Oral Wegovy approved

A hormone drug that slows appetite and digestion now comes as a weight-loss pill: the Food and Drug Administration approved Novo Nordisk’s once-daily oral Wegovy in December 2025. (prnewswire.com) The pill contains semaglutide, the same active ingredient used in Wegovy injections, and it is approved for adults with obesity or adults who are overweight with at least one weight-related medical problem, alongside diet and exercise. (prnewswire.com) Novo Nordisk said on December 22, 2025 that it was preparing a full United States launch in early January 2026, with tablets being made in North Carolina. The company also said the starter 1.5 milligram dose would be priced at $149 a month for self-pay patients with savings offers. (prnewswire.com) Glucagon-like peptide-1 drugs mimic a gut hormone that helps people feel full and slows how quickly food leaves the stomach. Until this approval, the best-known obesity medicines in this class in the United States were mostly injections taken weekly. (abcnews.go.com) The approval rests in part on the Phase 3 OASIS 4 trial, which enrolled 307 adults without diabetes who had obesity or were overweight with related complications. Participants were randomly assigned to oral semaglutide 25 milligrams or placebo, with lifestyle counseling, and stayed on therapy for 64 weeks. (acc.org) In that trial, average weight loss at week 64 was 13.6% with oral semaglutide versus 2.2% with placebo in the main analysis. In a separate estimate assuming people stayed on treatment as assigned, weight loss was 16.6% with the pill versus 2.7% with placebo. (ajmc.com, acc.org) Thirty percent of people taking oral semaglutide lost at least 20% of their body weight, compared with 3% on placebo. Gastrointestinal side effects were the most common, occurring in 74% of the semaglutide group and 42% of the placebo group, and discontinuation rates were 7% and 6%, respectively. (acc.org) The label also lets doctors use Wegovy tablets to reduce the risk of major cardiovascular events such as heart attack, stroke, or cardiovascular death in adults with established heart disease and overweight or obesity. That heart-risk reduction language extends a claim already associated with the Wegovy brand. (accessdata.fda.gov) The pill is not taken like a typical tablet. The prescribing information says patients should take it on an empty stomach with no more than 4 ounces of water and wait at least 30 minutes before eating, drinking other beverages, or taking other oral medicines. (accessdata.fda.gov) Novo Nordisk pitched that routine as a way to reach patients who do not want injections, while some clinicians have noted that a daily fasting schedule may be less convenient than a weekly shot. The approval still gives obesity treatment a new format: the same semaglutide molecule, but in a pill bottle instead of an injector pen. (abcnews.go.com, accessdata.fda.gov)