about 20%. This has been shown in studies, often with fewer side effects.”

The weight loss medication landscape is expected to expand further, with more oral GLP-1 options potentially coming to market in 2026. These include Eli Lilly’s Orforglipron application and a new combination drug from Novo Nordisk pending approval later next year.

“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,” Dr. Decotiis explained. “This is great news, as novel drugs affecting more receptors mean better long-term results in more patients.”

Despite the excitement around these medications, Dr. Decotiis emphasized that maintaining healthy lifestyle habits remains essential for lasting results. Proper nutrition with sufficient protein and fiber, along with increased hydration, are critical components of successful weight management.

“If not, patients will regain weight and could lose muscle and not enough body fat,” she warned.

The approval comes amid growing medical evidence supporting GLP-1 medications not only for weight management but potentially for other health benefits. Recent studies have suggested these drugs may offer protection against certain cancers in women and could add years to Americans’ lives, broadening their potential public health impact.