Invokana

(Canagliflozin)

ApprovedSmall molecule

Canagliflozin is used to help control blood sugar levels in people with type 2 diabetes. It works by helping the kidneys remove excess sugar through urine.[2] Invokana is currently approved and in use across 25 indications[4].[1]

Invokana is one of 531 small molecule programs targeting Pancreatic Carcinoma. It is currently in Approved.

Indications

122

Total Trials

Active Trials

530

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Pancreatic CarcinomaActive, not recruiting

Hepatic FailureApproved

Myocardial FibrosisActive, not recruiting

TicsCompleted

Alcoholic Fatty Liver DiseaseActive, not recruiting

Type 2 Diabetes MellitusUnknown status

Kidney DiseaseRecruiting

Weight LossCompleted

Fatty Liver DiseaseActive, not recruiting

Diabetes MellitusActive, not recruiting

Pancreatic CarcinomaPreclinical

Active, not recruiting

Hepatic FailureApproved

Approved

Myocardial FibrosisApproved

Active, not recruiting

TicsPhase 1

Completed

Alcoholic Fatty Liver DiseasePreclinical

Active, not recruiting

Type 2 Diabetes MellitusApproved

Unknown status

Kidney DiseasePhase 2

Recruiting

Weight LossApproved

Completed

Fatty Liver DiseasePreclinical

Active, not recruiting

Diabetes MellitusApproved

Active, not recruiting

Showing 10 of 25 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Invokana

WWim Janssens

Approved

1 2

Lexiscan

Astellas

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 5

Tricor

JJagotec

Preclinical

1 6

Ablavar

LLantheus Medical Imaging

Preclinical

2 7

Naltrexone/bupropion

Novo Nordisk

Preclinical

1 8

Sertraline ODT

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 9

Liposomal Irinotecan and Apatinib

SSecond Affiliated Hospital, School of Medicine, Zhejiang University

Preclinical

1 10

Ibrance

Pfizer

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2/3Recruiting

Vascular Inflammation

NCT05427084

Phase 2Recruiting

Study completion

NCT05507892

Phase 1Active, not recruiting

Tics

NCT02891954

Q1 2027

N/ANot yet recruiting

Pancreatic Carcinoma

NCT05903703

Q4 2027

Phase 2Active, not recruiting

Breast Cancer

NCT05090358

Post-ApprovalNot yet recruiting

Study completion

NCT06858436

Clinical

Trials by Indication[1]

Type 2 Diabetes Mellitus22 trials

Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus

Completed· Tanabe Pharma Corporation logo

Tanabe Pharma Corporation·Phase 4·NCT02622113·139 enrolled

A Study of the Effects of Canagliflozin on Plasma Volume in Patients With Type 2 Diabetes Mellitus

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01483781·36 enrolled

A Study of Two Methods for Determining the Renal Threshold for Glucose in Patients With Type 2 Diabetes Mellitus

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01273558·28 enrolled

Show 19 more trials

Cardiovascular Outcomes in Participants With Type 2 Diabetes Mellitus (T2DM)

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT03249506·25,358 enrolled

Effects of SGLT2 Inhibitors on Islet Cell Function and Insulin Sensitivity in Patients of Type 2 Diabetes Mellitus

Unknown status·PPeking Union Medical College Hospital·Phase 4·NCT04014192·40 enrolled

An Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01064414·272 enrolled

A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT03492580·714,582 enrolled

A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT01989754·5,813 enrolled

A Study to Evaluate the Effect of JNJ-28431754 (Canagliflozin) on Post-Meal Glucose in Patients With Type 2 Diabetes Mellitus

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01381887·37 enrolled

Efficacy and Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus

Completed· Tanabe Pharma Corporation logo

Tanabe Pharma Corporation·Phase 4·NCT02220920·146 enrolled

An Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01340664·279 enrolled

A Pharmacokinetic and Pharmacodynamic Study to Determine Blood Levels of JNJ-28431754 (Canagliflozin) in Patients With Type 2 Diabetes Mellitus

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01128985·39 enrolled

Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02009488·59 enrolled

A Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Alone or in Combination With a Sulphonylurea

