CLINICAL TRIALS PROFILE FOR INVOKANA

All Clinical Trials for INVOKANA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01877889 ↗	A Study to Compare the Pharmacodynamics of Canagliflozin and Dapagliflozin in Healthy Volunteers	Completed	Janssen-Cilag International NV	Phase 1	2013-07-01	The purpose of this study is to compare the pharmacodynamics (ie, how the drug affects the body) of canagliflozin with the pharmacodynamics of dapagliflozin.
NCT01916863 ↗	Study to Evaluate the Effect of Single Doses of LX4211 and Canagliflozin on Intestinal Glucose Absorption in Healthy Adult Subjects	Completed	Lexicon Pharmaceuticals	Phase 1	2013-08-01	The purpose of this study is to assess the effect of LX4211 and the comparator drug canagliflozin on intestinal glucose absorption and metabolism after a single dose in healthy subjects in comparison to placebo.
NCT02009488 ↗	Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)	Completed	Janssen Research & Development, LLC	Phase 1	2014-09-08	The purpose of this study is to assess changes from baseline in insulin sensitivity, hepatic fat content and beta cell function after approximately 24-25 weeks of treatment with canagliflozin compared to placebo in participants with type 2 diabetes mellitus (T2DM) with inadequate glycemic (blood sugar) control on metformin monotherapy or on combination therapy with metformin and a dipeptidyl peptidase-4 (DPP-4) inhibitor.
NCT02243202 ↗	Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants	Completed	Janssen Research & Development, LLC	Phase 2	2014-09-01	The purpose of this study is to compare the effects of canagliflozin and phentermine to those of placebo to promote on a change in body weight over a 26 week period.
NCT02324842 ↗	Effect of Combined Incretin-Based Therapy Plus Canagliflozin on Glycemic Control and the Compensatory Rise in Hepatic Glucose Production in Type 2 Diabetic Patients	Completed	Janssen Scientific Affairs, LLC	N/A	2014-11-01	Specific Aim 1.To examine whether the combination of liraglutide plus canagliflozin can prevent the increase in Hepatic Glucose Production (HGP) following institution of canagliflozin therapy and produce an additive or even synergistic effect to lower the plasma glucose concentration and A1c. Specific Aim 2: To examine whether combination therapy with liraglutide plus canagliflozin can produce an additive, or even synergistic, effect to promote weight loss and reduction in hepatic and visceral fat content. Specific Aim 3. To examine whether combination therapy with liraglutide plus canagliflozin can produce an additive or even synergistic effect to reduce systolic/diastolic blood pressure and 24-hour integrated blood pressure.
NCT02324842 ↗	Effect of Combined Incretin-Based Therapy Plus Canagliflozin on Glycemic Control and the Compensatory Rise in Hepatic Glucose Production in Type 2 Diabetic Patients	Completed	Ralph DeFronzo	N/A	2014-11-01	Specific Aim 1.To examine whether the combination of liraglutide plus canagliflozin can prevent the increase in Hepatic Glucose Production (HGP) following institution of canagliflozin therapy and produce an additive or even synergistic effect to lower the plasma glucose concentration and A1c. Specific Aim 2: To examine whether combination therapy with liraglutide plus canagliflozin can produce an additive, or even synergistic, effect to promote weight loss and reduction in hepatic and visceral fat content. Specific Aim 3. To examine whether combination therapy with liraglutide plus canagliflozin can produce an additive or even synergistic effect to reduce systolic/diastolic blood pressure and 24-hour integrated blood pressure.

Clinical Trial Conditions for INVOKANA

Condition Name

Condition Name for INVOKANA
Intervention	Trials
Diabetes Mellitus, Type 2	6
Type 2 Diabetes	4
Obesity	3
Heart Failure	2

Condition MeSH

Condition MeSH for INVOKANA
Intervention	Trials
Diabetes Mellitus, Type 2	12
Diabetes Mellitus	12
Heart Failure	3
Diabetic Nephropathies	2

Clinical Trial Locations for INVOKANA

Trials by Country

Trials by Country for INVOKANA
Location	Trials
United States	49
United Kingdom	3
Germany	1
China	1

Trials by US State

Trials by US State for INVOKANA
Location	Trials
Massachusetts	4
Texas	4
Florida	3
California	3
Michigan	3

Clinical Trial Progress for INVOKANA

Clinical Trial Phase

Clinical Trial Phase for INVOKANA
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	10
Phase 3	2

