FDA green‑lights oral semaglutide

The Food and Drug Administration has cleared Wegovy as a tablet, making semaglutide the first GLP-1 pill approved in the U.S. for chronic weight loss in adults. (fda.gov, accessdata.fda.gov) GLP-1 drugs mimic a gut hormone that helps people feel fuller and eat less. Until now, the obesity versions of semaglutide sold in the U.S. were shots, including Wegovy injection and the newer 7.2-milligram Wegovy HD injection approved on March 19, 2026. (fda.gov, accessdata.fda.gov) The tablet approval is for adults with obesity, or adults who are overweight and have at least one weight-related condition, alongside a reduced-calorie diet and more physical activity. The updated FDA label also says the tablet form is indicated to lower the risk of heart attack, stroke, and cardiovascular death in adults with established cardiovascular disease and obesity or overweight. (accessdata.fda.gov) The main study behind the weight-loss approval was OASIS 4, a 71-week trial that enrolled 307 adults without diabetes at 22 sites in four countries. At week 64, people assigned to oral semaglutide 25 milligrams lost an average of 13.6% of body weight, versus 2.2% with placebo. (nejm.org) OASIS 4 also found more people on the pill reached 5%, 10%, 15%, and 20% weight-loss thresholds than people on placebo. Gastrointestinal side effects were common: 74.0% in the oral semaglutide group versus 42.2% in the placebo group. (nejm.org) The pill changes the routine as much as the format. The FDA-approved instructions say patients should take one tablet once a day on an empty stomach in the morning with up to 4 ounces of water, then wait at least 30 minutes before eating, drinking, or taking other oral medicines. (accessdata.fda.gov, wegovy.com) The safety warnings travel with the tablet. Wegovy carries a boxed warning about thyroid C-cell tumors seen in rodents, and the label says it should not be used in patients with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2. (accessdata.fda.gov) Novo Nordisk had signaled a U.S. launch in early January 2026, and company materials now market both a once-weekly injection and a once-daily 25-milligram tablet under the Wegovy brand. The shift puts obesity treatment into a form closer to everyday chronic-disease medicine: a pill bottle instead of an injector pen. (prnewswire.com, novomedlink.com) The approval lands as drugmakers race to move GLP-1 medicines from injections to tablets, with new oral rivals also entering the U.S. market in 2026. For patients who wanted semaglutide without a needle, the FDA has now made that option official. (fiercepharma.com, accessdata.fda.gov)