Last Updated: June 24, 2026

CLINICAL TRIALS PROFILE FOR NATRECOR


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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
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Condition MeSH

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

Trials by Country

Trials by Country for NATRECOR
Location Trials
United States 36
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Trials by US State

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

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Withdrawn 1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

Sponsor Type for NATRECOR
Sponsor Trials
Other 28
Industry 20
NIH 12
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Last updated: April 26, 2026

NATRECOR: Clinical-Development Update, Market Analysis, and Sales Projections

What is NATRECOR and what is its current clinical posture?

“NATRECOR” is the brand name used for nesiritide (human B-type natriuretic peptide), indicated for treatment of acute decompensated heart failure (ADHF). The drug is not in active late-stage development in the way modern investigational cardiovascular assets typically are. Its clinical story is anchored in the established ADHF use-case and historical pivotal trials, with ongoing visibility mainly driven by label execution in markets and post-launch evidence rather than new registration-enabling studies.

A key commercial feature of nesiritide/NATRECOR is that it competes in an ADHF acute-care environment where guideline-aligned adoption and comparative outcomes versus diuretics and vasodilators shape utilization. In that setting, payer and hospital formularies tend to be restrictive when comparative evidence and guideline positioning do not strongly favor routine use.

What did the pivotal efficacy and safety evidence show?

The core pivotal dataset for nesiritide in ADHF is tied to large randomized controlled trials that evaluated hemodynamic response and clinical outcomes. The most cited evidence base includes:

  • VMAC trial: compared nesiritide vs nitroglycerin and isosorbide dinitrate in ADHF; it supported symptomatic/hemodynamic measures but did not establish robust superiority in hard outcomes in the way that drives broad guideline adoption.
  • ASCEND-HF trial: evaluated nesiritide vs placebo in ADHF and found that while there were signal endpoints related to dyspnea and biomarker or hemodynamic targets, the program did not produce a clean, durable overall clinical-outcome advantage large enough to reset standard-of-care.

These pivotal outcomes matter commercially because market adoption in ADHF is strongly driven by whether a product changes the likelihood of readmission, mortality, or need for rescue therapy, not just short-term dyspnea improvement.

Primary sources: ASCEND-HF (NEJM) is the main high-visibility placebo-controlled outcomes trial for nesiritide in ADHF. [1]


How is NATRECOR positioned in the ADHF market and where is demand coming from?

What drives hospital and payer demand for nesiritide in ADHF?

Demand for NATRECOR is concentrated in acute inpatient and emergency-admission settings for ADHF. Utilization is shaped by four operational drivers:

  1. Relative guideline alignment: products that materially shift outcomes or are recommended for specific phenotypes see higher adoption. When guideline endorsement is limited or conditional, formulary uptake slows.
  2. Workflows and monitoring: NATRECOR use requires hemodynamic and blood pressure monitoring. In practice, clinicians favor agents with simpler protocols and faster switching.
  3. Comparative efficacy in real-world protocols: many ADHF pathways start with IV diuretics and, when needed, add vasodilators. Nesiritide adoption depends on whether it reduces escalation frequency or improves discharge trajectory.
  4. Payer contracting and product availability: in hospital contracts, volume is constrained if the formulary does not assign it a default place in the pathway.

What are the competitive dynamics?

In ADHF, the therapeutic set includes:

  • IV loop diuretics (background standard-of-care)
  • Nitroglycerin and other nitrates
  • Vasodilator strategies guided by hemodynamics
  • Emerging or adjacent agents that compete for the same acute-care treatment slot (depending on geography and year)

Nesiritide competes more on “physiologic target” than on consistent hard outcome differentiation, which reduces formulary dominance and creates a pattern of use that is narrower than diuretics.


Clinical trials update: what is changing now?

Are there active registrational studies for NATRECOR/nesiritide?

No registrational phase-change program is indicated by the major outcomes literature that defined the market position for nesiritide in ADHF. The clinical evidence base is stable relative to the rapid cadence seen in contemporary cardiovascular drug development.

Practically, the clinical-trials “update” relevant to business planning is that the highest-profile efficacy and safety readouts are already established and do not indicate a new, outcome-changing trial that would restart adoption growth at scale.

Key clinical reference for business planning remains:

  • ASCEND-HF outcomes (primary NEJM trial underpinning contemporary comparative perception) [1]

Market analysis: addressable patient flow and revenue ceilings

How big is the addressable ADHF market?

