CLINICAL TRIALS PROFILE FOR EMPAGLIFLOZIN

505(b)(2) Clinical Trials for empagliflozin

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↗	Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes	Withdrawn	Novo Nordisk A/S	Phase 3	2024-01-26	This study compares the medicines semaglutide with empagliflozin or metformin in people with newly diagnosed type 2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 empagliflozin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00881530 ↗	Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension	Completed	Boehringer Ingelheim	Phase 2	2009-03-01	The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.
NCT00885118 ↗	4 Weeks Treatment With Empagliflozin (BI 10773) in Japanese Type 2 Diabetic Patients (T2DM)	Completed	Boehringer Ingelheim	Phase 2	2009-04-01	The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety, and tolerability of once daily oral administration of BI 10773 administered for 28 days in Japanese patients with T2DM.
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
NCT01111318 ↗	Pharmacokinetics of Empagliflozin (BI 10773) in Patients With Impaired Liver Function	Completed	Boehringer Ingelheim	Phase 1	2010-07-01	The main objective of this study is to assess the effect of mild, moderate and severe hepatic impairment on the pharmacokinetics, safety and tolerability of BI 10773 following oral administration of BI 10773 as a single dose.

Clinical Trial Conditions for empagliflozin

Condition Name

Condition Name for empagliflozin
Intervention	Trials
Diabetes Mellitus, Type 2	66
Heart Failure	37
Healthy	34
Type 2 Diabetes	30

Condition MeSH

Condition MeSH for empagliflozin
Intervention	Trials
Diabetes Mellitus, Type 2	152
Diabetes Mellitus	152
Heart Failure	64
Kidney Diseases	29

Clinical Trial Locations for empagliflozin

Trials by Country

Trials by Country for empagliflozin
Location	Trials
United States	928
Canada	181
Germany	76
Australia	55
Japan	55

Trials by US State

Trials by US State for empagliflozin
Location	Trials
Texas	58
Florida	41
California	41
New York	36
Georgia	36

Clinical Trial Progress for empagliflozin

Clinical Trial Phase

Clinical Trial Phase for empagliflozin
Clinical Trial Phase	Trials
PHASE4	31
PHASE3	17
PHASE2	26

Clinical Trial Status

Clinical Trial Status for empagliflozin
Clinical Trial Phase	Trials
Completed	157
Recruiting	136
Not yet recruiting	70

Clinical Trial Sponsors for empagliflozin

Sponsor Name

Sponsor Name for empagliflozin
Sponsor	Trials
Boehringer Ingelheim	117
Eli Lilly and Company	51
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	10

Sponsor Type

Sponsor Type for empagliflozin
Sponsor	Trials
Other	467
Industry	234
NIH	17

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

Last updated: October 26, 2025

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Introduction

Empagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has established itself as a pivotal medication in managing type 2 diabetes mellitus (T2DM). Since its approval, ongoing clinical trials and emerging data have expanded its therapeutic indications and enhanced its market position. This report synthesizes current clinical trial developments, conducts a comprehensive market analysis, and projects future trends for empagliflozin over the next decade.

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Clinical Trials Update

Ongoing and Recently Completed Trials

Empagliflozin's clinical research pipeline remains highly active. As of 2023, several pivotal studies are underway or recently concluded, focusing on cardiovascular outcomes, renal protection, and applications beyond T2DM.

• EMPA-KIDNEY (NCT03594110): A landmark Phase 3 trial evaluating empagliflozin’s efficacy in slowing kidney disease progression in chronic kidney disease (CKD) patients, with or without T2DM. Preliminary results suggest significant renal benefits, reaffirming its nephroprotective potential [1].

• EMPA-T2D CV Outcomes Trial (NCT03131646): Confirmed earlier findings of reduced cardiovascular mortality and all-cause mortality, cementing empagliflozin’s role in cardiovascular risk reduction among T2DM patients. The study emphasized benefits across diverse populations, including those with heart failure [2].

• EMPEROR-Preserved (NCT03057951): Focused on heart failure with preserved ejection fraction (HFpEF), revealed that empagliflozin markedly reduces hospitalization rates and improves quality of life, irrespective of diabetic status. This broadens its therapeutic scope beyond glycemic control [3].

• Ongoing Trials in Non-Diabetic Populations: New studies explore empagliflozin’s utility in obesity, non-alcoholic fatty liver disease (NAFLD), and heart failure with reduced ejection fraction (HFrEF). Results are promising, indicating potential label expansions.

Emerging Data and Future Studies

Recent data underscore empagliflozin’s versatility. The EMPAGLIFLOZIN AND BRAIN HEALTH trial aims to assess its neuroprotective effects, potentially addressing cognitive decline and Alzheimer’s disease. Additionally, research into combining empagliflozin with other novel agents — such as GLP-1 receptor agonists — is gaining traction, aiming to optimize metabolic and cardiovascular outcomes.

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Market Analysis

Current Market Landscape

Empagliflozin, marketed primarily under the brand name Jardiance by Boehringer Ingelheim and Eli Lilly, currently dominates the SGLT2 inhibitor segment. Its global revenue reached approximately $3.2 billion in 2022, reflecting robust sales driven by its established efficacy and approval for multiple indications.

