Canagliflozin clinical trials
Canagliflozin is named as an intervention in 8 current clinical trials in our China, Canada, Spain, Italy and Taiwan registers. 7 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is West China Hospital (2). The most-studied condition is Solid Tumor. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Canagliflozin is approved
All regulators →Of the three regulators tracked here, the first to approve Canagliflozin was the US, on 29 Mar 2013. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Canagliflozin patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Canagliflozin, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 3 listed patents; the last listed expires 26 Aug 2029 (US 7943582, including a 6-month paediatric extension).
- Latest patent on the drug substance itself: 26 Aug 2029 (US 7943582, with paediatric extension).
- Exclusivity PED: Pediatric exclusivity, until 18 Jun 2028.
- Exclusivity NPP: New patient population, until 18 Dec 2027.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Canagliflozin
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Canagliflozin works
All drug targets →- Sodium/glucose cotransporter 2 inhibitor InhibitorTarget: SLC5A2 solute carrier family 5 member 2✓ In ChEMBL and the Guide to Pharmacology
- Cognitive impairmentPhase 3
- Diabetic kidney diseasePhase 3
- Heart failurePhase 3
- OverweightPhase 2
- Chronic kidney diseasePhase 2
- Ischemic strokePhase 2
- Kidney failurePhase 2
- Obesity disorderPhase 2
- Type 1 diabetes mellitusPhase 2
- Polycystic ovary syndromePhase 1/2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4594217, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 4582, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Canagliflozin
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 3 technology appraisals of Canagliflozin. 3 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Canagliflozin for treating type 2 diabetes in people 10 to 17 years (terminated appraisal) NICE TA1137 | Terminated (no company submission) | 25 Feb 2026 | Current |
| Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes NICE TA390 | Optimised | 25 May 2016 | Current |
| Canagliflozin in combination therapy for treating type 2 diabetes NICE TA315 | Recommended | 25 Jun 2014 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Canagliflozin
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: InvokanaEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Canagliflozin
8 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Canagliflozin in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Canagliflozin. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
CANIDIAP; CANagliflozin In DIAlysis Patients
2025-522742-46-00 · CTIS ↗ · Not possible to specify
|
Phase 4 | Authorised | Universitair Medisch Centrum Groningen | Netherlands |
Canagliflozin across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
2 single-substance products containing Canagliflozin on the HPRA medicines list.
- Invokana 100 mg film-coated tabletsJanssen-Cilag International NV · EU/1/13/884/001-004
- Invokana 300 mg film-coated tabletsJanssen-Cilag International NV · EU/1/13/884/005-008
Supply shortages
No entry for Canagliflozin in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Canagliflozin
17 conditionsAll 17 conditions
| Condition (as registered) | Trials |
|---|---|
| Solid Tumor | 1 |
| SGLT 2 Inhibitors | 1 |
| Endometrioid Endometrial Cancer | 1 |
| Atypical Endometrial Hyperplasia | 1 |
| Colorectal Cancer | 1 |
| SGLT-2 Inhibitor | 1 |
| Chronic Kidney Disease stage3 | 1 |
| Chronic Kidney Disease stage4 | 1 |
| Chronic Kidney Disease Stage 1 | 1 |
| Chronic Kidney Disease Stage 2 | 1 |
| Glomerulonephritis | 1 |
| Immunoglobulin A Nephropathy | 1 |
| ESRD | 1 |
| CKD (Chronic Kidney Disease) Stage 5D | 1 |
| Diabetes Type 2 | 1 |
| Coronary Artery Disease | 1 |
| Acute Kidney Injury | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| West China Hospital | 2 |
| Wang Yingmei | 1 |
| Cardenal Herrera University | 1 |
| Fondazione Schena | 1 |
| McGill University Health Centre/Research Institute of the McGill University Health Centre | 1 |
| Ottawa Heart Institute Research Corporation | 1 |
| National Taiwan University Hospital | 1 |
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in China | 3 | 2 |
| Clinical trials in Canada | 2 | 2 |
| Clinical trials in Spain | 1 | 1 |
| Clinical trials in Italy | 1 | 1 |
| Clinical trials in Taiwan | 1 | 1 |
| EU register (CTIS) | 1 | — |
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Canagliflozin trials
How many clinical trials are testing Canagliflozin?
8 current trials in our China, Canada, Spain, Italy and Taiwan registers name Canagliflozin as a drug or biological intervention, as of the registry sync on 8 November 2026. Completed and withdrawn studies are not counted.
Are Canagliflozin trials recruiting patients?
Yes. 7 of the 8 trials are recruiting: 2 with sites in China, 2 with sites in Canada, 1 with sites in Spain, 1 with sites in Italy and 1 with sites in Taiwan. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Canagliflozin clinical trials?
West China Hospital (2), Wang Yingmei (1), Cardenal Herrera University (1) and Fondazione Schena (1), among 7 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Canagliflozin licensed in Ireland?
Yes. The HPRA medicines list includes 2 single-substance products containing Canagliflozin, for example Invokana 100 mg film-coated tablets (Janssen-Cilag International NV). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Canagliflozin shortage?
Not in the lists we track: Canagliflozin has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Canagliflozin works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Canagliflozin works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Canagliflozin (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 8 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.