ADHF incidence is large globally, but the treated acute-care portion eligible for vasodilator addition is the real addressable segment for NATRECOR. Without new registration-enabling trial advantages, NATRECOR’s ceiling is determined by:

  • proportion of ADHF patients receiving IV vasodilator strategies
  • proportion of those where nesiritide is formulary-preferred
  • dosing pattern and average duration of therapy
  • hospital formulary status across target geographies

Because the request is for market analysis and projections for NATRECOR specifically and not a generalized ADHF market-sizing exercise, the most decision-useful projection method is a sales-share framework rather than a purely epidemiologic top-down estimate.

What limits adoption and what increases it?

Adoption limiters

  • no durable hard-outcome superiority in the high-visibility placebo-controlled evidence base [1]
  • blood pressure monitoring requirements
  • hospital pathway standardization favoring diuretics and nitrates

Adoption drivers

  • specific phenotypes or clinical contexts where vasodilator effect is strongly needed quickly
  • payer contracting that makes NATRECOR cost-competitive versus alternatives
  • clinician familiarity and established order sets

Sales projection model for NATRECOR (scenario framework)

What projection structure fits NATRECOR’s real adoption profile?

A credible projection structure for NATRECOR is a three-layer model:

  1. Treated ADHF volume (inpatient and ED)
  2. Vasodilator-eligible fraction (where additional IV vasodilator therapy is used)
  3. NATRECOR share within vasodilators (driven by formulary tier, contracting, and pathway preference)

Given the absence of a current registrational catalyst, NATRECOR share tends to behave like a mature/legacy product:

  • slow share erosion where alternatives gain preference
  • stability where contracts lock in availability
  • modest share increases only where specific local protocols favor it

Projections (qualitative direction with decision thresholds)

Because NATRECOR is legacy and market-specific contracting dominates, use decision thresholds rather than false precision:

  • Base case: NATRECOR sales remain flat to modestly down as formularies converge toward diuretics-first pathways and selective vasodilator use.
  • Downside case: NATRECOR experiences share loss where nitrates and alternative strategies are pushed into default ADHF order sets.
  • Upside case: NATRECOR holds share or sees slight improvement in geographies where contract pricing and acute-care protocol standardization favor nesiritide.

If an investment thesis depends on a sharp growth step-up, it would require an outcome-changing clinical signal, label expansion, or major payer/institutional reclassification. The current evidence base does not point to such a step function. [1]


IP and regulatory reality check (what it means for revenue longevity)

Is NATRECOR still protected by meaningful new IP barriers?

NATRECOR is associated with an older molecule with mature regulatory and patent landscapes. For forecasting, the consequence is that:

  • price competition and channel dynamics usually matter more than patent exclusivity
  • growth is constrained to adoption and contracting, not new exclusivity-driven market creation

Business planning should treat NATRECOR like a legacy cardiology asset where product lifecycle actions (pricing, contracting, and institutional formularies) govern results.


Key Takeaways

  • NATRECOR (nesiritide) is a mature ADHF product whose clinical adoption is governed by acute-care pathways and formulary positioning rather than new registrational momentum.
  • The high-visibility outcomes evidence base (including ASCEND-HF) did not establish a decisive hard-outcome advantage that would typically drive broad guideline-driven expansion. [1]
  • Sales projections should be built on a share framework inside a vasodilator-eligible ADHF segment, with NATRECOR behaving like a legacy product: flat to declining in base case, with growth dependent on local contracting and protocol adoption rather than clinical breakthroughs.

FAQs

1) What is the main clinical evidence used to judge NATRECOR in ADHF?

The centerpiece outcomes evidence is ASCEND-HF in the New England Journal of Medicine, comparing nesiritide to placebo in ADHF. [1]

2) Why does NATRECOR adoption tend to be narrower than diuretics in ADHF?

ADHF pathways commonly start with IV diuretics, and NATRECOR’s use depends on additional vasodilator strategy needs plus monitoring requirements, while comparative clinical-outcome differentiation has not driven wide guideline-first adoption. [1]

3) What is the biggest driver of NATRECOR sales vs competitors?

Hospital formulary status and contracting within acute-care ADHF order sets, because prescribing is pathway-based and competition in ADHF is intense.

4) What would most likely change NATRECOR’s market trajectory upward?

A new clinical signal that materially improves hard outcomes and triggers guideline or payer reclassification, or a major channel shift that places NATRECOR in default ADHF pathways. The current landmark outcomes evidence does not indicate this shift. [1]

5) How should an investor model NATRECOR revenue?

Use a mature-product share model: ADHF treated volume times vasodilator-eligible fraction times NATRECOR share, rather than a growth model tied to new clinical development.


References

[1] ASCEND-HF Investigators. (2011). Nesiritide in Patients with Acute Decompensated Heart Failure. New England Journal of Medicine.

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