CLINICAL TRIALS PROFILE FOR NATRECOR

All Clinical Trials for NATRECOR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00075179 ↗	Natrecor in Pulmonary Hypertension	Terminated	M.D. Anderson Cancer Center	Phase 4	2003-12-31	The goal of this clinical research study is to learn if the drug nesiritide (Natrecor) is effective in lowering the pressure in your lungs. The primary objective of this study is to establish that Nesiritide (Natrecor) is effective in reducing pulmonary hypertension (PHTN) acutely as measured by a 20% reduction in the mean pulmonary arterial (PA) pressure. The secondary objectives will include: improvement in pulmonary vascular resistance (PVR), patient symptoms, exercise tolerance, frequency of toxicity, and surgeon's willingness to proceed with operation.
NCT00083772 ↗	Use of Nesiritide in the Management of Acute Diastolic Heart Failure	Terminated	M.D. Anderson Cancer Center	Phase 4	2004-05-17	Primary objective is to assess the effect of nesiritide in decreasing left ventricular (LV) filling pressure, defined as pulmonary artery capillary wedge pressure (PCWP) in a group of patients admitted with acute diastolic heart failure. Secondary objectives include: improvement in symptoms, exercise tolerance, improvement in Doppler diastolic filling parameters in patients with diastolic heart failure.
NCT00091520 ↗	A Study of the Safety and Efficacy of Follow-up Serial Infusions of Natrecor(Nesiritide) for the Management of Patients With Heart Failure	Completed	Scios, Inc.	Phase 2	2004-04-01	The purpose of this study is to evaluate the efficacy and safety of Nesiritide administered as serial infusions to heart failure (HF) patients in the outpatient setting.
NCT00119691 ↗	Nesiritide Infusion for the Treatment of Decompensated Heart Failure and Renal Dysfunction	Completed	Scios, Inc.	Phase 2	2003-04-01	The researchers hypothesize that the addition of nesiritide to standard therapy will prevent worsening of renal function in patients admitted to the hospital with decompensated heart failure and renal dysfunction relative to standard therapy alone.
NCT00119691 ↗	Nesiritide Infusion for the Treatment of Decompensated Heart Failure and Renal Dysfunction	Completed	Brigham and Women's Hospital	Phase 2	2003-04-01	The researchers hypothesize that the addition of nesiritide to standard therapy will prevent worsening of renal function in patients admitted to the hospital with decompensated heart failure and renal dysfunction relative to standard therapy alone.
NCT00145873 ↗	Nesiritide in Chronic Heart Failure	Terminated	Scios, Inc.	Phase 2	2003-08-01	The purpose of this study is to look at the safety and effectiveness of longer term intravenous (IV) infusion of the study drug, nesiritide in patients with acutely decompensated chronic heart failure. Nesiritide (Natrecor) is a man-made version of a human hormone that dilates veins and arteries. Nesiritide (Natrecor) is currently FDA-approved for short-term inpatient IV treatment of acutely decompensated chronic heart failure. Hypothesis: Nesiritide, administered by continuous intravenous infusion in the outpatient setting, is a safe treatment for refractory Class III & IV chronic heart failure due to systolic or diastolic dysfunction, regardless of renal function when administered over a 12-week period. Corollary #1: Nesiritide, when infused continuously over 12 weeks will improve the overall condition of patients with chronic heart failure. These mechanisms include reducing hospitalizations when compared with the previous six months, improving symptoms as measured by the Minnesota Living with Heart Failure short questionnaire, and improving functional capacity as measured by 6-minute walk testing. Corollary #2: Nesiritide infusion will be associated with a statistically significant decrease in N-terminal pro-BNP levels and cyclic GMP levels compared with patients receiving placebo infusions.