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01381900·678 enrolled

A Study to Evaluate the Efficacy and Safety of the Addition of Canagliflozin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT02025907·218 enrolled

A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes Mellitus

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01106651·716 enrolled

A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03170518·171 enrolled

A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01809327·1,186 enrolled

An Efficacy Study of Canagliflozin or Sitagliptin to Determine Glucose Variability in Mexican Participants With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT03267576·64 enrolled

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Canagliflozin in Older Children and Adolescents With Type 2 Diabetes Mellitus

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02000700·17 enrolled

Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus

Completed· Tanabe Pharma Corporation logo

Tanabe Pharma Corporation·Phase 4·NCT02227849·71 enrolled

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

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT01939496·171 enrolled

Metformin18 trials

A Pharmacokinetic and Pharmacodynamic Study of Metformin and Canagliflozin in Healthy Adult Volunteers

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01273571·18 enrolled

A Study to Assess Safety of Canagliflozin and Metformin Hydrochloride Combination Given as a Supplement to Diet and Exercise to Improve Blood Sugar Level in Indian Adult Participants With Diabetes

Completed·JJohnson & Johnson Private Limited·Phase 4·NCT04288778·276 enrolled

A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components in Healthy Fed Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02071368·3 enrolled

Show 15 more trials

Glycemic Durability After Metformin Failure

Unknown status·UUniversity of Campania Luigi Vanvitelli·Phase 4·NCT02142309·450 enrolled

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

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02865668·44 enrolled

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

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02221180·2 enrolled

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

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02851095·44 enrolled

The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01106625·469 enrolled

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

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02220218·2 enrolled

CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00968812·1,452 enrolled

A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02065752·2 enrolled

A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components in Healthy Fed Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02077803·47 enrolled

A Study of Canagliflozin and Metformin Immediate Release (50 mg/500 mg) FDC Tablets in Healthy Volunteers

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01508195·64 enrolled

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 Co-administered With Canagliflozin in Healthy Fed and Fasted Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02846506·44 enrolled

A Study of Canagliflozin and Metformin Immediate Release (150 mg/500 mg) FDC Tablets in Healthy Volunteers

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01508182·64 enrolled

A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02073227·52 enrolled

The CANTATA-MP Trial (CANagliflozin Treatment and Trial Analysis - Metformin and Pioglitazone)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01106690·344 enrolled

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

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02851212·44 enrolled

Type 2 Diabetes10 trials

TriMaster: Study of a DPP4 Inhibitor, SGLT2 Inhibitor and Thiazolidinedione as Third Line Therapy in Patients With Type 2 Diabetes.

Completed·RRoyal Devon and Exeter NHS Foundation Trust·Phase 4·NCT02653209·525 enrolled

Role of Canagliflozin on CD34+ Cells in Patients With Type 2 Diabetes

Completed·GGeorge Washington University·Phase 4·NCT02964585·34 enrolled

Efficacy and Safety of Semaglutide Versus Canagliflozin as add-on to Metformin in Subjects With Type 2 Diabetes

Completed· Novo Nordisk logo

Novo Nordisk·Phase 3·NCT03136484·788 enrolled

Show 7 more trials

The Effect of add-on Canagliflozin in Patients With Type 2 Diabetes Treated With U-500 Insulin

Withdrawn·JJoslin Diabetes Center·Phase 4·NCT02597309

Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Teneligliptin)

Completed· Tanabe Pharma Corporation logo

Tanabe Pharma Corporation·Phase 3·NCT02354222·154 enrolled

CARAT: Canagliflozin vs. Placebo for Post Bariatric Patients With Persistent Type 2 Diabetes

Terminated·TThe Cleveland Clinic·Phase 4·NCT02912455·16 enrolled

Comparing the Efficacy of Mulberry Twig Alkaloid Tablet and Canagliflozin in Patients With Type 2 Diabetes

Unknown status·NNanjing First Hospital, Nanjing Medical University·Phase 4·NCT05856578·60 enrolled

A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting

Completed·JJohnson & Johnson Private Limited··NCT03604224·178 enrolled

An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00642278·451 enrolled

Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin)

