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↗	Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes	Withdrawn	Novo Nordisk A/S	Phase 3	2024-01-26	This study compares the medicines semaglutide with empagliflozin or metformin in people with newly diagnosed type 2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
Kidney Diseases	8
Heart Failure	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
Kentucky	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
University Hospital, Basel, Switzerland	3

Sponsor Type

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

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

Last updated: October 28, 2025

Introduction

Jardiance (empagliflozin), developed and marketed by Boehringer Ingelheim and Eli Lilly, is a leading medication in the sodium-glucose cotransporter-2 (SGLT2) inhibitor class. It is primarily prescribed for type 2 diabetes mellitus (T2DM) management and has gained approval for cardiovascular and renal indications. As the diabetes treatment landscape evolves, evaluating Jardiance's clinical trial updates, market performance, and future growth prospects offers vital insights for stakeholders ranging from investors to healthcare providers.

Clinical Trials Update

Key Clinical Trials and Outcomes

Jardiance's clinical development has been extensive, with pivotal studies reinforcing its efficacy and safety profile:

• EMPA-REG OUTCOME (2015): A landmark cardiovascular outcomes trial involving over 7,000 patients with T2DM and established cardiovascular disease (CVD). Results demonstrated a 38% reduction in cardiovascular death, a 32% reduction in all-cause mortality, and significant decreases in hospitalization for heart failure. This trial solidified Jardiance's indication for reducing cardiovascular risk in T2DM patients with CVD.

• EMPA-KIDNEY (ongoing): An ongoing Phase 3 trial evaluating empagliflozin in patients with chronic kidney disease (CKD), regardless of diabetes status. Preliminary data suggest renal protective effects, hinting at expanded indications in CKD management.

• EMPEROR-Reduced and EMPEROR-Preserved (2020-2021): Trials assessing empagliflozin in heart failure with reduced and preserved ejection fraction, respectively. Results showed significant reductions in hospitalization and mortality, prompting label expansions for heart failure indications.

Recent and Upcoming Trials

Recent data released in 2022 and 2023 include insights from secondary analyses and subgroup evaluations, confirming cardiovascular and renal benefits across diverse populations. Upcoming trials aim to evaluate empagliflozin in non-diabetic populations and patients with heart failure with preserved ejection fraction (HFpEF), further expanding its therapeutic scope.

Regulatory Developments

Boeringer Ingelheim and Lilly continue to seek regulatory approvals for additional indications. Notably, the FDA approved Jardiance to reduce the risk of cardiovascular death in adult patients with heart failure with reduced ejection fraction (HFrEF), regardless of diabetes status, in 2021. The European Medicines Agency (EMA) has similarly expanded its indications.

Market Analysis

Market Size and Growth Drivers

Jardiance commands a significant share in the SGLT2 inhibitor class and the broader diabetes and cardiovascular treatment markets. The global diabetes therapeutics market was valued at approximately USD 70 billion in 2022, with SGLT2 inhibitors accounting for a substantial segment due to their dual benefits on glycemic control and cardiovascular protection.[1]

Key growth drivers include:

• Rising Diabetes Prevalence: The International Diabetes Federation estimates over 537 million adults afflicted globally in 2021, projected to reach 643 million by 2030.[2]
• Expanding Indications: Increasing approvals for heart failure and CKD management broaden Jardiance’s clinical application.
• Cardiovascular and Renal Benefits: Evidence from clinical trials supports its use beyond glycemic control, appealing to a wider patient population.

Market Penetration and Competitive Landscape

Jardiance holds approximately 25-30% market share within the SGLT2 class, trailing behind competitors like Novo Nordisk's Ozempic (semaglutide) and AstraZeneca's Farxiga (dapagliflozin). However, its early lead in cardiovascular and renal indications grants a competitive edge.

Major markets include:

• North America: Accounted for over 45% of sales in 2022, driven by high diabetes prevalence and stringent cardiovascular risk management standards.
• Europe and Asia-Pacific: Rapid adoption, fueled by expanding healthcare coverage, growing awareness, and regulatory approvals.

