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Data updated: Mar 10, 2026

INVOKANA

CANAGLIFLOZIN
Cardiovascular Approved 2013-03-29

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.

Source: FDA Label • Johnson & Johnson

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.

Source: FDA Label
8
Indications
--
Phase 3 Trials
2
Priority Reviews
12
Years on Market

Details

Status
Prescription
First Approved
2013-03-29
Routes
ORAL
Dosage Forms
TABLET

Companies

Active Ingredient: CANAGLIFLOZIN

INVOKANA Approval History

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What INVOKANA Treats

3 indications

INVOKANA 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
Source: FDA Label

INVOKANA Target & Pathway

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Target

SGLT2 (Sodium-Glucose Co-Transporter 2) Transporter

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

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10 other drugs also target SGLT2. Compare mechanisms, indications, and trial activity.

View all 10 SGLT2 drugs →
Drug = Competitor name Company = Manufacturer N indic. = FDA-approved indications → Date = Patent/exclusivity expiry

Competitors share the same molecular target (SGLT2). Earlier expiry dates signal biosimilar/generic opportunities.

Drugs Similar to INVOKANA

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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

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Indications & 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

Latest Patent: Aug 2029
Exclusivity: Jun 2028

Patents (40 active)

US7943582*PED Expires Aug 26, 2029
US7943582 Expires Feb 26, 2029
US8513202*PED Expires Jun 3, 2028
US7943788*PED Expires Jan 14, 2028
US8513202 Expires Dec 3, 2027
US7943788 Expires Jul 14, 2027
+ 30 more patents

Exclusivity

NPP Until Dec 2027
NPP Until Dec 2027
PED Until Jun 2028
PED Until Jun 2028
NPP Until Dec 2027
Source: FDA Orange Book

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.