Oral Wegovy OK'd

The Food and Drug Administration has approved Wegovy as a once-daily pill for adults with obesity or overweight with a weight-related condition. (accessdata.fda.gov) The new tablet uses semaglutide, the same glucagon-like peptide-1 drug already sold as injectable Wegovy. The label says the pill is indicated with diet and exercise for long-term weight reduction, and to cut the risk of major cardiovascular events in adults with established cardiovascular disease and obesity or overweight. (accessdata.fda.gov) In the Phase III OASIS 4 trial, 307 adults without diabetes were randomized in a 2-to-1 ratio to oral semaglutide 25 milligrams or placebo, plus lifestyle changes. At week 64, the estimated mean weight change was minus 13.6% with the drug and minus 2.2% with placebo. (nejm.org) Novo Nordisk separately reported an on-treatment analysis from the same study that put average weight loss at 16.6% for the pill versus 2.7% for placebo, with 34.4% of treated patients losing at least 20% of body weight. (novonordisk.com) The approval extends Wegovy beyond injections at a moment when drugmakers are racing to widen the obesity market with easier-to-take products. Novo Nordisk said in December 2025 that Wegovy pill was the first oral glucagon-like peptide-1 medicine for obesity cleared in the United States. (prnewswire.com) The Food and Drug Administration’s current label also shows how quickly the product has evolved. Wegovy tablets now sit in a combined prescribing document with the injection, and the agency approved January 27, 2026 supplements that removed the warning subsection on suicidal behavior and ideation from Wegovy labeling. (accessdata.fda.gov) The boxed warning did not disappear. The label still warns that semaglutide caused thyroid C-cell tumors in rodents, says the human risk is unknown, and lists personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 as contraindications. (accessdata.fda.gov) The most common tradeoff in OASIS 4 was stomach side effects, which are typical for this drug class. The New England Journal of Medicine paper said gastrointestinal adverse events occurred in 74.0% of patients on oral semaglutide and 42.2% on placebo. (nejm.org) Novo Nordisk said on December 22, 2025 that manufacturing was already underway in North Carolina and that a full U.S. launch was planned for early January 2026. The company framed the pill as a way to reach patients who have not wanted an injectable obesity medicine. (prnewswire.com)