First GLP‑1 pill approved

Semaglutide is a drug that copies a gut hormone released after eating, helping people feel full sooner and eat less. The United States Food and Drug Administration has now cleared that drug as a once-daily Wegovy tablet for adults with obesity, or overweight with a related condition. (fda.gov, accessdata.fda.gov) The tablet label says Wegovy tablets are approved with a reduced-calorie diet and more physical activity to reduce excess body weight and help maintain weight loss long term. The same label also adds a cardiovascular use: reducing the risk of cardiovascular death, heart attack, and stroke in adults with established cardiovascular disease and either obesity or overweight. (accessdata.fda.gov) Before this, semaglutide tablets in the United States were sold as Rybelsus for type 2 diabetes, not for obesity. Rybelsus remains approved to improve blood sugar control and reduce major cardiovascular events in some adults with type 2 diabetes. (accessdata.fda.gov) The approval gives Novo Nordisk an oral version of the same semaglutide franchise it already sells as weekly Wegovy injections. It also lands weeks after the agency approved a higher-dose Wegovy injection, 7.2 milligrams, on March 19, 2026. (accessdata.fda.gov, fda.gov) The main evidence came from the phase 3 OASIS 4 trial, which enrolled 307 adults with obesity or overweight plus at least one weight-related condition and no diabetes. ClinicalTrials.gov lists the study as completed in May 2024, and the New England Journal of Medicine reported the 25 milligram pill beat placebo on weight loss over 64 weeks. (clinicaltrials.gov, nejm.org) In that trial, the treatment-policy analysis showed average weight loss of 13.6% with oral semaglutide versus 2.2% with placebo at 64 weeks. In an analysis estimating results if patients stayed on treatment, weight loss was 16.6% with the pill versus 2.7% with placebo. (nejm.org, acc.org) The tablet is not a simple swap for an injection. The Rybelsus prescribing information for oral semaglutide says patients should take it on an empty stomach in the morning with no more than 4 ounces of water and wait at least 30 minutes before eating, drinking, or taking other oral medicines. (accessdata.fda.gov) The safety warnings also carry over. Wegovy tablets have a boxed warning about thyroid C-cell tumors seen in rodents, and the label says the drug is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. (accessdata.fda.gov) Access remains a separate question from approval. Novo Nordisk said on January 5, 2026 that the starter 1.5 milligram dose was broadly available through more than 70,000 United States pharmacies, with self-pay pricing starting at $149 a month for lower doses and $299 for higher strengths. (prnewswire.com, cnbc.com) The Food and Drug Administration has also warned patients not to treat approved semaglutide products and compounded copies as interchangeable. The agency says compounded semaglutide is not Food and Drug Administration-approved and has received adverse-event reports tied to those products. (fda.gov)