New GLP‑1 pill approved

The FDA’s approval was granted on Dec. 22, 2025 for Wegovy® tablets (oral semaglutide 25 mg), and Novo Nordisk scheduled a U.S. commercial launch in early January 2026. (prnewswire.com) Phase 3 OASIS‑4 showed a mean weight loss of 16.6% at 64 weeks under the trial’s adherence (treatment‑policy analysis gave ~13.6% weight loss), and roughly one‑third of participants lost ≥20% of body weight. (appliedclinicaltrialsonline.com) Novo Nordisk’s regulatory filing and the approval documents also list a reduction in major adverse cardiovascular events as an approved claim, based in part on data from the company’s cardiovascular program cited by regulators. (ajmc.com) Gastrointestinal events were the most common side effects in OASIS‑4, with nausea reported in 46.6% of participants and vomiting in 30.9%, while serious adverse events occurred less often with oral semaglutide than with placebo in the trial. (novonordisk.mediaroom.com) Novo Nordisk said an introductory 1.5 mg starting dose and savings offers were planned for early January at a list promotional price of $149 per month, and the company reported U.S. manufacturing and a “robust” initial supply. (prnewswire.com) Retail and telehealth distributors announced they would offer the Wegovy pill to eligible patients at launch, while rival oral obesity candidates — including orforglipron, with a PDUFA date in April 2026 — position near‑term competition for market share. (finance.yahoo.com)