FDA approves Novo Nordisk's oral semaglutide for cardiovascular (CV) risk reduction in adults with type 2 diabetes who are at high risk, including those who have not had a prior CV event

Rybelsus ® (semaglutide) tablets 7 mg or 14 mg, the only FDA-approved oral GLP-1 medicine available, now indicated to reduce the risk of major adverse cardiovascular events (MACE) such as CV death, heart attack, or stroke in adults with type 2 diabetes who are at high risk for these events 1

In the SOUL trial, oral semaglutide 14 mg reduced the risk of MACE by 14% compared to placebo, in addition to standard therapies

Milestone underscores the robust data supporting oral semaglutide and demonstrates Novo Nordisk's cardiometabolic leadership and commitment to people living with chronic disease

PLAINSBORO, N.J. and BAGSVÆRD, Denmark , Oct. 17, 2025 /PRNewswire/ -- Novo Nordisk announced today that the US Food and Drug Administration (FDA) has approved Rybelsus ® , the only