Novo Nordisk Cites 9,650-Patient SOUL Trial Behind Rybelsus Nod
Novo Nordisk Canada says Health Canada's approval of Rybelsus to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes is based on the SOUL trial, which randomized 9,650 patients to either Rybelsus 14 mg or placebo daily [Source: lifesciencesbc.ca/members/health-canada-approves-rybelsus-semaglutide-tablets-to-reduce-the-risk-of-major-adverse-cardiovascular-events-mace-in-adults-with-type-2-diabetes/].
The SOUL trial
SOUL was a randomized, double-blind, parallel-group, placebo-controlled trial evaluating Rybelsus in patients 50 years of age or older with type 2 diabetes mellitus and established cardiovascular disease and/or chronic kidney disease [Source: lifesciencesbc.ca/members/health-canada-approves-rybelsus-semaglutide-tablets-to-reduce-the-risk-of-major-adverse-cardiovascular-events-mace-in-adults-with-type-2-diabetes/]. The primary endpoint was the time to first occurrence of a three-part composite outcome that included cardiovascular death, non-fatal myocardial infarction and non-fatal stroke [Source: lifesciencesbc.ca/members/health-canada-approves-rybelsus-semaglutide-tablets-to-reduce-the-risk-of-major-adverse-cardiovascular-events-mace-in-adults-with-type-2-diabetes/].
What Novo Nordisk Canada said
"This approval marks an important milestone for type 2 diabetes patients in Canada, who are at higher risk of cardiovascular events due to the chronic disease," said Vince Lamanna, President, Novo Nordisk Canada Inc. [Source: lifesciencesbc.ca/members/health-canada-approves-rybelsus-semaglutide-tablets-to-reduce-the-risk-of-major-adverse-cardiovascular-events-mace-in-adults-with-type-2-diabetes/]. Lamanna added that Rybelsus "is the first and only approved GLP-1 in pill form in Canada that improves glycemic control and offers cardiovascular protection" [Source: lifesciencesbc.ca/members/health-canada-approves-rybelsus-semaglutide-tablets-to-reduce-the-risk-of-major-adverse-cardiovascular-events-mace-in-adults-with-type-2-diabetes/].
Rybelsus was first authorized by Health Canada in April 2020 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [Source: lifesciencesbc.ca/members/health-canada-approves-rybelsus-semaglutide-tablets-to-reduce-the-risk-of-major-adverse-cardiovascular-events-mace-in-adults-with-type-2-diabetes/]. The product monograph supporting the expanded indication is dated December 31, 2025 [Source: lifesciencesbc.ca/members/health-canada-approves-rybelsus-semaglutide-tablets-to-reduce-the-risk-of-major-adverse-cardiovascular-events-mace-in-adults-with-type-2-diabetes/].
Background on the brand pipeline
The SOUL data were published online in the New England Journal of Medicine on March 29, 2025, under the title "Oral Semaglutide and Cardiovascular Outcomes in High-Risk Type 2 Diabetes" [Source: lifesciencesbc.ca/members/health-canada-approves-rybelsus-semaglutide-tablets-to-reduce-the-risk-of-major-adverse-cardiovascular-events-mace-in-adults-with-type-2-diabetes/]. Novo Nordisk Canada is headquartered in Mississauga, Ontario [Source: lifesciencesbc.ca/members/health-canada-approves-rybelsus-semaglutide-tablets-to-reduce-the-risk-of-major-adverse-cardiovascular-events-mace-in-adults-with-type-2-diabetes/].
The expanded label arrives as Novo Nordisk's semaglutide franchise faces new competition. On April 28, 2026, Health Canada authorized the first generic semaglutide injection, a generic version of Ozempic filed by Dr. Reddy's Laboratories [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html]. Health Canada said it is reviewing eight other submissions for generic semaglutide by different companies and expects to make regulatory decisions on more of these submissions "in the coming weeks and months" [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html].
Plan sponsor outlook
Alberta Blue Cross's 2026 drug pipeline report identifies GLP-1 receptor agonists as a major cost driver for private plans [Source: ab.bluecross.ca/plans/group/drug-pipeline-2026.php]. The insurer states that while a semaglutide generic is expected in mid-2026, "overall GLP-1 therapy plan spend is unlikely to decline in future years due to growing use and continued expansion of GLP-1 therapies" [Source: ab.bluecross.ca/plans/group/drug-pipeline-2026.php]. The report notes a robust pipeline of new GLP-1 therapies under development and points to potential future expanded uses including metabolic dysfunction-associated steatohepatitis and obstructive sleep apnea [Source: ab.bluecross.ca/plans/group/drug-pipeline-2026.php].
The insurer also highlights that GLP-1 therapies "are more effective, have broader uses, last longer between doses and will increasingly be available in oral form" [Source: ab.bluecross.ca/plans/group/drug-pipeline-2026.php]. The Rybelsus MACE indication, supported by SOUL, fits that broader-uses trajectory for the oral form.
Pricing snapshot
Rybelsus prices listed on GLP1Prices.ca currently range from $230 to $293.99 CAD across Canadian pharmacies. For other brand semaglutide and tirzepatide products, current ranges are:
- Ozempic: $215 to $663 CAD
- Wegovy: $270 to $550 CAD — see Wegovy
- Mounjaro: $295 to $800 CAD — see Mounjaro
- Zepbound: $271.62 to $609 CAD — see Zepbound
Readers can monitor incoming generic semaglutide products through the generic semaglutide tracker and check plan rules with the insurance coverage checker. Additional background is available in the FAQ.
This article is for informational purposes only and does not constitute medical advice.
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