Natrecor

(Nesiritide)

ApprovedPeptide

Natrecor is a peptide that works as Atrial Natriuretic Peptide Receptor a Agonist.[2] It is being used across 13 indications, with its most advanced program in Approved.[1]

Natrecor is one of 320 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

319

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Cardiovascular DiseaseActive, not recruiting

Endothelial DysfunctionUnknown status

CardiomyopathyApproved

Acute Myocardial InfarctionApproved

Abnormal Cardiovascular System MorphologyApproved

Kidney DiseaseApproved

Pulmonary HypertensionTerminated

Diabetes MellitusApproved

Left Ventricular Diastolic DysfunctionApproved

Heart FailureCompleted

Cardiovascular DiseaseApproved

Active, not recruiting

Endothelial DysfunctionApproved

Unknown status

CardiomyopathyApproved

Approved

Acute Myocardial InfarctionApproved

Approved

Abnormal Cardiovascular System MorphologyApproved

Approved

Kidney DiseaseApproved

Approved

Pulmonary HypertensionApproved

Terminated

Diabetes MellitusApproved

Approved

Left Ventricular Diastolic DysfunctionApproved

Approved

Heart FailureApproved

Completed

Showing 10 of 12 indications

Competition

Competitive Landscape

198 competitors in Heart Failure

#DrugCompanyPhaseTrials

Natrecor

SScios, Inc.

Approved

13 2

Bayer Aspirin

Bayer

Preclinical

2 3

Brethine

Sanofi

Preclinical

1 4

Medrol

Pfizer

Preclinical

1 5

Amidate

Pfizer

Preclinical

1 6

Adriamycin

Savaysa

Xifaxan

2 9

Xylocaine

MMEDRx USA, Inc.

Preclinical

1 10

Oraverse

LLife Extension Foundation Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2030

Phase 1/2Recruiting

Hypertension

NCT02608996

Clinical

Trials by Indication[1]

Heart Failure13 trials

Renal Optimization Strategies Evaluation in Acute Heart Failure and Reliable Evaluation of Dyspnea in the Heart Failure Network (ROSE) Study

Completed·—·Phase 2·NCT01132846·360 enrolled

Tadalafil and Nesiritide as Therapy in Pre-clinical Heart Failure

Completed·MMayo Clinic·Phase 1/2·NCT01544998·43 enrolled

Role of Natriuretic Peptides in the Treatment of Acutely Decompensated Heart Failure Patient With Obstructive Airways Disease

Terminated·TThe Alfred·Phase 3·NCT00562692·6 enrolled

Show 10 more trials

An Open-label, One-arm, Study to Evaluate the Hemodynamic Changes and Safety of Nesiritide for Acute Decompensated Heart Failure

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00813202·41 enrolled

Double Blind Randomized Placebo Controlled Trial of Natrecor in Acute Decompensated Heart Failure With Normal EF

Withdrawn·UUniversity of Medicine and Dentistry of New Jersey·Phase 4·NCT00505791

An Exploratory Study of Nesiritide in Participants With Acute Heart Failure

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT00490724·67 enrolled

Effects of Nesiritide in Pediatric Patients With Heart Failure

Withdrawn·EEmory University·N/A·NCT00166010

Assessment of Biomarkers and Cardiorenal Syndrome in Acute Decompensated Heart Failure With Vasodilator Therapy

Completed·WWestern University of Health Sciences·Phase 4·NCT00842023·89 enrolled

A Study of the Safety and Efficacy of Follow-up Serial Infusions of Natrecor(Nesiritide) for the Management of Patients With Heart Failure

Completed·SScios, Inc.·Phase 2·NCT00091520·920 enrolled

Nesiritide Infusion for the Treatment of Decompensated Heart Failure and Renal Dysfunction

Completed·—·Phase 2·NCT00119691·34 enrolled

A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure

Completed·SScios, Inc.·Phase 3·NCT00475852·7,141 enrolled

Brain Natriuretic Peptide (BNP) to Preserve Renal Function in Hospitalized Patients With Heart Failure

Completed·MMayo Clinic·Phase 3·NCT00170183·104 enrolled

FUSION I Assesses Safety and Tolerability of Two Doses of NATRECOR (Nesiritide) Administered to Patients With Worsening Congestive (Decompensated) Heart Failure Who Are Concurrently Receiving Their Usual Cardiac Medications and Are at High Risk for Hospitalization.

Completed·SScios, Inc.·Phase 3·NCT00270361·214 enrolled

Congestive Heart Failure6 trials

Use of Nesiritide (BNP) in Kidney Function in Patients With Congestive Heart Failure (CHF) and Kidney Failure

Terminated·HHorng Chen·Phase 1/2·NCT00348556·4 enrolled

A Study Comparing Blood Flow and Clinical and Safety Effects of the Addition of Natrecor (Nesiritide), Placebo or Intravenous Nitroglycerin to Standard Care for the Treatment of Worsening Congestive Heart Failure.

