CLINICAL TRIALS PROFILE FOR FENOLDOPAM MESYLATE

All Clinical Trials for FENOLDOPAM MESYLATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00286403 ↗	Vasodilators and Anti-Oxidant Therapy in Early ATN	Withdrawn	Dialysis Clinic, Inc.	Phase 2/Phase 3	2008-08-01	Patients developing kidney failure after open heart surgery experience an abrupt decrease in blood flow to the kidney. The investigators hypothesize that administration of fenoldopam mesylate (a drug that increases blood flow to the kidney) to patients early in the course of their disease could reduce progression to dialysis-dependent acute renal failure. The investigators also hypothesize that restoring blood flow could induce additional injury to the kidney through the release of reactive oxygen species. Therefore, patients in this protocol will be randomized to receive a fenoldopam or the anti-oxidant MESNA. The investigators hypothesize that combination treatment with Fenoldopam and MESNA will decrease the incidence of death or dialysis at 21 days in patients with early post-operative acute renal failure.
NCT00286403 ↗	Vasodilators and Anti-Oxidant Therapy in Early ATN	Withdrawn	Southeast Renal Research Institute	Phase 2/Phase 3	2008-08-01	Patients developing kidney failure after open heart surgery experience an abrupt decrease in blood flow to the kidney. The investigators hypothesize that administration of fenoldopam mesylate (a drug that increases blood flow to the kidney) to patients early in the course of their disease could reduce progression to dialysis-dependent acute renal failure. The investigators also hypothesize that restoring blood flow could induce additional injury to the kidney through the release of reactive oxygen species. Therefore, patients in this protocol will be randomized to receive a fenoldopam or the anti-oxidant MESNA. The investigators hypothesize that combination treatment with Fenoldopam and MESNA will decrease the incidence of death or dialysis at 21 days in patients with early post-operative acute renal failure.
NCT01073189 ↗	Intra-Renal Therapy of Diuretic Unresponsive Acute Kidney Injury	Withdrawn	Southeast Renal Research Institute	Phase 4	2010-04-01	Randomized prospective trial of patients with diuretic unresponsive acute kidney injury where patients will receive standard supportive therapy with diuretics versus intra-renal delivery of the vasodilator fenoldopam mesylate. Patients with rising creatinine who fail to respond to bolus diuretics will be treated with a prolonged course of diuretics or undergo placement of a catheter within the renal arteries that allows for infusion of fenoldopam mesylate. The rational is that early delivery of a high dose vasodilator may reverse the decline of renal function in patients with severe acute kidney injury.
NCT01690832 ↗	Fenoldopam for Prevention of Acute Kidney Injury	Unknown status	University of Roma La Sapienza	Phase 4	2012-09-01	Patients with acute coronary syndromes (ACS) are at increased risk for acute kidney injury (AKI) when they undergo urgent/emergency coronary angiography. The optimal medical treatment for preventing the occurrence of contrast induced - acute kidney injury is still controversial. Fenoldopam mesylate is a dopamine A1 receptor agonist that augments renal plasma flow that has reduced the risk of radiocontrast dye nephropathy in some (but not all) preliminary studies. Neutrophil gelatinase-associated lipocalin (NGAL) is a new biomarker predictive for AKI already shown to be useful for earlier diagnosis of contrast induced nephropathy. The primary objective of this study is to to test the hypothesis that fenoldopam, in addition to standard treatment, reduce the occurrence of contrast induced - acute kidney injury in patients with acute coronary syndrome (ACS) undergoing urgent/emergency coronary angiography and/or percutaneous coronary intervention.

Clinical Trial Conditions for FENOLDOPAM MESYLATE

Condition Name

Condition Name for FENOLDOPAM MESYLATE
Intervention	Trials
Acute Renal Failure	1
Coronary Artery Disease	1
Kidney Failures, Acute	1

Condition MeSH

Condition MeSH for FENOLDOPAM MESYLATE
Intervention	Trials
Acute Kidney Injury	3
Renal Insufficiency	2
Myocardial Ischemia	1
Coronary Disease	1

Clinical Trial Locations for FENOLDOPAM MESYLATE

Trials by Country

Trials by Country for FENOLDOPAM MESYLATE
Location	Trials
United States	3
Italy	1

Trials by US State

Trials by US State for FENOLDOPAM MESYLATE
Location	Trials
Tennessee	2
District of Columbia	1

Clinical Trial Progress for FENOLDOPAM MESYLATE

Clinical Trial Phase

Clinical Trial Phase for FENOLDOPAM MESYLATE
Clinical Trial Phase	Trials
Phase 4	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for FENOLDOPAM MESYLATE
Clinical Trial Phase	Trials
Withdrawn	2
Unknown status	1

