Oral GLP‑1s win FDA approvals

A class of obesity drugs that mimic a gut hormone that signals fullness now has two new pill options in the United States, after the Food and Drug Administration cleared oral Wegovy and Eli Lilly’s Foundayo within the same regulatory window. (fda.gov, appliedclinicaltrialsonline.com) Glucagon-like peptide-1 drugs, usually shortened to GLP-1, help people eat less by slowing stomach emptying and increasing satiety, or the feeling of being full. Until late 2025, the best-known obesity versions in the United States were mostly weekly injections such as Wegovy. (fda.gov, nejm.org) Novo Nordisk’s oral Wegovy is a once-daily semaglutide tablet for adults with obesity, or adults who are overweight and have at least one weight-related condition. Applied Clinical Trials reported the Food and Drug Administration approved it in December 2025, and Novo Nordisk said it planned a full United States launch in January 2026. (appliedclinicaltrialsonline.com, ntb.no) The approval rested on the Phase 3 OASIS 4 trial, which tested oral semaglutide 25 milligrams once daily in 307 adults without diabetes over 64 weeks. In the trial’s on-treatment analysis, participants on the pill lost an average of 16.6% of body weight, versus 2.7% on placebo, and 34.4% lost at least 20% of body weight. (nejm.org, markets.ft.com) Eli Lilly’s Foundayo, the brand name for orforglipron, is also a once-daily obesity pill, but it is a small-molecule drug rather than a peptide like semaglutide. The Food and Drug Administration approved Foundayo on April 1, 2026, 50 days after filing and 294 days before its original January 20, 2027 target date. (fda.gov, pi.lilly.com) That speed came through the Food and Drug Administration’s Commissioner’s National Priority Voucher pilot, a program meant to compress review times for selected applications. The agency said Foundayo was the fifth approval under the pilot and the fastest approval of a new molecular entity since 2002. (fda.gov, federalregister.gov) The same pilot also cleared a higher-dose injectable semaglutide, Wegovy HD, on March 19, 2026. The new 7.2 milligram weekly dose was approved 54 days after filing for adults with obesity, or adults who are overweight with at least one weight-related condition. (fda.gov, ajmc.com) Wegovy HD gives Novo Nordisk a second injectable dose tier alongside the long-standing 2.4 milligram version, while oral Wegovy gives it a pill for people who do not want injections. Lilly said Foundayo is now available through LillyDirect, telehealth providers and United States retail pharmacies. (fda.gov, medical.lilly.com) Both products carry the class’s familiar safety language, including a boxed warning tied to thyroid C-cell tumors seen in rodents, and are meant to be used with reduced-calorie diets and more physical activity. The labels also reflect a practical difference: oral Wegovy is a semaglutide tablet added to an established franchise, while Foundayo is Lilly’s first approved obesity pill in this category. (pi.lilly.com, fda.gov) The result is a broader obesity market built around the same idea: medicines that lower appetite are no longer confined to weekly shots. By April 2026, the Food and Drug Administration had approved one oral semaglutide, one oral orforglipron and one higher-dose Wegovy injection in a span of months. (appliedclinicaltrialsonline.com, fda.gov, fda.gov)