Clinical Trials

Numerous clinical trials evaluate canagliflozin across diverse indications, primarily type 2 diabetes mellitus, cardiovascular conditions, heart failure, postprandial hypoglycemia, healthy aging, and solid malignancies such as breast and lung cancers. These Phase 1 through Phase 4 trials and observational cohorts are sponsored by pharmaceutical corporations as well as academic and specialized institutions. Recruitment statuses span completed, active, withdrawn, and terminated protocols, including studies assessing gerotherapeutic protocols and pharmacogenomic responses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07703163 NOT_YET_RECRUITING
Solid Tumor; SGLT 2 Inhibitors
West China Hospital
 2026-07-31 PHASE1
NCT06182839 RECRUITING
ESRD, CKD Stage 4, CKD Stage 5
McGill University Health Centre/Research Institute of the McGill University Health Centre
 2024-05-01 PHASE2
NCT06913647 RECRUITING
ESRD; CKD (Chronic Kidney Disease) Stage 5D
McGill University Health Centre/Research Institute of the McGill University Health Centre
 2026-02-01 PHASE2
NCT06858436 NOT_YET_RECRUITING
Acute Ischemic Stroke From Large Vessel Occlusion
Taichung Veterans General Hospital
 2026-04-13 PHASE4
NCT05090358 ACTIVE_NOT_RECRUITING
Breast Cancer; Breast Cancer Stage IV; Metastatic Breast Cancer
Memorial Sloan Kettering Cancer Center
 2021-10-08 PHASE2
NCT06528405 RECRUITING
Acute Kidney Injury
National Taiwan University Hospital
 2024-11-21 PHASE2
NCT07527390 NOT_YET_RECRUITING
Dialysis; Chronic Kidney Disease (Stages 4 and 5)
University Medical Center Groningen
 2026-06-01 PHASE4
NCT05507892 ACTIVE_NOT_RECRUITING
Type 2 Diabetes; Diabetic Kidney Disease
University of Colorado, Denver
 2022-10-10 PHASE2
NCT05427084 RECRUITING
Diabetes Type 2; Coronary Artery Disease
Ottawa Heart Institute Research Corporation
 2024-11-15 PHASE2; PHASE3
NCT07711171 RECRUITING
Type 2 Diabetes Mellitus; Cognitive Impairment
Fudan University
 2024-08-19 PHASE4
NCT05903703 NOT_YET_RECRUITING
Pancreatic Cancer
Zhang Xiaofeng,MD
 2023-10-01
NCT06851962 COMPLETED
Diabetes Mellitus Type 2
Fundación para la Investigación del Hospital Clínico de Valencia
 2025-05-26 PHASE4
NCT07076823 RECRUITING
Colorectal Cancer; SGLT-2 Inhibitor
West China Hospital
 2025-07-31 PHASE1
NCT05309785 COMPLETED
ESRD; CKD Stage 4; CKD Stage 5
McGill University Health Centre/Research Institute of the McGill University Health Centre
 2022-11-24 PHASE4
NCT06256289 UNKNOWN
Polycystic Ovary Syndrome; Non-Alcoholic Fatty Liver Disease
Ping Li,MD
 2024-03-31 PHASE4
NCT05367063 COMPLETED
Type 2 Diabetes; Cardiovascular Risk
Shanghai Zhongshan Hospital
 2022-01-05 PHASE4
NCT05135039 UNKNOWN
PreDiabetes; Hiv
xiaolong zhao
 2022-01-01
NCT06301529 COMPLETED
Healthy Aging
AgelessRx
 2024-02-12 PHASE4
NCT06301529 Enrolling by invitation
Healthy Aging
AgelessRx
 2024-02-12 Phase 4
NCT04796428 UNKNOWN
Diabetes Mellitus, Type 2
Center for Outcomes Research and Clinical Epidemiology, Italy
 2021-06-30 PHASE4
NCT05364190 COMPLETED
Chronic Heart Failure; Acute Heart Failure; Diabetes Mellitus