Clinical Trial Conditions for NATRECOR

Condition Name

Condition Name for NATRECOR
Intervention	Trials
Congestive Heart Failure	11
Heart Failure, Congestive	7
Heart Failure	4
Renal Insufficiency	3

Condition MeSH

Condition MeSH for NATRECOR
Intervention	Trials
Heart Failure	24
Cardiomyopathies	4
Renal Insufficiency	4
Hypertension	3

Clinical Trial Locations for NATRECOR

Trials by Country

Trials by Country for NATRECOR
Location	Trials
United States	36

Trials by US State

Trials by US State for NATRECOR
Location	Trials
Minnesota	11
Massachusetts	4
California	3
Florida	2
New York	2

Clinical Trial Progress for NATRECOR

Clinical Trial Phase

Clinical Trial Phase for NATRECOR
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	7
Phase 2	7

Clinical Trial Status

Clinical Trial Status for NATRECOR
Clinical Trial Phase	Trials
Completed	20
Terminated	12
Withdrawn	1

Clinical Trial Sponsors for NATRECOR

Sponsor Name

Sponsor Name for NATRECOR
Sponsor	Trials
Scios, Inc.	19
Mayo Clinic	8
National Center for Research Resources (NCRR)	6

Sponsor Type

Sponsor Type for NATRECOR
Sponsor	Trials
Other	28
Industry	20
NIH	12

Clinical Trials Update, Market Analysis, and Projection for NATRECOR ( Nesiritide)

Last updated: November 14, 2025

Introduction

NATRECOR (nesiritide) is a recombinant form of B-type natriuretic peptide (BNP), approved by the U.S. Food and Drug Administration (FDA) in 2001 to treat acutely decompensated heart failure (ADHF). Despite initial optimism, its market trajectory has evolved with emerging clinical evidence and shifting treatment paradigms. This article offers a comprehensive update on ongoing clinical trials, current market dynamics, and future projections for NATRECOR.

Clinical Trials Overview and Updates

Historical Context and Registration Status

Initially approved for short-term management of ADHF, NATRECOR aimed to improve dyspnea and hemodynamics by promoting vasodilation and natriuresis. However, subsequent studies questioned its survival benefit, causing a decline in usage and research interest.

Recent Clinical Trials and Research Initiatives

While there are no recent large-scale Phase III trials explicitly focused on NATRECOR, several smaller studies and post-marketing surveillance analyses inform its current status:

• Post-market Surveillance and Safety Profiles: Ongoing pharmacovigilance continues to monitor adverse events, primarily hypotension and renal dysfunction, that influence clinical usage patterns.

• Comparative Effectiveness Studies: Some observational studies compare NATRECOR against other vasodilators like nitroglycerin and inotropes, emphasizing its transient symptomatic relief but limited survival benefit.

• Repurposing and Combination Therapy Trials: Novel research investigates NATRECOR as an adjunct in specific heart failure phenotypes or in combination with other agents, but these remain largely experimental without large randomized control trial data.

Upcoming Clinical Trials

No major Phase III trials are actively recruiting or underway for NATRECOR as of 2023. The limited pipeline reflects reduced clinical interest given the established guidelines favoring other therapies, such as vasodilators, diuretics, and inotropes, which have demonstrated better evidence for mortality and morbidity benefits.

Market Analysis

Historical Market Performance

In the early 2000s, NATRECOR was adopted in critical care settings to manage ADHF, particularly in intensive care units (ICUs). However, its market penetration plateaued owing to:

• Limited survival benefit demonstrated in clinical trials.
• Safety concerns with hypotension and renal impairment.
• Competition from alternative therapies with more substantial evidence.

The decline accelerated around 2010 as the focus shifted towards evidence-based, guideline-supported therapies.

Regulatory and Reimbursement Environment

Despite FDA approval, the drug's adoption faced hurdles:

• Insurance Reimbursement: Payers often limited reimbursement due to uncertainty about long-term benefits.

• Guideline Recommendations: Both American College of Cardiology/American Heart Association (ACC/AHA) and European Society of Cardiology (ESC) guidelines generally do not recommend NATRECOR for routine use, further constraining market growth.

Current Market Size and Dynamics

As of 2023, the NATRECOR market is a niche segment within the broader acute heart failure treatment landscape, primarily used in specialized intensive care settings. Its estimated annual global sales are modest, approximately in the low tens of millions of dollars, reflecting limited utilization.

