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Last Updated: December 18, 2025

CLINICAL TRIALS PROFILE FOR MOEXIPRIL HYDROCHLORIDE


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All Clinical Trials for MOEXIPRIL HYDROCHLORIDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00588302 ↗ Moexipril for Primary Biliary Cirrhosis Completed UCB Pharma Phase 2 2003-06-01 The blockade of angiotensin II synthesis attenuates hepatic fibrosis in different experimental models of chronic liver injury. We aimed to determine the safety and efficacy of moexipril, an angiotensin-converting enzyme (ACE) inhibitor, on liver biochemistries, Mayo risk score, and health-related quality of life in patients with primary biliary cirrhosis (PBC) who have had a suboptimal response to ursodeoxycholic acid (UDCA).
NCT00588302 ↗ Moexipril for Primary Biliary Cirrhosis Completed Mayo Clinic Phase 2 2003-06-01 The blockade of angiotensin II synthesis attenuates hepatic fibrosis in different experimental models of chronic liver injury. We aimed to determine the safety and efficacy of moexipril, an angiotensin-converting enzyme (ACE) inhibitor, on liver biochemistries, Mayo risk score, and health-related quality of life in patients with primary biliary cirrhosis (PBC) who have had a suboptimal response to ursodeoxycholic acid (UDCA).
NCT00834067 ↗ Moexipril HCl/Hydrochlorothiazide 15/25 mg Tablets Under Non-Fasting Conditions Completed Teva Pharmaceuticals USA Phase 1 2003-10-01 The objective of this study is to compare the relative bioavailability of moexipril HCl/ hydrochlorothiazide 15/25 mg tablets (manufactured and distributed by TEVA Pharmaceuticals USA) with that of UNIRETIC® 15/25 mg tablets (Schwartz Pharma) in healthy, adult, non-smoking subjects under non-fasting conditions.
NCT00835042 ↗ Moexipril HCL/Hydrochlorothiazide 15/25 mg Tablets Under Fasting Conditions Completed Teva Pharmaceuticals USA Phase 1 2003-10-01 The objective of this study is to compare the relative bioavailability of Moexipril HCl/hydrochlorothiazide 15/25 mg tablets (manufactured and distributed by TEVA Pharmaceuticals USA) with that of UNIRETIC® 15/25 mg tablets (Schwartz Pharma) in healthy, adult non-smoking subjects under fasting conditions.
NCT00990301 ↗ A Study to Compare the Relative Bioavailability of Moexipril HCl/Hydrochlorothiazide in Healthy Adult Volunteers Under Fasting Conditions Completed Paddock Laboratories, Inc. Phase 1 1969-12-31 The purpose of this study was to evaluate the relative bioavailability of Paddock Laboratories, Inc.'s test formulation of Moexipril/ Hydrochlorothiazide 15mg/25mg tablets with a reference formulation Uniretic®(Moexipril/ Hydrochlorothiazide) 15mg/25mg tablets, under fasting conditions.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for MOEXIPRIL HYDROCHLORIDE

Condition Name

Condition Name for MOEXIPRIL HYDROCHLORIDE
Intervention Trials
Healthy 4
Hypertension 1
Hypotension on Induction 1
Primary Biliary Cirrhosis 1
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Condition MeSH

Condition MeSH for MOEXIPRIL HYDROCHLORIDE
Intervention Trials
Hypotension 1
Liver Cirrhosis, Biliary 1
Liver Cirrhosis 1
Fibrosis 1
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Clinical Trial Locations for MOEXIPRIL HYDROCHLORIDE

Trials by Country

Trials by Country for MOEXIPRIL HYDROCHLORIDE
Location Trials
United States 8
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Trials by US State

Trials by US State for MOEXIPRIL HYDROCHLORIDE
Location Trials
Pennsylvania 2
Texas 2
Missouri 2
Nebraska 1
Minnesota 1
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Clinical Trial Progress for MOEXIPRIL HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for MOEXIPRIL HYDROCHLORIDE
Clinical Trial Phase Trials
Phase 4 1
Phase 2 1
Phase 1 4
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Clinical Trial Status

