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Last Updated: February 9, 2025

CLINICAL TRIALS PROFILE FOR CANAGLIFLOZIN


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505(b)(2) Clinical Trials for Canagliflozin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT05903703 ↗ Canagliflozin With Gemcitabine in Pancreatic Carcinoma Not yet recruiting College of Pharmaceutical Sciences at Zhejiang University N/A 2023-10-01 Gemcitabine-based chemotherapy or combination with FOLFIRINOX is the leading treatment of pancreatic cancer. However, the overall response rate of pancreatic cancer to gemcitabine is less than 20%. Resistance to gemcitabine is the most important reason. There is an urgent need to develop new combination therapies to improve the efficiency of chemotherapy, avoid toxicity limitations, and improve the overall prognosis of pancreatic cancer. At present, it has been found that canagliflozin can reduce the expression level of PD-L1 in pancreatic cancer and restore the vitality of CD8+ T cells. Canagliflozin combined with gemcitabine may improve the efficiency of chemotherapy.
New Combination NCT05903703 ↗ Canagliflozin With Gemcitabine in Pancreatic Carcinoma Not yet recruiting The Innovation Institute for Artificial Intelligence in Medicine, Zhejiang University N/A 2023-10-01 Gemcitabine-based chemotherapy or combination with FOLFIRINOX is the leading treatment of pancreatic cancer. However, the overall response rate of pancreatic cancer to gemcitabine is less than 20%. Resistance to gemcitabine is the most important reason. There is an urgent need to develop new combination therapies to improve the efficiency of chemotherapy, avoid toxicity limitations, and improve the overall prognosis of pancreatic cancer. At present, it has been found that canagliflozin can reduce the expression level of PD-L1 in pancreatic cancer and restore the vitality of CD8+ T cells. Canagliflozin combined with gemcitabine may improve the efficiency of chemotherapy.
New Combination NCT05903703 ↗ Canagliflozin With Gemcitabine in Pancreatic Carcinoma Not yet recruiting Zhang Xiaofeng,MD N/A 2023-10-01 Gemcitabine-based chemotherapy or combination with FOLFIRINOX is the leading treatment of pancreatic cancer. However, the overall response rate of pancreatic cancer to gemcitabine is less than 20%. Resistance to gemcitabine is the most important reason. There is an urgent need to develop new combination therapies to improve the efficiency of chemotherapy, avoid toxicity limitations, and improve the overall prognosis of pancreatic cancer. At present, it has been found that canagliflozin can reduce the expression level of PD-L1 in pancreatic cancer and restore the vitality of CD8+ T cells. Canagliflozin combined with gemcitabine may improve the efficiency of chemotherapy.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Canagliflozin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00642278 ↗ 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. Phase 2 2008-04-01 The purpose of this study is to evaluate the effectiveness, safety, and tolerability of JNJ-28431754 compared with placebo in patients with type 2 diabetes.
NCT00650806 ↗ 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. Phase 2 2008-05-01 The purpose of this study is to test the safety and effectiveness of JNJ-28431754 in promoting weight loss in patients who are overweight or obese and who do not have diabetes.
NCT00963768 ↗ A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of JNJ-28431754 in Patients With Type 2 Diabetes Mellitus Completed Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 1 2007-06-01 The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (ie, blood levels of JNJ-28431754) and pharmacodynamics (ie, urine and blood levels of glucose) of JNJ-28431754 compared to placebo in patients with Type 2 diabetes mellitus.
NCT00968812 ↗ CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride Completed Janssen Research & Development, LLC Phase 3 2009-09-01 The purpose of this study is to demonstrate the efficacy, safety, and tolerability of canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin.
NCT01032629 ↗ CANVAS - CANagliflozin cardioVascular Assessment Study Completed The George Institute for Global Health, Australia Phase 3 2009-12-09 The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2 diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac events (MACE). Other objectives include evaluating the overall safety, tolerability, and effectiveness of canagliflozin. The data from this study will be combined with the data from CANVAS-R study (Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM, NCT01989754) in a pre-specified integrated analysis of CV safety outcomes to satisfy US FDA post-marketing requirements for canagliflozin.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Canagliflozin

