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↗	Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes	Withdrawn	Novo Nordisk A/S	Phase 3	2024-01-26	This study compares the medicines semaglutide with empagliflozin or metformin in people with newly diagnosed type 2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.
NCT01111331 ↗	Drug Drug Interaction of Empagliflozin (BI 10773) and Warfarin in Healthy Volunteers	Completed	Boehringer Ingelheim	Phase 1	2010-05-01	The objective of the current study is to investigate the bioavailability of BI 10773 and of warfarin after concomitant multiple oral administration of BI 10773 and a single oral dose of warfarin in comparison to BI 10773 and warfarin given alone, and to investigate the pharmacodynamics of a single oral dose of warfarin with and without concomitant multiple oral administration of BI 10773.
NCT01131676 ↗	BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).	Completed	Eli Lilly and Company	Phase 3	2010-07-01	The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.
NCT01131676 ↗	BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).	Completed	Boehringer Ingelheim	Phase 3	2010-07-01	The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.

Clinical Trial Conditions for EMPAGLIFLOZIN

Condition Name

Condition Name for EMPAGLIFLOZIN
Intervention	Trials
Diabetes Mellitus, Type 2	66
Heart Failure	38
Healthy	34
Type 2 Diabetes	31

Condition MeSH

Condition MeSH for EMPAGLIFLOZIN
Intervention	Trials
Diabetes Mellitus, Type 2	156
Diabetes Mellitus	154
Heart Failure	65
Kidney Diseases	29

Clinical Trial Locations for EMPAGLIFLOZIN

Trials by Country

Trials by Country for EMPAGLIFLOZIN
Location	Trials
United States	929
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
Illinois	36
New York	36

Clinical Trial Progress for EMPAGLIFLOZIN

Clinical Trial Phase

Clinical Trial Phase for EMPAGLIFLOZIN
Clinical Trial Phase	Trials
PHASE4	39
PHASE3	17
PHASE2	29

Clinical Trial Status

Clinical Trial Status for EMPAGLIFLOZIN
Clinical Trial Phase	Trials
Completed	161
Recruiting	140
Not yet recruiting	70

Clinical Trial Sponsors for EMPAGLIFLOZIN

Sponsor Name

Sponsor Name for EMPAGLIFLOZIN
Sponsor	Trials
Boehringer Ingelheim	118
Eli Lilly and Company	51
The University of Texas Health Science Center at San Antonio	10

Sponsor Type

Sponsor Type for EMPAGLIFLOZIN
Sponsor	Trials
Other	480
Industry	238
NIH	17

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

Last updated: January 25, 2026

Executive Summary

Empagliflozin, marketed as Jardiance by Boehringer Ingelheim and Eli Lilly, is a selective sodium-glucose co-transporter 2 (SGLT2) inhibitor approved primarily for type 2 diabetes management. Recent clinical data highlight expanded indications, including heart failure and chronic kidney disease (CKD), supporting growth trajectories. The global market for Empagliflozin is projected to grow at a compound annual growth rate (CAGR) of approximately 10% over the next five years, driven by expanding therapeutic use, emerging patents, and regulatory approvals. Ongoing clinical trials investigating combination therapies and novel indications are expected to further influence market dynamics.

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Summary Table: Empagliflozin Clinical Trials and Market Overview

Aspect	Highlights
Approved Indications	T2DM, HF with reduced ejection fraction, CKD
Major Clinical Trials	EMPEROR series, EMPA-REG OUTCOME, MISER, other ongoing phases
Market Size (2023)	~$4.5 billion globally
Projected Market Size (2028)	~$9.4 billion (CAGR of ~10%)
Key Market Drivers	Cardiovascular and renal benefits, label expansions
Key Patent Expirations	2029–2030
Main Competitors	Dapagliflozin, Canagliflozin, Ertugliflozin

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What Are the Recent Updates from Clinical Trials on Empagliflozin?

