MedPath

Canagliflozin

Generic Name
Canagliflozin
Brand Names
Invokamet, Invokana
Drug Type
Small Molecule
Chemical Formula
C24H25FO5S
CAS Number
842133-18-0
Unique Ingredient Identifier
6S49DGR869
Background

Canagliflozin, also known as Invokana, is a sodium-glucose cotransporter 2 (SGLT2) inhibitor used in the management of type 2 diabetes mellitus along with lifestyle changes including diet and exercise .

It was initially approved by the FDA in 2013 for the management of diabetes and later approved in 2018 for a second indication of reducing the risk of cardiovascular events in patients diagnosed with type 2 diabetes mellitus , .

Canagliflozin is the first oral antidiabetic drug approved for the prevention of cardiovascular events in patients with type 2 diabetes . Cardiovascular disease is the most common cause of death in these patients .

Indication

This drug is used in conjunction with diet and exercise to increase glycemic control in adults diagnosed with type 2 diabetes mellitus .

Another indication for canagliflozin is the prevention of major cardiovascular events (myocardial infarction, stroke, or death due to a cardiovascular cause) in patients with type 2 diabetes, as well as hospitalization for heart failure in patients with type 2 diabetes.

In addition to the above, canagliflozin can be used to lower the risk of end-stage kidney disease and major increases in serum creatinine and cardiovascular death for patients with a combination of type 2 diabetes mellitus, diabetic nephropathy, and albuminuria.

It is important to note that this drug is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis .

Associated Conditions
Cardiovascular Mortality, End Stage Renal Disease (ESRD), Hospitalizations, Major Adverse Cardiac Events, Type 2 Diabetes Mellitus, Doubling of serum creatinine

SGLT2 Inhibitors Demonstrate Significant Renal Benefits in Heart Failure and Chronic Kidney Disease

• SGLT2 inhibitors significantly reduce the risk of acute kidney injury and renal failure in heart failure patients, with empagliflozin showing a 30% reduction in kidney injury risk according to a meta-analysis of over 10,000 participants. • A new study reveals SGLT2 inhibitors effectively increase hemoglobin and hematocrit levels in chronic kidney disease patients, potentially addressing anemia—a common complication—while providing established renoprotective benefits. • Despite strong clinical evidence supporting their cardiorenal benefits, SGLT2 inhibitors remain underprescribed, prompting the development of collaborative prescription algorithms and educational initiatives to improve utilization in primary care settings.

Merck and Pfizer Launch Competitively Priced SGLT2 Inhibitor Steglatro for Type 2 Diabetes

• FDA approves Steglatro (ertugliflozin) and its combination therapies Steglujan and Segluromet for type 2 diabetes management, expanding treatment options in the SGLT2 inhibitor class. • Merck and Pfizer strategically price Steglatro at $8.94 per day, significantly lower than competitors Farxiga ($11.57) and Jardiance ($13+), aiming to gain market share. • Cardiovascular outcomes data from the 8,000-patient Vertis CV Study is expected by October 2019, which could impact the drug's competitive position in the market.

FDA Fast-Tracks Jardiance for Chronic Kidney Disease Treatment

The FDA has granted fast-track designation to Eli Lilly and Boehringer Ingelheim's Jardiance (empagliflozin) for treating chronic kidney disease and reducing cardiovascular death risk. This potential expansion builds on promising results from the EMPA-REG OUTCOME trial, which showed a 39% reduction in new-onset and worsening kidney disease in diabetic patients with cardiovascular disease.

FDA Approves Ozempic for Reducing Kidney Disease Risks in Type 2 Diabetes Patients

• The FDA has approved Ozempic to reduce the risk of kidney disease worsening, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease. • A Phase 3 clinical trial demonstrated a 24% reduction in the risk of kidney disease progression and cardiovascular death compared to placebo with Ozempic. • Ozempic is now the most broadly indicated GLP-1 receptor agonist, offering a new treatment option for millions of adults with type 2 diabetes and chronic kidney disease. • The approval was based on the FLOW trial, which showed significant benefits in kidney and cardiovascular outcomes, leading to early termination due to efficacy.

Finerenone sNDA Submitted to FDA for Heart Failure with Preserved Ejection Fraction

• Bayer has submitted a supplemental New Drug Application (sNDA) to the FDA for finerenone to treat heart failure patients with LVEF ≥40%. • The sNDA is based on the Phase III FINEARTS-HF trial, which demonstrated a 16% reduction in cardiovascular death and heart failure events. • Finerenone is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) already approved for chronic kidney disease in type 2 diabetes. • If approved, finerenone could address a significant unmet need in heart failure patients with mildly reduced or preserved ejection fraction.
© Copyright 2025. All Rights Reserved by MedPath