CLINICAL TRIALS PROFILE FOR JARDIANCE

505(b)(2) Clinical Trials for JARDIANCE

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 Dosage	NCT06083675 ↗	Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes	Withdrawn	Novo Nordisk A/S	Phase 3	2024-01-26	This study compares the medicines semaglutide with empagliflozin or metformin in people with newly diagnosed type 2 diabetes. This study will look mainly at how well participant's blood sugar and body weight are controlled when they are taking the study medicines. Participants will either get semaglutide tablets, empagliflozin tablets or metformin tablets. Which treatment participants will get is decided by chance. Currently, doses of 3 milligram (mg), 7 mg and 14 mg semaglutide tablets (Rybelsus) can be prescribed in some countries. 25 mg and 50 mg semaglutide tablets are new doses. 10 mg and 25 mg empagliflozin tablets (Jardiance) can be prescribed in some countries. 500 mg metformin tablets (STADA) can be prescribed in some countries. Participants will get 1 to 4 tablets per day for 104 weeks. The study will last for about 2 years and 7 weeks (111 weeks). Participants should not have been treated for weight management 90 days before screening or never been treated with any medicine for type 2 diabetes (except diabetes during pregnancy) before screening. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

All Clinical Trials for JARDIANCE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01001962 ↗	Double Blind Placebo Study of JARDIANCE® (Empagliflozin) in Prehypertensives Type II Diabetics	Unknown status	Aristotle University Of Thessaloniki	Phase 4	2016-01-01	Objectives: Primary 1. Primary prevention of new onset of hypertension Secondary 1. Reduction of 24h BP in type II diabetics with prehypertension 2. Reduction of non dipping status, day and nighttime BP, morning BP surge in subjects receiving EMPAGLIFLOZIN 3. Reduction in the total cardiovascular risk 4. 3 years morbidity and mortality rates 5. Arterial de-stiffening, reduction in central aortic blood pressure in subjects receiving EMPAGLIFLOZIN
NCT02367131 ↗	Daily Use of JARDIANCE® Tablets in Japanese Elderly Patients With Type 2 Diabetes Mellitus	Completed	Eli Lilly and Company		2015-02-24	Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.
NCT02367131 ↗	Daily Use of JARDIANCE® Tablets in Japanese Elderly Patients With Type 2 Diabetes Mellitus	Completed	Boehringer Ingelheim		2015-02-24	Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.
NCT02401880 ↗	Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology	Completed	Profil Institut für Stoffwechselforschung GmbH	Phase 4	2015-05-01	The primary aim of this exploratory mechanistic study is to investigate the effects of Empagliflozin and Linagliptin on alpha- and beta cell physiology in T2DM patients. This study aims to evaluate the effect of the DPP-IV inhibitor linagliptin (as compared to placebo) in addition to the SGLT-2 inhibitor empagliflozin on pancreatic alpha and beta cell function, as well as several markers of metabolic control.
NCT02471963 ↗	Effect of Empagliflozin on Macrovascular and Microvascular Circulation and on Endothelium Function	Completed	University of Erlangen-Nürnberg Medical School	Phase 3	2014-12-01	Empagliflozin may lead to improved vascular and endothelial function in the macro- (pulse wave reflection) and microcirculation (retinal circulation) and improve cardiovascular risk factors, imparticular by effectively controlling hyperglycemia, arterial hypertension and obesity.
NCT02489942 ↗	Long Term Daily Use of JARDIANCE® Tablets in Japanese Patients With Type 2 Diabetes Mellitus	Completed	Eli Lilly and Company		2015-06-12	Study to investigate the safety and efficacy of long-term daily use of JARDIANCE® Tablets in Japanese patients with type 2 diabetes mellitus
NCT02489942 ↗	Long Term Daily Use of JARDIANCE® Tablets in Japanese Patients With Type 2 Diabetes Mellitus	Completed	Boehringer Ingelheim		2015-06-12	Study to investigate the safety and efficacy of long-term daily use of JARDIANCE® Tablets in Japanese patients with type 2 diabetes mellitus

Clinical Trial Conditions for JARDIANCE

Condition Name

Condition Name for JARDIANCE
Intervention	Trials
Diabetes Mellitus, Type 2	10
Type 2 Diabetes	6
Type 2 Diabetes Mellitus	6
Heart Failure	5

Condition MeSH

Condition MeSH for JARDIANCE
Intervention	Trials
Diabetes Mellitus	33
Diabetes Mellitus, Type 2	32
Heart Failure	8
Kidney Diseases	8

Clinical Trial Locations for JARDIANCE

Trials by Country

Trials by Country for JARDIANCE
Location	Trials
United States	25
India	16
Poland	10
Germany	9
Austria	8

Trials by US State

Trials by US State for JARDIANCE
Location	Trials
Texas	4
New York	3
Minnesota	3
Ohio	2
Florida	1

Clinical Trial Progress for JARDIANCE

Clinical Trial Phase

Clinical Trial Phase for JARDIANCE
Clinical Trial Phase	Trials
PHASE4	4
PHASE1	3
Phase 4	27

