CLINICAL TRIALS PROFILE FOR QUINAPRIL HYDROCHLORIDE

All Clinical Trials for QUINAPRIL HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00065559 ↗	Treatment of Diabetic Nephropathy	Terminated	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	N/A	2003-04-01	COX-2 is an enzyme that is found in several different tissues in the body. COX-2 appears to produce a substance called prostaglandins, mainly at sites of inflammation. Several drugs have been approved by the FDA that inhibit COX-2 such as celecoxib, or brand name Celebrex®. These drugs are primarily used in patients with osteoarthritis and rheumatoid arthritis to decrease inflammation and pain. COX-2 inhibitors have been developed because they are more selective in treatment of inflammation and pain and tend to have fewer gastrointestinal side effects than NSAIDs (nonsteroidal anti-inflammatory drugs) such as aspirin, ibuprofen, naproxen, etc. The normal adult kidney expresses COX-2 in various regions. Prostaglandins, which are produced in the kidney by COX-2, may contribute to glomerular and tubulointerstitial inflammatory diseases (types of kidney diseases due to inflammation). In some animal studies, COX-2 inhibitors have been shown to be potentially beneficial in reducing the amount of protein spilled in the urine and preserving kidney function with these inflammatory kidney diseases. This study will compare the effects of COX-2 inhibitor to placebo (an inactive substance) in patients with diabetic nephropathy (kidney disease due to diabetes) and proteinuria (spilling protein in the urine) on 24-hour urinary protein excretion. This study is designed to see whether COX-2 inhibitors are useful in treating diabetic patients with kidney disease. The purpose of this study is a short-term pilot study that will allow the gathering of important data such as the ability to carry out the study and carry it out safely. Subjects with proteinuria and diabetic kidney disease already on ACE (Angiotensin-Converting Enzyme) inhibitor or ARB (Angiotensin Receptor Blocker) therapy (types of blood pressure medicines) will be randomized to a type of study in which each subject will serve as their own control. The study is set up so that each subject will receive either the COX-2 inhibitor or placebo for a period followed by a period of no drug and then followed by a period of receiving either the COX-2 inhibitor or placebo (whichever they did not receive the first period).
NCT00147524 ↗	Non-Comparative Study To Evaluate Changes In FMD After Quinapril Therapy In Hypertensive Women	Completed	Pfizer	Phase 4	2003-10-01	ACE inhibitors are thought to modify the endothelium in a number of ways. Quinapril is an effective and well-tolerated ACE-I for the treatment of patients with hypertension and congestive heart failure. Quinapril produces favourable haemodynamic changes and improves ventricular and endothelial function in patients with various cardiovascular disorders. These effects are mediated through the binding of quinaprilat to both tissue and plasma-ACE. Quinapril 10 to 40 mg once daily improved endothelial function (as measured by improved FMD or reduced vasoconstrictive/increased vasodilative response to Ach) in patients with CAD and hypertension over 2 to 6 months of therapy; improved endothelial function was also observed in patients with CHF receiving a single infusion of quinaprilat. In general, quinapril showed neutral or beneficial effects on lipid profiles, glycaemia and renal haemodynamics. (3) There are no data available considering effects of quinapril on endothelial dysfunction in post- menopausal woman with mild to moderate hypertension and with pathological endothelial function.
NCT00150826 ↗	QWISE - Study of Quinapril in Women With Chest Pain, Coronary Flow Reserve Limitations and Evidence of Myocardial Ischemia	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 4	2000-05-01	INDICATION Microvascular angina. OBJECTIVES To investigate the effect of ACE (angiotensin converting enzyme) inhibition (quinapril) in improving coronary microvascular function. PATIENT POPULATION Women who meet the National Heart, Lung and Blood Institute-sponsored WISE (Women Ischemia Syndrome Evaluation) study criteria of chest discomfort, coronary flow reserve limitations and evidence for myocardial ischemia in the absence of significant coronary artery stenosis. STUDY DESIGN A prospective, randomized, placebo-controlled, comparative trial. TREATMENT Quinapril 80 mg/d versus placebo for four months. PRIMARY EFFICACY PARAMETER(S) Coronary flow reserve (CFR) at Week 16 adjusted for baseline CFR, treatment group assignment, site-specific variables, and site by treatment effects. SECONDARY EFFICACY PARAMETERS Week 16 change in chest discomfort as measured by the Seattle Angina Questionnaire adjusting for baseline values, site, and site by treatment effects. SAFETY PARAMETERS Hematology, blood chemistries, blood pressure and pulse, and frequency and occurrence of adverse events. STATISTICAL RATIONALE AND ANALYSIS A statistical rationale for the number of patients in the study has been provided. Interim analyses are planned after 15 patients have been enrolled in each group. ANTICIPATED TOTAL NUMBER OF PATIENTS 78 (39 per group). ANTICIPATED NUMBER OF PATIENTS AT EACH SITE Approximately 26

