Drugs / Nesiritide
Nesiritide
also known as
NATRECOR · BNP · BNP, Nesiritide · BNP-32 · Brain Natriuretic Peptide · fhBNP · human B-type natriuretic factor · human b-type natriuretic peptide · +4 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | NATRECOR | — | 2001-08-10 | fda.gov ↗ |
Trials 44
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02642523 | ? → Feb 2017 | hyperinsulinism, obesity disorder | Vanderbilt University Medical Center | Withdrawn | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT00252213 | Aug 2002 → Jan 2006 | myocardial infarction | Mayo Clinic | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/27 trials · 1 missed | ||||||
| Phase 1/2 | NCT01514357 | Apr 2012 → Jul 2014 | hypertensive disorder | John C Burnett | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT01544998 | Feb 2012 → Aug 2013 | congestive heart failure | Mayo Clinic | Completed | Missed primary |
| Phase 1/2 | NCT00281671 | Apr 2006 → Oct 2008 | congenital heart disease | Boston Children's Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT00387621 | Feb 2006 → Aug 2008 | congestive heart failure | Horng Chen | Completed | No outcome recorded |
| Phase 1/2 | NCT00348556 | Dec 2005 → Mar 2010 | cardio-renal syndrome | Horng Chen | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT00252200 | Mar 2003 → Oct 2007 | acute kidney injury | Mayo Clinic | Completed | No outcome recorded |
| Phase 1/2 | NCT00309868 | Dec 2002 → Dec 2003 | diastolic heart failure | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 28 trials · 2 missed | ||||||
| Phase 2 | NCT00543309 | Oct 2007 → Jan 2013 | congenital heart disease | John M Costello | Terminated | Missed primary |
| Phase 2 | NCT00490724 | Mar 2007 → Jun 2008 | congestive heart failure | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 2 | NCT00338455 | Sep 2006 → Oct 2007 | congestive heart failure, impaired renal function disease, kidney failure | Scios, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00091520 | Apr 2004 → Dec 2006 | congestive heart failure | Scios, Inc. | Completed | Missed primary |
| Phase 2 | NCT00653042 | Mar 2004 → Jun 2005 | congestive heart failure, coronary artery intramyocardial course, coronary atherosclerosis, myocardial ischemia | Scios, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00145873 | Aug 2003 → Sep 2006 | heart failure | University of Chicago | Terminated | No outcome recorded |
| