FDA approves oral semaglutide

The Food and Drug Administration has cleared Wegovy tablets, making semaglutide the first glucagon-like peptide-1 weight-loss drug available as a pill in the United States. (accessdata.fda.gov) The label says the once-daily tablet is approved with diet and exercise for adults with obesity, or adults who are overweight and have at least one weight-related condition. It also carries the same cardiovascular indication as injectable Wegovy for adults with established cardiovascular disease and either obesity or overweight. (accessdata.fda.gov) Semaglutide is a hormone-mimicking drug that helps people feel fuller and eat less; until now, the obesity version was given by weekly injection. The tablet form is approved at 25 milligrams once a day, with lower starter doses before patients reach maintenance treatment. (accessdata.fda.gov) The approval followed the Phase 3 OASIS 4 trial, which enrolled 307 adults with overweight or obesity and no diabetes. ClinicalTrials.gov lists the study as a 64-week treatment trial of oral semaglutide 25 milligrams once daily versus placebo. (clinicaltrials.gov) Novo Nordisk said OASIS 4 showed average weight loss of 13.6% at 64 weeks regardless of treatment discontinuation, or 16.6% among patients who stayed on treatment, versus 2.4% and 2.7% with placebo. The company said it planned a full United States launch in early January 2026. (prnewswire.com) The New England Journal of Medicine paper on OASIS 4 reported that oral semaglutide 25 milligrams produced a greater reduction in mean body weight than placebo in adults with overweight or obesity. American College of Cardiology reviewers said the weight loss was comparable to results seen with higher-dose oral semaglutide and with the injected 2.4 milligram version in earlier studies. (nejm.org) (acc.org) The tablet arrives as obesity drugmakers race to move beyond injections and widen access to patients who do not want weekly shots. In March 2026, the Food and Drug Administration also approved a higher-dose injectable Wegovy, called Wegovy HD, under its National Priority Voucher pilot. (fda.gov) The safety picture looks familiar to doctors who already prescribe semaglutide. The Food and Drug Administration label carries a boxed warning about thyroid C-cell tumors seen in rodents and says the drug should not be used in patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. (accessdata.fda.gov) Common side effects remain mostly gastrointestinal, including nausea, vomiting, diarrhea, constipation, and abdominal pain. That means the new pill changes how the drug is taken, not the basic tradeoff patients and doctors already weigh with injectable semaglutide. (fda.gov)