Clinical Trial Conditions for QUINAPRIL HYDROCHLORIDE

Condition Name

Condition Name for QUINAPRIL HYDROCHLORIDE
Intervention	Trials
Hypertension	10
Healthy	6
CABG	1

Condition MeSH

Condition MeSH for QUINAPRIL HYDROCHLORIDE
Intervention	Trials
Hypertension	10
Diabetes Mellitus	4
Diabetic Neuropathies	2

Clinical Trial Locations for QUINAPRIL HYDROCHLORIDE

Trials by Country

Trials by Country for QUINAPRIL HYDROCHLORIDE
Location	Trials
United States	12
India	11
Spain	4
Canada	3
Hungary	2

Trials by US State

Trials by US State for QUINAPRIL HYDROCHLORIDE
Location	Trials
North Dakota	4
Tennessee	2
Nebraska	1
Georgia	1
Texas	1

Clinical Trial Progress for QUINAPRIL HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for QUINAPRIL HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	16
Phase 3	1
Phase 1	4

Clinical Trial Status

Clinical Trial Status for QUINAPRIL HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	24
Terminated	2
Unknown status	1

Clinical Trial Sponsors for QUINAPRIL HYDROCHLORIDE

Sponsor Name

Sponsor Name for QUINAPRIL HYDROCHLORIDE
Sponsor	Trials
Pfizer	7
Mylan Pharmaceuticals	4
Montreal Heart Institute	2

Sponsor Type

Sponsor Type for QUINAPRIL HYDROCHLORIDE
Sponsor	Trials
Other	23
Industry	18
NIH	4

Quinapril Hydrochloride: Clinical Trials Update, Market Analysis, and 5-Year Projection

Last updated: April 23, 2026

What is quinapril hydrochloride and where is it used clinically?

Quinapril hydrochloride is an oral angiotensin-converting enzyme (ACE) inhibitor used for:

• Hypertension
• Heart failure (commonly studied/labelled for reduced left ventricular function after myocardial infarction or symptomatic heart failure in major markets)

It is an established, off-patent small-molecule with mature global prescribing and pricing dynamics driven primarily by generic competition, tendering, and national reimbursement rather than by new clinical efficacy differentiation.

What does the clinical trials landscape look like right now?

Across the quinapril hydrochloride clinical research ecosystem, the ongoing activity is dominated by:

• Bioequivalence (BE) studies for generic and follow-on products
• Formulation and pharmacokinetic (PK) comparability work
• Subgroup or real-world observational research tied to safety monitoring and tolerability

Current activity pattern (high-level)

Because quinapril is widely generic, the number of new, large, placebo-controlled, hypothesis-driving efficacy trials is structurally low. Most “trial updates” in the system are regulatory BE/PK and product lifecycle trials.

What matters for a business view: clinical trial visibility for quinapril is less about new clinical endpoints and more about regulatory readiness for specific market entries, product launches, and lifecycle extension through formulation.

Which trial types drive near-term evidence value for quinapril?

For a drug with broad generic uptake, evidence that changes commercial outcomes typically comes from:

• BE compliance supporting launches (ANDA filings in the US; national generic approvals elsewhere)
• Safety/performance monitoring in routine use (post-marketing pharmacovigilance and observational cohorts)
• Formulation differentiation (if any) that enables better patient adherence or improved tolerability in specific cohorts

Practical implication for pipeline analytics

A “clinical trials update” for quinapril is best interpreted as a proxy for:

• How many generic products are still cycling through new approvals
• How aggressively manufacturers are entering or expanding in specific jurisdictions
• Whether any sustained innovation is occurring via formulation or combination products (vs. monotherapy)

What is the market for quinapril hydrochloride today?

Quinapril’s market is shaped by three forces:

1. Patent expiry and generic proliferation
2. ACE-inhibitor class competition (lisinopril, enalapril, ramipril, perindopril, captopril)
3. Pricing compression through tenders and automatic substitution rules

Market structure

• Monotherapy dominates older prescribing patterns
• Combination products (e.g., ACE inhibitor plus diuretic) can shift share depending on country reimbursement and guideline preference
• Retail vs. institutional procurement materially changes observed ASPs

Where demand tends to hold up

Quinapril maintains baseline demand in markets where:

• ACE inhibitors remain first-line or guideline-concordant options
• Generic availability is broad enough to sustain low-cost prescribing
• Chronic care pathways support stable usage

How competitive is quinapril versus other ACE inhibitors?

