CLINICAL TRIALS PROFILE FOR CANAGLIFLOZIN

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.

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.

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

Condition MeSH

Condition MeSH for CANAGLIFLOZIN
Intervention	Trials
Diabetes Mellitus, Type 2	64
Diabetes Mellitus	60
Kidney Diseases	11

Clinical Trial Locations for CANAGLIFLOZIN

Trials by Country

Trials by Country for CANAGLIFLOZIN
Location	Trials
United States	611
Canada	64
India	22
Mexico	18
Spain	14

Trials by US State

Trials by US State for CANAGLIFLOZIN
Location	Trials
Florida	32
California	30
Texas	29
Arizona	26
Ohio	22

Clinical Trial Progress for CANAGLIFLOZIN

Clinical Trial Phase

Clinical Trial Phase for CANAGLIFLOZIN
Clinical Trial Phase	Trials
PHASE4	7
PHASE2	2
PHASE1	1

Clinical Trial Status

Clinical Trial Status for CANAGLIFLOZIN
Clinical Trial Phase	Trials
Completed	95
Recruiting	22
Not yet recruiting	15

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

Sponsor Type

Sponsor Type for CANAGLIFLOZIN
Sponsor	Trials
Other	108
Industry	104
NIH	6

Canagliflozin: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Overview of Canagliflozin

Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor developed by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, approved primarily for the management of type 2 diabetes mellitus (T2DM). It functions by inhibiting renal glucose reabsorption, promoting glucosuria, and thereby reducing blood glucose levels. Since its initial FDA approval in 2013, Canagliflozin has gained prominence due to its dual benefits in glycemic control and cardiovascular risk reduction.

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Recent Clinical Trials Update

Ongoing and Recent Studies

In recent years, Canagliflozin has been subject to extensive clinical evaluation beyond its foundational indication. Notable studies include:

• CANVAS Program (CANagliflozin cardioVascular Assessment Study):
  A series of trials comprising CANVAS and CANVAS-R evaluated the cardiovascular safety and benefits of Canagliflozin in T2DM patients at high cardiovascular risk. Published in 2017, the results demonstrated a significant reduction in major adverse cardiovascular events (MACE), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. These findings contributed to expanded labeling.

• CREDENCE Trial (NCT02065791):
  A landmark Phase III trial, completed in 2019, assessed Canagliflozin's efficacy in diabetic nephropathy. The study found significant renoprotective effects, with reductions in eGFR decline and progression to end-stage renal disease (ESRD), leading to FDA approval for the treatment of diabetic kidney disease (DKD) in 2020.

• CANOPY Trial (NCT04031061):
  Currently ongoing, this clinical study investigates the role of Canagliflozin in post-acute coronary syndrome patients, aiming to evaluate its cardiovascular and renal protective effects in a broader patient population.

• Additional Trials:
  Studies are exploring Canagliflozin's effects on heart failure outcomes, weight management, and non-diabetic renal diseases, reflecting its expanding therapeutic landscape.

Adverse Events and Safety Profile

Post-approval surveillance and trial data continue to monitor safety. The occurrence of events such as lower limb amputation (noted in some studies) has prompted updates to labeling and risk mitigation strategies. The FDA issued a black box warning for amputations in 2018, highlighting the need for careful patient selection.

Market Analysis

Market Size and Growth Drivers

The global SGLT2 inhibitor market, including drugs like Canagliflozin, has experienced robust growth, driven by:

• Rising prevalence of T2DM:
  WHO estimates indicate over 540 million adults affected worldwide, with projections exceeding 700 million by 2045 [1].

• Expanded indications:
  From glycemic control to cardiovascular and renal protection, broadening therapeutic uses boost market potential.

• Guideline endorsements:
  Leading organizations, including ADA and EASD, now recommend SGLT2 inhibitors for patients with T2DM and high cardiovascular or renal risk, enhancing prescription rates.

Competitive Landscape

Canagliflozin's primary competitors include:

• Empagliflozin (Jardiance):
  FDA-approved for similar indications, with proven CV and renal benefits.

