Core Viewpoint - Novo Nordisk has submitted a New Drug Application (NDA) to the FDA for the oral formulation of Wegovy® (semaglutide) aimed at chronic weight management in adults with obesity or overweight and associated comorbidities, potentially becoming the first oral GLP-1 treatment for this purpose [1][3]. Group 1 - The FDA has accepted the NDA for Wegovy®, which is intended for adults with obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m²) and one or more comorbidities [1][3]. - The application is based on the results of the OASIS 4 trial, a 64-week Phase 3 randomized controlled trial involving 307 participants [3][4]. - The OASIS 4 trial included a 12-week dose escalation period and a 7-week follow-up after treatment, with participants randomly assigned to receive either the oral semaglutide or a placebo [4]. Group 2 - The FDA is expected to make a decision on the approval of the oral formulation of Wegovy® in the fourth quarter of 2025 [4]. - Novo Nordisk's senior vice president emphasized the importance of personalized treatment options for obesity, highlighting the company's extensive experience and innovation in this field [3].