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.
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.
NCT01032629 ↗	CANVAS - CANagliflozin cardioVascular Assessment Study	Completed	Janssen Research & Development, LLC	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.

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	8

Condition MeSH

Condition MeSH for CANAGLIFLOZIN
Intervention	Trials
Diabetes Mellitus, Type 2	64
Diabetes Mellitus	60
Kidney Diseases	11
Diabetic Nephropathies	8

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 Forecast (2026–2035)

Last updated: July 25, 2026

Canagliflozin (Invokana; Janssen/Bayer) is an SGLT2 inhibitor used in type 2 diabetes (T2D), chronic kidney disease (CKD), and heart failure indications. The near-term competitive outlook is dominated by the broader SGLT2 class shift toward agents with strong CKD and heart failure uptake (notably empagliflozin and dapagliflozin), while canagliflozin continues to defend share through established payer channels and indication breadth. Forecast risk remains concentrated in patent and exclusivity transitions, plus competitive displacement from class leaders.

Clinical-trial activity that meaningfully changes near-term product trajectory is limited: most late-stage updates in recent years consolidate prior outcomes (renal and cardiovascular) rather than introduce a new mechanism or a fundamentally higher-efficacy claim that would materially re-rate long-term demand.

What is the latest clinical trials update for canagliflozin (2024–2026)?

Bottom line: Clinical updates cluster around expanding or refining use in kidney and cardiovascular subpopulations, real-world evidence programs, and combination regimens. Late-stage “registration-changing” programs are not apparent from the current public read-through of major SGLT2 endpoints after the landmark renal/CV trial era.

Which trial themes are still driving canagliflozin studies

• CKD outcome subgroups: enrollment and endpoint analyses focused on baseline eGFR, albuminuria strata, and progression-to-dialysis proxies.
• Heart failure stratification: HFpEF versus HFrEF subgroup performance and background-therapy interactions (RAS blockade, MRAs, loop diuretics).
• Combination and sequencing: add-on strategies with GLP-1 receptor agonists, non-steroidal MRAs, and lipid-lowering therapies aimed at incremental renal or CV risk reduction.
• Cardiometabolic extensions: durable glycemic control and weight trajectory analytics as part of long-term safety monitoring.

Safety and tolerability monitoring trends

• Genital mycotic infections and volume depletion: continued emphasis on risk mitigation, dosing education, and concomitant diuretic management.
• Lower-limb amputation signal: ongoing post-marketing surveillance and label risk-management approaches.
• Renal function monitoring cadence: protocols that manage early eGFR dip and dehydration risk.

How does canagliflozin’s clinical evidence compare with empagliflozin and dapagliflozin?

Bottom line: All three agents carry strong renal and cardiovascular outcome data as members of the SGLT2 class, but competitive positioning differs by label strength, prescriber familiarity, and payer protocols. In practice, empagliflozin and dapagliflozin have enjoyed broader uptake in many health systems due to stronger institutional formularies and large-scale evidence adoption pathways.

Comparative positioning by therapeutic anchor

• Renal protection: all are positioned for slowing CKD progression; uptake for each depends on label details and payer coverage design.
• Heart failure: empagliflozin and dapagliflozin tend to have more “default” status in many formularies for HFrEF and HF populations.
• Diabetes intensification: canagliflozin remains a legacy option with entrenched prescribing in T2D add-on or second-line use.

Formulary behavior and “class default” risk

• SGLT2 inhibitors are increasingly treated as a class, which raises the probability of substitution during formulary switches unless canagliflozin has a defensible pricing or contract advantage.

What patents protect canagliflozin in the US and when do they expire?

Bottom line: The canagliflozin platform is built on layered IP: composition of matter, formulation, and method-of-use. The near-term market impact is driven by whether specific, enforceable second-generation claims remain in force for targeted formulations or therapeutic uses.

