GLP‑1 Pill Approved

The Food and Drug Administration has cleared Wegovy tablets, making semaglutide available as a weight-loss pill in the United States for the first time. (fda.gov) Semaglutide is a glucagon-like peptide-1 drug, a medicine that copies a gut hormone released after eating to curb appetite and increase fullness. The new tablet is approved for adults with obesity, or adults who are overweight and have at least one weight-related condition, alongside diet and exercise. (fda.gov; fda.gov) The approval was announced on December 22, 2025, and Novo Nordisk said it planned a full U.S. launch in early January 2026. The once-daily pill is also cleared to reduce the risk of cardiovascular death, heart attack, and stroke in adults with established cardiovascular disease and obesity or overweight. (prnewswire.com; fda.gov) That changes a market built around weekly injections such as Wegovy shots, because the same active ingredient now comes in a tablet that can be prescribed for chronic weight management. The label keeps the same prescription-only status and adds tablet-specific instructions: take it on an empty stomach and wait at least 30 minutes before food, drink, or other oral medicines. (fda.gov; fda.gov) The Food and Drug Administration label includes a boxed warning about thyroid C-cell tumors seen in rodents, and it says the drug is contraindicated for patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. The label also warns about gastrointestinal side effects and acute kidney injury related to volume depletion. (fda.gov) The approval rests in part on the OASIS 4 trial, a 64-week study of 307 adults without diabetes who had obesity or overweight with at least one obesity-related complication. In that trial, oral semaglutide produced 13.6% average weight loss under the main analysis, versus 2.2% with placebo. (nejm.org; ajmc.com) A second OASIS 4 analysis estimated 16.6% average weight loss for patients who stayed on treatment, compared with 2.7% for placebo. AJMC reported that 93.1% of patients on oral semaglutide and 85.3% on placebo had adverse events, mostly mild or moderate. (prnewswire.com; ajmc.com) The cardiovascular claim on the tablet label draws on earlier semaglutide evidence from the SELECT trial, which tested weekly injectable semaglutide in adults with overweight or obesity and established cardiovascular disease but without diabetes. In that trial, semaglutide cut major adverse cardiovascular events by 20% versus placebo over a mean follow-up of 39.8 months. (nejm.org; acc.org) Novo Nordisk said the pill would start at 1.5 milligrams daily before titration to a 25-milligram maintenance dose, and said the starting dose would be priced at $149 a month with savings offers. Those launch terms came from the company, not the Food and Drug Administration. (prnewswire.com; novo-pi.com) The result is a new semaglutide option for patients who want a pill instead of a shot, but it still comes with the same need for long-term use, monitoring, and insurance or cash-pay decisions that have shaped the broader GLP-1 market. (fda.gov; fda.gov)