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. (accessdata.fda.gov) Glucagon-like peptide-1 drugs mimic a gut hormone that helps people feel full and eat less. Until this approval, the obesity version of semaglutide was sold in the United States as a once-weekly injection. (accessdata.fda.gov; fda.gov) The new tablet is approved for adults with obesity, or adults who are overweight and have at least one weight-related medical problem, alongside diet and exercise. The label also says the pill can be used to cut the risk of cardiovascular death, heart attack, and stroke in adults with established cardiovascular disease and either obesity or overweight. (accessdata.fda.gov) The approval rested on the Phase 3b OASIS 4 trial, which enrolled 307 adults without diabetes at 22 sites in four countries. Participants were assigned in a 2-to-1 ratio to oral semaglutide 25 milligrams once daily or placebo, plus lifestyle changes. (nejm.org) At 64 weeks, the estimated mean weight change was minus 13.6% with oral semaglutide and minus 2.2% with placebo in the treatment-policy analysis published in The New England Journal of Medicine. Novo Nordisk separately said the figure reached 16.6% among patients who stayed on treatment throughout the study. (nejm.org; prnewswire.com) Patients on the pill were also more likely to lose at least 5%, 10%, 15%, and 20% of body weight, according to the journal report. Gastrointestinal side effects were more common with semaglutide than placebo, with nausea, diarrhea, and related stomach problems driving much of the difference. (nejm.org) The prescribing label carries the same boxed warning used on other semaglutide products 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 notes that oral dosing can affect other medicines, including increased levothyroxine exposure in a drug-interaction study. (accessdata.fda.gov) Novo Nordisk announced the approval on December 22, 2025, and said a full United States launch would begin in early January 2026, with manufacturing in North Carolina. The company said the starting 1.5 milligram dose would be offered at $149 a month for self-pay patients with savings offers. (prnewswire.com) The early rollout suggests the pill is bringing in some patients who had avoided injections because of needle fear or out-of-pocket cost. CNBC reported on April 7 that Novo Nordisk’s tablet was drawing many first-time users rather than simply shifting existing injection patients to a new form. (cnbc.com) The pill market is already getting more crowded. Eli Lilly won Food and Drug Administration approval for its oral obesity drug orforglipron last week, setting up a direct contest over whether patients and insurers prefer a daily pill with food restrictions or one without them. (ajmc.com; pharmacytimes.com) For now, semaglutide’s shift from shot to tablet gives obesity treatment a form many patients have been asking for: the same drug class, but without the needle. (accessdata.fda.gov; cnbc.com)