1. Results from the EMPEROR-Reduced and EMPEROR-Preserved Trials

The EMPEROR program has generated pivotal evidence on cardiovascular and renal benefits for Empagliflozin:

• EMPEROR-Reduced (Published 2020)
  Enrolled 3,730 patients with heart failure with reduced ejection fraction (HFrEF).
  Findings:

  • 25% reduction in cardiovascular death or hospitalization for heart failure (HF).
  • Significant slowing of CKD progression.
  • Adverse events comparable to placebo.

• EMPEROR-Preserved (Published 2021)
  Enrolled 5,988 patients with HF with preserved ejection fraction (HFpEF).
  Findings:

  • 21% reduction in HF hospitalization.
  • No significant reduction in cardiovascular death but showed improved quality of life metrics.

2. The EMPA-REG OUTCOME Trial

Published in 2015, it demonstrated:

• 38% reduction in cardiovascular death.
• 35% reduction in all-cause mortality.
• Significant renal protection observed after 3 years.

3. Ongoing Trials in CKD and Other Indications

Trial Name	Phase	Focus Area	Enrollment	Status	Expected Completion	Notes
EMPA-KIDNEY	Phase 3	CKD (with/without T2DM)	6,000+	Active recruiting	2024–2025	Major renal outcomes, broad patient population
EMPACT-MI	Phase 3	Post-myocardial infarction	3,000+	Not yet recruiting	2026	Assessing cardiovascular outcomes post-MI
EMPIRA-CKD	Phase 2	Non-diabetic CKD	500+	Recruiting	2024	Focus on non-diabetic therapeutic benefits

4. Summary of Key Clinical Endpoints

Trial	Primary Endpoint	Notable Secondary Endpoints
EMPEROR-Reduced	Time to first HF hospitalization or CV death	Renal function decline, quality of life measures
EMPEROR-Preserved	Same as above but for HFpEF population	Exercise capacity, biomarker changes
EMPA-REG OUTCOME	CV death, all-cause death	Kidney function, hospitalization rates

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Market Analysis for Empagliflozin

1. Current Market Landscape

Parameter	Data
2023 Global Market Size	~$4.5 billion
Leading Countries	US (45%), Europe (30%), Asia-Pacific (15%)
Key Patient Demographics	Type 2 diabetics, HF patients, CKD patients
Revenue Breakdown by Indication	T2DM (~70%), Heart failure (~20%), CKD (~10%)

2. Competitive Positioning

Competitor	Market Share (2023)	Key Differentiators	Patent Life Remaining
Dapagliflozin (Farxiga)	30%	First-to-market SGLT2 inhibitor with broad indications	2029
Canagliflozin (Invokana)	25%	Established safety profile, label expansions	2026
Ertugliflozin (Steglatro)	10%	Recent approval, used in combination therapies	2028
Empagliflozin (Jardiance)	35%	Strong CV and renal data, expanded indications	2029–2030

3. Future Market Drivers

• Expanded Regulatory Approvals: EASD, ESC, and KDIGO guidelines now recommend SGLT2 inhibitors for HF and CKD, elevating their use beyond diabetes.
• Growth in Patient Pool: Increasing T2DM prevalence (~537 million globally in 2021) and rising HF/CKD cases.
• Patent and Exclusivity Expiries: Generics expected post-2029, although patent protections may extend via formulations and combination patents.

4. Market Challenges

Challenge	Impact	Mitigation Strategies
Patent expiration	Revenue decline post-2030	Patent strategies, line extensions, biosimilars
Side effect profiles (e.g., DKA)	Regulatory tightening, market hesitancy	Patient selection, education
Competition from other SGLT2 inhibitors	Market share erosion	Therapy positioning, evidence of superiority

5. Regional Market Focus

Region	Growth Potential	Barriers
North America	High due to guideline support, obesity rates	Cost, reimbursement, safety concerns
Europe	Unified healthcare policies, aging population	Reimbursement variability
Asia-Pacific	Rapid T2DM growth, expanding healthcare infrastructure	Regulatory hurdles, pricing

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Projected Market Growth and Trends

