12 January 2026 - The indication expansion is based on positive outcomes observed in the cardiovascular outcomes (SOUL) trial data, which demonstrated that Rybelsus decreased the risk of major adverse cardiovascular events.

Novo Nordisk announced today that Health Canada has approved Rybelsus (semaglutide tablets) to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or are at high risk for these events.

Read Novo Nordisk press release