FDA approves oral semaglutide (Wegovy pill)

The U.S. Food and Drug Administration approved Novo Nordisk’s oral semaglutide, sold as Wegovy, on December 22, 2025, as the first GLP-1 pill for chronic weight management. The approval added an oral version of semaglutide to the Wegovy franchise, which had previously been known for weekly injections. AJMC reported that Novo Nordisk planned to launch the once-daily 25 mg pill in the United States in early January 2026. The FDA-approved label shows the tablet is also cleared to reduce the risk of major adverse cardiovascular events in certain adults with obesity or overweight. ### When did the approval actually happen? December 22, 2025, is the approval date shown in AJMC’s report, which described the decision as the first FDA clearance of an oral GLP-1 medicine for weight loss. That matters because some later write-ups have referred to the approval more generally, but the dated report places the action in late 2025 rather than May 2026. (ajmc.com) The FDA label available through Drugs@FDA lists Wegovy as both an injection and tablets for oral use. The label also shows recent major changes in August 2025 and December 2025, consistent with the timing of the tablet approval. ### Who can take the Wegovy pill under the FDA label? The FDA label says Wegovy tablets are indicated, with diet and physical activity, to reduce excess body weight and maintain weight reduction long term in adults with obesity, or adults with overweight who have at least one weight-related comorbid condition. (ajmc.com) The same label says the tablets are also indicated to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight. (accessdata.fda.gov) The approved tablet is not labeled for pediatric weight management in the excerpts available from the current label, while the injection remains indicated for adults and pediatric patients aged 12 and older with obesity. That distinction is in the label text and separates the oral product from the injectable formulation. (accessdata.fda.gov) ### What evidence did the FDA rely on? AJMC reported that the approval was based on results from the OASIS clinical trials and the SELECT trial. In OASIS 4, 307 adults without diabetes who had obesity or overweight were assigned to oral semaglutide or placebo, according to the report. The same report said patients on oral semaglutide had a mean body-weight change of minus 13.6% at 64 weeks, compared with minus 2.2% on placebo. (accessdata.fda.gov) AJMC also reported that most adverse events were mild or moderate, with adverse events reported in 93.1% of patients on oral semaglutide and 85.3% on placebo. (ajmc.com) ### What did Novo Nordisk say about the pill? Mike Doustdar, president and CEO of Novo Nordisk, said in a statement quoted by AJMC: “The pill is here.” He added that the once-daily pill would give patients “a convenient, once-daily pill” that could help them lose weight at levels comparable to the original Wegovy injection, according to the report. (ajmc.com) Novo Nordisk’s U.S. news hub now treats the Wegovy pill as part of its current obesity portfolio, and the company has separately posted later updates on access programs and higher-dose injectable Wegovy. The company’s U.S. site also highlights continuing information on semaglutide access and safety. ### What are the main safety limits in the label? (ajmc.com) The FDA label carries a boxed warning on risk of thyroid C-cell tumors. 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. (novonordisk-us.com) The label also instructs clinicians to counsel patients about the potential risk of thyroid tumors and related symptoms. Those warnings apply to Wegovy broadly and are included in the current prescribing information for the tablet formulation. ### What comes next for patients and prescribers? Early January 2026 was the launch window Novo Nordisk gave in the December 22 AJMC report for the U.S. rollout of Wegovy 25 mg tablets. (accessdata.fda.gov) The FDA label is the primary source for indication, dosing form and boxed-warning details, while Novo Nordisk’s U.S. site continues to post access updates tied to Wegovy products. (ajmc.com)