FDA approves oral semaglutide for weight loss

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. The approval added a tablet form of semaglutide to the Wegovy label for adults with obesity, or adults with overweight and at least one weight-related condition, according to the FDA prescribing information. The label also says the tablets may be used to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight. The decision gives Novo Nordisk an oral version of the same active ingredient used in its injectable obesity medicine. AJMC reported that the approval covered once-daily oral semaglutide 25 mg and cited company plans to launch the product in the United States in early January 2026. Novo Nordisk’s U.S. product page now lists Wegovy tablets 25 mg among its obesity medicines. (accessdata.fda.gov) ### Which patients can get the pill? The FDA label says Wegovy tablets are indicated with a reduced-calorie diet and increased physical activity for adults with obesity, or adults with overweight who have at least one weight-related comorbid condition. The same label includes a cardiovascular risk-reduction indication for adults with established cardiovascular disease and either obesity or overweight. (ajmc.com) The approval letter shows Novo Nordisk filed the application on February 28, 2025, and that the agency approved it with agreed labeling and minor editorial revisions. The letter also requires the company to submit final structured product labeling within 14 days and final printed carton and container labeling within 30 days after printing. (accessdata.fda.gov) ### What dose did the FDA clear? The approved oral product is Wegovy tablets 25 mg, according to AJMC’s report and Novo Nordisk’s U.S. product listing. AJMC said Novo Nordisk planned a once-daily regimen, and the FDA label identifies Wegovy tablets as the oral semaglutide form covered by the approval. (accessdata.fda.gov) The FDA labeling carries the same boxed warning used across semaglutide obesity products for risk of thyroid C-cell tumors observed in rodents. The 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. (ajmc.com) ### What evidence supported the approval? The OASIS 4 study enrolled 307 adults with obesity or overweight and compared oral semaglutide with placebo over 64 weeks, according to AJMC and materials linked to the New England Journal of Medicine. AJMC reported mean weight loss of 13.6% with oral semaglutide versus 2.2% with placebo at week 64. (accessdata.fda.gov) The cardiovascular portion of the label draws on prior semaglutide outcomes data in patients with obesity or overweight and established cardiovascular disease. A New England Journal of Medicine report on the SELECT trial found weekly semaglutide reduced cardiovascular death, nonfatal heart attack or nonfatal stroke versus placebo in that population. (ajmc.com) ### How does this fit with Novo Nordisk’s other semaglutide products? Novo Nordisk already sells injectable Wegovy for obesity and, separately, oral semaglutide for type 2 diabetes under the Ozempic pill branding disclosed in a May 1, 2026 U.S. press release. The company’s U.S. news archive also shows it launched Wegovy HD, a higher-dose injectable semaglutide, nationwide on April 7, 2026. (nejm.org) AJMC said Mike Doustdar, Novo Nordisk’s president and chief executive, described the approval as giving patients a “convenient, once-daily pill” that could help them lose weight. The publication said the company planned the U.S. launch for early January 2026. ### What comes next for doctors and patients? (novonordisk-us.com) The FDA approval letter says the Wegovy tablet labeling must be filed in structured product labeling format and then posted in public labeling repositories. The same letter sets a 36-month expiry dating period when the tablets are stored at 20 degrees to 25 degrees Celsius. (ajmc.com) Novo Nordisk’s U.S. product page now links prescribing information for Wegovy tablets 25 mg, and the company’s obesity portfolio page lists the oral product alongside injectable Wegovy. For prescribers and pharmacies, the FDA label and the company’s updated product materials are the next reference points as distribution continues in the United States. (novonordisk-us.com) (accessdata.fda.gov)