Oral GLP‑1 pill approved

Semaglutide works by copying a gut hormone that helps people feel full and eat less. On December 22, 2025, the Food and Drug Administration approved Wegovy tablets as the first glucagon-like peptide-1 pill for chronic weight management in adults. (fda.gov) (prnewswire.com) The new product is oral semaglutide, the same active ingredient used in Wegovy injections, but taken once a day as a tablet instead of once a week as a shot. The prescribing information lists Wegovy as both an injection and an oral tablet product. (novo-pi.com) The tablet is approved with a reduced-calorie diet and increased physical activity for adults with obesity, and for adults with overweight who have at least one weight-related condition. The label also says patients must wait at least 30 minutes after taking the tablet before eating, drinking, or taking other oral medicines. (novo-pi.com) The approval gives doctors a pill option in a market that had been dominated by injections such as Wegovy and Zepbound. The Food and Drug Administration had already approved oral semaglutide as Rybelsus for type 2 diabetes, but not for weight loss. (fda.gov 1) (fda.gov 2) In the phase 3 OASIS 4 trial, 307 adults without diabetes were randomized in a 2-to-1 ratio to oral semaglutide 25 milligrams or placebo at 22 sites in four countries. At week 64, the estimated mean body-weight change was minus 13.6% with semaglutide and minus 2.2% with placebo. (nejm.org) The same trial found gastrointestinal side effects were common: 74.0% in the semaglutide group versus 42.2% with placebo. The Wegovy label carries a boxed warning about thyroid C-cell tumors seen in rodents and says the drug is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. (nejm.org) (novo-pi.com) Novo Nordisk said at approval that a 1.5 milligram starting dose would be available in the United States in early January 2026 and priced at $149 per month with savings offers. The company also said the pill was being produced in the United States with supply on hand. (prnewswire.com) The approval landed just three months before Eli Lilly won clearance for its own oral obesity drug, orforglipron, widening the shift from injectable to oral weight-loss medicines. Novo Nordisk has since used April 2026 conference data to argue that its Wegovy pill produced greater weight loss and fewer discontinuations than orforglipron in an indirect comparison. (managedhealthcareexecutive.com) (novonordisk.com) For patients who put off treatment because they did not want injections, the new question is simpler than the science: whether they can take a daily pill, on an empty stomach, for months or years. (novo-pi.com)