FDA approves oral Wegovy pill as first oral GLP-1

The U.S. Food and Drug Administration approved Novo Nordisk’s once-daily Wegovy tablet on December 22, 2025, giving the company the first oral GLP-1 medicine cleared in the United States for chronic weight management in adults. The approval added tablets to the existing Wegovy brand, which had already been sold as a weekly injection. The label says the tablets are indicated, with diet and exercise, to reduce excess body weight and maintain weight reduction in adults with obesity or adults with overweight and at least one weight-related condition. The tablet label also includes a cardiovascular risk-reduction indication in adults with established cardiovascular disease and either obesity or overweight. ### When did the approval actually happen? December 22, 2025, is the approval date cited by Novo Nordisk in its announcement, and the FDA labeling now lists “Wegovy tablets, for oral use” alongside the injection form. The approval is not new on May 15, 2026; what is current now is continued rollout and new trial analyses presented this week. (accessdata.fda.gov) The FDA prescribing information shows recent label changes through 2025 and 2026 and names both injection and tablet formulations under the Wegovy brand. The agency’s label is the controlling document for the approved uses and warnings. ### What exactly is the pill approved to treat? Wegovy tablets are approved for adults with obesity, or adults with overweight plus at least one weight-related comorbidity, when used with a reduced-calorie diet and increased physical activity. (prnewswire.com) The same label says the tablets are also indicated to reduce the risk of major adverse cardiovascular events — cardiovascular death, non-fatal heart attack or non-fatal stroke — in adults with established cardiovascular disease and either obesity or overweight. (accessdata.fda.gov) Novo Nordisk said the oral product is a once-daily 25 mg semaglutide tablet. The company described it as the first oral GLP-1 medicine for obesity in the United States. ### What evidence did the FDA use? Novo Nordisk said the approval was based on the phase 3 OASIS 4 trial, a 64-week study in 307 adults with obesity or overweight and at least one weight-related comorbidity, without diabetes. (accessdata.fda.gov) In the company’s release, participants taking oral semaglutide 25 mg with diet and exercise lost 16.6% of body weight in the on-treatment analysis, compared with 2.7% for placebo. In the treatment-policy analysis, which counts outcomes regardless of whether patients stayed on treatment, weight loss was 13.6% versus 2.4% for placebo. (prnewswire.com) New analyses presented at the 2026 European Congress on Obesity this week focused on subgroups from OASIS 4, including so-called early responders. Those presentations came after the approval and do not change the basic trial results cited in the approval announcement. (prnewswire.com) ### How does the tablet fit with injected Wegovy? The FDA label keeps the tablet and injection under the same Wegovy brand but lists them as separate dosage forms with distinct prescribing information details. The boxed warning for thyroid C-cell tumors applies to Wegovy, and the label says the drug is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2. (biopharminternational.com) The safety information on Novo Nordisk’s prescribing page also warns about pancreatitis, gallbladder problems and use in pregnancy. The company says patients should stop Wegovy two months before a planned pregnancy. ### What happened after approval? January 2026 was the launch timing Novo Nordisk gave when it announced the approval, saying a 1.5 mg starting dose would be available in early January at a self-pay price of $149 per month with savings offers. (accessdata.fda.gov) The company also said manufacturing was underway in North Carolina and that supply was on hand for a full U.S. launch. (wegovy.com) May 2026 coverage has focused on commercial rollout and additional OASIS 4 analyses rather than a new FDA action. The current state of play is that oral Wegovy is already approved and in the market, while Novo Nordisk continues to present follow-up data to physicians and investors. (prnewswire.com)