INVOKANA
INVOKANA (canagliflozin) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated to improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise. It is also used to reduce the risk of major adverse cardiovascular events, including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, in adults with type 2 diabetes and established cardiovascular disease. Furthermore, the medication is indicated to reduce the risk of end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes and diabetic nephropathy. Use is not recommended for patients with type 1 diabetes or for glycemic control in patients with an eGFR less than 30 mL/min/1.73 m².
How INVOKANA Works
Canagliflozin inhibits SGLT2, a transporter in the proximal renal tubules responsible for the majority of glucose reabsorption from the tubular lumen. By blocking this transporter, the medication reduces the reabsorption of filtered glucose and increases urinary glucose excretion. The drug also increases the delivery of sodium to the distal tubule by blocking SGLT2-dependent sodium reabsorption. This action is believed to increase tubuloglomerular feedback and reduce intraglomerular pressure.
Details
- Status
- Prescription
- First Approved
- 2013-03-29
- Routes
- ORAL
- Dosage Forms
- TABLET
INVOKANA Approval History
What INVOKANA Treats
3 indicationsINVOKANA is approved for 3 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Glycemic control in adults with type 2 diabetes mellitus
- Major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease
- End-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria
INVOKANA Target & Pathway
ProTarget
A transporter in the kidney that reabsorbs glucose back into the bloodstream. Blocking SGLT2 causes excess glucose to be excreted in urine, lowering blood sugar. These drugs also provide cardiovascular and kidney protection beyond glucose control.
INVOKANA Competitors
Pro10 other drugs also target SGLT2. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (SGLT2). Earlier expiry dates signal biosimilar/generic opportunities.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
INVOKANA FDA Label Details
ProIndications & Usage
FDA Label (PDF)INVOKANA (canagliflozin) is indicated: as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD). to reduce the risk of end-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greate...
INVOKANA Patents & Exclusivity
Patents (40 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.