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In December 2025, the U.S. FDA approved the use of oral semaglutide for weight reduction in adults with obesity and in adults with overweight who have at least one weight-related comorbidity.
Oral semaglutide was first approved by the FDA in 2019 to improve glycemic control in patients with type 2 diabetes, and then in October 2025 to reduce cardiovascular risk in those patients. For both indications, the drug was marketed under the brand name Rybelsus, with recommended daily doses starting as low as 1.5 mg and titrated as high as 14 mg. Now, the drug has been approved for weight reduction, with a maximal daily dose of 25 mg, and is being marketed as oral Wegovy.
Approval for this indication was based primarily on a rand…