Completed· Tanabe Pharma Corporation logo

Tanabe Pharma Corporation·Phase 3·NCT02354235·138 enrolled

Tics8 trials

A Pharmacodynamics, Pharmacokinetics, and Safety Study of Hydrochlorothiazide and Canagliflozin in Healthy Volunteers

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01294631·30 enrolled

A Study to Assess the Effects of Multiple-Dose Probenecid on the Multiple-Dose Pharmacokinetics of Canagliflozin in Healthy Volunteers

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01428284·14 enrolled

A Study to Evaluate the Effects of Rifampin on Single-Dose Pharmacokinetics of Canagliflozin in Healthy Volunteers

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01395927·14 enrolled

Show 5 more trials

A Study to Assess the Pharmacokinetics and Pharmacodynamics of Canagliflozin (JNJ-28431754) in Healthy Indian Volunteers

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01748526·16 enrolled

A Study to Assess the Effects of Cyclosporine on the Pharmacokinetics and Safety of Canagliflozin (JNJ-28431754) in Healthy Volunteers

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01718652·18 enrolled

A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics, Pharmacodynamics, and Safety of Glyburide in Healthy Volunteers

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01733108·29 enrolled

Genetics of Response to Canagliflozin

Active, not recruiting·UUniversity of Maryland, Baltimore·Phase 1·NCT02891954·700 enrolled

A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics and Safety of Digoxin in Healthy Volunteers.

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01714206·18 enrolled

Treatment3 trials

Impact of a Short-term Treatment With Canagliflozin (Canacardia-HF)

Withdrawn·UUniversité de Sherbrooke·N/A·NCT03298009

The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01137812·756 enrolled

The CANTATA-D Trial (CANagliflozin Treatment and Trial Analysis - DPP-4 Inhibitor Comparator Trial)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01106677·1,284 enrolled

49 more indications

Interaction2 trials

A Drug Interaction Study of Warfarin and Canagliflozin in Healthy Adult Volunteers

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01195324·14 enrolled

A Study to Investigate Whether Pharmacokinetic and Pharmacodynamic Interactions Exist Between Metformin and Canagliflozin (JNJ-28431754) in Healthy Volunteers

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01756417·18 enrolled

Adult2 trials

A Pharmacokinetic and Pharmacodynamic Study of Once-Daily and Twice-Daily Dosing With Canagliflozin in Healthy Adult Volunteers

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01286103·34 enrolled

The Effect of Food on the Administration of Canagliflozin in Healthy Adult Volunteers

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01343290·24 enrolled

Alcoholic Fatty Liver Disease2 trials

Effect of Canagliflozin on Liver Inflammation Damage in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver Disease

Unknown status·FFirst Affiliated Hospital Xi'an Jiaotong University··NCT05513729·80 enrolled

Canagliflozin on Liver Inflammation Damage in Type 2 Diabetes Patients With Nonalcoholic Fatty Liver Disease

Unknown status·FFirst Affiliated Hospital Xi'an Jiaotong University·N/A·NCT05422092·80 enrolled

Heart Failure2 trials

Canagliflozin in Patients With Acute Decompansted Heart Failure

Completed·OOctober 6 University·Phase 3·NCT05364190·142 enrolled

A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT04252287·476 enrolled

Weight loss2 trials

Mechanisms of Weight Loss With SGLT2 Inhibition

Completed·—·Phase 4·NCT02360774·30 enrolled

A Study of the Safety and Effectiveness of Canagliflozin (JNJ-28431754) in Promoting Weight Loss in Overweight and Obese Patients Who do Not Have Diabetes

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00650806·376 enrolled

Function2 trials

A Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Volunteers With Varying Degrees of Kidney Function

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01759576·40 enrolled

A Study of Canagliflozin in Study Participants With Various Degrees of Impaired Hepatic (Liver) Function