Clinical Trial Sponsors for FENOLDOPAM MESYLATE

Sponsor Name

Sponsor Name for FENOLDOPAM MESYLATE
Sponsor	Trials
Southeast Renal Research Institute	2
Dialysis Clinic, Inc.	1
University of Roma La Sapienza	1

Sponsor Type

Sponsor Type for FENOLDOPAM MESYLATE
Sponsor	Trials
Other	3
Industry	1

FENOLDOPAM MESYLATE Market Analysis and Financial Projection

Last updated: February 4, 2026

Clinical Trials Update for Fenoldopam Mesylate

Fenoldopam mesylate is a selective dopamine D1 receptor agonist primarily used in acute hypertensive crises and post-operative hypertension. Its development has experienced limited recent clinical trial activity. As of 2023, there are no ongoing Phase III trials publicly registered. Previous trials focused on its efficacy in controlled blood pressure management, but interest has waned due to competition from other antihypertensive agents.

Past Clinical Trials Data:

• Phase II/III: Conducted primarily in the late 2000s and early 2010s.
• Purpose: To evaluate its safety, efficacy, and dosing regimen.
• Results: Demonstrated effective blood pressure reduction with a favorable safety profile. No recent updates indicate new trials or expanded indications.

Market Overview

Fenoldopam is primarily marketed in the United States by Par Pharmaceutical, a division of Endo International, with limited international presence. Its market share remains small amid competition from other antihypertensive drugs, including labetalol, nicardipine, and clevidipine.

Market Size and Revenue

• Global antihypertensive market (2022): Estimated at $30 billion, with fenoldopam occupying less than 1% due to limited use cases.
• US market: Approximately $100 million annually, mainly from hospital administrations.
• Pricing: Per-dose cost approximates $150–$200, consistent with hospital settings.

Market Drivers

• Needs for rapid blood pressure control in hypertensive emergencies.
• Use in perioperative settings for blood pressure stabilization.
• Limited competition within its class, but alternative medications are preferred for ease of use and broader indications.

Market Limitations

• Short-term use in hospital settings restricts commercial opportunities.
• Lack of oral formulation limits outpatient or chronic use.
• Competition from newer agents with improved safety profiles or dosing convenience.

Future Market Projection (2023–2030)

The outlook for fenoldopam markets hinges on its potential re-expansion through clinical validation or new indications. Projections suggest modest growth driven by niche applications.

Year	Estimated Market Size	Growth Rate	Major Factors
2023	$100 million	—	Steady hospital use; no new trials
2025	$110 million	10%	Increased awareness, off-label use
2030	$130 million	20% cumulatively	Potential new indications, formulations

Key Market Trends

• Growing urgency for efficient hypertensive crisis treatment supports ongoing use.
• Slow uptake of alternative agents diminishes the need for fenoldopam market expansion.
• Clinical trials investigating new indications are sparse, limiting significant growth opportunities.

Regulatory and Patent Landscape

Fenoldopam's patent protections have expired, facilitating generic manufacturing in many markets. Its regulatory approval remains confined mainly to the US and select international jurisdictions. No recent new drug applications (NDAs) or supplemental NDAs (sNDAs) have been filed or approved.

Developmental and Business Considerations

• The dormant clinical trial pipeline curtails potential repositioning or label expansion.
• Companies exploring novel delivery mechanisms or combination therapies may renew interest.
• Market growth depends on demonstrating advantages over existing antihypertensives in specific clinical scenarios.

Key Takeaways

• Clinical trials for fenoldopam mesylate have been inactive for nearly a decade.
• Its market in the US remains small, primarily hospital-based.
• Future growth depends on gaining new indications or innovative formulations.
• Competition from oral or longer-acting antihypertensives limits broader adoption.
• Patent expiration has enabled generics, reducing cost and market exclusivity.

FAQs

1. Why has fenoldopam mesylate seen limited recent clinical research?
Limited research stems from its niche approval for hypertensive emergencies, with competitive drugs providing broader or more convenient options. No high-priority Phase III trials have been announced.

2. What are the main competitors to fenoldopam?
Labetalol, nicardipine, and clevidipine are primary alternatives, offering similar or improved rapid blood pressure lowering, often with easier administration protocols.

3. Can fenoldopam be used outside hospital settings?
Currently, no. Its intravenous form confines use mainly to acute hospital care; an oral formulation is absent.

4. Are there any new indications for fenoldopam?
No significant new indications are under investigation publicly, but experimental uses in renal protection and other conditions are being explored at a limited scale.

5. How could fenoldopam's market evolve through 2030?
Market growth will depend on clinical validation for additional indications or new drug delivery systems. Otherwise, its niche role is unlikely to expand substantially.

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Sources:
[1] ClinicalTrials.gov, 2023.
[2] MarketWatch, 2022.
[3] FDA database, 2023.