FDA Approves First Oral GLP-1 for Weight Management

The US Food and Drug Administration (FDA) has approved the Wegovy® pill (once-daily oral semaglutide 25 mg) for weight management. This marks the first oral glucagon-like peptide-1 (GLP-1) receptor agonist therapy for this purpose. The approval, based on the OASIS and SELECT trials, allows the pill to reduce excess body weight, maintain long-term weight reduction, and decrease the risk of major adverse cardiovascular events. In the OASIS 4 trial, the pill demonstrated a mean weight loss of 16.6% in adults with obesity or overweight and comorbidities, comparable to the injectable version. Novo Nordisk expects to launch the Wegovy® pill in the US in early January 2026 and has submitted applications to the EMA and other regulatory authorities. The drug is also indicated for cardiovascular risk reduction in adults with known heart disease and obesity or overweight.