INVOKAMET XR (canagliflozin)
Invokana (canagliflozin) is an SGLT2 inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). It is also indicated to reduce the risk of major adverse cardiovascular events—including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke—in adults with T2DM and established cardiovascular disease. Additionally, in patients with T2DM and diabetic nephropathy with albuminuria (>300 mg/day), it is indicated to reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure. **Limitations of Use:** It is not recommended for patients with type 1 diabetes mellitus or for glycemic
Development Insights
Details
- Status
- Prescription
- First Approved
- 2016-09-20
- Patent Cliff
- 2029
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
INVOKAMET XR Approval History
What INVOKAMET XR Treats
4 indicationsINVOKAMET XR is approved for 4 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 Diabetes
- Diabetic Nephropathy
- Heart Failure
- End-Stage Kidney Disease
INVOKAMET XR 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.
INVOKAMET XR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in INVOKAMET XR's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications INVOKAMET XR treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to INVOKAMET XR
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
41 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05427084 CANTORSING | 20220176-01H | Ph 2, Ph 3 | recruiting | Canagliflozin Targeting Vascular Inflammation |
| NCT06851962 EPHIC-DIA2 | EPHIC-DIA2 2025-520686-46-00 | Ph 4 | active not recruiting | Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes. |
| NCT03436693 results posted | TA-7284-14 | Ph 3 | completed | Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy |
| NCT02354222 results posted | MT-2412-J02 | Ph 3 | completed | Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Teneligliptin) |
| NCT02354235 results posted | MT-2412-J03 | Ph 3 | completed | Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin) |
| NCT06528405 ESS-AKD | 202404095MINE | Ph 2 | recruiting | The Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors in Patients With Acute Kidney Disease |
| NCT02891954 | HP-00069977 R01DK118942 | Ph 1 | active not recruiting | Genetics of Response to Canagliflozin |
| NCT05090358 | 21-123 | Ph 2 | active not recruiting | Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer |
| NCT07076823 | Approval No. 729 (2025) | Ph 1 | recruiting | Safety and Efficacy of Canagliflozin in Patients With Metastatic High Microsatellite Instability (MSI-H) Colorectal Cancer |
| NCT05507892 | 22-0668 | Ph 2 | recruiting | Renal Mechanism of SGLT2 Inhibition |
| NCT02404870 | 140195 14-DK-0195 | Ph 1 | completed | Acute Effects of Canagliflozin, a Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitor on Bone Metabolism in Healthy Volunteers |
| NCT02865668 | CR108198 28431754DIA1073 | Ph 1 | completed | A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release With Respect to Metformin XR Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants |
| NCT02851095 | CR108199 28431754DIA1074 | Ph 1 | completed | A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release (XR) With Respect to Metformin XR Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants |
| NCT05364190 The CANA -AHF | CL (2973) | Ph 3 | completed | Canagliflozin in Patients With Acute Decompansted Heart Failure |
| NCT04304261 ESCDP | ESCDP | Ph 3 | completed | Effects of SGLT2i on the Cognitive Function in T2DM Patient (ESCDP) |
| NCT02964585 results posted | GW-CANA-081635 | Ph 4 | completed | Role of Canagliflozin on CD34+ Cells in Patients With Type 2 Diabetes |
| NCT02462421 SGLT2iPGx results posted | HP-00058350 R21DK105401 | Ph 4 | terminated | Pharmacogenetics of SGLT2 Inhibitors |
| NCT02912455 results posted | 16-574 | Ph 4 | terminated | CARAT: Canagliflozin vs. Placebo for Post Bariatric Patients With Persistent Type 2 Diabetes |
| NCT02694263 Can Do | 0527 | Ph 4 | completed | Canagliflozin (Invokana™) vs. Standard Dual Therapy Regimen for T2DM During Ramadan |
| NCT03136484 SUSTAIN 8 results posted | NN9535-4270 2016-000989-35, U1111-1180-3651 | Ph 3 | completed | Efficacy and Safety of Semaglutide Versus Canagliflozin as add-on to Metformin in Subjects With Type 2 Diabetes |
