FDA approves oral semaglutide for weight loss

The U.S. Food and Drug Administration approved Wegovy tablets on December 22, 2025, giving Novo Nordisk the first oral GLP-1 medicine cleared in the United States for chronic weight management. The approval covers adults with obesity, or adults with overweight who have at least one weight-related comorbid condition, when used with a reduced-calorie diet and increased physical activity. (accessdata.fda.gov) FDA records also show the oral product carries a cardiovascular-risk-reduction indication in adults with established cardiovascular disease and either obesity or overweight. (ajmc.com) Novo Nordisk said it planned a U.S. launch in early January 2026. ### Which drug did the FDA actually approve? Wegovy tablets are oral semaglutide, the same active ingredient used in Novo Nordisk’s injectable Wegovy and Ozempic products, but in a once-daily pill form. FDA labeling identifies Wegovy as a glucagon-like peptide-1 receptor agonist and lists both the injection and tablet formulations in the prescribing information. The tablets are approved for long-term weight reduction and maintenance in eligible adults, not as an over-the-counter product. December 22, 2025, is the approval date shown in FDA and AJMC materials. AJMC reported that the newly approved oral product is a 25 mg once-daily semaglutide tablet marketed under the Wegovy brand. (accessdata.fda.gov) Novo Nordisk said the pill would offer a non-injectable option for patients seeking obesity treatment. ### Who can take the pill under the FDA label? FDA labeling says Wegovy tablets are indicated for adults with obesity, or adults with overweight in the presence of at least one weight-related comorbid condition, alongside diet and exercise. The same labeling also includes use to reduce the risk of major adverse cardiovascular events — cardiovascular death, non-fatal heart attack, or non-fatal stroke — in adults with established cardiovascular disease and either obesity or overweight. (accessdata.fda.gov) The boxed warning in the FDA label says semaglutide caused thyroid C-cell tumors in rodents and that the drug is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. (accessdata.fda.gov) The label also says patients should be counseled about the potential risk and symptoms of thyroid tumors. ### How much weight loss did the main trial show? The OASIS 4 phase 3 trial enrolled 307 adults without diabetes who had obesity or overweight with at least one obesity-related complication, according to AJMC and Novo Nordisk. Participants were assigned oral semaglutide or placebo with lifestyle counseling, and the co-primary endpoints included percent change in body weight and the share of patients losing at least 5% of body weight at week 64. (accessdata.fda.gov) At 64 weeks, AJMC reported mean weight loss of 13.6% with oral semaglutide versus 2.2% with placebo. Novo Nordisk separately highlighted an estimated 16.6% weight loss in an analysis assuming patients remained on treatment, compared with 2.7% for placebo. (accessdata.fda.gov) AJMC said adverse events were mostly mild or moderate, with nausea, diarrhea and vomiting among the gastrointestinal effects associated with semaglutide treatment. ### Why is the pill drawing attention beyond convenience? The approval matters because previous U.S. obesity approvals for semaglutide had been injectable. JAMA reported in January 2026 that the Wegovy pill became broadly available through more than 70,000 pharmacies nationwide after Novo Nordisk announced availability on January 5. (ajmc.com) That gave prescribers a daily oral option in a market that had been dominated by weekly injections. Mike Doustdar, then president and CEO of Novo Nordisk, said in a company statement cited by AJMC: “The pill is here.” He said patients would have “a convenient, once-daily pill” that could help them lose weight at levels comparable to the original Wegovy injection. (ajmc.com) ### Where are the official documents and what comes next? FDA approval materials for Wegovy tablets, including the approval letter and prescribing information, are available through the agency’s Drugs@FDA records. The approval letter says Novo Nordisk filed the application on February 28, 2025, and directs the company to submit final structured labeling and printed carton and container labeling after approval. (jamanetwork.com) Early January 2026 was the launch window Novo Nordisk gave after the decision. The company said manufacturing was underway in North Carolina, while FDA records show the Wegovy tablet approval and updated label are already on file for prescribers reviewing indications, contraindications and dosing information. (ajmc.com) (prnewswire.com) (accessdata.fda.gov)