FDA approves first oral semaglutide weight‑loss pill, opening non‑injectable GLP‑1 option
- The Food and Drug Administration approved Novo Nordisk’s once-daily Wegovy tablet on December 22, 2025, making it the first oral glucagon-like peptide-1 medicine cleared in the US for chronic weight loss. - The approved pill uses oral semaglutide 25 milligrams and is labeled for adults with obesity, or overweight adults with a weight-related condition, alongside diet and exercise. - The label also covers cardiovascular risk reduction, extending semaglutide beyond injections as Novo Nordisk pushes a broader obesity franchise. (fda.gov)
A glucagon-like peptide-1 drug helps people feel fuller and eat less; on December 22, 2025, the Food and Drug Administration approved the first pill version for weight loss in the US. (fda.gov) The drug is Novo Nordisk’s Wegovy tablet, a once-daily oral form of semaglutide. The approval covers adults with obesity and adults who are overweight and have at least one weight-related condition. (fda.gov 1) (fda.gov 2) The same approval letter says the tablet should be used with a reduced-calorie diet and increased physical activity. The label also authorizes it to reduce major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight. (fda.gov 1) (fda.gov 2) The key shift is format. Until this decision, Wegovy for obesity in the US was known as a weekly injection, and oral semaglutide in the US had been marketed for type 2 diabetes under Rybelsus. (fda.gov 1) (fda.gov 2) Novo Nordisk’s late-stage OASIS 4 trial tested a 25-milligram daily pill in 307 adults with obesity or overweight, excluding people with diabetes, over 64 weeks. (nejm.org) (markets.ft.com) In that trial, average weight loss reached 16.6% among participants who adhered to treatment, versus 2.7% with placebo. In the broader treatment-policy analysis, weight loss was 13.6% versus 2.2%, and 34.4% of adherent patients lost at least 20% of body weight. (nejm.org) (markets.ft.com) The tradeoff looked familiar for this drug class: stomach side effects. Novo Nordisk reported nausea in 46.6% of patients on oral semaglutide and vomiting in 30.9%, versus 18.6% and 5.9% on placebo. (biospace.com) The FDA label carries the same boxed warning seen on other semaglutide products about thyroid C-cell tumors observed in rodents. It says the drug is contraindicated for patients with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2. (fda.gov) Novo Nordisk has been building around semaglutide on several fronts. On March 19, 2026, the FDA also approved Wegovy HD, a 7.2-milligram higher-dose injection for certain adults, giving the company another obesity option alongside the new pill. (fda.gov) The result is a broader semaglutide lineup: a weekly shot, a higher-dose weekly shot, and now a daily pill. For patients who delayed treatment because they did not want injections, the FDA has now cleared a non-injectable Wegovy option. (fda.gov) (fda.gov)
