First oral GLP‑1 pill

GLP-1 drugs copy a gut hormone that helps people feel fuller and eat less, but until now obesity patients mostly had to take them by injection. In December 2025, the Food and Drug Administration approved Wegovy tablets, an oral semaglutide pill, for chronic weight management in adults. (fda.gov) The new tablet is taken once a day, not once a week, and the label says to swallow it on an empty stomach in the morning with up to 4 ounces of water. The approval also covers reducing major cardiovascular events in adults with established cardiovascular disease and obesity or overweight. (fda.gov) In the phase 3 OASIS 4 trial, 307 adults without diabetes were randomized in a 2-to-1 ratio to oral semaglutide 25 milligrams or placebo, both with lifestyle counseling. At 64 weeks, mean weight loss was 13.6% with the pill versus 2.2% with placebo. (nejm.org) The same trial found gastrointestinal side effects were more common with oral semaglutide, affecting 74.0% of participants, compared with 42.2% on placebo. The study also found more patients on the pill reached 5%, 10%, 15%, and 20% weight-loss thresholds. (nejm.org) The cardiovascular part of the label rests on earlier semaglutide evidence, not a brand-new pill-only outcomes trial. In the SELECT trial, weekly injectable semaglutide 2.4 milligrams cut the rate of cardiovascular death, nonfatal heart attack, or nonfatal stroke in adults with cardiovascular disease and overweight or obesity but no diabetes. (nejm.org) Novo Nordisk said in December 2025 that it planned a U.S. launch in early January 2026. The company’s own science page says semaglutide had already become the only oral GLP-1 on the market for type 2 diabetes in 2019, and that the obesity version became the first U.S. oral GLP-1 for weight management in 2025. (ajmc.com) (novonordisk.com) Getting a GLP-1 into a pill has been difficult because the stomach breaks down protein-based medicines the way it breaks down food. Novo Nordisk says oral semaglutide required a formulation that could survive that process long enough to be absorbed. (novonordisk.com) The approval adds a pill option to a market built around shots, but it does not remove the same safety warnings that apply to semaglutide more broadly. The Wegovy label carries a boxed warning about thyroid C-cell tumors seen in rodents and says the drug is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. (fda.gov) For patients who wanted the effects of semaglutide without learning injections, the change is simple: the same drug class has moved from pen to pill. The tradeoff is a stricter daily routine, with fasting and water-only instructions built into the label. (fda.gov)