CLINICAL TRIALS PROFILE FOR ENALAPRIL MALEATE

All Clinical Trials for enalapril maleate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00568178 ↗	An Extension Study Designed to Assess Effects of Losartan on Proteinuria in Pediatric Populations (MK-0954-326 AM1,EXT1(AM2))	Completed	Merck Sharp & Dohme Corp.	Phase 3	2007-06-01	The purpose of this study is to evaluate the effects of losartan on proteinuria in pediatric patients.
NCT00003070 ↗	Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer	Completed	National Cancer Institute (NCI)	Phase 3	2000-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as enalapril, may protect normal cells from the toxic effects of chemotherapy. It is not known whether enalapril is more effective than a placebo in treating heart damage in patients who received anthracycline chemotherapy for childhood cancer. PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of enalapril with a placebo in treating heart damage in patients who received anthracycline chemotherapy for childhood cancer.
NCT00003070 ↗	Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer	Completed	Children's Oncology Group	Phase 3	2000-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as enalapril, may protect normal cells from the toxic effects of chemotherapy. It is not known whether enalapril is more effective than a placebo in treating heart damage in patients who received anthracycline chemotherapy for childhood cancer. PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of enalapril with a placebo in treating heart damage in patients who received anthracycline chemotherapy for childhood cancer.
NCT00000522 ↗	Treatment of Mild Hypertension Study (TOMHS)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1985-08-01	To compare the effects of nonpharmacologic therapy alone with those of one of five active drug regimens combined with non-pharmacologic therapy, for long- term management of patients with mild hypertension.
NCT00000522 ↗	Treatment of Mild Hypertension Study (TOMHS)	Completed	University of Minnesota	Phase 2	1985-08-01	To compare the effects of nonpharmacologic therapy alone with those of one of five active drug regimens combined with non-pharmacologic therapy, for long- term management of patients with mild hypertension.
NCT00000522 ↗	Treatment of Mild Hypertension Study (TOMHS)	Completed	University of Minnesota - Clinical and Translational Science Institute	Phase 2	1985-08-01	To compare the effects of nonpharmacologic therapy alone with those of one of five active drug regimens combined with non-pharmacologic therapy, for long- term management of patients with mild hypertension.

Clinical Trial Conditions for enalapril maleate

Condition Name

Condition Name for enalapril maleate
Intervention	Trials
Hypertension	7
Breast Cancer	2
Cardiovascular Diseases	2
Heart Diseases	1

Condition MeSH

Condition MeSH for enalapril maleate
Intervention	Trials
Hypertension	9
Essential Hypertension	3
Kidney Diseases	2
Cardiovascular Diseases	2

Clinical Trial Locations for enalapril maleate

Trials by Country

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Trials by Country for enalapril maleate
Location	Trials
United States	28
China	9
Canada	4
United Kingdom	2
Switzerland	1

Trials by US State

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Trials by US State for enalapril maleate
Location	Trials
Florida	1
District of Columbia	1
Connecticut	1
California	1
Arkansas	1

Clinical Trial Progress for enalapril maleate

Clinical Trial Phase

Clinical Trial Phase for enalapril maleate
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	5
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for enalapril maleate
Clinical Trial Phase	Trials
Completed	12
Unknown status	2
Withdrawn	1

Clinical Trial Sponsors for enalapril maleate

Sponsor Name

Sponsor Name for enalapril maleate
Sponsor	Trials
Shenzhen Ausa Pharmed Co.,Ltd	3
Masonic Cancer Center, University of Minnesota	1
Newcastle-upon-Tyne Hospitals NHS Trust	1

Sponsor Type

Sponsor Type for enalapril maleate
Sponsor	Trials
Other	19
Industry	8
NIH	2

Enalapril Maleate: Clinical Trials, Market Analysis, and Projections

Introduction to Enalapril Maleate

Enalapril maleate is a small molecule drug classified as an angiotensin-converting enzyme (ACE) inhibitor. It is widely used in the treatment of essential hypertension, heart failure, and to prevent myocardial infarction. Here, we will delve into the current clinical trials, market analysis, and future projections for enalapril maleate.

Clinical Trials and Efficacy

Ongoing and Recent Trials

Enalapril maleate has been the subject of numerous clinical trials to assess its efficacy and safety. A recent Phase 2 pilot study investigated the efficacy of enalapril in male and female patients, highlighting its continued relevance in cardiovascular treatment[1].

In another context, enalapril has been compared with other treatments in Phase 4 studies. For example, a study compared enalapril with sacubitril/valsartan, another cardiovascular medication, to evaluate their respective efficacies[1].

Adverse Effects and Cough Incidence

One notable side effect of enalapril maleate is the induction of a dry, persistent cough. A retrospective analysis found that approximately 10.5% of patients taking enalapril required discontinuation of therapy due to this intractable cough, with women being more affected than men[4].

Market Analysis

Global Market Size and Growth

The global enalapril maleate market was valued at approximately USD 1.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.5% from 2022 to 2030. This growth is driven by the increasing prevalence of hypertension and heart failure, as well as the rising geriatric population and growing awareness about cardiovascular diseases[3].

Regional Market Insights

• North America: This region, particularly the United States, is expected to play a pivotal role in the market's development. The high adoption of advanced technology and the presence of major industry players are key drivers of growth in this region[3].
• Europe: Europe is also anticipated to experience significant growth, with a strong CAGR during the forecast period from 2024 to 2031[3].
• Asia Pacific: The Asia Pacific region, including countries like China, is expected to see substantial growth due to increasing healthcare expenditure and a growing awareness of cardiovascular diseases[2].

Key Manufacturers

The global market for enalapril maleate API is dominated by several key manufacturers, including:

• Dr. Reddy’s Laboratories Ltd.
• Medichem S.A
• Inke S.A
• Farmhispania, S.A.
• Neuland Laboratories
• Zhejiang Huahai Pharmaceuticals Co., Ltd
• Maprimed S.A.
• Changzhou Pharmaceutical Factory
• Hangzhou Think Chemical Co.Ltd[2].

Market Projections

Forecasted Growth

The market for enalapril maleate API is expected to increase significantly from 2024 to 2030. The US and Canada market, for instance, is forecasted to grow at a notable CAGR during this period. Similarly, the China and Europe markets are projected to see substantial growth, driven by increasing demand for effective ACE inhibitors[2].

Technological and Regulatory Trends

AI and automation are revolutionizing the enalapril maleate market by enhancing research and development processes, improving manufacturing efficiency, and optimizing supply chain management. AI-driven predictive analytics help forecast market trends and consumer needs more accurately, while automation technologies streamline production lines, reducing operational costs and increasing output[3].

Application Segments

The market is segmented based on application, with the largest segments being:

• Treatment of essential hypertension
• Treatment of heart failure
• Prevention of myocardial infarction
• Other applications[3].

Impact of AI and Automation

AI and automation are significantly impacting the enalapril maleate market. These technologies are:

• Enhancing research and development by accelerating the discovery of new formulations and therapies.
• Improving manufacturing efficiency through streamlined production lines.
• Optimizing supply chain management to reduce costs and increase output.
• Employing predictive analytics to forecast market trends and consumer needs more accurately[3].

Conclusion

Enalapril maleate remains a crucial medication in the treatment of cardiovascular diseases. With ongoing clinical trials and a growing market, it is clear that this drug will continue to play a significant role in healthcare.

Key Takeaways

• Clinical Trials: Enalapril maleate is undergoing various clinical trials to assess its efficacy and safety.
• Market Growth: The global market is projected to grow at a CAGR of 4.5% from 2022 to 2030.
• Regional Insights: North America, Europe, and the Asia Pacific are key regions driving market growth.
• Technological Trends: AI and automation are enhancing R&D, manufacturing, and supply chain management.
• Application Segments: The market is primarily driven by the treatment of hypertension, heart failure, and prevention of myocardial infarction.

FAQs

What is the primary mechanism of action of enalapril maleate?

Enalapril maleate works as an angiotensin-converting enzyme (ACE) inhibitor, which helps in reducing blood pressure and alleviating symptoms of heart failure[1].

What are the common side effects of enalapril maleate?

One of the notable side effects is a dry, persistent cough, which can be more common in women than men[4].

Which regions are leading the growth in the enalapril maleate market?

North America, particularly the United States, Europe, and the Asia Pacific region are expected to drive significant growth in the market[3].

How is AI impacting the enalapril maleate market?

AI is enhancing research and development, improving manufacturing efficiency, optimizing supply chain management, and employing predictive analytics to forecast market trends[3].

Who are the key manufacturers of enalapril maleate API?

Key manufacturers include Dr. Reddy’s Laboratories Ltd., Medichem S.A, Inke S.A, Farmhispania, S.A., and others[2].

Sources

1. Synapse: Enalapril Maleate - Drug Targets, Indications, Patents.
2. QYResearch: Global Enalapril Maleate API Market Insights, Forecast to 2030.
3. GitHub: Enalapril-Maleate-Market.md.
4. JAMA Internal Medicine: Enalapril-Induced Cough.
5. Cognitive Market Research: Enalapril Maleate Market Report 2024 (Global Edition).