Patent estate: what matters for launch timing and entry barriers

• Composition of matter (core active): sets the outer boundary.
• Method-of-use for CKD/HF: can delay substitution if still enforceable and if generics are designed to avoid infringement.
• Formulation and dosing: controlled release and tablet composition claims can block “at-risk” launches if design-arounds are insufficient.

US exclusivity and regulatory exclusivity interactions

• Even after patent loss, regulatory exclusivities can delay generic entry for certain product strengths or indications, but in a mature molecule like canagliflozin these effects tend to be limited relative to active IP and settlement constraints.

(No jurisdiction-specific expiration dates, patent numbers, or Orange Book listings are provided here because the required, source-backed dataset is not included in the prompt.)

What is the Orange Book status of canagliflozin and what generic entry risks exist?

Bottom line: Canagliflozin is already marketed broadly, which suggests generic availability is not the gating factor for overall market size. The key risks are substitution erosion and loss of brand premium rather than a “first generic” breakthrough.

Generic entry risk map (practical lens)

• Strength-level substitution: if certain strengths remain less traded or have higher copay hurdles, brand retains more stickiness.
• Indication-level substitution: if label carve-outs or clinical pathway preferences exist, brand uptake can remain more resilient.
• Contracting and rebates: payer-level switching can accelerate displacement when generic economics improve.

Paragraph IV and litigation relevance

• For mature molecules, Paragraph IV litigation mostly affects share durability through timing of settlements and brand pricing concessions rather than creating a sudden market event.

(No Orange Book listing table is provided due to missing cited source data.)

How strong is the patent estate for canagliflozin by indication (T2D vs CKD vs heart failure)?

Bottom line: In SGLT2 inhibitors, method-of-use claims for kidney and cardiovascular outcomes often receive the most attention, but enforceability and design-around feasibility determine whether the brand maintains meaningful exclusivity beyond the initial composition of matter horizon.

Indication-by-indication risk factors

• T2D: tends to face earlier and broader generic substitution because it is historically the largest volume driver and has fewer “pathway uniqueness” constraints.
• CKD and HF: has higher likelihood of payer pathway controls, but those can still be overridden with class substitution and negotiated pricing.

What formulations are protected for canagliflozin (tablet strengths) and do they change launch barriers?

Bottom line: For canagliflozin, tablet strengths and standard formulation are mature. Any remaining formulation IP has to be specific enough to block generic manufacturing and labeling for the exact strengths and dosing regimens used in practice.

Formulation barriers that can matter in practice

• Specific excipient or granulation processes
• Manufacturing method claims
• Stability or dissolution-related formulation claims
• Dose-specific improvements

(No formulation patent map is provided because specific cited patents and their claims are not included.)

What clinical-trial endpoints matter most for canagliflozin’s future label expansions?

Bottom line: The endpoints that drive regulatory decisions for SGLT2 class expansion are well established: renal composite endpoints (sustained eGFR decline, end-stage kidney disease, dialysis initiation, renal death) and cardiovascular composites (CV death, HF hospitalization, and all-cause mortality in specific contexts).

Endpoint selection that influences clinical and regulatory impact

• Renal: time-to-event composites, albuminuria change analytics, and sustained eGFR decline definitions.
• Heart failure: HHF/HF hospitalization burden, fatal outcomes, and subgroup consistency.
• Safety: volume depletion, genital infections, amputation outcomes, ketoacidosis risk.

Canagliflozin market analysis: who buys it and what drives demand?

Bottom line: Demand is driven by CKD and HF guideline adoption, payer preference for SGLT2 inhibitors, and switching behavior among class members. Canagliflozin’s commercial performance is tied to how often it remains the lowest-cost formulary option or a contracted brand.

Commercial demand drivers

• Guideline integration: kidney disease and heart failure pathways that default to SGLT2 initiation.
• HbA1c add-on use: continued T2D role as an insulin-sparing and cardiorenal benefit agent.
• Renal-protection narratives in payer policies: coverage restrictions tied to eGFR/albuminuria criteria.
• Real-world adherence and persistence: dosing tolerance and management of early eGFR dips.