Completed·SScios, Inc.·Phase 3·NCT00270374·498 enrolled

Nesiritide for Ventilated Congestive Heart Failure

Unknown status·SShanghai Zhongshan Hospital··NCT04455477·30 enrolled

Show 3 more trials

A Safety Study Comparing Natrecor (Nesiritide) Versus Dobutamine Therapy for Worsening Congestive Heart Failure

Completed·SScios, Inc.·Phase 3·NCT00270400·255 enrolled

A Study of Two Doses of Intravenous NATRECOR hBNP (Nesiritide) in Patients With Worsening Congestive Heart Failure Who Have Difficulty Breathing at Rest

Completed·SScios, Inc.·Phase 3·NCT00288730·127 enrolled

A Study to Develop Additional Safety and Clinical Experience With NATRECOR hBNP (Nesiritide) in the Treatment of Patients With Worsening Congestive Heart Failure Who Require Inpatient Intravenous Therapy With Medications That Influence the Tone and Caliber of Blood Vessels

Completed·SScios, Inc.·Phase 3·NCT00271557·305 enrolled

Function3 trials

Nesiritide and Renal Function After the Total Artificial Heart

Terminated·VVirginia Commonwealth University·Phase 4·NCT01836809·2 enrolled

Human B-type Natriuretic Peptide (BNP) (Nesiritide) to Help Heart, Kidney, and Hormonal Functions in Persons With Lower Heart Pumping Function

Completed·MMayo Clinic·Phase 1/2·NCT00405639·37 enrolled

Natriuretic Peptide System as Therapy in Human Preclinical Left Ventricle Dysfunction

Completed·HHorng Chen·Phase 1/2·NCT00387621·58 enrolled

Coronary Artery Bypass2 trials

Clinical Study to Evaluate Nesiritide in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery A014 / NAPA

Completed·SScios, Inc.·Phase 2·NCT00653042·305 enrolled

An Efficacy and Safety Study for Nesiritide in Heart Failure Patients With Reduced Kidney Function Undergoing Coronary Artery Bypass Graft Surgery Requiring Cardiopulmonary Bypass (CPB Pump or Heart Lung Machine)

Withdrawn·SScios, Inc.·Phase 3·NCT00530361

Hypertension2 trials

Nesiritide in Hypertension

Recruiting·OOslo University Hospital·Phase 1/2·NCT02608996·15 enrolled

Nesiritide in Resistant Hypertension

Terminated·JJohn C Burnett·Phase 1/2·NCT01514357·12 enrolled

15 more indications

Diastolic Heart Failure2 trials

Use of Nesiritide in the Management of Acute Diastolic Heart Failure

Terminated·MM.D. Anderson Cancer Center·Phase 4·NCT00083772·9 enrolled

Catheterization Laboratory Study: Acute Responses in Diastolic Heart Failure

Completed·UUniversity of Wisconsin, Madison·N/A·NCT00204945·15 enrolled

Cardiac Surgery1 trial

Nesiritide Use Following Cardiac Surgery in Infants

Terminated·—·Phase 1/2·NCT00281671·9 enrolled

Obesity1 trial

Natriuretic Peptides and Metabolic Risk in Obesity

Withdrawn·VVanderbilt University Medical Center·Phase 1·NCT02642523

Dilated Cardiomyopathy1 trial

Nesiritide - Dilated Cardiomyopathy

Completed·UUniversity of California, Los Angeles·N/A·NCT00709163·20 enrolled

Renal Protection1 trial

Does Nesiritide Provide Renal Protection

Completed·UUniversity of Florida·Phase 2·NCT01440881·37 enrolled

Testosterone1 trial

Testosterone Regulation of the Natriuretic Peptide System

Withdrawn·MMassachusetts General Hospital·N/A·NCT02269072

Infusion1 trial

Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery

Terminated·JJohn M Costello·Phase 2·NCT00543309·106 enrolled

Endothelial Dysfunction1 trial

Effect of BNP (Brain Natriuretic Peptides) on Endothelial Dysfunction Induced by Coronary Angioplasty

Unknown status·TThe Baruch Padeh Medical Center, Poriya·Phase 4·NCT00262574·500 enrolled

Myocardial Infarction1 trial

Nesiritide Therapy to Preserve Function of the Left Ventricle After Myocardial Infarction

Completed·MMayo Clinic·Phase 2·NCT00573144·59 enrolled

Metabolism1 trial

BNP Pharmacodynamics and Effects on Metabolism in Lean and Obese Subjects

Completed·—·Phase 1·NCT01977859·4 enrolled

Postoperative Recovery1 trial

Impact of Nesiritide on Early Postoperative Recovery After Total Cavo-Pulmonary Connection Surgery in Children

Unknown status·CChina National Center for Cardiovascular Diseases·N/A·NCT03207295·108 enrolled

Pulmonary Hypertension1 trial

Natrecor in Pulmonary Hypertension

Terminated·MM.D. Anderson Cancer Center·Phase 4·NCT00075179·15 enrolled

Aneurysm1 trial

The Use of Nesiritide in Thoracic Aneurysm Repair to Prevent Acute Renal Failure

Unknown status·—·Phase 3·NCT00110201·124 enrolled

Outcome1 trial

BNP Therapy Observation Unit Outcomes STudy (BOOST)

Terminated·EEmory University·Phase 4·NCT00453453·17 enrolled

Unspecified1 trial

Renal Effects of Intrarenal Nesiritide

Terminated·UUniversity of Maryland, Baltimore·Phase 4·NCT00270829·2 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 10, 2001

NATRECOR

NDA NDA020920

Sources

References

[1]
ClinicalTrials.gov — 42 trial records for Nesiritide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Nesiritide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Nesiritide. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA020920). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Scios, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Atrial Natriuretic Peptide Receptor a Agonist[2]
Modality: Peptide[2]
Highest Phase: Approved[1]
Company: SScios, Inc.

Natrecor

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2030

Trials by Indication[1]

Heart Failure13 trials

Congestive Heart Failure6 trials

Function3 trials

Coronary Artery Bypass2 trials

Hypertension2 trials

Diastolic Heart Failure2 trials

Cardiac Surgery1 trial

Obesity1 trial

Dilated Cardiomyopathy1 trial

Renal Protection1 trial

Testosterone1 trial

Infusion1 trial

Endothelial Dysfunction1 trial

Myocardial Infarction1 trial

Metabolism1 trial

Postoperative Recovery1 trial

Pulmonary Hypertension1 trial

Aneurysm1 trial

Outcome1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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