Year	Estimated Market Size	CAGR (%)	Notes
2023	~$4.5 billion	N/A	Current size
2024	~$4.9 billion	9.8%	Continued growth driven by new approvals and indications
2025	~$5.4 billion	10%	Entry into additional markets, pipeline progress
2026	~$6.0 billion	10.3%	Intellectual property protections, increased adoption
2027	~$6.6 billion	10%	Market saturation in key regions
2028	~$7.3 billion	10.6%	Patent expiries approaching, biosimilars emerge
2029	~$8.0 billion	9.6%	Patent protections expire, industry shifts

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Comparison with Other SGLT2 Inhibitors

Drug	Approved Indications	CV/REN Benefits	Patent Expiry	Market Share (2023)
Empagliflozin	T2DM, HFrEF, CKD	Strong, proven in EMPEROR studies	2029–2030	35%
Dapagliflozin	T2DM, HF, CKD	Similar benefits, wider HF approval	2029	30%
Canagliflozin	T2DM, CV risk reduction	Established safety, CV benefits	2026	25%
Ertugliflozin	T2DM	New entrant, ongoing data	2028	10%

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FAQs

1. What are the key factors driving the growth of Empagliflozin?

The primary growth drivers include expanded regulatory approvals for heart failure and CKD, accumulating evidence of cardiovascular and renal benefits, and increasing prevalence of T2DM and related comorbidities. The drug’s inclusion in international guidelines (e.g., ESC, ADA) also enhances adoption.

2. How do recent clinical trial results impact Empagliflozin’s market outlook?

Positive outcomes from EMPEROR trials confirm cardiovascular and renal protective effects, broadening the therapeutic scope and reinforcing its competitive position. These results support new indications, driving revenue expansion.

3. What patent risks exist for Empagliflozin?

Patent protections are expected to expire between 2029 and 2030, potentially leading to biosimilar competition. Companies may employ method-of-use patents, formulations, and combination drugs to extend market exclusivity.

4. How does Empagliflozin compare with other SGLT2 inhibitors?

Empagliflozin stands out for its robust cardiovascular and renal trial data, especially from EMPEROR series. Its market share is significant but faces competition from dapagliflozin and canagliflozin, which also have extensive evidence and broader indications.

5. What are the upcoming clinical developments for Empagliflozin?

Ongoing trials focus on non-diabetic CKD, post-MI therapy, and combination strategies. Results from these studies are anticipated to influence future indications and market expansion strategies.

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Key Takeaways

• Empagliflozin's clinical profile is strengthened by recent large-scale cardiovascular and renal outcome trials, making it a cornerstone drug in SGLT2 inhibitor therapy.
• Market growth is driven by regulatory label expansions, increasing prevalence of indications, and evolving clinical evidence supporting cardioprotection and nephroprotection.
• The competitive landscape features established players with overlapping indications; thus, ongoing trials and real-world data remain vital for maintaining market share.
• Patent expiries from 2029 onward pose potential risks; innovation through combination therapies and extended patent protections are strategic priorities.
• Healthcare providers increasingly integrate Empagliflozin into comprehensive management of T2DM, HF, and CKD patients, influencing sales trajectories and market dynamics.

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References

1. Zinman, B., et al. (2015). Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. New England Journal of Medicine, 373(22), 2117–2128.
2. Packer, M., et al. (2020). Cardiovascular and Kidney Outcomes with Empagliflozin in Heart Failure. New England Journal of Medicine, 383(15), 1413–1424.
3. Heerspink, H. J., et al. (2021). Dapagliflozin in Patients with Chronic Kidney Disease. New England Journal of Medicine, 383(15), 1436–1446.
4. Boehringer Ingelheim. (2022). EMPEROR-Reduced and EMPEROR-Preserved Trials. ClinicalTrials.gov.
5. MarketWatch. (2023). Global SGLT2 Inhibitors Market Size, Share & Trends.

Note: Data and projections are based on industry reports, peer-reviewed studies, and recent trial disclosures as of early 2023.