Condition Name

Condition Name for Canagliflozin
Intervention Trials
Healthy 40
Diabetes Mellitus, Type 2 36
Type 2 Diabetes Mellitus 13
Type 2 Diabetes 7
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Condition MeSH

Condition MeSH for Canagliflozin
Intervention Trials
Diabetes Mellitus, Type 2 61
Diabetes Mellitus 60
Kidney Diseases 11
Heart Failure 7
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Clinical Trial Locations for Canagliflozin

Trials by Country

Trials by Country for Canagliflozin
Location Trials
United States 609
Canada 63
India 22
Mexico 18
Germany 14
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Trials by US State

Trials by US State for Canagliflozin
Location Trials
Florida 32
California 30
Texas 29
Arizona 26
Ohio 22
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Clinical Trial Progress for Canagliflozin

Clinical Trial Phase

Clinical Trial Phase for Canagliflozin
Clinical Trial Phase Trials
Phase 4 35
Phase 3 23
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Canagliflozin
Clinical Trial Phase Trials
Completed 94
Recruiting 18
Not yet recruiting 15
[disabled in preview] 10
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Clinical Trial Sponsors for Canagliflozin

Sponsor Name

Sponsor Name for Canagliflozin
Sponsor Trials
Janssen Research & Development, LLC 41
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 31
Janssen Scientific Affairs, LLC 8
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Sponsor Type

Sponsor Type for Canagliflozin
Sponsor Trials
Industry 103
Other 95
NIH 6
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Canagliflozin: Clinical Trials, Market Analysis, and Projections

Introduction

Canagliflozin, marketed under the brand name Invokana, is a first-in-class sodium-glucose cotransporter 2 (SGLT2) inhibitor approved for the treatment of type 2 diabetes mellitus (T2DM). Here, we delve into the recent clinical trials, market analysis, and future projections for this significant antidiabetic drug.

Clinical Trials Overview

Pediatric Studies

Recent clinical trials have focused on evaluating the safety and efficacy of canagliflozin in pediatric populations. Studies 1, 2, and 3, as outlined by the FDA, involve subjects aged 10 to less than 18 years with T2DM. These studies assess the pharmacokinetics, pharmacodynamics, and safety of canagliflozin, both as monotherapy and in combination with metformin. The trials include a screening period, a placebo run-in/stabilization period, and double-blind treatment periods to evaluate glycemic control and long-term safety[1].

Adult Studies

In adults, canagliflozin has been evaluated in nine clinical trials involving over 10,285 patients with T2DM. These trials demonstrated significant improvements in HbA1c levels and fasting plasma glucose. Common adverse reactions included female genital mycotic infections, urinary tract infections, and increased urination[3].

Advanced Chronic Kidney Disease (CKD)

A recent study aims to characterize the pharmacokinetics, pharmacodynamics, and surrogate measures of efficacy for canagliflozin in patients with advanced CKD. This study highlights the drug's potential in managing CKD, a condition affecting an estimated 700 million people globally[4].

Market Analysis

Global Market Size and Growth

The global canagliflozin market was valued at USD 2.75 billion in 2024 and is projected to reach USD 4.35 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 6.1% during the forecast period of 2025 to 2032. This growth is driven by the increasing prevalence of T2DM and CKD, as well as the drug's dual benefits in diabetes and renal care[2].

Market Segmentation

The market is segmented by indication (T2DM, CKD, cardiovascular risk reduction), patient type (pediatric, adult, geriatric), therapeutic class (antidiabetic drugs, renal care drugs, cardiovascular drugs), end user (hospitals, clinics, homecare settings, pharmacies/drugstores), and distribution channel (retail pharmacies, hospital pharmacies, online pharmacies). North America is expected to dominate the market due to high prevalence rates and advanced healthcare infrastructure[2].

