First GLP‑1 pill approved

The Food and Drug Administration has cleared Wegovy tablets, making semaglutide the first glucagon-like peptide-1 pill approved in the United States for chronic weight management. (fda.gov) The label says the oral form is approved for adults with obesity, or adults who are overweight with at least one weight-related condition, alongside a reduced-calorie diet and more physical activity. The same tablet label also includes use to lower major cardiovascular event risk in adults with established cardiovascular disease and obesity or overweight. (fda.gov) Glucagon-like peptide-1 drugs mimic a gut hormone that helps people feel fuller and slows stomach emptying. Semaglutide was already sold as weekly Wegovy injections for weight loss and as Rybelsus tablets for type 2 diabetes before this obesity-pill approval. (fda.gov 1) (fda.gov 2) The obesity approval rests on the Phase 3 OASIS 4 trial, which enrolled 307 adults without diabetes at 23 sites in the United States, Canada, and Germany. Participants were randomized 2-to-1 to daily oral semaglutide 25 milligrams or placebo, with 64 weeks of treatment and 7 weeks of follow-up. (nejm.org) (clinicaltrials.gov) In that trial, average body weight fell 13.6% with oral semaglutide and 2.2% with placebo by week 64, a gap of 11.4 percentage points. Gastrointestinal side effects were more common with the pill, affecting 74.0% of the semaglutide group versus 42.2% of the placebo group. (nejm.org) The pill comes with handling rules that injections do not. Novo Nordisk’s prescribing guide says patients should take Wegovy tablets on an empty stomach with up to 4 ounces of water and wait at least 30 minutes before eating, drinking, or taking other oral medicines. (novomedlink.com) The dosing schedule is also different from the weekly shot. Wegovy tablets are titrated through 1.5 milligrams, 4 milligrams, and 9 milligrams before reaching the 25 milligram maintenance dose, according to prescribing materials. (novomedlink.com) (fda.gov) The approval lands weeks after the Food and Drug Administration cleared a higher-dose Wegovy injection, called Wegovy HD, on March 19, 2026. It also arrives days after Eli Lilly’s oral obesity drug orforglipron won Food and Drug Administration approval, giving the market two branded weight-loss pills instead of one. (fda.gov) (ajmc.com) Wegovy tablets carry the same boxed warning tied to semaglutide’s rodent thyroid tumor findings. The label says the drug should not be used in patients with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2. (fda.gov) For doctors and patients, the new option is not a new molecule but a new format: the same semaglutide in a daily tablet instead of a weekly pen. That shifts the choice in obesity treatment from shot versus no shot to shot versus pill. (fda.gov)