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01186588·24 enrolled

Diabetic Nephropathy2 trials

Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02065791·4,401 enrolled

Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy

Completed· Tanabe Pharma Corporation logo

Tanabe Pharma Corporation·Phase 3·NCT03436693·308 enrolled

Women1 trial

CANA/Met in Non-diabetic Women With PCOS

Completed·SShengjing Hospital·Phase 1/2·NCT04973891·52 enrolled

Pancreatic Carcinoma1 trial

Canagliflozin With Gemcitabine in Pancreatic Carcinoma

Not yet recruiting·ZZhang Xiaofeng,MD·N/A·NCT05903703·20 enrolled

Myocardial fibrosis1 trial

Canagliflozin and Myocardial Fibrosis

Completed·SShanghai Zhongshan Hospital·Phase 4·NCT05367063·45 enrolled

Polycystic Ovary Syndrome1 trial

Efficacy of Canagliflozin Versus Metformin in Women With Polycystic Ovary Syndrome

Unknown status·PPing Li,MD·Phase 4·NCT06256289·50 enrolled

Monotherapy1 trial

The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01081834·678 enrolled

T2DM1 trial

Canagliflozin (Invokana™) vs. Standard Dual Therapy Regimen for T2DM During Ramadan

Completed·UUniversity of Leicester·Phase 4·NCT02694263·25 enrolled

Dapagliflozin1 trial

A Study to Compare the Pharmacodynamics of Canagliflozin and Dapagliflozin in Healthy Volunteers

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01877889·60 enrolled

Type 2 Diabetic Patients1 trial

Effect of Combined Incretin-Based Therapy Plus Canagliflozin on Glycemic Control and the Compensatory Rise in Hepatic Glucose Production in Type 2 Diabetic Patients

Completed·TThe University of Texas Health Science Center at San Antonio·N/A·NCT02324842·45 enrolled

RCT1 trial

Harmonizing RCT-Duplicate Emulations In A Real World Replication Program (HARRP)

Completed· AstraZeneca logo

AstraZeneca··NCT06099067·239,990 enrolled

Vascular Inflammation1 trial

Canagliflozin Targeting Vascular Inflammation

Recruiting·OOttawa Heart Institute Research Corporation·Phase 2/3·NCT05427084·24 enrolled

Diabetes1 trial

Replication of the CANVAS Diabetes Trial in Healthcare Claims

Completed·—··NCT03936010·152,202 enrolled

Systolic Heart Failure1 trial

Treatment of Diabetes in Patients With Systolic Heart Failure

Completed·VVirginia Commonwealth University·Phase 4·NCT02920918·36 enrolled

Colorectal Cancer1 trial

Safety and Efficacy of Canagliflozin in Patients With Metastatic High Microsatellite Instability (MSI-H) Colorectal Cancer

Recruiting·WWest China Hospital·Phase 1·NCT07076823·15 enrolled

PreDiabetes1 trial

Intervention Effect of Canagliflozin on Prediabetes in Patients With HIV.

Unknown status·Xxiaolong zhao·N/A·NCT05135039·218 enrolled

Drug1 trial

Cognitive Protective Effect of Newer Antidiabetic Drugs

Unknown status·—··NCT05347459·100 enrolled

Type 1 Diabetes1 trial

Effect of Canagliflozin in T1DM (Type 1 Diabetes Melitus) After Interruption of Continuous Subcutaneous Insulin Infusion

Completed·YYale University·N/A·NCT02673138·10 enrolled

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02139943·352 enrolled

Hemodynamic1 trial

Effects of Canagliflozin on Intravascular Volume and Hemodynamics

Withdrawn·TThe University of Texas Health Science Center at San Antonio·Phase 4·NCT03190798

Cardiovascular1 trial

CANVAS - CANagliflozin cardioVascular Assessment Study

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01032629·4,330 enrolled

Oral1 trial

A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics and Safety of an Oral Contraceptive in Healthy Volunteers

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01714193·30 enrolled

Obese1 trial

Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Otherwise Healthy Obese Volunteers

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01756404·80 enrolled

Patients With Advanced Solid Tumors1 trial

A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors

Unknown status·PPetra Pharma·Phase 1/2·NCT04073680·60 enrolled

Hyperinsulinemic Hypoglycemia1 trial

Canagliflozin in Postprandial Hyperinsulinemic Hypoglycemia (CANA-PHH-RYGB)

Unknown status·HHospital Universitari Vall d'Hebron Research Institute·N/A·NCT04720859·40 enrolled

