FDA approves oral semaglutide pill

The U.S. Food and Drug Administration approved Novo Nordisk’s oral Wegovy in December 2025, clearing the first GLP-1 pill for chronic weight management in adults with obesity or overweight and at least one weight-related condition. The approval also covers reduction of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight, according to FDA labeling. Novo Nordisk said at the time it planned to launch the once-daily 25 mg tablet in the United States in early January 2026. The decision added a pill option to a market that had been dominated by weekly injections. ### When did the approval actually happen? AJMC published its report on December 22, 2025, and identified that date as the FDA approval date for oral semaglutide under the Wegovy brand. That means the action was not new on May 19, 2026; it was a December 2025 approval that has continued to draw attention as oral obesity drugs move into the market. (ajmc.com) FDA labeling posted to the agency’s database shows Wegovy tablets for oral use alongside the injectable version, with “recent major changes” dated August 2025 and December 2025. The label lists the oral product as part of the Wegovy prescribing information and confirms the obesity and cardiovascular risk-reduction indications for adults. (ajmc.com) ### What exactly is approved for patients? Wegovy tablets are approved with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity, or adults with overweight plus at least one weight-related comorbid condition, the FDA label says. The same label also says the tablets are indicated to reduce the risk of cardiovascular death, non-fatal heart attack and non-fatal stroke in adults with established cardiovascular disease and either obesity or overweight. (accessdata.fda.gov) The oral product is semaglutide, a GLP-1 receptor agonist already familiar to prescribers through injectable Wegovy and diabetes treatments in the same class. Novo Nordisk described the approved oral obesity product as a once-daily 25 mg tablet. ### What evidence did the FDA rely on? (accessdata.fda.gov) The OASIS 4 trial enrolled 307 adults without diabetes who had obesity or overweight, AJMC reported. In that study, patients assigned oral semaglutide had a 13.6% mean reduction in body weight at 64 weeks, compared with 2.2% for placebo. (ajmc.com) AJMC said the approval was based on results from the OASIS clinical program and the SELECT trial. The article also said most adverse events in OASIS 4 were mild or moderate, with 93.1% of patients on oral semaglutide and 85.3% on placebo reporting adverse events. ### What are the main safety limits and warnings? (ajmc.com) FDA labeling for Wegovy carries a boxed warning on the risk of thyroid C-cell tumors. The label says semaglutide caused thyroid C-cell tumors in rodents, though it is unknown whether Wegovy causes those tumors, including medullary thyroid carcinoma, in humans. (ajmc.com) The FDA label says Wegovy is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. The labeling also directs clinicians to counsel patients about the potential risk and symptoms of thyroid tumors. (accessdata.fda.gov) ### What did Novo Nordisk say about the pill? Mike Doustdar, president and chief executive of Novo Nordisk, said in a statement carried by AJMC: “The pill is here.” He said the once-daily product would give patients “a convenient, once-daily pill” and called it “the first oral GLP-1 treatment for people living with overweight or obesity.” (accessdata.fda.gov) Novo Nordisk’s U.S. news hub continues to list Wegovy pill updates among its recent materials, including comparative data presented in 2026. The company’s site also says its U.S. media pages are where it posts press releases and launch-related updates. ### Where can readers look for the next concrete update? (ajmc.com) FDA’s prescribing information for Wegovy remains the clearest source for the approved indications, boxed warning and product form. Novo Nordisk’s U.S. news hub is the company’s public source for launch and commercial updates, and AJMC’s December 22, 2025 report remains the cited account of the approval date and planned early January 2026 U.S. launch. (novonordisk-us.com) (accessdata.fda.gov)