• Dapagliflozin (Farxiga):
  Approved for T2DM, heart failure, and CKD.

• Ertugliflozin (Steglatro):
  A newer agent with similar profile.

Despite competition, Canagliflozin maintains significant share due to its early market entry and extensive trial support.

Revenue Trends

In 2022, Janssen reported that Canagliflozin generated over $2 billion worldwide, with steady growth driven by expanding indications and geographic penetration. The renal and cardiovascular claims particularly finance sustained revenue streams.

Market Projections

Based on current data, several factors underpin future projections:

Growth Trajectory (2023-2028)

• Compound Annual Growth Rate (CAGR):
  Industry analysts project a CAGR of approximately 8-10% for the global SGLT2 inhibitor market, with Canagliflozin contributing significantly.

• Region Expansion:
  Adoption is expanding in emerging markets like China, India, and Latin America, where T2DM prevalence is highest. Increased access and guideline adoption will further accelerate growth.

• Indication Expansion:
  Ongoing trials investigating Canagliflozin in non-diabetic populations (e.g., heart failure with preserved ejection fraction) could open additional markets.

• Impact of Biosimilars:
  While biosimilars are less relevant for small molecules like Canagliflozin, generic competition for older drugs could affect pricing strategies.

Forecasted Market Value

By 2028, the global SGLT2 inhibitor market is forecasted to reach $20-25 billion, with Canagliflozin accounting for approximately 10-15%, considering ongoing patent protections and expanded indications [[2]].

Challenges and Opportunities

• Safety concerns:
  Amputation risk remains a concern; however, risk mitigation strategies and patient selection can sustain market share.

• Pricing and reimbursement:
  Negotiations with payers, especially in cost-sensitive markets, will influence access.

• Pipeline developments:
  Potential combination therapies and new formulations could enhance adherence and efficacy, providing competitive advantages.

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Conclusion

Canagliflozin continues to be a cornerstone in the management of T2DM, especially with its emerging roles in cardiovascular and renal protection. Ongoing clinical trials promise to broaden its therapeutic scope further. Market-wise, the drug remains a significant revenue contributor and is well-positioned for sustained growth driven by increasing disease prevalence, expanding guidelines, and positive clinical outcomes. However, addressing safety concerns and navigating competitive pressures will be crucial for maintaining its market dominance.

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Key Takeaways

• Clinical advances:
  Latest trials reinforce Canagliflozin's benefits in renal and cardiovascular outcomes, expanding its clinical utility beyond glucose control.

• Market potential:
  The drug’s strong position is supported by global T2DM prevalence, favorable guideline endorsements, and broadening indications.

• Growth prospects:
  Projected to sustain a double-digit CAGR through 2028, especially with geographic expansion and new indications.

• Risks and challenges:
  Safety management (notably amputation risk), pricing strategies, and competition remain key factors influencing future market performance.

• Strategic priorities:
  Engagement in ongoing trials, careful risk mitigation, and optimizing payer strategies will be essential for continued success.

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FAQs

1. What are the latest clinical benefits of Canagliflozin?
   Recent studies confirm Canagliflozin's efficacy in reducing cardiovascular events and slowing renal disease progression in high-risk diabetic populations.

2. How has the safety profile evolved with ongoing research?
   Though initial concerns about amputations persist, risk mitigation strategies have been implemented, and overall safety remains acceptable within prescribed patient populations.

3. What are the key factors for Canagliflozin's market growth?
   Expanding indications, increasing global T2DM prevalence, guideline endorsements, and ongoing clinical evidence drive its growth potential.

4. Are there upcoming trials that could impact Canagliflozin’s market application?
   Yes, studies exploring benefits in non-diabetic conditions like heart failure could open new therapeutic avenues.

5. How does Canagliflozin compare with competitors?
   It boasts a robust evidence base and early market presence, but its future competitiveness depends on continuous data support and safety management.

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References

1. World Health Organization. Diabetes Fact Sheet. 2022.
2. MarketWatch. SGLT2 Inhibitors Market Analysis & Outlook. 2023.