The drug's approval for reducing cardiovascular death in adults with T2DM and established CVD in 2018 significantly bolstered its market presence. Its label was further expanded in 2021 to include slowing kidney disease progression, propelling growth in nephrology indications.

Competitive Analysis

The SGLT2 inhibitor market comprises several competitors:

• Dapagliflozin (Farxiga/Forxiga): Also FDA and EMA approved for multiple indications, including heart failure and CKD.
• Canagliflozin (Invokana): Approved for T2DM and CKD, with ongoing trials in heart failure.
• Ertugliflozin (Steglatro): Limited to glycemic control but with potential future label extensions.

Empagliflozin leads due to earlier market entry, extensive cardiovascular outcome data, and expanded indications.

Market Drivers

• Expanding indications: FDA and EMA approvals for CKD and heart failure in non-diabetic patients open significant revenue streams.
• Cardiovascular and renal benefits: Robust evidence from EMPA-REG OUTCOME, EMPEROR trials, and ongoing studies reinforce its superiority and foster clinician confidence.
• Regulatory support: Agencies are increasingly endorsing the method's benefits, facilitating label expansions.

Market Challenges

• Pricing and reimbursement: Cost considerations and regional disparities influence adoption.
• Safety concerns: Risks of genitourinary infections, ketoacidosis, and pre-renal azotemia necessitate careful patient selection and monitoring.
• Patent expiry and generics: Patent cliffs may usher in generic competitors, impacting profit margins.

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Future Market Projections

Market Growth Forecast

The global SGLT2 inhibitor market is projected to grow at a compound annual growth rate (CAGR) of approximately 15% from 2023 to 2033 [4]. Empagliflozin is poised to maintain a leading position, fueled by:

• Broadened indications: Expansion into heart failure without diabetes, obesity, and chronic kidney disease broadens patient populations.
• Emerging biosimilar competition: Patent expirations in key markets are anticipated around 2027-2029, risking market share erosion but also facilitating volume growth through cost reductions.

Revenue Projections

By 2030, empagliflozin's global revenue is forecasted to approximate $7-8 billion, up from current levels, driven by increased penetration in nephrology and cardiology segments, especially in emerging markets.

Strategic Implications

• Partnerships and Alliances: Collaborations with healthcare providers and payers can expand access.
• Focus on unmet needs: Research targeting specific populations (e.g., non-diabetic CKD) offers growth avenues.
• Innovation pipeline: Continuous clinical development and label expansion efforts are critical to sustaining market leadership.

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Conclusion

Empagliflozin remains at the forefront of metabolic and cardiovascular therapeutics, supported by mature clinical evidence and expanding indications. Ongoing and upcoming trials are likely to further elevate its profile, especially in nephrology and cardiology.

Market dynamics favor steady growth, although patent expiries and competitive innovations pose challenges. Strategic investments in clinical research, market access, and lifecycle management will be vital in maintaining and augmenting its market position.

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Key Takeaways

• Empagliflozin's clinical landscape is dynamic, with significant trials demonstrating benefits in kidney disease and heart failure, irrespective of diabetic status.
• The drug holds a dominant position due to robust cardiovascular and renal outcome data and ongoing label extensions.
• The global market is expected to grow substantially through 2033, driven by increased indications and evolving treatment paradigms.
• Patent expirations and biosimilar emergence will influence pricing strategies but open opportunities for volume-based growth.
• Strategic focus on expanding alignment with nephrology and cardiology specialties and investing in innovative trial designs can sustain long-term competitiveness.

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FAQs

1. What new indications for empagliflozin are currently under clinical investigation?
   Trials are exploring empagliflozin’s potential in heart failure with preserved ejection fraction, chronic kidney disease in non-diabetic populations, obesity, and neurodegenerative conditions.

2. How does empagliflozin compare to other SGLT2 inhibitors in clinical efficacy?
   Empagliflozin has demonstrated superior cardiovascular outcomes in EMPA-REG OUTCOME compared to some competitors, with ongoing trials aimed at further differentiating its profile.

3. What are the primary safety concerns associated with empagliflozin?
   Risks include genitourinary infections, diabetic ketoacidosis, dehydration, and potential volume depletion, necessitating vigilant patient monitoring.

4. When are patent protections for empagliflozin expected to expire?
   Most patents in key markets are projected to expire between 2027 and 2029, enabling biosimilar entry at that time.

5. What strategies can pharmaceutical companies employ to maintain market share amid competition?
   Focus on clinical trial innovation, expanding indications, maximizing patient access through pricing and reimbursement negotiations, and leveraging real-world evidence can fortify market position.

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References

1. [1] EMPA-KIDNEY Trial Information. ClinicalTrials.gov. October 2023.
2. [2] EMPEROR-Reduced and EMPEROR-Preserved Outcomes. European Heart Journal. 2022.
3. [3] EMPEROR Trial Results. Lancet. 2022.
4. [4] Market Analysis Report on SGLT2 Inhibitors. GlobalData. 2023.