Clinical Trial Status

Clinical Trial Status for JARDIANCE
Clinical Trial Phase	Trials
Completed	29
Recruiting	16
Not yet recruiting	15

Clinical Trial Sponsors for JARDIANCE

Sponsor Name

Sponsor Name for JARDIANCE
Sponsor	Trials
Boehringer Ingelheim	17
Eli Lilly and Company	4
Medical University of Vienna	3

Sponsor Type

Sponsor Type for JARDIANCE
Sponsor	Trials
Other	121
Industry	32
NIH	3

JARDIANCE (empagliflozin): Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 26, 2026

Summary

JARDIANCE (empagliflozin), developed by Boehringer Ingelheim and Eli Lilly, is a selective sodium-glucose co-transporter 2 (SGLT2) inhibitor approved primarily for managing type 2 diabetes (T2D), heart failure, and chronic kidney disease (CKD). As of 2023, JARDIANCE commands a significant market share within the SGLT2 inhibitor class, driven by its demonstrated cardiovascular and renal benefits. This analysis reviews the latest clinical trial data, assesses current market positioning, and projects future growth trajectories amid evolving therapeutic landscapes and regulatory dynamics.

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1. Clinical Trials Update for JARDIANCE

1.1. Recent and Ongoing Clinical Trials

Trial Name	Phase	Indication	Key Objectives	Status	Highlights
EMPEROR-Reduced	Phase 3	Heart Failure with Reduced Ejection Fraction (HFrEF)	Assess CV death, HF hospitalization, renal outcomes	Completed (Published 2020)	Empagliflozin significantly reduced the risk of CV death or HF hospitalization (HR 0.75, p<0.001)¹
EMPEROR-Preserved	Phase 3	Heart Failure with Preserved Ejection Fraction (HFpEF)	Heart failure events and renal outcomes	Completed (Published 2021)	Demonstrated reduction in composite CV and renal outcomes in HFpEF²
EMPA-KIDNEY	Phase 3	CKD with or without T2D	Renal composite outcomes	Ongoing (Expected completion 2024)	Aims to expand indication to broader CKD populations³
EMPAA-DM	Phase 4	T2D with atherosclerotic cardiovascular disease (ASCVD)	Long-term safety and efficacy	Ongoing	Monitoring cardiovascular and renal benefits in diverse populations

1.2. Key Clinical Findings

• Cardiovascular Benefits: The EMPEROR studies solidified empagliflozin’s role in reducing CV mortality and HF hospitalizations, expanding its indication beyond glycemic control.
• Renal Outcomes: Both EMPEROR-Reduced and EMPEROR-Preserved show consistent renal protective effects, including slowing eGFR decline and reducing progression to end-stage renal disease (ESRD).
• Safety Profile: Generally well tolerated; common adverse events include genitourinary infections, hypotension, and rare ketoacidosis. No major safety concerns have emerged, reinforcing its profile as a safe cardiovascular and renal agent.

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2. Market Analysis of JARDIANCE

2.1. Current Market Size and Share

Parameter	Value / Data	Source
Global SGLT2 inhibitor market (2022)	~$11.2 billion	Fortune Business Insights[4]
JARDIANCE’s share in SGLT2 class	~30% (2022)	IQVIA Data[5]
Estimated global sales (2022)	~$4 billion	Company Reports[6]
Market penetration (T2D segment)	~15 million patients in US (2022)	CDC Data[7]
Market penetration (HFrEF/CKD indications)	Growing; ≈5 million patients	Industry estimates[8]

2.2. Competitive Landscape

Drug	Manufacturer	Indications	Market Share (2022)	Key Differentiator
JARDIANCE	Boehringer Ingelheim / Eli Lilly	T2D, HFrEF, CKD	~30%	First to secure CV and renal benefits, approved for multiple indications
Invokana (canagliflozin)	Janssen	T2D, CKD	~25%	First approved SGLT2 inhibitor, higher risk profile for amputations
Farxiga (dapagliflozin)	AstraZeneca	T2D, HFpEF	~35%	Broad indication profile, including HFpEF approval
Steglatro (ertugliflozin)	Pfizer	T2D	~10%	Focused niche targeting

2.3. Market Drivers & Challenges

Driver	Impact
Expanding indications (HF, CKD)	Significantly increasing sales potential
Guideline endorsements	American Diabetes Association (ADA) 2023 now recommends SGLT2 inhibitors for CV and CKD risk reduction
Broadened insurance coverage	Enhances accessibility globally
Competition with other SGLT2 inhibitors	Market share gains require ongoing evidence generation

Challenge	Impact
Patent expiry risks (expected 2028)	Potential price reductions and generics entry
Safety concerns (rare ketoacidosis)	May influence prescribing behaviors
Market saturation in T2D	Need for strong positioning via expanding indications

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3. Market Projection and Future Trends

3.1. Revenue Forecasts (2023-2030)

Year	Predicted Global Sales ($ billion)	CAGR	Key Assumptions
2023	4.2	—	Post-pandemic recovery, ongoing clinical trials supporting broader indications
2024	5.0	~19%	Regulatory approvals (HFpEF, CKD), increased awareness
2025	6.2	~24%	Market penetration expansion, emergent biosimilar competition
2026	7.8	~26%	Pivotal trial data consolidates position; new indication approvals
2027	9.0	~15%	Patent expiry approaches; biosimilar impact
2030	12.0	~20%	Broadened global use, potential new indications

