FDA Approves Once-Daily Oral Semaglutide
The US Food and Drug Administration (FDA) has approved Novo Nordisk’s once-daily oral formulation of semaglutide, marketed as Wegovy® pill, marking the first oral GLP-1 receptor agonist approved for chronic weight management in the United States. The approval includes indications for adults with obesity or overweight with at least one weight-related comorbidity, as well as for reducing the risk of major adverse cardiovascular events (MACE) in patients with established cardiovascular disease.
Wegovy® pill is approved to be used alongside a reduced-calorie diet and increased physical activity. The formulation is expected to appeal to patients who may have previously avoided injectable options.
“We are offering a magnitude of weight loss that no other oral GLP-1 obesity candidate has been able to duplicate in phase 3 trials,” said Executive Vice President, US Operations at Novo Nordisk Dave Moore.
The FDA's decision was supported by findings from the 64-week phase 3 OASIS 4 trial, which enrolled 307 adults with obesity or overweight (BMI ≥27 kg/m²) and at least one weight-related comorbidity, excluding patients with diabetes. Participants were randomized 2:1 to receive either once-daily oral semaglutide 25 mg or placebo alongside lifestyle intervention.
Results showed an average weight loss of 16.6% in the treatment group vs 2.7% with placebo under the trial product estimand (assuming continued adherence to therapy). Under the treatment policy estimand (including all participants regardless of adherence), semaglutide pill users achieved an average 13.6% weight loss vs 2.4% with placebo. Additionally, 76% of patients in the treatment arm achieved ≥5% body weight reduction, compared with 31% in the placebo group. Common adverse events included gastrointestinal symptoms similar to those observed with injectable semaglutide.
“Wegovy® pill expands the possibilities for weight management with semaglutide, giving healthcare professionals a powerful, efficacious medicine in a new method of delivery,” said Timothy Garvey, MD, professor of medicine at the University of Alabama at Birmingham.
Wegovy® pill is set for full US launch in January 2026, starting with a 1.5 mg dose and pricing initiatives aimed at improving accessibility.