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↗	Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes	Withdrawn	Novo Nordisk A/S	Phase 3	2024-01-26	This study compares the medicines semaglutide with empagliflozin or metformin in people with newly diagnosed type 2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

Clinical Trial Conditions for EMPAGLIFLOZIN

Condition Name

Condition Name for EMPAGLIFLOZIN
Intervention	Trials
Diabetes Mellitus, Type 2	62
Healthy	31
Heart Failure	26
Type 2 Diabetes	23

Condition MeSH

Condition MeSH for EMPAGLIFLOZIN
Intervention	Trials
Diabetes Mellitus	137
Diabetes Mellitus, Type 2	129
Heart Failure	47
Kidney Diseases	27

Clinical Trial Locations for EMPAGLIFLOZIN

Trials by Country

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Trials by Country for EMPAGLIFLOZIN
Location	Trials
United States	732
Canada	147
Germany	64
Japan	51
Australia	36

Trials by US State

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Trials by US State for EMPAGLIFLOZIN
Location	Trials
Texas	45
Florida	35
California	34
New York	31
Ohio	29

Clinical Trial Progress for EMPAGLIFLOZIN

Clinical Trial Phase

Clinical Trial Phase for EMPAGLIFLOZIN
Clinical Trial Phase	Trials
Phase 4	93
Phase 3	75
Phase 2/Phase 3	14

Clinical Trial Status

Clinical Trial Status for EMPAGLIFLOZIN
Clinical Trial Phase	Trials
Completed	135
Recruiting	76
Not yet recruiting	70

Clinical Trial Sponsors for EMPAGLIFLOZIN

Sponsor Name

Sponsor Name for EMPAGLIFLOZIN
Sponsor	Trials
Boehringer Ingelheim	105
Eli Lilly and Company	51
University Hospital, Basel, Switzerland	7

Sponsor Type

Sponsor Type for EMPAGLIFLOZIN
Sponsor	Trials
Other	357
Industry	202
NIH	10

Empagliflozin: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction to Empagliflozin

Empagliflozin, marketed under the brand name Jardiance among others, is a sodium-glucose cotransporter 2 (SGLT2) inhibitor used in the treatment of type 2 diabetes, heart failure, and chronic kidney disease (CKD). This medication has garnered significant attention for its multifaceted benefits, including reducing the risk of cardiovascular events and kidney disease progression.

Clinical Trials Update

EMPA-KIDNEY Trial

The EMPA-KIDNEY trial, led by researchers at Oxford Population Health, has demonstrated that empagliflozin reduces the risk of kidney disease progression or death from cardiovascular disease by 28% in patients with CKD, with and without diabetes. This trial has established empagliflozin as a foundational treatment for CKD in many countries[1].

EASi-KIDNEY Trial

Building on the success of the EMPA-KIDNEY trial, the EASi-KIDNEY trial is currently underway to investigate whether the combination of vicadrostat (BI 690517) and empagliflozin can further reduce the risk of kidney disease progression, hospitalization for heart failure, or death from cardiovascular disease. This trial is significant as it involves a novel selective aldosterone synthase inhibitor, vicadrostat, which has shown promising results in earlier Phase II trials, including a significant reduction of albuminuria by up to 40% when combined with empagliflozin[1].

EMPACT-MI Trial

The EMPACT-MI trial has shown that empagliflozin can reduce heart failure events among patients who have suffered a heart attack, regardless of their baseline kidney function. This multicenter, randomized trial involved over 6,500 adults from 22 countries and demonstrated that empagliflozin reduced the risk of hospitalization for heart failure and maintained stable eGFR compared to the placebo group[4].

EMPEROR-Preserved Trial

The EMPEROR-Preserved trial focused on patients with heart failure with preserved ejection fraction (HFpEF) and showed that empagliflozin significantly reduced hospitalizations for heart failure and improved patient-reported health status. However, the long-term cost-effectiveness of empagliflozin in this population remains a subject of ongoing analysis[3].

Market Analysis

Market Size and Growth

The global empagliflozin market is projected to grow substantially, with a compound annual growth rate (CAGR) of 32% from 2024 to 2032. The market size is expected to reach approximately USD 100,922.59 million by 2032. This growth is driven by the increasing adoption of empagliflozin in various clinical settings, including hospitals and drug stores, particularly in regions like North America and Europe[2].