October 6 University
 2022-06-04 PHASE3
NCT04304261 COMPLETED
Diabetes Mellitus, Type 2; Cognitive Functions Confusion
Third Military Medical University
 2021-07-01 PHASE3
NCT02891954 ACTIVE_NOT_RECRUITING
Diabetes Mellitus, Type 2
University of Maryland, Baltimore
 2016-09 PHASE1
NCT03170518 COMPLETED
Diabetes Mellitus, Type 2
Janssen Research & Development, LLC
 2017-07-21 PHASE3
NCT05856578 UNKNOWN
Type 2 Diabetes Mellitus
Nanjing First Hospital, Nanjing Medical University
 2022-03-15 PHASE4
NCT05422092 UNKNOWN
Type 2 Diabetes Mellitus With Complication
First Affiliated Hospital Xi'an Jiaotong University
 2022-09-20
NCT05764811 COMPLETED
Fatty Liver Disease
National Cheng-Kung University Hospital
 2020-03-06
NCT04288778 COMPLETED
Diabetes Mellitus
Johnson & Johnson Private Limited
 2020-11-25 PHASE4
NCT02462421 TERMINATED
Diabetes Mellitus; Gout; Hyperuricemia
University of Maryland, Baltimore
 2015-06-01 PHASE4
NCT04252287 COMPLETED
Heart Failure
Janssen Research & Development, LLC
 2020-03-10 PHASE3
NCT04073680 UNKNOWN
Breast Cancer; Endometrial Cancer; Lung Cancer; Colo-rectal Cancer; Head and Neck Cancer
Petra Pharma
 2020-09-01 PHASE1; PHASE2
NCT04973891 COMPLETED
Polycystic Ovary Syndrome
Shengjing Hospital
 2021-04-07 PHASE1; PHASE2
NCT04700839 COMPLETED
Polycystic Ovary Syndrome
Shanghai 10th People's Hospital
 2020-05-01 PHASE4
NCT03436693 COMPLETED
Diabetic Nephropathy
Tanabe Pharma Corporation
 2018-02-15 PHASE3
NCT02653209 COMPLETED
Type 2 Diabetes
Royal Devon and Exeter NHS Foundation Trust
 2016-11-01 PHASE4
NCT04014192 UNKNOWN
Type 2 Diabetes Mellitus
Peking Union Medical College Hospital
 2019-09-01 PHASE4
NCT02964585 COMPLETED
Type 2 Diabetes Mellitus
George Washington University
 2016-11 PHASE4
NCT04720859 UNKNOWN
Postprandial Hypoglycemia
Hospital Universitari Vall d'Hebron Research Institute
 2018-01-05
NCT03426956 UNKNOWN
Overweight
Hvidovre University Hospital
 2018-02-08
NCT02404870 COMPLETED
Healthy Volunteers
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2014-09-16 PHASE1
NCT02065791 COMPLETED
Diabetes Mellitus, Type 2; Diabetic Nephropathy
Janssen Research & Development, LLC
 2014-02-17 PHASE3
NCT03136484 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
 2017-03-15 PHASE3
NCT03267576 COMPLETED
Diabetes Mellitus, Type 2
Janssen Research & Development, LLC
 2017-10-27 PHASE4
NCT02694263 COMPLETED
Diabetes Mellitus, Type 2
University of Leicester
 2016-07 PHASE4
NCT02920918 COMPLETED
Heart Failure, Systolic; Diabetes Mellitus, Type 2
Virginia Commonwealth University
 2016-10 PHASE4
NCT03190798 WITHDRAWN
Type2 Diabetes Mellitus; Cardiovascular Diseases
The University of Texas Health Science Center at San Antonio
 2017-09-01 PHASE4
NCT02360774 COMPLETED
Type 2 Diabetes; Overweight; Obesity
Beth Israel Deaconess Medical Center
 2015-02 PHASE4
NCT02912455 TERMINATED
Diabetes Mellitus, Type 2; Obesity
The Cleveland Clinic
 2017-01-05 PHASE4
NCT02624908 UNKNOWN
Diabetes Mellitus, Type 2
Foundation for Atlanta Veterans Education and Research, Inc.
