FDA approves oral semaglutide pill

Semaglutide is a hormone-mimicking drug that slows digestion and cuts appetite, and the Food and Drug Administration cleared a once-daily pill version for chronic weight management in December 2025. (ajmc.com) The drug will be sold as Wegovy tablets by Novo Nordisk, making it the first oral glucagon-like peptide-1 medicine approved in the United States for adults with obesity or with overweight plus a weight-related condition. Novo Nordisk said it planned a United States launch in early January 2026. (ajmc.com) (prnewswire.com) The approval leaned on the Phase 3 OASIS 4 trial, which enrolled 307 adults without diabetes and compared oral semaglutide 25 milligrams with placebo plus lifestyle counseling. At 64 weeks, average weight loss was 13.6% with the pill versus 2.2% with placebo. (nejm.org) (ajmc.com) In OASIS 4, 30% of patients on oral semaglutide lost at least 20% of their body weight, compared with 3% on placebo. The trial also reported improvements in waist size, blood sugar, blood fats, and C-reactive protein, a marker tied to inflammation. (acc.org) The pill gives Novo Nordisk a second Wegovy format after weekly injections, at a time when obesity drugs have become one of the drug industry’s biggest markets. Oral dosing also targets patients who want to avoid injections or start treatment in primary care with a familiar form. (managedhealthcareexecutive.com) (ajmc.com) The label also extends beyond weight loss alone. AJMC reported the Food and Drug Administration cleared oral semaglutide to reduce major adverse cardiovascular events, drawing on the broader semaglutide evidence base that includes the SELECT cardiovascular outcomes trial. (ajmc.com) Patients should expect the same side-effect pattern seen with injected glucagon-like peptide-1 drugs: mostly nausea, diarrhea, and vomiting. In OASIS 4, gastrointestinal side effects were reported in 74% of the oral semaglutide group and 42% of the placebo group, while discontinuation rates were 7% and 6%. (acc.org) The approval arrived as Novo Nordisk was separately dealing with Food and Drug Administration scrutiny over safety reporting. On March 5, 2026, the agency sent Novo Nordisk a warning letter after a 2025 inspection of its Plainsboro, New Jersey site found serious violations of postmarketing adverse drug experience reporting requirements. (fda.gov) Novo Nordisk said on March 10, 2026 that it had been addressing the inspection findings since receiving a Form FDA 483 on February 7, 2025 and had provided an initial response plus seven updates. The company said the warning letter “does not make any conclusions about the quality or safety of our medicines” and that it did not expect an impact on production or 2026 guidance. (novonordisk.mediaroom.com) So the story is two tracks moving at once: a new obesity pill is now on the market, and the company behind it is still answering regulators about how it handles safety reports after launch. Both tracks will shape how quickly Wegovy tablets spread through clinics in 2026. (fda.gov) (novonordisk.mediaroom.com)