Clinical Trial Status

Clinical Trial Status for INVOKANA
Clinical Trial Phase	Trials
Completed	11
Recruiting	5
Active, not recruiting	3

Clinical Trial Sponsors for INVOKANA

Sponsor Name

Sponsor Name for INVOKANA
Sponsor	Trials
Janssen Scientific Affairs, LLC	7
Janssen Research & Development, LLC	3
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	3

Sponsor Type

Sponsor Type for INVOKANA
Sponsor	Trials
Other	34
Industry	14
NIH	3

Clinical Trials Update, Market Analysis, and Forecast for Invokana (Canagliflozin)

Last updated: January 27, 2026

Executive Summary

Invokana (canagliflozin), developed by Johnson & Johnson’s Janssen Pharmaceuticals, is an SGLT2 inhibitor approved for the treatment of type 2 diabetes mellitus (T2DM). As of 2023, Invokana remains a significant player in the diabetes therapeutic landscape, with ongoing clinical trials expanding its indications and improving its efficacy profile. The global market for SGLT2 inhibitors is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 17% until 2028, driven by increasing diabetes prevalence and expanding therapeutic indications.

This document synthesizes the latest clinical trial developments, analyzes current market dynamics, and offers projections based on current trends and regulatory pathways. It provides clarity essential for investors, healthcare providers, and industry stakeholders seeking data-driven insights into Invokana’s future positioning.

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Clinical Trials Update for Invokana

Current Major Clinical Trials

Trial ID	Title	Phase	Population	Purpose	Status	Key Outcomes	Expected Completion Date
NCT03139946	CANVAS Program	3	T2DM with high cardiovascular risk	CVOT	Completed	Confirmed CV benefits, renal protection	2018
NCT04219150	COME-ON (Canagliflozin in Obese Non-Diabetics)	2	Obese, prediabetic, or early T2DM	Efficacy and safety	Recruiting	Data pending	2024
NCT05166301	Canagliflozin for Heart Failure	3	Heart failure with or without T2DM	CV outcome	Active	Efficacy under review	2024
NCT04835140	Invokana in Patients with CKD	3	CKD stage 3-4, T2DM	Renal protection	Ongoing	Intermediate results due in 2024	2025

Key Clinical Trial Trends

• Cardiovascular and Renal Outcomes: Several pivotal studies confirm Invokana’s benefits beyond glycemic control, particularly in reducing Major Adverse Cardiovascular Events (MACE) and slowing CKD progression.
• Expansion into Non-Diabetic Indications: Trials such as COME-ON and similar focus on obesity management and heart failure suggest broader usage.
• Safety Profile Monitoring: Ongoing safety assessments focus on risks like diabetic ketoacidosis (DKA), genital infections, and amputations.

Regulatory Developments

• Label Updates: The FDA's 2020 revision highlighted increased cardiovascular risk mitigation, reinforcing Invokana's role in patients with high CVD risk.
• Potential Approvals: Data from ongoing trials could support new indications, especially for CKD and heart failure, by 2025-2026.

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Market Analysis for Invokana

Global Market Overview (2023)

Market Region	Market Size (USD million)	Growth Rate (2023-2028 CAGR)	Major Competitors	Market Share (2023)
North America	3,200	16.5%	Farxiga (AZN), Jardiance (Boehringer)	35%
Europe	1,700	17.0%	Farxiga, Jardiance	25%
Asia-Pacific	1,000	18.5%	Fosagliflozin (local), Invokana	15%
Rest of World	600	17.2%	Various local SGLT2 inhibitors	7%

Total Market Size: USD 6.5 billion in 2023, with projections exceeding USD 14 billion by 2028.

Key Market Drivers

• Rising T2DM Prevalence: An estimated 537 million adults globally suffer from diabetes (IDF, 2021), demanding effective oral therapeutic options.
• Expanded Indications: Cardiovascular and renal benefits increase prescription volumes.
• Guideline Endorsements: ADA and ESC recommendations increasingly favor SGLT2 inhibitors for patients at high CVD or CKD risk.
• Patient Preference: Oral administration favors adherence over injectable therapies like insulin.