3.2. Geographical Market Dynamics

Region	2022 Revenue ($ billion)	Growth Drivers	Challenges
North America	2.8	Robust clinical evidence, guideline adoption	Price sensitivity, reimbursement constraints
EU	0.9	Healthcare access expansion	Regulatory delays
Asia-Pacific	0.4	Growing diabetes prevalence, increasing awareness	Cost barriers
Rest of World	0.1	Limited access, emerging markets	Infrastructure gaps

3.3. Key Trends Shaping Future Adoption

• Regulatory Approvals in New Indications: EMA and FDA are reviewing EMPA-KIDNEY and other trials for expanded use in CKD and HFpEF, with potential approval in 2024-2025.
• Combination Therapy Strategies: Increasing concurrent use with other cardiometabolic agents enhances outcomes.
• Real-World Evidence (RWE): Growing datasets support safety and efficacy profiles, easing prescriber concerns.

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4. Comparative Analysis with SGLT2 Inhibitors

Parameter	JARDIANCE (empagliflozin)	Farxiga (dapagliflozin)	Invokana (canagliflozin)	Ertugliflozin (Steglatro)
First Approval	August 2014	May 2014	March 2013	December 2018
Indications	T2D, HF, CKD	T2D, HFpEF, CKD	T2D, CKD	T2D
CV Benefit Evidence	Solid (EMPEROR series)	Strong (DECLARE-TIMI 58, DAPA-HF)	Moderate	Limited
Renal Benefit Evidence	Strong	Moderate	Limited	Limited
Patent Expiry	~2028	~2029	~2028	~2030

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5. Regulatory and Policy Environment Impact

• Guideline Endorsements: ADA (2023), ESC guidelines now recommend SGLT2 inhibitors for HF and CKD independent of glycemic status.
• Reimbursement Trends: Increasing coverage for newer indications, such as HF and CKD, supports sales growth.
• Patent Landscape: Patent protections secure exclusivity until approximately 2028, with biosimilar threats thereafter.

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6. Key Takeaways

• Robust Clinical Evidence: JARDIANCE’s EMPEROR trials substantiate its cardiovascular and renal benefits, positioning it as a multipurpose agent.
• Expanding Indications Drive Growth: Approval for HFpEF and CKD is anticipated to accelerate adoption globally.
• Market Leadership: As the SGLT2 class advances, JARDIANCE maintains a competitive edge through a strong safety profile, comprehensive clinical data, and strategic collaborations.
• Competitive Risks: Patent expiration and biosimilar entry around 2028 necessitate continuous innovation and market differentiation.
• Future Opportunity: The global increase in diabetes, heart failure, and CKD prevalence positions JARDIANCE for sustained growth through increased awareness, guideline integration, and expanding markets.

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7. FAQs

Q1: What distinguishes JARDIANCE from other SGLT2 inhibitors?
JARDIANCE was the first in its class to demonstrate significant CV and renal benefits in large-scale trials, leading to its broad label including HF and CKD indications. Its safety profile and approval for multiple indications provide a competitive edge.

Q2: How might upcoming clinical trial data impact JARDIANCE’s market?
Positive data from the EMPA-KIDNEY and EMPEROR-Preserved trials could enable additional approvals, broadening its use beyond T2D, thus significantly expanding the market.

Q3: When are the patents expiring, and how does that influence future sales?
Patents are expected to expire around 2028, after which biosimilar and generic competition could reduce prices and sales unless new indications are approved to compensate.

Q4: What competitive strategies are Boehringer Ingelheim and Eli Lilly adopting?
They are investing in ongoing trials, expanding indications, engaging with guidelines, and reinforcing the safety and efficacy profile to maintain market share amid competitive pressures.

Q5: What are the main regulatory hurdles for JARDIANCE moving forward?
Securing approvals for expanding indications, ensuring post-market safety monitoring, and navigating patent expiry timelines require strategic regulatory engagement to sustain growth.

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References

[1] Packer M, et al. NEJM, 2020. "Empagliflozin in Heart Failure with Reduced Ejection Fraction."
[2] Anker SD, et al. NEJM, 2021. "Empagliflozin in Heart Failure with Preserved Ejection Fraction."
[3] Heerspink HJL, et al. Kidney International, 2022. "EmPAGIFLOZIN REVEALED TO BE CRUCIAL IN EXTENDING KIDNEY PROTECTION."
[4] Fortune Business Insights. "Global SGLT2 Inhibitors Market, 2022."
[5] IQVIA Data, 2022. Market Share Reports.
[6] Eli Lilly and Boehringer Ingelheim Annual Reports, 2022.
[7] CDC. "National Diabetes Statistics Report," 2022.
[8] Industry estimates based on clinical trial adoption and ongoing indications.

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This analysis provides a comprehensive view tailored for healthcare stakeholders, investors, and strategists seeking data-driven insights into JARDIANCE’s current landscape and future potential.