FDA approves oral semaglutide pill

The U.S. Food and Drug Administration approved Novo Nordisk’s once-daily Wegovy pill on December 22, 2025, giving adults with obesity — or overweight with at least one weight-related condition — the first oral GLP-1 medicine cleared in the United States for chronic weight management. The approval also covers reducing the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight, according to the prescribing information. Novo Nordisk said the pill would be launched in the United States in early January 2026. The product adds a non-injectable option in a market that has been dominated by weekly shots. ### What exactly did the FDA clear? The FDA-approved label says Wegovy tablets are indicated, along 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 in adults with overweight who have at least one weight-related comorbid condition. The same label says the tablets are also indicated to reduce the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke in adults with established cardiovascular disease and either obesity or overweight. The prescribing information identifies Wegovy as semaglutide, a GLP-1 receptor agonist. The oral product sits alongside injectable Wegovy, which already had U.S. approvals for weight management and cardiovascular risk reduction, according to the FDA label. ### Who is eligible to take it? Adults with obesity qualify under the label, and adults with overweight qualify if they also have at least one weight-related comorbid condition, the prescribing information says. (accessdata.fda.gov) AJMC’s report on the approval described the trial population as adults with a body mass index of at least 30, or at least 27 with one obesity-related complication, and no diabetes. Novo Nordisk described the approved use in similar terms, saying the pill is for adults with obesity, or adults with overweight who also have weight-related medical problems, to help them lose weight and keep it off. ### What evidence did the FDA use? (accessdata.fda.gov) Novo Nordisk said the approval was based on the OASIS 4 phase 3 trial, a 64-week study in 307 adults with obesity or overweight with one or more weight-related comorbidities and without diabetes. The company said patients taking once-daily Wegovy pill achieved average weight loss of 13.6% regardless of treatment discontinuation, compared with 2.4% for placebo, and 16.6% under a treatment-adherence estimate, compared with 2.7% for placebo. (prnewswire.com) AJMC reported similar efficacy figures from OASIS 4, including a 13.6% mean weight loss at 64 weeks and a significantly greater drop in body weight than placebo. The outlet also said the approval drew on OASIS studies and the SELECT cardiovascular outcomes trial. ### What are the main safety warnings? (prnewswire.com) The FDA label carries a boxed warning about the risk of thyroid C-cell tumors seen in rodents. The prescribing information says Wegovy should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. (ajmc.com) AJMC reported that most adverse events in OASIS 4 were mild or moderate. Novo Nordisk’s release and the FDA label place gastrointestinal side effects among the known reactions associated with semaglutide treatment. ### When did patients get access? Novo Nordisk said on December 22, 2025 that it was prepared for a full U.S. launch in early January 2026, with manufacturing underway in North Carolina. (accessdata.fda.gov) The company also said the approved product was a 25 mg once-daily tablet. (ajmc.com) The FDA’s label already lists both Wegovy injection and Wegovy tablets, indicating the oral version had moved from approval into the formal prescribing framework. Patients and clinicians can find the authorized indications, contraindications and warnings in the FDA-approved prescribing information and Novo Nordisk’s U.S. product materials. (accessdata.fda.gov) (prnewswire.com)