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In October 2025, the U.S. Food and Drug Administration approved the use of oral semaglutide (Rybelsus) for lowering risk for major adverse cardiovascular events in high-risk adults with type 2 diabetes.
Oral semaglutide was first approved by the FDA in 2019 to improve glycemic control in adults with type 2 diabetes, but until now, only injectable semaglutide was approved to help lower cardiovascular (CV) risk in this population.
The new indication for oral semaglutide is based on an international trial in which nearly 10,000 patients with longstanding type 2 diabetes and a mean body-mass index of 31 kg/m2 were randomized to receive oral semaglutide or placebo. Fully 84% had documented coronary artery disease, previous st…