Commercial headwinds

• Class substitution: empagliflozin/dapagliflozin often win formulary positioning.
• Cost pressure: as more generics or lower-priced options are used, brand pricing is compressed.
• Safety communications: local risk-management policies can influence prescriber comfort.

Market projection for canagliflozin (2026–2035): base, upside, downside

Bottom line: The most likely trajectory is slow volume growth with declining net price, yielding modest revenue expansion or flat-to-declining brand revenue depending on contracting. Forecast direction hinges on whether canagliflozin retains formulary placement against competing SGLT2s and on payer reimbursement stability.

(No numeric revenue forecast is provided because the prompt does not include baseline sales, competitor sales, or a source-backed dataset required to produce a defensible projection range.)

Scenario structure (what changes the curve)

• Base case: continued CKD/HF guideline use offsets price erosion from class substitution.
• Upside: payer contracts restore canagliflozin as a preferred option in targeted health systems and subpopulations.
• Downside: more aggressive switching to empagliflozin/dapagliflozin, and adverse contracting terms compress net revenue further.

Which competitors pose the biggest threat to canagliflozin share?

Bottom line: The principal competitive threat is within-class switching, led by empagliflozin and dapagliflozin due to their adoption patterns, formulary coverage, and clinical-program reinforcement.

Competitive pressure points

• Payer formularies: step therapy and preferred drug lists.
• Hospital acquisition pathways: for CKD and HF clinics.
• Patient-level selection: co-morbidities and clinician familiarity.

Indirect competitive pressure

• GLP-1 receptor agonists in diabetes intensification can reduce incremental SGLT2 use when prescribers prioritize glycemic weight and CV benefits.
• Non-SGLT2 kidney therapies: rising use of other kidney-protective agents can shift sequencing.

What is the R&D pipeline outlook for canagliflozin beyond class extensions?

Bottom line: The pipeline outlook is dominated by incremental studies and combination regimens rather than new active mechanisms. Any meaningful “pipeline event” would require a label expansion supported by a large event-driven trial, not just pharmacokinetics or biomarker endpoints.

Highest-probability development categories

• Expanded subgroup analyses in CKD and HF
• Combination studies with GLP-1 RAs and other cardiometabolic agents
• Post-authorization safety and outcomes studies

Key Takeaways

• Canagliflozin clinical updates are largely consolidation and subgroup refinement rather than mechanism-changing programs.
• Competitive risk is primarily substitution against empagliflozin and dapagliflozin via payer formularies and contracting.
• Market outlook most likely depends on net price erosion versus volume support from CKD and HF guideline adoption.
• Patent and regulatory barriers are more relevant to brand economics and substitution pace than to a first-entry generic shock.

FAQs

1. What new outcomes trials could materially expand canagliflozin’s CKD or heart failure label?
2. How do payer formularies affect canagliflozin switching among SGLT2 inhibitors?
3. What safety monitoring protocols reduce canagliflozin discontinuation rates in real-world use?
4. How does canagliflozin sequencing compare with GLP-1 receptor agonists in T2D patients with CKD?
5. What combination regimens are most likely to drive incremental canagliflozin uptake in clinic practice?

References

1. FDA. Drugs@FDA label information for Invokana (canagliflozin). US Food and Drug Administration.
2. Neuen BL, et al. SGLT2 inhibitors and renal outcomes: evidence synthesis in CKD populations. (Journal article references).
3. Zinman B, et al. CANVAS Program cardiovascular outcomes with canagliflozin. (Journal article references).
4. Perkovic V, et al. CREDENCE trial results for canagliflozin in diabetic kidney disease. (Journal article references).
5. McMurray JJV, et al. CANVAS/other SGLT2 class heart failure outcomes evidence context. (Journal article references).