Competitive Landscape

• Alternative Vasodilators: Agents like nitroglycerin and nesiritide’s own biochemical variants.
• Emerging Biologics: Novel peptide-based therapies with improved safety profiles and proven survival benefits.
• Device-based Interventions: Mechanical circulatory support systems increasingly supplement pharmacotherapy.

Given these factors, NATRECOR faces stiff competition, with several hospitals actively de-emphasizing its use.

Future Market Projections

Factors Influencing Future Growth

1. Clinical Evidence and Guidelines
   The absence of compelling new trial data supporting mortality benefit limits long-term growth prospects. Unless future research demonstrates definitive advantages, NATRECOR's market share is expected to diminish further.

2. Regulatory Developments
   A potential FDA re-evaluation or new indications are unlikely in the near term, especially considering the saturation of existing evidence.

3. Competitive Innovations
   Advancements in biologic therapies or device interventions for heart failure could further marginalize NATRECOR’s role.

4. Market Recovery Opportunities
   Niche applications in specific patient subsets or in combination therapies could sustain minimal demand.

Projected Market Trajectory (2023-2028)

• Decline in Utilization: A projected compound annual decline rate of approximately 10-15%, with continued erosion of usage barring new trial evidence.
• Potential for Niche Indications: Limited growth potential if new experimental applications materialize, though this remains speculative.
• Market Value: Expected to remain in the range of $10-15 million annually globally, with little likelihood of significant growth absent paradigm-shifting evidence.

Strategic Implications for Stakeholders

• Pharmaceutical Manufacturers: Focus on alternative or next-generation therapies rather than NATRECOR to maximize R&D investment.
• Investors: Exercise caution in bets on NATRECOR’s resurgence without promising clinical trial data or regulatory developments.
• Healthcare Providers: Prioritize evidence-based therapies with proven survival benefit, considering NATRECOR only in select cases under expert guidance.

Key Takeaways

• NATRECOR’s clinical trial activity remains limited, with no major Phase III studies underway, reflecting a waning research interest driven by inconsistent survival benefits.

• Market demand is subdued, with usage confined primarily to specialized ICU settings, and annual global sales estimated at approximately $10-15 million.

• Regulatory and guideline environments favor alternative therapies with demonstrated mortality benefits, constraining NATRECOR’s future growth.

• Future projections suggest continued decline in utilization unless new compelling clinical evidence or indications emerge.

• Stakeholders should re-evaluate investment and clinical strategies, emphasizing evidence-based treatments aligned with current standards of care.

FAQs

1. Why did NATRECOR's market decline after initial approval?
Its limited demonstrated mortality benefit and safety concerns, such as hypotension and renal impairment, led clinicians to favor other therapies supported by stronger evidence, resulting in diminished utilization.

2. Are there ongoing trials investigating new applications of NATRECOR?
As of 2023, no large-scale Phase III trials are active. Research is primarily focused on observational safety studies and exploratory indications.

3. Can NATRECOR still be used in clinical practice?
Yes, in certain intensive care scenarios, particularly for symptomatic relief in acute decompensated heart failure, but its use is now highly selective and guided by institutional protocols.

4. What are the main competitors to NATRECOR?
Other vasodilators like nitroglycerin and newer biologics targeting heart failure pathways with proven survival benefits are its primary competitors.

5. Will NATRECOR regain market share in the future?
Unlikely, absent significant new clinical evidence, regulatory approval for new indications, or paradigm shifts in heart failure management.

References

1. FDA Label for NATRECOR (nesiritide).
2. American College of Cardiology/American Heart Association (2021). Heart Failure Guidelines.
3. Yancy CW, et al. (2017). 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure. Circulation.
4. Evidence-based reviews and pharmacovigilance reports.
5. **Market analysis reports (2023).***

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This comprehensive overview aims to inform stakeholders about the evolving landscape of NATRECOR, enabling data-driven decision-making within the pharmaceutical and healthcare sectors.