Quinapril faces established substitution among ACE inhibitors. In formularies, switching typically depends on:

• Lowest cost to payer (generic price and tender position)
• Patient tolerance history
• Prescriber preference and local guideline language

Commercial impact: unless a competitor has a stronger tender position or better real-world formulary placement, quinapril share changes gradually. The faster movements usually occur at tender re-bids and reimbursement resets.

What are the drivers of pricing and volume for quinapril?

Pricing drivers

• Generic price erosion after each new entrant
• Tender outcomes (public procurement can cut annual revenue sharply even if unit volumes remain stable)
• Reimbursement classification in retail channels

Volume drivers

• Stable incidence of hypertension and heart failure in aging populations
• Guideline adherence to ACE inhibitors or class-based substitution
• Formulary placement and switching rules

What is the near-term investment case for quinapril-focused commercialization?

For a business pursuing market entry or expansion in quinapril:

• The value proposition tends to be cost, supply reliability, and access rather than incremental clinical differentiation.
• The commercial “activity” tends to correlate with registration/launch cadence and procurement cycles.
• Clinical trial novelty usually matters only insofar as it enables faster regulatory approval or expanded label positioning tied to local requirements.

What is the 5-year market projection for quinapril hydrochloride?

A defensible projection for an off-patent, broadly generic ACE inhibitor must be framed around unit growth and price compression. The most consistent pattern in mature generics is:

• Units grow slowly with epidemiology and guideline persistence
• Revenue grows minimally or declines modestly due to price erosion, offset partly by volume and tender-driven rebalancing

5-year projection framework (directional ranges)

• Base-case revenue CAGR: -1% to +1%
• Unit growth CAGR: 0% to +3%
• Share dynamics: gradual redistribution among generics; biggest swings at tender resets and retailer formulary changes

Scenario view

Scenario (5 years)	Unit growth (CAGR)	Revenue (CAGR)	Primary reason
Downside	-1% to 1%	-3% to 0%	stronger price erosion, weaker tender position
Base case	0% to 2%	-1% to +1%	typical generic market compression, stable prescribing
Upside	1% to 3%	+1% to +3%	better procurement placement and new pack/formulation wins

Key forecast sensitivities

• Tender and reimbursement resets (timing changes can dominate the year-by-year pattern)
• Supply disruptions for specific manufacturing sites (can shift short-term share)
• Class switching within ACE inhibitors (local prescriber habits)

What could change the clinical and commercial trajectory?

Two change channels exist:

1. Regulatory updates that tighten bioequivalence requirements or change labeling language for generics
2. Combination strategy (ACE inhibitor plus diuretic or other partner drug) that improves guideline alignment and payer acceptance

However, without a new mechanism or breakthrough clinical endpoint, quinapril’s trajectory remains primarily commercial and regulatory rather than clinical.

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Key Takeaways

• Quinapril hydrochloride is an established ACE inhibitor with market dynamics dominated by generic competition, tendering, and reimbursement.
• The “clinical trials update” for quinapril is largely bioequivalence and formulation/PK work rather than new efficacy trials.
• The 5-year outlook is consistent with mature generics: units grow slowly, revenue is flat to slightly negative, and share shifts at procurement cycles.
• Forecast base case: revenue CAGR -1% to +1% over 5 years; biggest swings come from tenders and formulary placement, not from new clinical endpoints.

FAQs

1) Is quinapril still undergoing meaningful efficacy trials?

Research activity for quinapril is structurally concentrated in BE/PK and lifecycle studies, which reflects its mature off-patent status.

2) What drives commercial performance for quinapril more than clinical outcomes?

For established generics, tender position, reimbursement status, and pricing typically drive performance more than incremental clinical evidence.

3) How should projections be modeled for an off-patent ACE inhibitor?

Use a two-track model: unit growth driven by chronic disease prevalence and prescribing stability, and revenue driven by price compression and procurement outcomes.

4) Do combination products matter for quinapril demand?

Yes, where combination therapy aligns better with guideline and payer preference, it can shift some demand away from monotherapy.

5) What are the biggest near-term risks to revenue?

The principal risks are faster-than-expected price erosion, loss of tender placement, and supply constraints at active manufacturing sites.

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References (APA)

[1] U.S. Food and Drug Administration. (n.d.). Drug trials snapshots. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots
[2] ClinicalTrials.gov. (n.d.). Quinapril studies. https://clinicaltrials.gov/
[3] World Health Organization. (n.d.). Global burden of disease and risk factors (hypertension and related cardiovascular outcomes). https://www.who.int/data/gho/data/themes/topics
[4] IQVIA. (n.d.). Global medicines use and market reporting (ACE inhibitor class and generics market insights). https://www.iqvia.com/insights
[5] EMA. (n.d.). Guidelines on bioequivalence and generic medicines. https://www.ema.europa.eu/