CLINICAL TRIALS PROFILE FOR ENALAPRILAT

All Clinical Trials for enalaprilat

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01413542 ↗	Pharmacogenetics of Ace Inhibitor-Associated Angioedema	Completed	Vanderbilt University	N/A	2011-11-01	The investigators would like to find out if sitagliptin (dipeptidyl peptidase-4 or DPP4 inhibition), a drug to treat diabetes, affects blood vessel relaxation in healthy people receiving enalapril (angiotensin converting enzyme or ACE inhibition), a blood pressure medicine. Understanding how these drugs interact in healthy people will help us learn their potential effects in people who have diabetes.
NCT00741156 ↗	The Acute Effects of the Angiotensin-converting Enzyme Inhibitor Enalaprilat on Flow Distribution	Completed	The Hospital for Sick Children	Phase 3	2008-07-01	The primary objective of this study is to study the acute effects of angiotensin-converting enzyme inhibitor (ACEI) on systemic, pulmonary and cerebral blood flow in post bidirectional cavopulmonary connection (BCPC) patients.
NCT00226096 ↗	Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage	Completed	National Health and Medical Research Council, Australia	N/A	2005-11-01	The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.
NCT00226096 ↗	Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage	Completed	The George Institute	N/A	2005-11-01	The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.
NCT01324245 ↗	Intervention Study to Compare the Natriuretic Effects of Enalapril on Low and High Salt Diet	Completed	University of Virginia	N/A	2002-11-01	The kidney plays a crucial role in maintaining salt balance by two opposing physiological mechanisms: the renal dopaminergic system which enhances salt excretion and the renin-angiotensin system (RAS) which causes salt retention. Salt-sensitive hypertension occurs when this balance is altered or abnormal. We hypothesized that this balance is influenced by salt intake: therefore dietary salt affects the natriuretic response to the renal dopaminergic agonist Fenoldopam, and the Angiotensin Converting Enzyme inhibitor, Enalapril. In this trial we study normal salt balance mechanisms in salt resistant adults with normal blood pressure.
NCT01324245 ↗	Intervention Study to Compare the Natriuretic Effects of Enalapril on Low and High Salt Diet	Completed	Georgetown University	N/A	2002-11-01	The kidney plays a crucial role in maintaining salt balance by two opposing physiological mechanisms: the renal dopaminergic system which enhances salt excretion and the renin-angiotensin system (RAS) which causes salt retention. Salt-sensitive hypertension occurs when this balance is altered or abnormal. We hypothesized that this balance is influenced by salt intake: therefore dietary salt affects the natriuretic response to the renal dopaminergic agonist Fenoldopam, and the Angiotensin Converting Enzyme inhibitor, Enalapril. In this trial we study normal salt balance mechanisms in salt resistant adults with normal blood pressure.

Clinical Trial Conditions for enalaprilat

Condition Name

Condition Name for enalaprilat
Intervention	Trials
Heart Failure	3
Hypertension	2
Intracranial Hemorrhages	1
Bile Salt Export Pump (BSEP) Transporter	1

Condition MeSH

Condition MeSH for enalaprilat
Intervention	Trials
Hypertension	4
Heart Failure	3
Cardiomyopathy, Dilated	2
Cardiomyopathies	2

Clinical Trial Locations for enalaprilat

Trials by Country

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Trials by Country for enalaprilat
Location	Trials
Australia	5
United States	4
United Kingdom	2
Austria	2
Serbia	2

Trials by US State

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−

Trials by US State for enalaprilat
Location	Trials
Tennessee	2
Maryland	1
District of Columbia	1

Clinical Trial Progress for enalaprilat

Clinical Trial Phase

Clinical Trial Phase for enalaprilat
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for enalaprilat
Clinical Trial Phase	Trials
Completed	7
Unknown status	3
Recruiting	1

Clinical Trial Sponsors for enalaprilat

Sponsor Name

Sponsor Name for enalaprilat
Sponsor	Trials
Ethicare GmbH	3
Vanderbilt University	2
National Health and Medical Research Council, Australia	2

Sponsor Type

Sponsor Type for enalaprilat
Sponsor	Trials
Other	16
Industry	4

Enalapril and Enalaprilat: Clinical Trials, Market Analysis, and Projections

Introduction

Enalapril, a widely used angiotensin-converting enzyme (ACE) inhibitor, is converted in the body to its active metabolite, enalaprilat. This drug is crucial in the management of hypertension and heart failure. Here, we will delve into recent clinical trials, market analysis, and projections for enalapril and its metabolite enalaprilat.

Clinical Trials: Enalapril vs. Other Treatments

Comparison with Sacubitril-Valsartan

In the context of heart failure with reduced ejection fraction (HFrEF), several clinical trials have compared enalapril with sacubitril-valsartan. The PIONEER-HF trial, for instance, showed that sacubitril-valsartan reduced N-terminal pro b-type natriuretic peptide (NT-proBNP) levels more significantly than enalapril among patients admitted with acute decompensated heart failure (ADHF)[4].

