FDA approves oral semaglutide

Novo Nordisk’s oral semaglutide has already moved the obesity-drug market beyond the weekly injection. U.S. labeling shows Wegovy tablets were approved in 2025 for chronic weight management and cardiovascular risk reduction in adults with obesity or overweight and established cardiovascular disease. The approval put the first GLP-1 weight-loss pill on the market, giving Novo a lead in a category that Eli Lilly entered weeks later with Foundayo, its oral obesity drug. (cnbc.com) Novo said this month it is preparing launches outside the United States, while Lilly is responding to FDA demands for longer-term safety follow-up on its newer molecule. ### How is the pill different from the injectable version already on the market? Wegovy tablets use the same active ingredient, semaglutide, that Novo has sold in injectable form, but the oral format changes how patients start and stay on therapy. Novo says semaglutide became the first oral GLP-1 for type 2 diabetes in 2019 and the first oral GLP-1 approved in the United States for weight management in 2025. That matters because obesity treatment has been dominated by injections even as demand broadened beyond specialist clinics. The FDA label shows the tablet carries the same boxed warning on thyroid C-cell tumors seen across semaglutide products and the same broad weight-management indication for adults with obesity, or overweight with at least one related condition. (accessdata.fda.gov) The oral version also carries language on monitoring the effects of concomitant oral drugs, reflecting absorption and drug-interaction issues that do not arise in the same way with a shot. ### Why are investors and drugmakers focused on pills now? More than 2 million prescriptions for Novo’s Wegovy pill had been written in the United States by last week, CNBC reported, citing the company. (novonordisk.com) Emil Kongshøj Larsen, Novo’s executive vice president for international operations, told CNBC the U.S. launch had created a strong base ahead of expansion abroad and said, “When we launch, we’ll go all in.” The U.S. market still accounts for more than half of sales at both Novo and Lilly, CNBC reported, but the oral format gives both companies a way to reach patients who may resist injections or seek treatment through telehealth. (accessdata.fda.gov) Larsen said telehealth had helped broaden access in Germany, where he said patients were getting treatment in a more convenient way. ### What is Novo Nordisk doing outside the United States? Novo said last week it expects first launches of the Wegovy pill outside the United States later in 2026, pending approvals, according to CNBC. (cnbc.com) Larsen did not name the first countries, but CNBC said analysts had pointed to the United Kingdom, Germany and Denmark as likely early markets. Novo’s international push comes as the company looks for growth beyond a U.S. market pressured by lower prices and, in some countries, generic competition. CNBC reported that Novo still expects 2026 sales and profit to decline by 4% to 12%, even after slightly raising guidance. (cnbc.com) ### Why is Lilly facing extra FDA scrutiny on Foundayo? Pharmaceutical Executive reported on April 16 that the FDA asked Eli Lilly for additional post-approval studies on Foundayo, orforglipron, after concluding the approval-era data did not fully characterize several risks. (cnbc.com) The agency requested longer-term evaluation of cardiovascular events, drug-induced liver injury, delayed gastric emptying and thyroid cancer risk, including at least 15 years of thyroid cancer follow-up, the publication said. Lilly said updated data reaffirmed Foundayo’s cardiovascular and overall safety profile, according to Pharmaceutical Executive. (cnbc.com) The publication also said the FDA required a pediatric obesity registry and a pregnancy exposure registry as part of post-approval monitoring. ### What should readers watch next? Later in 2026, Novo plans its first ex-U.S. launches for the Wegovy pill, subject to local approvals, CNBC reported. Lilly, meanwhile, is expected to carry out the FDA-requested post-approval studies and registries for Foundayo, including long-term thyroid cancer surveillance and additional cardiovascular and liver safety follow-up. (pharmexec.com) (cnbc.com)