FDA approves oral semaglutide weight pill

The U.S. Food and Drug Administration has approved an oral form of semaglutide for chronic weight management in adults, giving Novo Nordisk the first GLP-1 pill cleared in the United States for that use. FDA approval documents show the product is branded as Wegovy tablets and is indicated, with diet and exercise, for adults with obesity or adults who are overweight and have at least one weight-related comorbidity. The same label also includes a cardiovascular risk-reduction use in adults with established cardiovascular disease and either obesity or overweight. Novo Nordisk had not posted launch timing or pricing details in its U.S. materials reviewed on Monday. ### Which drug did the FDA actually approve? FDA approval records identify the medicine as Wegovy tablets, an oral version of semaglutide, under NDA 218316. The approval letter says the application was received on February 28, 2025, and was approved effective on the date of the letter. The prescribing information lists both Wegovy injection and Wegovy tablets under the same semaglutide brand family. (accessdata.fda.gov) Novo Nordisk already sells semaglutide in other forms and indications. Company materials describe Ozempic pill as an FDA-approved oral peptide GLP-1 medicine for adults with type 2 diabetes, while Wegovy has been the company’s obesity brand in injectable form. The new approval extends the Wegovy brand into a pill for obesity care. ### Who can take it under the new label? (accessdata.fda.gov) FDA labeling says Wegovy tablets are indicated alongside a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain long-term weight reduction in adults with obesity, or in adults with overweight who have at least one weight-related comorbid condition. The 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. (novonordisk-us.com) The prescribing information carries the same boxed warning used with semaglutide products about thyroid C-cell tumors seen in rodents. FDA labeling says 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) ### How much weight loss did oral semaglutide show in trials? The Lancet published results from the OASIS 1 trial showing once-daily oral semaglutide 50 mg produced greater weight loss than placebo over 68 weeks in adults with overweight or obesity. Novo Nordisk said in 2023 that OASIS 1 enrolled 667 adults and that oral semaglutide 50 mg led to 15.1% weight loss under the trial’s treatment-policy analysis, or 17.4% if all participants adhered to treatment. (accessdata.fda.gov) The New England Journal of Medicine later published data from a separate trial of oral semaglutide 25 mg in adults with overweight or obesity. NEJM’s summary says once-daily oral semaglutide 25 mg resulted in a greater mean reduction in body weight than placebo, and NEJM Clinician said the FDA weight-reduction approval uses a 25 mg daily maintenance dose. (thelancet.com) ### Does the approval also cover heart-risk reduction? FDA labeling says yes. The tablets are 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 New England Journal of Medicine reported in 2023 that injectable semaglutide 2.4 mg was superior to placebo in reducing major adverse cardiovascular events in patients with preexisting cardiovascular disease and overweight or obesity but without diabetes. (nejm.org) FDA’s tablet label carries that cardiovascular language for the oral product. ### What has Novo Nordisk said about availability? (accessdata.fda.gov) Novo Nordisk’s U.S. news archive, as reviewed on May 18, did not show a same-day press release with launch timing or list price for Wegovy tablets. The company’s obesity product page lists current chronic weight-management products and prescribing information links, but it did not provide commercial rollout details for the newly approved tablets in the material reviewed. (nejm.org) FDA’s approval letter requires Novo Nordisk to submit final labeling in structured product format within 14 days and final printed carton and container labeling within 30 days after printing. Those filings are the next formal steps visible in the approval record, while Novo Nordisk remains the named company responsible for U.S. commercialization. (accessdata.fda.gov) (novonordisk-us.com)