For research and educational purposes only. Not medical advice.
Canagliflozin Reference
Educational, not medical advice reference for Canagliflozin: Metabolic; regulatory status, evidence posture, source review, and schedule notes. Also known as…
Reference summary
CANVAS (Neal 2017 NEJM, integrated analysis of CANVAS and CANVAS-R, n=10,142 adults with T2D and high CV risk) reported a 14 percent relative reduction in the primary MACE composite over a mean 188 weeks. CREDENCE subsequently established renal-outcome benefit in T2D patients with CKD. The CANVAS program also identified a 1.97-fold increased risk of lower-extremity amputation (toes / feet) that prompted an initial boxed warning, later removed in 2020 after additional data review.
Regulatory and posture
- Categories
- Metabolic
- Aliases
- Invokana, SGLT2 inhibitor (small molecule, not a peptide)
- Evidence posture
- human - CANVAS identified an amputation risk signal that distinguishes canagliflozin from empagliflozin and dapagliflozin in class-comparative discussion. The initial boxed warning was removed in 2020.
- Regulatory status
- FDA-approved as Invokana for type 2 diabetes (2013), reduction in major adverse cardiovascular events in adults with T2D and established cardiovascular disease (2018), and treatment of diabetic kidney disease in adults with T2D (2019). Fixed-dose combination with metformin (Invokamet) is also approved.
- Content review status
- label verified