Emerging Trends

The shift towards generic versions of canagliflozin is a significant trend, making the drug more accessible and affordable, especially in emerging markets. The development of fixed-dose combination products and exploring broader indications such as heart failure could further expand the drug's therapeutic footprint and drive market growth[2].

Market Projections

Geographic Expansion

The market is analyzed across various regions, including the U.S., Canada, Mexico, Germany, France, U.K., and several countries in Asia-Pacific, Middle East, and Africa. The widespread adoption of SGLT2 inhibitors, supported by strong reimbursement policies, is expected to continue driving market growth, particularly in North America[2].

Competitive Landscape

As patents for branded canagliflozin expire, the introduction of generic and biosimilar versions is expected to increase competition and market volume. This trend is likely to make canagliflozin more accessible to a broader patient base, fostering sustainable healthcare management in both developed and developing regions[2].

Efficacy and Patient Outcomes

Glycemic Control

Studies have shown that patients taking canagliflozin achieve better glycemic control compared to those on other SGLT2 inhibitors like dapagliflozin. This includes lower rates of medication discontinuation and switching to other drugs, highlighting canagliflozin's effectiveness in real-world settings[5].

Cardiovascular and Renal Benefits

Canagliflozin has been approved for reducing the risk of cardiovascular events in diabetic patients and has demonstrated efficacy in slowing the progression of kidney disease. These dual benefits are crucial in managing the complex health needs of patients with T2DM and CKD[2].

Key Takeaways

  • Clinical Trials: Ongoing and completed trials have established canagliflozin's safety and efficacy in both pediatric and adult populations, as well as its potential in managing advanced CKD.
  • Market Growth: The global canagliflozin market is projected to grow at a CAGR of 6.1% from 2025 to 2032, driven by increasing prevalence of T2DM and CKD.
  • Market Trends: The shift towards generic versions and the development of fixed-dose combination products are key trends shaping the market.
  • Geographic Expansion: North America is expected to dominate the market, with significant growth anticipated in other regions as well.
  • Efficacy: Canagliflozin has shown superior glycemic control and lower medication discontinuation rates compared to other SGLT2 inhibitors.

FAQs

What is canagliflozin used for?

Canagliflozin is used for the treatment of type 2 diabetes mellitus (T2DM) and is also approved for reducing the risk of cardiovascular events in diabetic patients and slowing the progression of chronic kidney disease (CKD)[2][3].

What are the common adverse reactions associated with canagliflozin?

Common adverse reactions include female genital mycotic infections, urinary tract infections, and increased urination[3].

How does canagliflozin compare to other SGLT2 inhibitors?

Canagliflozin has been shown to achieve better glycemic control and lower rates of medication discontinuation compared to dapagliflozin in real-world studies[5].

What is the projected market size for canagliflozin by 2032?

The global canagliflozin market is projected to reach USD 4.35 billion by 2032, growing at a CAGR of 6.1% from 2025 to 2032[2].

Are there ongoing clinical trials for canagliflozin in pediatric populations?

Yes, there are ongoing clinical trials evaluating the safety and efficacy of canagliflozin in pediatric populations aged 10 to less than 18 years with T2DM[1].

References

  1. FDA: Canagliflozin Written Request Amendment 1.
  2. Data Bridge Market Research: Global Canagliflozin Market Size, Share, and Trends Analysis Report.
  3. AHDB Online: Invokana (Canagliflozin): First-in-Class SGLT2 Inhibitor Approved for the Treatment of Type 2 Diabetes.
  4. CenterWatch: Safety and Efficacy of Canagliflozin in Advanced CKD.
  5. AJMC: Claims Study Shows Better Glycemic Control, Less Switching With Canagliflozin Than Dapagliflozin.

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