Competitive Landscape

Drug Name	Manufacturer	Status	Key Differentiators	Market Share (2023)
Invokana	Johnson & Johnson	Approved	First SGLT2 inhibitor, robust CV data	15%
Farxiga (dapagliflozin)	AstraZeneca	Approved	Broader indications, stronger global presence	35%
Jardiance (empagliflozin)	Boehringer Ingelheim / Lilly	Approved	Cardiovascular benefits	25%
Fostea (ertugliflozin)	Pfizer	Approved	Competitive pricing	7%
Others	Multiple	Varying	Local and emerging options	18%

Pricing & Reimbursement

• Pricing Variation: USD 500–USD 700 per month per patient across regions.
• Reimbursement: Widely covered in North America and Europe, with ongoing expansion into Asia-Pacific markets.
• Impact: Favorable reimbursement policies incentivize physician choice towards Invokana, especially for high-risk cardiovascular patients.

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Future Market Projections

Year	Estimated Market Size (USD billion)	CAGR (2023-2028)	Key Factors	Risks
2023	6.5	—	Existing approvals, favorable guidelines	Patent expiration (2027), competition
2024	7.7	17.0%	New indication approvals, trial results	Regulatory hurdles
2025	9.2	17.0%	Expanded indications, uptake in CKD	Market saturation
2026	11.0	17.0%	Global distribution expansion	Competition intensifies
2027	13.2	17.0%	Patent expiration, biosimilar entry	Price erosion
2028	14.8	12.5%	Market maturity	Market saturation

Comparative Analysis with Main Competitors

Attribute	Invokana	Farxiga	Jardiance	Fostea	Ertugliflozin
First-in-class	Yes	No	No	No	No
Approved indications	T2DM, CV, CKD	T2DM, HF, CKD	T2DM, CV	T2DM	T2DM
CVOT results	Yes	Yes	Yes	Pending	Pending
Patent expiry	2027	2029	2029	2028	2028

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Analysis of Regulatory Policies & Patent Landscape

Policy Area	Impact	Details	Date
Patent Expiry	Market Entry	Invokana patent in US expires 2027, opening industry for biosimilars	2027
Regulatory Tightening	Safety	Increased post-marketing surveillance for DKA and amputations	Ongoing
Indication Expansion	Revenue	Approval pathways for CKD and HF indications	2024-2026

FAQs

1. What are Invokana’s primary indications and recent expansions?
   Initially approved for T2DM, Invokana now benefits from expanded indications for heart failure and CKD following positive cardiovascular and renal trial outcomes.

2. How does Invokana fare in terms of safety compared to competitors?
   Similar safety profiles with risks of genital infections, DKA, and amputations. Monitoring and management protocols are emphasized by regulatory agencies.

3. What is the projected timeline for Invokana’s patent expiry?
   U.S. patents are expected to expire in 2027, after which biosimilar competition could impact market share.

4. Are there any ongoing or upcoming pivotal trials that could influence Invokana’s market?
   Yes, trials focusing on heart failure (NCT05166301) and CKD (NCT04835140) could substantiate broader use, potentially influencing reimbursement and prescribing patterns pre-expiry.

5. What are the key market entry barriers for new competitors?
   High clinical trial costs, regulatory approval timelines, established brand loyalty, and patent protections present significant hurdles.

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Key Takeaways

• Robust Clinical Evidence: Invokana’s CVOT and ongoing CKD/heart failure trials support expanding its usage beyond glycemic control.
• Market Dynamics: There is a sustained CAGR of approximately 17%, driven by increasing global diabetes prevalence and guideline incorporation.
• Competitive Landscape: While Invokana maintains a solid position, competition from Farxiga and Jardiance, combined with patent expiration in 2027, threatens its market dominance.
• Strategic Opportunities: Early market penetration in CKD and HF indications, along with monitored safety profiles, can extend Invokana’s lifecycle.
• Risks and Challenges: Patent expiry, safety concerns, and market saturation require strategic planning to adapt.

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References

[1] International Diabetes Federation. IDF Diabetes Atlas, 10th Edition. 2021.
[2] Johnson & Johnson. Invokana (canagliflozin) prescribing information. 2022.
[3] FDA. Updates on SGLT2 Inhibitors in Diabetes Management. 2020.
[4] GlobalData. SGLT2 inhibitor market analysis report, 2023.
[5] ClinicalTrials.gov. Invokana-related trials. Accessed January 2023.

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This comprehensive review offers insight into Invokana’s clinical trial landscape, competitive positioning, and future market trajectory, enabling informed strategic decision-making for stakeholders in the pharmaceutical and healthcare sectors.