FDA clears oral semaglutide pill
- The U.S. Food and Drug Administration approved Novo Nordisk’s once-daily Wegovy pill on December 22, 2025, making it the first oral glucagon-like peptide-1 drug cleared in the U.S. for obesity treatment. - The tablet contains 25 milligrams of semaglutide and was cleared for adults with obesity, or overweight plus a related condition, and also for cardiovascular risk reduction in eligible adults. - The decision extended semaglutide beyond injections and diabetes tablets, adding a pill option to the Wegovy franchise as demand and access battles reshape obesity care. (fda.gov)
The Food and Drug Administration cleared Novo Nordisk’s Wegovy pill on December 22, 2025, giving the U.S. its first oral GLP-1 treatment for obesity. (fda.gov) (prnewswire.com) GLP-1 drugs copy a gut hormone that helps the body release insulin after eating and also acts on the brain to curb appetite and increase fullness. Semaglutide is the GLP-1 ingredient already sold in the U.S. as Ozempic, Rybelsus and Wegovy. (fda.gov) The newly approved product is Wegovy tablets, an oral 25-milligram form of semaglutide used with a reduced-calorie diet and increased physical activity. The label covers adults with obesity, or adults with overweight plus at least one weight-related condition. (fda.gov) The tablet also carries a cardiovascular indication: reducing the risk of cardiovascular death, heart attack or stroke in adults with established cardiovascular disease and either obesity or overweight. That matches a key selling point Novo Nordisk has already used for injectable Wegovy. (fda.gov 1) (fda.gov 2) Novo Nordisk said the approval was backed by the 64-week OASIS 4 phase 3 trial in 307 adults with obesity, or overweight plus at least one weight-related condition, without diabetes. In the company’s report, patients on the pill lost 16.6% of body weight if all stayed on treatment, versus 2.7% on placebo. (prnewswire.com) Using the trial’s broader analysis regardless of whether patients stayed on treatment, Novo Nordisk reported average weight loss of 13.6% on Wegovy pill versus 2.4% on placebo. The company said it planned a full U.S. launch in early January 2026. (prnewswire.com) The approval changed semaglutide’s U.S. lineup. Before Wegovy tablets, the Food and Drug Administration listed Rybelsus tablets only for type 2 diabetes, while Wegovy for weight loss was available as an injection. (fda.gov 1) (fda.gov 2) Wegovy tablets carry the same boxed warning used across semaglutide products about thyroid C-cell tumors seen in rodents. The label says the drug is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. (fda.gov) The timing also matters because the Food and Drug Administration approved a higher-dose Wegovy injection, called Wegovy HD, on March 19, 2026. Novo Nordisk now has both a new pill format and a new higher-dose shot competing for patients who want weight-loss treatment in different forms. (fda.gov)