 2016-01 PHASE4
NCT03298009 WITHDRAWN
Type2 Diabetes; Heart Failure
Université de Sherbrooke
 2018-05-01
NCT02324842 COMPLETED
Type 2 Diabetes Mellitus
The University of Texas Health Science Center at San Antonio
 2014-11
NCT04720859 Unknown status
Postprandial Hypoglycemia
Hospital Universitari Vall d''Hebron Research Institute
 2018-01-05 Not Applicable
NCT02597309 WITHDRAWN
Diabetes, Obesity
Joslin Diabetes Center
 2015-11 PHASE4
NCT01989754 COMPLETED
Diabetes Mellitus, Type 2; Albuminuria
Janssen Research & Development, LLC
 2014-01-16 PHASE4
NCT01032629 COMPLETED
Diabetes Mellitus, Type 2; Cardiovascular Diseases; Risk Factors
Janssen Research & Development, LLC
 2009-12-09 PHASE3
NCT02009488 COMPLETED
Diabetes Mellitus, Type 2
Janssen Research & Development, LLC
 2014-09-08 PHASE1
NCT02673138 COMPLETED
Type 1 Diabetes
Yale University
 2016-01
NCT02851095 COMPLETED
Healthy
Janssen Research & Development, LLC
 2016-08 PHASE1
NCT02865668 COMPLETED
Healthy
Janssen Research & Development, LLC
 2016-08 PHASE1
NCT02846506 COMPLETED
Healthy
Janssen Research & Development, LLC
 2016-08 PHASE1
NCT02851212 COMPLETED
Healthy
Janssen Research & Development, LLC
 2016-08 PHASE1
NCT02891954 Enrolling by invitation
Diabetes Mellitus Type 2
University of Maryland Baltimore|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2016-09 Phase 1
NCT02622113 COMPLETED
Type 2 Diabetes Mellitus
Tanabe Pharma Corporation
 2014-12 PHASE4
NCT02000700 COMPLETED
Diabetes Mellitus, Type 2
Janssen Research & Development, LLC
 2014-03 PHASE1
NCT02737657 Completed
Diabetes Mellitus Type 2
Janssen-Cilag International NV
 2016-04 --
NCT02227849 COMPLETED
Type 2 Diabetes Mellitus
Tanabe Pharma Corporation
 2014-08 PHASE4
NCT02857764 Completed
Diabetes Mellitus Type 2
Janssen Research & Development LLC
 2016-02-15 --
NCT02354222 COMPLETED
Type 2 Diabetes Mellitus
Tanabe Pharma Corporation
 2015-01 PHASE3
NCT02220907 COMPLETED
Type 2 Diabetes Mellitus
Tanabe Pharma Corporation
 2014-08 PHASE3
NCT02354235 COMPLETED
Type 2 Diabetes Mellitus
Tanabe Pharma Corporation
 2015-01 PHASE3
NCT02142309 UNKNOWN
Type 2 Diabetes
University of Campania Luigi Vanvitelli
 2005-10 PHASE4
NCT02025907 COMPLETED
Diabetes Mellitus, Type 2
Janssen Research & Development, LLC
 2014-02 PHASE4
NCT02220920 COMPLETED
Type 2 Diabetes Mellitus
Tanabe Pharma Corporation
 2014-08 PHASE4
NCT02243202 COMPLETED
Obesity
Janssen Research & Development, LLC
 2014-09 PHASE2
NCT02139943 COMPLETED
Diabetes Mellitus, Type 1
Janssen Research & Development, LLC
 2014-05 PHASE2
NCT01939496 COMPLETED
Diabetes Mellitus, Type 2; Hypertension
Janssen Scientific Affairs, LLC
 2013-10 PHASE4
NCT01809327 COMPLETED
Diabetes Mellitus, Type 2
Janssen Research & Development, LLC
 2013-06-04 PHASE3
NCT02221180 COMPLETED
Bioequivalence
Janssen Research & Development, LLC
 2014-08 PHASE1
NCT02220218 COMPLETED
Healthy
Janssen Research & Development, LLC
 2014-08 PHASE1
NCT02077803 COMPLETED
Healthy
Janssen Research & Development, LLC
 2014-03 PHASE1
NCT02073227 COMPLETED
Healthy Volunteers
Janssen Research & Development, LLC
 2014-02 PHASE1
NCT02071368 COMPLETED
Healthy
Janssen Research & Development, LLC
 2014-02 PHASE1
NCT02053116 TERMINATED
Type 2 Diabetes Mellitus
Pfizer
 2014-03 PHASE2
NCT02065752 COMPLETED
Healthy Volunteers
Janssen Research & Development, LLC
 2014-02 PHASE1
NCT01877889 COMPLETED
Healthy
Janssen-Cilag International NV
 2013-07 PHASE1
NCT02039258 COMPLETED
Healthy Volunteers
Janssen Research & Development, LLC
 2014-01 PHASE1
NCT02039245 COMPLETED
Healthy Volunteers
Janssen Research & Development, LLC
 2014-01 PHASE1
NCT01916863 COMPLETED
Healthy Subjects
Lexicon Pharmaceuticals
 2013-08 PHASE1
NCT01381900 COMPLETED
Diabetes Mellitus, Type 2
Janssen Research & Development, LLC
 2011-08 PHASE3
NCT01665638 COMPLETED
Healthy
Janssen-Cilag International NV
 2012-09 PHASE1
NCT01483781 COMPLETED
Diabetes Mellitus, Type 2; Plasma Volume
Janssen Research & Development, LLC
 2011-12 PHASE1
NCT01707316 COMPLETED
Healthy
Janssen Research & Development, LLC
 2012-06 PHASE1
NCT01340664 COMPLETED
Diabetes Mellitus, Type 2
Janssen Research & Development, LLC
 2011-07 PHASE2
NCT01508182 COMPLETED
Healthy
Janssen Research & Development, LLC
 2012-01 PHASE1
NCT01508195 COMPLETED
Healthy
Janssen Research & Development, LLC
 2012-01 PHASE1
NCT01137812 COMPLETED
Diabetes Mellitus, Type 2
Janssen Research & Development, LLC
 2010-07 PHASE3
NCT01463228 COMPLETED
Healthy
Janssen Research & Development, LLC
 2011-09 PHASE1
