FDA clears first GLP‑1 pill for weight loss — oral semaglutide (Wegovy)

The U.S. Food and Drug Administration approved Wegovy tablets, an oral semaglutide formulation from Novo Nordisk, in December 2025 for chronic weight management in adults with obesity or overweight plus at least one weight-related condition. The approval made Wegovy the first oral GLP-1 medicine cleared in the United States for weight loss, according to AJMC and the FDA-approved prescribing information. Novo Nordisk said at the time it planned a U.S. launch in early January 2026. The drug joins injectable Wegovy, which was already marketed for weight management and certain cardiovascular-risk reduction uses. ### When did the approval actually happen? AJMC’s December 22, 2025 report said the FDA had approved oral semaglutide as the first GLP-1 pill for weight loss and for reducing major adverse cardiovascular events. The FDA-approved label available through Drugs@FDA lists “Wegovy tablets” alongside “Wegovy injection” and shows recent major label changes dated August 2025 and December 2025, indicating the tablet approval was already in force by then. (ajmc.com) 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 in adults with overweight who have at least one weight-related comorbid condition. The same label also says the tablets are indicated to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight. (ajmc.com) ### Who can take the pill, and how is that different from the shot? The FDA label limits Wegovy tablets to adults, while Wegovy injection remains approved for adults and for pediatric patients aged 12 years and older with obesity. That means the oral version expands format choice for eligible adults but does not mirror every population covered by the injectable form. (accessdata.fda.gov) Novo Nordisk’s product materials and AJMC’s report describe the oral product as a once-daily 25 mg semaglutide tablet. AJMC reported that Novo Nordisk planned to launch the once-daily pill in the United States in early January 2026. ### What evidence did the FDA rely on? AJMC reported that the approval was based on results from the OASIS clinical program and the SELECT trial. (accessdata.fda.gov) In OASIS 4, AJMC said 307 adults without diabetes who had obesity or overweight were randomized to oral semaglutide or placebo with lifestyle counseling. The OASIS 4 study showed a 13.6% mean weight loss at 64 weeks for patients on oral semaglutide, compared with 2.2% for placebo, AJMC reported. (ajmc.com) AJMC also said the hypothetical treatment-effect analysis showed a 16.6% mean weight loss for oral semaglutide versus 2.7% for placebo if patients adhered to assigned treatment. ### What warnings and practical limits come with it? (ajmc.com) The FDA-approved prescribing information carries a boxed warning on risk of thyroid C-cell tumors. The label says semaglutide 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) The label also says levothyroxine exposure increased 33% in a drug-interaction study with the semaglutide tablet, and advises monitoring effects of oral medications given at the same time. AJMC reported that adverse events in OASIS 4 were mostly mild or moderate, with 93.1% of oral semaglutide patients and 85.3% of placebo patients reporting adverse events. (accessdata.fda.gov) ### What comes next for patients and prescribers? Novo Nordisk’s U.S. news archive shows the company continued building out its obesity franchise through 2026, including access and product updates for Wegovy and Ozempic pill products. The FDA label now lists both injection and tablet forms under Wegovy, so the next practical step for patients and clinicians is checking current prescribing, coverage and pharmacy availability through Novo Nordisk and the FDA-approved labeling. (accessdata.fda.gov) (novonordisk-us.com)