The FDA has approved Novo Nordisk’s pill version of Wegovy, making it the first oral GLP-1 receptor agonist therapy cleared for chronic weight management.
The once-daily 25-milligram oral semaglutide is indicated to reduce excess body weight, maintain long-term weight loss and lower the risk of major adverse cardiovascular events, according to a Dec. 22 news release from the Denmark-based drugmaker. Novo Nordisk plans to launch the therapy in the U.S. in early January 2026.
The approval was based on data from the OASIS and SELECT trials. In OASIS 4, adults with obesity or who were overweight and had at least one comorbidity lost an average of 16.6% of body weight. One in three participants achieved 20% or greater weight loss. The pill demonstrated a safety and tolerability profile consistent with previous semaglutide trials, according to the release.
Novo Nordisk is also seeking regulatory approvals in Europe and other markets.
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