FDA clears oral GLP‑1 pills

Weight-loss drugs that mimic a gut hormone are now available as pills, not just injections, after the Food and Drug Administration cleared daily oral versions from Novo Nordisk and Eli Lilly. (appliedclinicaltrialsonline.com) (fda.gov) These medicines copy glucagon-like peptide-1, or GLP-1, a hormone that helps people feel full and slows stomach emptying. Novo Nordisk’s pill is oral semaglutide sold as Wegovy, and Eli Lilly’s pill is orforglipron sold as Foundayo. (appliedclinicaltrialsonline.com) (fda.gov) Oral Wegovy was approved by the Food and Drug Administration on December 22, 2025, and Novo Nordisk said it was preparing a full United States launch in early January 2026. In the Phase 3 OASIS 4 trial, adults on oral semaglutide 25 milligrams lost 16.6% of body weight at 64 weeks with full adherence, versus 2.7% on placebo. (appliedclinicaltrialsonline.com) (pharmaceutical-tech.com) Foundayo was approved on April 1, 2026, for adults with obesity or adults who are overweight with at least one weight-related condition, alongside diet and exercise. The Food and Drug Administration said it made the decision 50 days after filing, 294 days before the original January 20, 2027 target date. (fda.gov) The agency said Foundayo is the first new molecular entity approved under its Commissioner’s National Priority Voucher pilot program and the fastest new molecular entity approval since 2002. The starting dose is 0.8 milligrams, with step-ups after at least 30 days to 2.5 milligrams and 5.5 milligrams, and possible increases to 9 milligrams, 14.5 milligrams, or 17.2 milligrams. (fda.gov) The practical difference between the two pills starts with how patients take them. The Food and Drug Administration said Foundayo does not need to be taken on an empty stomach, and Lilly said it can be taken any time of day without food or water restrictions. (fda.gov) (prnewswire.com) Trial results also differ. Lilly said adults who stayed on the highest Foundayo dose in the ATTAIN-1 trial lost an average 27.3 pounds, or 12.4% of body weight, versus 2.2 pounds, or 0.9%, on placebo. (prnewswire.com) Novo Nordisk’s oral Wegovy approval also included a cardiovascular claim. Applied Clinical Trials reported that the label covers reducing the risk of major adverse cardiovascular events, including death, heart attack, or stroke, in adults who qualify. (appliedclinicaltrialsonline.com) Distribution is already shifting around the new pills. Reuters reported on April 9 that Amazon Pharmacy will stock Foundayo at kiosks in some One Medical clinics and offer same-day delivery in the United States. (usnews.com) The two approvals turn a market built around weekly injections into a daily-pill race between the same companies that dominate obesity drugs now. What happens next will depend less on whether the drugs work than on price, supply, insurance coverage, and how easily patients can actually get them. (statnews.com) (biospace.com)