Regional Outlook

North America, especially the United States, is expected to play a crucial role in the market growth due to the high adoption of advanced technologies and the presence of major pharmaceutical companies. Europe also shows significant growth potential, with a notable CAGR during the forecast period. The Asia-Pacific region, including countries like China and India, is also expected to contribute significantly to the market expansion[2].

Competitive Landscape

The market is dominated by several key manufacturers, including Boehringer Ingelheim (Germany), Kelun (China), CTTQ (China), Jiangsu Aosaikang Pharmaceutical (China), HANSOH (China), MSN Labs (India), and Lupin Limited (India). These companies are investing heavily in research and development to maintain their market share and explore new therapeutic applications for empagliflozin[2].

Market Projections

Forecasted Sales

The forecasted sales data for empagliflozin from 2025 to 2032 indicate a robust growth trajectory. The market is expected to expand due to extensive research, incremental healthcare spending, and the launch of new therapies. The report highlights that the market scenario for lipodystrophy, among other conditions, is set to change, enabling drug manufacturers to penetrate deeper into the market[5].

Regulatory Milestones and Development Activities

Empagliflozin has achieved several regulatory milestones, and ongoing research and development activities are focused on novel approaches to treat various disease conditions. The report provides detailed insights into the clinical trials, trial interventions, and developmental activities, which are crucial for understanding the current and future market scenario[5].

Cost-Effectiveness Analysis

While empagliflozin has shown significant clinical benefits, its cost-effectiveness remains a critical factor. Studies like the EMPEROR-Preserved trial have highlighted that empagliflozin provides low economic value compared to standard care for HFpEF, mainly due to its high cost and limited benefit on mortality and quality of life. However, the overall cost-effectiveness can vary based on factors such as monthly cost, quality-of-life benefits, and the effect on cardiovascular mortality[3].

Key Takeaways

• Clinical Efficacy: Empagliflozin has demonstrated significant reductions in kidney disease progression, heart failure events, and cardiovascular mortality across various clinical trials.
• Market Growth: The global empagliflozin market is projected to grow at a CAGR of 32% from 2024 to 2032, driven by increasing adoption and expanding therapeutic applications.
• Regional Impact: North America and Europe are expected to be key regions driving market growth, with significant contributions from the Asia-Pacific region.
• Cost-Effectiveness: While clinically beneficial, the cost-effectiveness of empagliflozin varies and is a subject of ongoing economic evaluations.

FAQs

What is the primary use of empagliflozin?

Empagliflozin is primarily used in the treatment of type 2 diabetes, but it also has benefits in reducing the risk of heart failure and chronic kidney disease progression.

Which companies are the largest manufacturers of empagliflozin?

The largest manufacturers include Boehringer Ingelheim (Germany), Kelun (China), CTTQ (China), and others such as MSN Labs (India) and Lupin Limited (India)[2].

What are the key findings of the EMPA-KIDNEY trial?

The EMPA-KIDNEY trial showed that empagliflozin reduces the risk of kidney disease progression or death from cardiovascular disease by 28% in patients with CKD, with and without diabetes[1].

How does empagliflozin impact patients with heart failure?

Empagliflozin has been shown to reduce hospitalizations for heart failure and improve patient-reported health status in patients with heart failure, including those with preserved ejection fraction (HFpEF)[3][4].

What is the projected market size of empagliflozin by 2032?

The global empagliflozin market is projected to reach approximately USD 100,922.59 million by 2032, growing at a CAGR of 32% from 2024 to 2032[2].

Sources

1. New trial to test potential treatment for chronic kidney disease - Oxford Population Health
2. Empagliflozin Tablets Market Set to Achieve USD 100922.59 Million By 2032 - OpenPR
3. Cost-effectiveness of Empagliflozin in Patients With Heart Failure - JAMA Internal Medicine
4. SGLT2 Inhibitor Empagliflozin Is Shown to Be Safe and Effective for Treating Patients Who Have Suffered a Heart Attack - Mount Sinai
5. Empagliflozin Market Size, Forecast, and Emerging Insight − 2032 - Research and Markets