NCT00968812 COMPLETED
Diabetes Mellitus, Type 2
Janssen Research & Development, LLC
 2009-09 PHASE3
NCT01064414 COMPLETED
Diabetes Mellitus, Type 2; Renal Insufficiency
Janssen Research & Development, LLC
 2010-06 PHASE3
NCT01459094 COMPLETED
Healthy
Janssen Research & Development, LLC
 2011-10 PHASE1
NCT01463774 COMPLETED
Healthy
Janssen Research & Development, LLC
 2011-09 PHASE1
NCT01106690 COMPLETED
Diabetes Mellitus, Type 2
Janssen Research & Development, LLC
 2010-06 PHASE3
NCT01381887 COMPLETED
Diabetes Mellitus, Type 2
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2011-06 PHASE1
NCT01518712 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2011-09 PHASE1
NCT01454622 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2011-09 PHASE1
NCT01106651 COMPLETED
Diabetes Mellitus, Type 2
Janssen Research & Development, LLC
 2010-06 PHASE3
NCT01428284 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2011-08 PHASE1
NCT01106677 COMPLETED
Diabetes Mellitus, Type 2
Janssen Research & Development, LLC
 2010-05 PHASE3
NCT01106625 COMPLETED
Diabetes Mellitus, Type 2
Janssen Research & Development, LLC
 2010-05 PHASE3
NCT01340677 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2011-05 PHASE1
NCT01081834 COMPLETED
Diabetes Mellitus, Type 2
Janssen Research & Development, LLC
 2010-03 PHASE3
NCT01395927 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2011-07 PHASE1
NCT01294631 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2011-03 PHASE1
NCT01343290 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2011-04 PHASE1
NCT01186588 COMPLETED
Healthy; Hepatic Insufficiency
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2010-08 PHASE1
NCT01718652 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2011-02 PHASE1
NCT01281579 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2011-01 PHASE1
NCT01195324 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2010-09 PHASE1
NCT01714206 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2009-06 PHASE1
NCT00642278 COMPLETED
Diabetes Mellitus, Type II; Diabetes Mellitus, Non Insulin Dependent
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2008-04 PHASE2
NCT01759576 COMPLETED
Renal Insufficiency; Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2008-03 PHASE1
NCT01787357 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2008-06 PHASE1
NCT01821027 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2008-08 PHASE1
NCT00650806 COMPLETED
Obesity
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2008-05 PHASE2
NCT01748526 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2008-08 PHASE1
NCT01733108 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2008-07 PHASE1
NCT01714193 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2008-02 PHASE1
NCT01756404 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2007-06-14 PHASE1
NCT00963768 COMPLETED
Diabetes Mellitus, Type 2
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2007-06 PHASE1
NCT01756417 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2007-10 PHASE1
NCT01791231 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2007-08 PHASE1
NCT01177150 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2006-11 PHASE1
NCT01128985 COMPLETED
Diabetes Mellitus, Type 2
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2010-03 PHASE1
NCT01286103 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2011-01 PHASE1
NCT01157000 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2010-05 PHASE1
NCT01273571 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2010-12 PHASE1
NCT01177163 COMPLETED
Diabetes Mellitus, Type 2
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2008-05 PHASE1
NCT01173549 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2010-11 PHASE1
NCT01273558 COMPLETED
Diabetes Mellitus, Type 2
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2011-01 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-14)

Check the Canagliflozin (JNJ-28431754) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Canagliflozin selectively binds to and inhibits subtype 2 sodium-glucose transport proteins (SGLT2) in the proximal renal tubules, thereby blocking sodium-dependent glucose reabsorption and promoting urinary glucose excretion. This targeted glucose clearance lowers blood glucose levels and reduces intravascular volume, providing therapeutic efficacy in clinical investigations targeting type 2 diabetes mellitus, cardiovascular disease, and heart failure.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.