• NT-proBNP Reduction: The trial indicated a 46.7% reduction in NT-proBNP levels with sacubitril-valsartan compared to a 25.3% reduction with enalapril.
• Biomarkers: Sacubitril-valsartan also led to greater declines in high-sensitivity troponin T (hsTnT) and soluble ST2 (sST2) compared to enalapril.
• Clinical Outcomes: Although not powered for clinical endpoints, the trial suggested a reduction in rehospitalization for heart failure and the composite clinical endpoint with sacubitril-valsartan.

Another study focused on central aortic stiffness and found that treatment with sacubitril-valsartan did not significantly reduce central aortic stiffness compared to enalapril in patients with HFrEF[1].

Pharmacokinetics and Formulations

A population pharmacokinetic study analyzed the pharmacokinetics of enalapril and its active metabolite enalaprilat in healthy adults using different formulations, including child-appropriate orodispersible mini-tablets (ODMT) and the reference formulation (Renitec®). The study found that the pharmacokinetics of enalapril and enalaprilat were similar between the two formulations, with some differences in mean transit time (MTT) of enalapril absorption[3].

Market Analysis and Projections

Global Market Size and Growth

The global enalapril market is expected to experience significant growth due to the rising prevalence of cardiovascular diseases. According to Cognitive Market Research, the global enalapril market size is projected to expand at a compound annual growth rate (CAGR) of 6.20% from 2024 to 2031, reaching a substantial value by the end of the forecast period[5].

• Regional Growth: North America currently dominates the enalapril market, driven by the high prevalence of hypertension and cardiovascular diseases. The Asia-Pacific region is expected to show the highest CAGR, driven by increasing healthcare access and awareness of cardiovascular health.
• Market Segments: The market is segmented by type (capsule, pill) and application (treatment of essential hypertension, heart failure, prevention of myocardial infarction, etc.), with each segment contributing to the overall growth[2].

Market Drivers and Challenges

The market growth is driven by several factors, including:

• Increasing Prevalence of Cardiovascular Diseases: The rising incidence of hypertension and heart failure globally is a significant driver.
• Early Diagnosis and Preventive Care: Growing awareness and early diagnosis of cardiovascular diseases are increasing the demand for enalapril.
• Availability of Conventional Alternatives: The availability of less expensive conventional alternatives is also driving the market[5].

However, the market also faces challenges such as:

• Side Effects: Enalapril can cause side effects like hyperkalemia and hypotension, which may limit its use in some patients.
• Competition from New Therapies: The emergence of new therapies like sacubitril-valsartan may pose a competitive challenge to enalapril[4].

Market Trends and Opportunities

Geographical Expansion

The Asia-Pacific region is expected to be a key growth area due to increasing healthcare access and a growing awareness of cardiovascular health. This region offers significant opportunities for market expansion[5].

Product Innovations

The development of new formulations, such as child-appropriate orodispersible mini-tablets, can expand the market by making the drug more accessible to a broader patient population[3].

Regulatory Environment

Changes in regulatory policies and the approval of new formulations can also impact market dynamics. For instance, the absence of an approved child-appropriate dosage formulation for pediatric heart failure treatment highlights a need that, if addressed, could further boost the market[3].

Key Takeaways

• Clinical Trials: Enalapril has been compared with sacubitril-valsartan in several trials, showing varying outcomes in terms of biomarker reduction and clinical endpoints.
• Market Growth: The global enalapril market is projected to grow significantly, driven by the increasing prevalence of cardiovascular diseases and early diagnosis.
• Regional Focus: North America and the Asia-Pacific region are key markets, with the latter expected to show the highest growth rate.
• Product Innovations: New formulations and regulatory approvals can expand market opportunities.

FAQs

What is the primary use of enalapril?

Enalapril is primarily used for the treatment of hypertension and heart failure.

How does enalapril compare to sacubitril-valsartan in clinical trials?

In clinical trials, sacubitril-valsartan has shown greater reductions in NT-proBNP and other biomarkers compared to enalapril, particularly in patients with acute decompensated heart failure.

What are the key drivers of the enalapril market?

The key drivers include the rising prevalence of cardiovascular diseases, early diagnosis and preventive care, and the availability of conventional alternatives.

Which regions are expected to show significant growth in the enalapril market?

North America and the Asia-Pacific region are expected to show significant growth, with the Asia-Pacific region having the highest CAGR.

What are the potential challenges facing the enalapril market?

Challenges include side effects such as hyperkalemia and hypotension, and competition from new therapies like sacubitril-valsartan.

Sources

1. Effect of Sacubitril-Valsartan vs Enalapril on Aortic Stiffness in Patients With Heart Failure and Reduced Ejection Fraction: The PERSPECTIVE Randomized Clinical Trial. JAMA, 2019.
2. Global Enalapril Maleate Market Size, Trends and Projections. Market Research Intellect, 2024.
3. Simultaneous Semi-Mechanistic Population Pharmacokinetic Modeling of Enalapril and Enalaprilat in Healthy Adults. PMC, 2019.
4. Comparison of Sacubitril–Valsartan versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode - PIONEER-HF. American College of Cardiology, 2020.
5. Global Enalapril Market Report. Cognitive Market Research, 2024.