Oral Wegovy Approved
The FDA approved oral semaglutide (Wegovy) for chronic weight management — the first GLP‑1 pill — backed by Phase III OASIS 4 data showing meaningful weight loss and cardiometabolic benefit. This expands non‑injectable GLP‑1 options for people with type 2 diabetes and weight‑management needs, shifting the therapeutic landscape for T2D care FDA Approves Oral Wegovy Following Positive Phase III OASIS 4 Trial Results | Applied Clinical Trials Online.
OASIS 4 randomized 307 adults without diabetes (205 to oral semaglutide 25 mg, 102 to placebo) across 22 sites in four countries, with 64 weeks on therapy and 71 weeks total follow-up. (nejm.org) A full‑adherence (on‑treatment) analysis reported mean weight loss of 16.6% with oral semaglutide versus 2.7% for placebo, while the treatment‑policy (intention‑to‑treat) analysis showed 13.6% versus 2.2% (estimated difference −11.4 percentage points); roughly one‑third of adherent participants lost ≥20% of body weight. (appliedclinicaltrialsonline.com) Post‑hoc and pooled OASIS analyses presented additional cardiometabolic detail: 71% of participants with prediabetes reverted to normal blood glucose on treatment versus 33% with placebo, and weight loss ≥15% correlated with greater improvements in blood pressure and lipid measures. (appliedclinicaltrialsonline.com) Safety signals in the trial included more frequent gastrointestinal events with oral semaglutide (74.0% vs. 42.2%) and a lower rate of serious adverse events versus placebo in reported analyses (3.9% vs. 8.8%); the official label also carries class warnings and contraindications such as a personal/family history of medullary thyroid carcinoma and MEN2. (nejm.org) Novo Nordisk said manufacturing is underway at U.S. facilities and that it prepared for a full U.S. commercial launch in early January 2026, while regulators and clinicians will watch longer‑term durability, safety, and applicability to people with type 2 diabetes—OASIS 4 excluded patients with diabetes, so extrapolation to that population relies on other datasets and future studies. (prnewswire.com)
