StoryRegulatory
FDA approves oral Wegovy (semaglutide 25 mg) as first oral GLP-1 for obesity
The FDA approved oral Wegovy (semaglutide 25 mg once daily) on December 22, 2025, marking the first oral GLP-1 receptor agonist approved for chronic weight management. The approval was based on the OASIS-4 Phase 3 trial, which showed 16.6% average weight loss at 64 weeks with one in three patients achieving ≥20% weight loss.
- OASIS-4 trial demonstrated non-inferiority to injectable Wegovy (2.4 mg weekly); safety and tolerability were consistent with known semaglutide profiles.
- The 25 mg once-daily dose is much higher than the 2.4 mg injection because oral absorption of peptides is limited; the formulation includes SNAC (sodium caprate), an absorption enhancer.
- Novo Nordisk expected U.S. market launch in early January 2026; the oral option addresses patient preference for pills over injections.
- Approved for adults with obesity or overweight and at least one weight-related comorbidity (hypertension, type 2 diabetes, cardiovascular disease).