Statin1 trial

A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics, Pharmacodynamics, and Safety of Simvastatin in Healthy Volunteers

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01821027·22 enrolled

Adult Subject1 trial

Study to Evaluate the Effect of Single Doses of LX4211 and Canagliflozin on Intestinal Glucose Absorption in Healthy Adult Subjects

Completed·LLexicon Pharmaceuticals·Phase 1·NCT01916863·25 enrolled

CAR1 trial

A Study to Assess Electrocardiogram Results in Healthy Volunteers Receiving Canagliflozin (JNJ-28431754)

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01787357·60 enrolled

Renal Disease1 trial

Canagliflozin in Advanced Renal Disease With MRI Endpoints

Recruiting·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·Phase 2·NCT06182839·92 enrolled

Obesity1 trial

SGLT-2 Inhibitor Effects on Cardiac and Hepatic Metabolic Profiles for the Diabetes Patients Combined With Obesity

Completed·NNational Cheng-Kung University Hospital·N/A·NCT05764811·40 enrolled

Fibrosis1 trial

Effect of Canagliflozin on Ultrafiltration & Fibrosis in Patients on Peritoneal Dialysis

Recruiting·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·Phase 2·NCT06913647·30 enrolled

Cognitive Function1 trial

Effects of SGLT2i on the Cognitive Function in T2DM Patient (ESCDP)

Completed·TThird Military Medical University·Phase 3·NCT04304261·100 enrolled

Kidney Disease1 trial

The Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors in Patients With Acute Kidney Disease

Recruiting·NNational Taiwan University Hospital·Phase 2·NCT06528405·264 enrolled

CLE1 trial

Effects of Canagliflozin on C-peptide Clearance in Healthy Volunteers

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01665638·10 enrolled

Overweight1 trial

Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02243202·335 enrolled

SGLT2 Inhibitors1 trial

Pharmacogenetics of SGLT2 Inhibitors

Terminated·UUniversity of Maryland, Baltimore·Phase 4·NCT02462421·30 enrolled

Endometrioid Endometrial Cancer1 trial

A Prospective Randomized Controlled Trial of Canagliflozin Combined With Progestin for Atypical Endometrial Hyperplasia and Early-Stage Endometrial Carcinoma

Not yet recruiting·WWang Yingmei·Phase 2·NCT07890064·102 enrolled

Chronic Kidney Disease1 trial

A Pilot Randomized Clinical Trial to Assess Feasibility, Safety, and Efficacy of Rapid, Simultaneous Therapy Initiation in Chronic Kidney Disease and Type 2 Diabetes: RAPID-CKD

Enrolling by invitation·BBaylor Research Institute·Approved·NCT07547878·64 enrolled

Solid Tumor1 trial

Safety and Efficacy of Canagliflozin in Patients With Locally Advanced or Advanced Solid Cancer

Recruiting·WWest China Hospital·Phase 1·NCT07703163·15 enrolled

Diabetes Mellitus, Type 21 trial

Open-label, Double-arm, Controlled, Randomized, Multicentre Clinical Trial to Evaluate the Impact of Pharmacogenetic-guided Treatment in Patients With Insufficiently Controlled Type 2 Diabetes.

Completed·FFundación para la Investigación del Hospital Clínico de Valencia·Approved·NCT06851962·92 enrolled

Breast Cancer1 trial

Targeting Insulin Feedback to Enhance Alpelisib (TIFA): A Phase 2 Randomized Control Trial in Metastatic PIK3CA-mutant Hormone-Receptor Positive Breast Cancer

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT05090358·15 enrolled

Unspecified6 trials

Canagliflozin-Mealtime Insulin Rescue

Unknown status·FFoundation for Atlanta Veterans Education and Research, Inc.·Phase 4·NCT02624908·40 enrolled

SGLT2 Inhibitor Utilization Re-perfusion Therapy

Not yet recruiting·TTaichung Veterans General Hospital·Phase 4·NCT06858436·150 enrolled

A Pharmacokinetic Dose Proportionality Study of Canagliflozin in Healthy Volunteers

