FDA clears oral Wegovy

Wegovy is now available in the United States as a daily pill, not just a weekly shot, after the Food and Drug Administration approved oral semaglutide for adults with obesity and some adults with overweight. (accessdata.fda.gov) The new tablets are approved with a reduced-calorie diet and increased physical activity for long-term weight reduction in adults with obesity, or adults with overweight plus at least one weight-related condition. The label also includes use to reduce major cardiovascular events in adults with established cardiovascular disease and obesity or overweight. (accessdata.fda.gov) Semaglutide is a hormone-mimicking drug that helps people feel fuller and eat less. Wegovy already sold as an injection, and the tablet version gives patients a non-injectable option using the same active ingredient. (accessdata.fda.gov) The approval leaned on the Phase 3 OASIS 4 trial, a 71-week study that randomly assigned 307 adults without diabetes in a 2-to-1 ratio to oral semaglutide 25 milligrams or placebo, alongside lifestyle changes. The trial ran at 22 sites in four countries, with treatment lasting 64 weeks. (nejm.org) By week 64, the oral semaglutide group had an estimated mean weight change of minus 13.6%, compared with minus 2.2% for placebo. Gastrointestinal side effects were more common with the drug, affecting 74.0% of patients on oral semaglutide versus 42.2% on placebo. (nejm.org) The Food and Drug Administration label keeps the same boxed warning carried by injectable Wegovy: a rodent finding of thyroid C-cell tumors. The drug is contraindicated for patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. (accessdata.fda.gov) Novo Nordisk said before launch that manufacturing for the pill was underway in North Carolina and that a full United States rollout was planned for early January 2026. By April 2026, the company was already promoting new data comparing the Wegovy pill with Eli Lilly’s oral obesity candidate orforglipron. (prnewswire.com) (novonordisk.com) The approval also extends a fast-moving stretch for Wegovy in the United States. On March 19, 2026, the Food and Drug Administration cleared a higher-dose 7.2 milligram injection called Wegovy HD under its Commissioner’s National Priority Voucher pilot program. (fda.gov) For patients and doctors, the practical change is simple: the same obesity drug class that reshaped the market as a shot now has a pill form with federal approval and a label for chronic weight management. (accessdata.fda.gov)