Revenue and Sales Trends

In 2022, Jardiance generated over USD 2.4 billion in global sales, reflecting strong growth driven by expanded indications and increasing patient outreach. The drug's revenue has grown at a compound annual growth rate (CAGR) of approximately 15% over the past five years.[3]

Future Projections

Market Growth Forecast

Industry analysts project the SGLT2 inhibitor segment, including Jardiance, to reach USD 38 billion globally by 2030, with a CAGR of around 12% from 2023 to 2030. Key factors influencing growth include:

• Continued approval for heart failure and CKD.
• Increasing adoption in non-diabetic populations.
• Technological advancements improving adherence and outcomes.

Key Opportunities and Challenges

Opportunities:

• Broader Therapeutic Indications: Pending approval in HFpEF and CKD patients without diabetes.
• Combination Therapies: Integration with other antidiabetic agents for enhanced efficacy.
• Digital Health: Utilization of real-world data and digital tools to optimize treatment adherence and outcomes.

Challenges:

• Pricing and Reimbursement: High costs may hinder access in some markets.
• Competitive Pressure: Other SGLT2 inhibitors and GLP-1 receptor agonists vying for market share.
• Side Effect Profile: Concerns regarding genitourinary infections, ketoacidosis, and rare adverse events.

Strategic Outlook

Boehringer Ingelheim and Lilly are positioned to leverage clinical trial data for aggressive marketing and regulatory strategies to accelerate market adoption. The emphasis on cardiovascular and renal benefits aligns with current healthcare priorities, likely to sustain and enhance Jardiance’s market trajectory.

Conclusion

Jardiance has cemented its status as a ground-breaking SGLT2 inhibitor, with robust clinical trial evidence supporting its cardiovascular and renal benefits. The ongoing development of new indications, combined with rising global demand for comprehensive diabetes and cardiovascular management, underscores its growth potential. Strategic positioning, clinical data dissemination, and addressing market challenges will determine its future market dominance.

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Key Takeaways

• Clinical Excellence: Jardiance's pivotal trials demonstrate significant cardiovascular and renal benefits, expanding its traditional role in diabetes management.
• Market Leadership: Despite intense competition, Jardiance maintains a strong position, with revenues surpassing USD 2.4 billion in 2022 and poised for further growth.
• Expansion Opportunities: New indications in heart failure and CKD without diabetes can significantly broaden its patient base.
• Growth Drivers: Rising global diabetes prevalence, aging populations, and regulatory support underpin optimistic growth forecasts.
• Challenges: Pricing pressures, safety concerns, and competitive dynamics require strategic responses to sustain market leadership.

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FAQs

1. What are the primary indications for Jardiance?
Jardiance is approved for the management of type 2 diabetes in adults, reducing the risk of cardiovascular death in patients with established CVD, and has received regulatory approval for heart failure with reduced ejection fraction (HFrEF), regardless of diabetes status, and for chronic kidney disease.

2. How does Jardiance outperform other SGLT2 inhibitors clinically?
Jardiance distinguishes itself via comprehensive evidence demonstrating reduction in cardiovascular mortality, hospitalization for heart failure, and renal progression, supported by robust clinical trial data, especially from EMPA-REG OUTCOME and EMPEROR series.

3. What is the outlook for Jardiance in non-diabetic populations?
Clinical trials like EMPEROR-Preserved and ongoing studies in CKD suggest strong potential for Jardiance in non-diabetic heart failure and kidney disease management, which could significantly expand its market.

4. How are regulation and reimbursement shaping Jardiance’s market growth?
Regulatory approvals for new indications enhance market access, but reimbursement challenges, especially in cost-sensitive regions, could limit uptake. Demonstrating cost-effectiveness will be crucial.

5. What are the main competitive threats to Jardiance?
Key competitors include other SGLT2 inhibitors like Farxiga (dapagliflozin) and Invokana (canagliflozin), as well as emerging therapies like GLP-1 receptor agonists. Differentiation through clinical outcomes and expanded indications remains vital.

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Sources

1. GlobalData. "Diabetes Therapeutics Market Analysis." 2022.
2. International Diabetes Federation. "IDF Diabetes Atlas," 2021.
3. Boehringer Ingelheim Annual Report, 2022.