First GLP‑1 Pill OK'd

A hormone drug that helps people feel full now comes as a weight-loss pill: the Food and Drug Administration approved Wegovy tablets on December 22, 2025. (ajmc.com) The pill contains semaglutide, the same glucagon-like peptide-1 medicine sold as weekly Wegovy shots, and it is approved for adults with obesity or for adults who are overweight and have at least one weight-related medical problem. (accessdata.fda.gov) Food slows absorption of this drug, so the label says 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 food, drinks, or other oral medicines. (accessdata.fda.gov) The approval rested on Novo Nordisk’s 64-week OASIS 4 trial in 307 adults without diabetes. Average weight loss was 13.6% with the pill versus 2.2% with placebo, and the estimate for people who stayed on treatment was 16.6% versus 2.7%. (ajmc.com) The label also lets doctors use Wegovy tablets to lower the risk of major cardiovascular events — death, heart attack, or stroke — in adults with established cardiovascular disease and either obesity or overweight. That part of the approval draws on the earlier SELECT outcomes trial of injectable semaglutide, which showed fewer such events than placebo over a mean 39.8 months. (accessdata.fda.gov, (nejm.org)) Until this approval, the biggest weight-loss sales in this drug class came from injections, which require weekly shots and have faced years of demand and supply strain. Novo Nordisk said in December that it planned a full United States launch in early January 2026 and said production was underway in North Carolina. (prnewswire.com) The pill does not erase the class’s tradeoffs. The prescribing information carries a boxed warning about thyroid C-cell tumors seen in rodents, bars use in patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, and warns about stomach side effects and dehydration-related kidney injury. (accessdata.fda.gov) Novo Nordisk said the tablet would start at 1.5 milligrams and step up to a 25 milligram maintenance dose, with a $149-a-month introductory self-pay offer announced for the launch period. Insurance coverage will depend on each plan, as with the injectable version. (prnewswire.com, (novomedlink.com)) The approval gives obesity treatment a version that swaps a weekly pen for a daily pill, but it keeps the same basic bargain: meaningful weight loss for many patients, with strict dosing rules and the same safety warnings. (accessdata.fda.gov, (ajmc.com))