Oral Wegovy approved

Wegovy is now available as a once-daily pill in the U.S., giving obesity patients the first Food and Drug Administration-approved oral GLP-1 option for long-term weight management. (accessdata.fda.gov) GLP-1 drugs mimic a gut hormone that helps people feel fuller and eat less; until now, Wegovy for obesity was sold as a weekly injection. The new tablet form is approved for adults with obesity, or adults who are overweight with at least one weight-related condition, alongside diet and exercise. (accessdata.fda.gov) The tablet label also includes Wegovy’s cardiovascular claim: reducing the risk of heart attack, stroke, and cardiovascular death in adults with established cardiovascular disease and either obesity or overweight. That gives the pill the same broad headline uses listed in the current Wegovy prescribing information. (accessdata.fda.gov) The approval was backed by the Phase 3 OASIS 4 trial, a 71-week study at 22 sites in four countries. Researchers randomized 205 participants to oral semaglutide 25 milligrams and 102 to placebo, all with lifestyle counseling and none with diabetes. (nejm.org) By week 64, patients on the pill had an estimated mean weight loss of 13.6%, versus 2.2% on placebo. The semaglutide group was also more likely to lose at least 5%, 10%, 15%, and 20% of body weight, and posted better physical-function scores on a quality-of-life measure. (nejm.org) The safety tradeoff looked familiar from the injectable version. Gastrointestinal side effects were more common with the pill than placebo, 74.0% versus 42.2%, and the Wegovy label carries a boxed warning about thyroid C-cell tumors seen in rodents and a contraindication for patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. (nejm.org) (accessdata.fda.gov) The timing also lands in the middle of a coverage fight between obesity drug makers and pharmacy benefit managers. CVS Caremark said Zepbound was removed from its Standard Control, Advanced Control, and Value formularies effective July 1, 2025, and that it continues to prefer Wegovy. (business.caremark.com) CVS has tied that decision to net cost and to semaglutide’s cardiovascular outcomes data, noting on its formulary page that tirzepatide cardiovascular outcomes are still being studied. In a May 1, 2025 earnings release, CVS Health said it was updating its formulary to improve access to GLP-1 drugs and pairing preferred Wegovy coverage with its weight-management program. (business.caremark.com) (cvshealth.com) Novo Nordisk has spent the past year widening the Wegovy franchise, including a higher-dose Wegovy HD injection approved on March 19, 2026. Its 2025 annual report says the company also launched Wegovy pill in the U.S. as the “first and only approved once-daily oral GLP-1 medicine for weight management.” (fda.gov) (annualreport.novonordisk.com) For patients, the new question is no longer just which brand works best, but which form their doctor, stomach, and insurance plan will accept. The FDA has now cleared Wegovy as both a shot and a pill, and large payers are already steering demand. (accessdata.fda.gov) (business.caremark.com)