FDA clears first GLP‑1 pill

The Food and Drug Administration has cleared Wegovy tablets, making semaglutide the first glucagon-like peptide-1 weight-loss medicine available as a pill in the United States. (accessdata.fda.gov) Wegovy tablets are approved for adults with obesity, or adults who are overweight and have at least one weight-related condition, and the label also includes adults with cardiovascular disease for lowering the risk of heart attack, stroke, or cardiovascular death. (accessdata.fda.gov) Glucagon-like peptide-1 drugs copy a gut hormone that helps people feel full and slows stomach emptying, which is why semaglutide has been sold mostly as a weekly shot for obesity treatment. The tablet form keeps the same drug but changes the delivery. (fda.gov) (accessdata.fda.gov) The approval adds a non-injectable option to a market that has been dominated by pens and syringes, including Wegovy injection, which the Food and Drug Administration first cleared for chronic weight management in 2021 and later expanded for cardiovascular risk reduction. (accessdata.fda.gov) (fda.gov) In a 71-week phase 3 trial published in The New England Journal of Medicine in 2025, 205 participants were assigned to oral semaglutide 25 milligrams and 102 to placebo. Average weight fell 13.6% in the semaglutide group versus 2.2% with placebo by week 64. (nejm.org) That study enrolled adults without diabetes at 22 sites in four countries, and it tested once-daily oral semaglutide alongside lifestyle changes. Gastrointestinal side effects were more common with the drug, affecting 74.0% of participants on semaglutide versus 42.2% on placebo. (nejm.org) The tablet is not semaglutide’s first oral use. The Food and Drug Administration approved Rybelsus, another oral semaglutide product, in September 2019 for adults with type 2 diabetes, but that clearance was for blood-sugar control, not obesity treatment. (fda.gov) (accessdata.fda.gov) Wegovy tablets carry the same boxed warning used for semaglutide products about thyroid C-cell tumors seen in rodents, and the label says the drug is contraindicated for people with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. (accessdata.fda.gov) Novo Nordisk has told investors the 25-milligram oral version delivered 16.6% weight loss among participants who adhered to treatment, a figure the company said was in line with injectable Wegovy 2.4 milligrams. The Food and Drug Administration’s decision now turns that trial program into a commercial pill option for obesity care. (annualreport.novonordisk.com)