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

Novo Nordisk

17 October 2025 - In the SOUL trial, oral semaglutide 14 mg reduced the risk of MACE by 14% compared to placebo, in addition to standard therapies.

Novo Nordisk announced today that the US FDA has approved Rybelsus, the only oral GLP-1 medication available, for reducing the risk of major adverse cardiovascular events such as cardiovascular death, heart attack, or stroke in adults with type 2 diabetes who are at high risk for these events, whether they've had a prior cardiovascular event or not (primary and secondary prevention).

Read Novo Nordisk press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Registration