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FDA approves oral Wegovy pill for weight loss
Novo Nordisk announced on December 22, 2025, that FDA has approved the Wegovy pill (oral semaglutide 25 mg once daily) to reduce excess body weight, maintain weight reduction long term, and reduce the risk of major adverse cardiovascular events. The medication is indicated for adults with obesity or overweight and ≥1 weight‑related comorbidity.
Approval was based on data from the OASIS‑4 trial (NCT05564117), where participants lost an average of 16.6% of body weight at 64 weeks—comparable to injectable Wegovy—with one in three achieving ≥20% weight loss. Safety and tolerability were consistent with existing semaglutide profiles.
Because oral absorption is limited, the formulation uses a higher dose (25 mg vs. 2.4 mg for injections). While oral semaglutide is already available for diabetes as Rybelsus (max 14 mg), weight loss with Rybelsus is significantly less than with Wegovy injections. Novo Nordisk expects a U.S. launch in early January 2026.
Sources:
(2025, December 22). Novo Nordisk. Novo Nordisk A/S: Wegovy® pill approved in the US as first oral GLP-1 for weight management [News release]. https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=916472
Tirrell, M. (2025, December 22). CNN. With FDA approval of Wegovy pill, new era of oral GLP-1 weight loss drugs begins. https://www.cnn.com/2025/12/22/health/wegovy-pill-glp1-weight-loss-drugs
Wharton S, et al; OASIS 4 Study Group. (2025, September 18). N Engl J Med. Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity. https://pubmed.ncbi.nlm.nih.gov/40934115/
Wegovy (semaglutide) [package insert]. Novo Nordisk. https://www.novo-pi.com/wegovy.pdf Revised December 2025. Accessed December 22, 2025.