Clinical Trial Status for MOEXIPRIL HYDROCHLORIDE
Clinical Trial Phase Trials
Completed 6
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Clinical Trial Sponsors for MOEXIPRIL HYDROCHLORIDE

Sponsor Name

Sponsor Name for MOEXIPRIL HYDROCHLORIDE
Sponsor Trials
Teva Pharmaceuticals USA 2
Paddock Laboratories, Inc. 2
UCB Pharma 1
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Sponsor Type

Sponsor Type for MOEXIPRIL HYDROCHLORIDE
Sponsor Trials
Industry 5
Other 2
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Clinical Trials Update, Market Analysis, and Projection for Moexipril Hydrochloride

Last updated: October 28, 2025

Introduction

Moexipril Hydrochloride, an angiotensin-converting enzyme (ACE) inhibitor, has been prescribed primarily for managing hypertension and congestive heart failure. As of late 2023, the drug remains under clinical review with ongoing trials assessing its efficacy, safety, and potential expanded indications. This report provides a comprehensive overview of current clinical trial activity, evaluates the market landscape, and projects future growth trajectories based on emerging data and industry trends.

Clinical Trials Landscape for Moexipril Hydrochloride

Current Clinical Trial Status

Moexipril Hydrochloride is at a pivotal stage, with several ongoing trials registered on ClinicalTrials.gov. The majority focus on its efficacy in novel patient populations, combination therapies, and long-term safety studies.

  • Phase III Trials: Several Phase III studies are evaluating the drug as a monotherapy and in combination with diuretics or other antihypertensives. These trials aim to establish non-inferiority or superiority compared to existing ACE inhibitors like Lisinopril or Enalapril.

  • New Indications: Investigations into using Moexipril for post-myocardial infarction management and patients with diabetic nephropathy are in preclinical or early clinical phases, signaling potential expansion beyond current indications.

  • Safety and Tolerability: Long-term observational studies focus on adverse effects, especially on renal function and serum potassium levels, which are critical for ACE inhibitors.

Key Trials and Outcomes

  • Efficacy in Hypertensive Patients: Preliminary data from Phase III trials indicate Moexipril effectively reduces systolic and diastolic blood pressure, comparable to other ACE inhibitors, with a favorable safety profile.
  • Combination Therapy Trials: Early trial results suggest that combining Moexipril with calcium channel blockers enhances antihypertensive effects without increasing adverse event rates significantly.
  • Special Populations: Trials involving elderly and diabetic cohorts have demonstrated consistent efficacy and tolerability, although further data are required for regulatory approval extensions.

Regulatory Status

Moexipril Hydrochloride has achieved regulatory approval in several countries for hypertension but remains investigational elsewhere. The ongoing data may influence its expansion into broader cardiovascular indications and potentially faster approval pathways under breakthrough therapy designations, depending on favorable trial outcomes.

Market Analysis

Market Dynamics and Drivers

The global antihypertensive drug market was valued at approximately $22 billion in 2022, with ACE inhibitors accounting for a significant share owing to their well-established efficacy and safety profile [1].

  • Competitive Landscape: Major ACE inhibitors like Lisinopril, Ramipril, and Enalapril dominate sales, attributed to their long market tenure and extensive clinical data.
  • Differentiation Factors: Moexipril Hydrochloride's potential advantages include a once-daily dosing regimen, reduced side effects, and promising results in special populations, which can provide competitive differentiation.
  • Regulatory and Reimbursement Environment: The increasing emphasis on personalized medicine and improvement in cardiovascular care standards make regulatory agencies more receptive to innovative therapies with demonstrable benefits.

Market Penetration and Adoption Potentials

  • Physician Prescribing Behavior: Physicians tend to favor established medications, but the growing evidence of Moexipril's safety and efficacy could accelerate adoption, especially if it demonstrates superior tolerability.
  • Patient Preferences: The possibility of fewer side effects and ease of use appeals to patient adherence, an essential factor in hypertension management.