| NCT02065791 CREDENCE results posted | CR103517 2013-004494-28, 28431754DNE3001 | Ph 3 | completed | Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy |
| NCT02920918 results posted | HM20007043 28431754DIATBD | Ph 4 | completed | Treatment of Diabetes in Patients With Systolic Heart Failure |
| NCT02360774 results posted | 2014P000335 | Ph 4 | completed | Mechanisms of Weight Loss With SGLT2 Inhibition |
| NCT01939496 results posted | CR102208 28431754DIA4002 | Ph 4 | completed | Evaluation of Blood Pressure Reduction, Safety, and Tolerability of Canagliflozin in Patients With Hypertension and Type 2 Diabetes Mellitus on Stable Doses of Anti-hyperglycemic and Anti-hypertensive Agents |
| NCT02597309 I-Can | CHS# 2015-03 | Ph 4 | withdrawn | The Effect of add-on Canagliflozin in Patients With Type 2 Diabetes Treated With U-500 Insulin |
| NCT01081834 results posted | CR017011 28431754DIA3005 | Ph 3 | completed | The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial |
| NCT02851212 | CR108201 28431754DIA1076 | Ph 1 | completed | A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release With Respect to Metformin Extended Release Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants |
| NCT02243202 results posted | CR103086 28431754OBE2002 | Ph 2 | completed | Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants |
| NCT02221180 | CR104980 28431754DIA1071 | Ph 1 | completed | Bioequivalence Study of Metformin Component of Fixed Dose Combination (FDC) Immediate Release (IR) Tablet of Canagliflozin and Metformin Compared to Metformin IR Tablet Co-administered With Canagliflozin in Healthy Fed and Fasted Participants |
| NCT02220218 | CR104979 28431754DIA1070 | Ph 1 | completed | Bioequivalence Study of Metformin Component of Canagliflozin and Metformin Fixed Dose Combination Immediate Release (IR) Tablet Comparing With Metformin IR Tablet Co-administered With Canagliflozin Tablet in Healthy Fed and Fasted Participants |
| NCT01483781 | CR100685 28431754DIA1047, 2011-004117-17 | Ph 1 | completed | A Study of the Effects of Canagliflozin on Plasma Volume in Patients With Type 2 Diabetes Mellitus |
| NCT01157000 | CR017197 28431754DIA1021 | Ph 1 | completed | A Pharmacokinetic and Bioavailability Study of 28431754 (Canagliflozin) in Healthy Male Volunteers |
| NCT01877889 | CR101974 28431754DIA1056, 2013-000994-54 | Ph 1 | completed | A Study to Compare the Pharmacodynamics of Canagliflozin and Dapagliflozin in Healthy Volunteers |
| NCT01064414 results posted | CR017008 28431754DIA3004 | Ph 3 | completed | An Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment |
| NCT01106677 results posted | CR017023 28431754DIA3006 | Ph 3 | completed | The CANTATA-D Trial (CANagliflozin Treatment and Trial Analysis - DPP-4 Inhibitor Comparator Trial) |
| NCT01106690 results posted | CR017032 28431754DIA3012 | Ph 3 | completed | The CANTATA-MP Trial (CANagliflozin Treatment and Trial Analysis - Metformin and Pioglitazone) |
| NCT01106625 results posted | CR017005 28431754DIA3002 | Ph 3 | completed | The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea) |
| NCT01186588 | CR017227 | Ph 1 | completed | A Study of Canagliflozin in Study Participants With Various Degrees of Impaired Hepatic (Liver) Function |
| NCT01395927 | CR018604 28431754DIA1029 | Ph 1 | completed | A Study to Evaluate the Effects of Rifampin on Single-Dose Pharmacokinetics of Canagliflozin in Healthy Volunteers |
| NCT01273558 | CR017719 28431754DIA1025 | Ph 1 | completed | A Study of Two Methods for Determining the Renal Threshold for Glucose in Patients With Type 2 Diabetes Mellitus |
| NCT01343290 | CR018016 284317541043 | Ph 1 | completed | The Effect of Food on the Administration of Canagliflozin in Healthy Adult Volunteers |
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.
INVOKAMET XR FDA Label Details
Indications & Usage
FDA Label (PDF)INVOKAMET XR is indicated for the treatment of Type 2 Diabetes; Diabetic Nephropathy; Heart Failure; End-Stage Kidney Disease.
INVOKAMET XR Patents & Exclusivity
Patents (6 active)
Exclusivity
Pro Intelligence Preview
Deep insights for INVOKAMET XR
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • 160 active patents
Trial Analysis
- • 42 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment