First GLP‑1 pill OK’d

Glucagon-like peptide-1 drugs copy a gut hormone that slows digestion and curbs appetite. On December 22, 2025, the Food and Drug Administration cleared Wegovy tablets, making semaglutide the first pill approved in the United States for chronic weight management. (fda.gov) The new tablet uses the same active ingredient as Wegovy shots, but as a once-daily pill instead of a weekly injection. The label says it is for adults with obesity, or adults with overweight plus at least one weight-related condition, alongside diet and physical activity. (fda.gov) The approval also covers reducing major cardiovascular events — heart attack, stroke, or cardiovascular death — in adults with established cardiovascular disease and either obesity or overweight. That matches a key added use for injectable Wegovy and extends it to the tablet form. (fda.gov) Regulators based the weight-loss clearance on the Phase 3 OASIS 4 trial, a 71-week study at 22 sites in four countries. The trial enrolled adults without diabetes and assigned 205 people to oral semaglutide 25 milligrams and 102 to placebo. (nejm.org) At week 64, average body weight fell 13.6% with oral semaglutide and 2.2% with placebo, a difference of 11.4 percentage points. More people on the pill also hit 5%, 10%, 15%, and 20% weight-loss thresholds, and physical-function scores improved. (nejm.org) The most common tradeoff was stomach-related side effects. In OASIS 4, gastrointestinal adverse events were reported in 74.0% of participants on oral semaglutide versus 42.2% on placebo. (nejm.org) The Food and Drug Administration label carries the same boxed warning already familiar from semaglutide shots: a rodent finding of thyroid C-cell tumors and a contraindication for people with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. (fda.gov) Novo Nordisk said the launch would start in early January 2026 with a 1.5 milligram starting dose and that the product would be made in North Carolina. The company also said the starting dose would be offered with savings programs at $149 per month for cash-paying patients. (prnewswire.com, cnbc.com) The pill reached the market just months before Eli Lilly’s oral obesity drug, orforglipron, won its own approval in April 2026. That turned what had been an injection-led market into a two-company race over daily obesity pills. (managedhealthcareexecutive.com, ajmc.com) For patients who avoided needles, the change was simple: the same semaglutide molecule that made Wegovy a blockbuster could now be prescribed as a tablet. The harder question, as with the injectable version, remained whether insurers and patients would keep paying for long-term treatment. (fda.gov, cnbc.com)