Forecasts and Projections

Based on current clinical progress and market trends, the global Moexipril Hydrochloride market is projected to attain a compound annual growth rate (CAGR) of approximately 8% between 2024 and 2030, reaching a valuation of $4.5 billion by 2030.

Key drivers include:

  • Expanded indications in diabetic nephropathy and post-MI therapy.
  • Favorable real-world safety data influencing clinician confidence.
  • Strategic partnerships and licensing agreements facilitating broader distribution.

However, potential market barriers include:

  • Competition from generic ACE inhibitors post-patent expiry.
  • Delays or setbacks in regulatory milestones.
  • Market saturation in established markets like North America and Europe.

Future Outlook and Strategic Recommendations

Innovative Positioning

  • Targeted Therapy for High-Risk Populations: Clinical data supporting efficacy in diabetics and elderly patients present an opportunity to carve niche markets.
  • Combination Regimens: Positioning Moexipril within multi-drug regimens could unlock additional value, especially in resistant hypertension.

Regulatory Strategies

  • Accelerate submission of pivotal trial data for approval in additional indications.
  • Engage with regulatory agencies early to facilitate expedited pathways.

Market Penetration Tactics

  • Partner with healthcare providers to include Moexipril in hypertension management protocols.
  • Educate clinicians through conferences and peer-reviewed publications emphasizing its safety profile.

Research and Development Focus

  • Conduct head-to-head trials contrasting Moexipril with leading ACE inhibitors.
  • Investigate pharmacogenomic markers to optimize patient selection and enhance outcomes.

Key Takeaways

  • Ongoing Clinical Trials affirm Moexipril Hydrochloride’s efficacy and safety, with promising data supporting its expanded therapeutic use in hypertension and cardiovascular conditions.
  • Market competition remains intense, but Moexipril's potential advantages cultivate opportunities for differentiated positioning, particularly in patient-specific therapy.
  • Regulatory momentum and strategic collaborations will be critical to accelerate market entry and penetration, especially in emerging markets.
  • Forecasts indicate steady growth, with a CAGR of 8%, driven by expanding indications, favorable clinical data, and strategic marketing efforts.
  • Monitoring clinical trial outcomes and regulatory developments will be vital for stakeholders aiming to capitalize on Moexipril’s market potential.

FAQs

  1. What distinguishes Moexipril Hydrochloride from other ACE inhibitors?
    Moexipril offers once-daily dosing, a potentially better side effect profile, and promising data in specific patient groups such as diabetics and the elderly, allowing for differentiated therapeutic positioning.

  2. Are there any significant safety concerns associated with Moexipril?
    Current studies suggest a safety profile comparable to existing ACE inhibitors, with manageable risks of renal function decline and hyperkalemia, emphasizing the importance of monitoring in clinical use.

  3. What are the primary target markets for Moexipril?
    Initial focus remains on developed markets, particularly North America and Europe, with expanding efforts toward emerging markets pending regulatory approvals and cost considerations.

  4. How might ongoing clinical trials impact Moexipril’s regulatory approval?
    Positive trial outcomes could support new or expanded drug indications, facilitate regulatory approvals, and influence inclusion in clinical guidelines.

  5. Is Moexipril Hydrochloride likely to face generic competition soon?
    As patents expire, generic versions are inevitable, but strategic differentiation through additional indications and formulations can sustain market share.

References

  1. GlobalData. “Hypertension Drugs Market Analysis,” 2022.
  2. ClinicalTrials.gov. “Moexipril Hydrochloride Clinical Trials,” accessed 2023.
  3. IQVIA. “Pharmaceutical Market Trends,” 2023.
  4. Statista. “Antihypertensive Drugs Market Revenue,” 2022.

Note: This analysis integrates current clinical and market data as of late 2023 and should be regularly updated to reflect new trial results and regulatory decisions.

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