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01340677·24 enrolled

Show 3 more trials

Renal Mechanism of SGLT2 Inhibition

Recruiting·UUniversity of Colorado, Denver·Phase 2·NCT05507892·40 enrolled

A Pharmacokinetic and Bioavailability Study of 28431754 (Canagliflozin) in Healthy Male Volunteers

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01157000·9 enrolled

A Single and Multiple Dose Study of Canagliflozin in Healthy Volunteers

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01281579·27 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 29, 2013

INVOKANA

NDA NDA204042

Nov 26, 2013

INVOKANA

NDA NDA204042

May 15, 2014

INVOKANA

NDA NDA204042

Jun 5, 2014

INVOKANA

NDA NDA204042

Mar 3, 2015

INVOKANA

NDA NDA204042

Sep 9, 2015

INVOKANA

NDA NDA204042

Sep 10, 2015

INVOKANA

NDA NDA204042

Dec 4, 2015

INVOKANA

NDA NDA204042

Mar 8, 2016

INVOKANA

NDA NDA204042

Mar 28, 2016

INVOKANA

NDA NDA204042

May 20, 2016

INVOKANA

NDA NDA204042

May 20, 2016

INVOKANA

NDA NDA204042

Jun 16, 2016

INVOKANA

NDA NDA204042

Aug 17, 2016

INVOKANA

NDA NDA204042

Feb 1, 2017

INVOKANA

NDA NDA204042

Jul 25, 2017

INVOKANA

NDA NDA204042

Oct 26, 2018

INVOKANA

NDA NDA204042

Oct 29, 2018

INVOKANA

NDA NDA204042

Sep 27, 2019

INVOKANA

NDA NDA204042

Jan 24, 2020

INVOKANA

NDA NDA204042

Aug 18, 2020

INVOKANA

NDA NDA204042

Oct 13, 2022

INVOKANA

NDA NDA204042

Jul 5, 2023

INVOKANA

NDA NDA204042

Aug 23, 2024

INVOKANA

NDA NDA204042

Aug 23, 2024

INVOKANA

NDA NDA204042

Dec 18, 2024

INVOKANA

NDA NDA204042

Jun 3, 2026

INVOKANA

NDA NDA204042

Sources

References

[1]
ClinicalTrials.gov — 122 trial records for Canagliflozin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Invokana drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Canagliflozin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Canagliflozin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA204042). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Wim Janssens company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sodium/glucose Cotransporter 2 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: WWim Janssens

Invokana

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q4 2027

Trials by Indication[1]

Type 2 Diabetes Mellitus22 trials

Metformin18 trials

Type 2 Diabetes10 trials

Tics8 trials

Treatment3 trials

Interaction2 trials

Adult2 trials

Alcoholic Fatty Liver Disease2 trials

Heart Failure2 trials

Weight loss2 trials

Function2 trials

Diabetic Nephropathy2 trials

Women1 trial

Pancreatic Carcinoma1 trial

Myocardial fibrosis1 trial

Polycystic Ovary Syndrome1 trial

Monotherapy1 trial

T2DM1 trial

Dapagliflozin1 trial

Type 2 Diabetic Patients1 trial

RCT1 trial

Vascular Inflammation1 trial

Diabetes1 trial

Systolic Heart Failure1 trial

Colorectal Cancer1 trial

PreDiabetes1 trial

Drug1 trial

Type 1 Diabetes1 trial

Metabolism1 trial

Elderly1 trial

Type 1 Diabetes Mellitus1 trial

Hemodynamic1 trial

Cardiovascular1 trial

Oral1 trial

Obese1 trial

Patients With Advanced Solid Tumors1 trial

Hyperinsulinemic Hypoglycemia1 trial

Statin1 trial

Adult Subject1 trial

CAR1 trial

Renal Disease1 trial

Obesity1 trial

Fibrosis1 trial

Cognitive Function1 trial

Kidney Disease1 trial

CLE1 trial

Overweight1 trial

SGLT2 Inhibitors1 trial

Endometrioid Endometrial Cancer1 trial

Chronic Kidney Disease1 trial

Solid Tumor1 trial

Diabetes Mellitus, Type 21 trial

Breast Cancer1 trial

Unspecified6 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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