FDA approves oral semaglutide pill

Novo Nordisk said on December 22, 2025, that the U.S. Food and Drug Administration approved once-daily Wegovy pill, making oral semaglutide the first oral GLP-1 medicine cleared in the United States for obesity. The company said the tablet is indicated for adults with obesity, or overweight patients with weight-related medical problems, alongside diet and exercise. (prnewswire.com) Novo Nordisk also said the pill carries a cardiovascular risk-reduction indication for adults with overweight or obesity and established cardiovascular disease. The approval put an oral version of the weight-loss market’s best-known drug class into direct competition with injectable therapies and set up a second race over convenience, supply and payer access. (cms.gov) ### When did the FDA act, and what exactly was approved? Novo Nordisk said the FDA approval came on December 22, 2025, for Wegovy pill, a once-daily 25 mg semaglutide tablet for chronic weight management. The company said the product is approved in the United States for adults with obesity, or adults who are overweight and have at least one weight-related condition. The same December 22 release said Wegovy pill is also indicated to reduce the risk of major adverse cardiovascular events such as death, heart attack or stroke in adults with overweight or obesity and established cardiovascular disease. Novo Nordisk said it planned a full U.S. launch in early January 2026 and that manufacturing was underway in North Carolina. (prnewswire.com) ### What did the semaglutide pill show in trials? Novo Nordisk said the FDA decision 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. In that trial, the company said patients taking Wegovy pill lost an average of about 17% of body weight if they stayed on treatment, compared with about 3% for placebo. (prnewswire.com) The same trial readout said the average weight loss was about 14% regardless of whether all patients stayed on treatment, versus about 2% for placebo. Those figures came from the company’s announcement and were part of the evidence Novo Nordisk cited for the approval. (prnewswire.com) ### How quickly did rivals move into oral obesity drugs? The FDA approved Eli Lilly’s Foundayo, orforglipron, on April 1, 2026, according to an FDA press release and Lilly’s announcement. The FDA said Foundayo was approved for adults with obesity or adults who are overweight with at least one weight-related comorbid condition, and described it as a once-daily tablet. (prnewswire.com) Lilly said Foundayo can be taken without food or water restrictions and would be available through LillyDirect, telehealth providers and retail pharmacies. The company said shipments began in early April and listed pricing starting at $25 a month for eligible commercially insured patients and $149 a month for self-pay patients at the lowest dose. (prnewswire.com) In Lilly’s ATTAIN-1 trial, the company said patients on the highest dose who stayed on treatment lost an average of 27.3 pounds, or 12.4%, compared with 2.2 pounds, or 0.9%, on placebo. FDA Commissioner Martin Makary said the April 1 approval came 50 days after filing under the agency’s Commissioner’s National Priority Voucher pilot program. (fda.gov) ### What changes on July 1 for Medicare patients? CMS said its Medicare GLP-1 Bridge short-term demonstration will begin July 1, 2026, and run through December 31, 2027. The agency said the program will give eligible Medicare Part D beneficiaries access to certain GLP-1 drugs outside the normal Part D coverage and payment flow. (investor.lilly.com) CMS said a single central processor will handle prior authorization, claims adjudication and pharmacy payment in 2026. The agency’s public FAQ names Wegovy, Foundayo and Zepbound among the products addressed in the program materials, while Lilly said eligible Medicare Part D patients may be able to get Foundayo for $50 per month beginning July 1, 2026. (fda.gov) ### Where does the market go next? January 2026 was Novo Nordisk’s target for the first U.S. Wegovy pill launch, and April 2026 was Lilly’s date for broad Foundayo availability through LillyDirect, telehealth providers and retail pharmacies. Those launches mean both major obesity-drug makers now have oral products on the U.S. market for weight loss. (cms.gov) July 1, 2026, is the next date to watch. CMS said the Medicare GLP-1 Bridge starts that day, and the agency said it would provide additional design information in spring 2026 as pharmacies, prescribers and beneficiaries prepare for enrollment and dispensing. (prnewswire.com) (cms.gov)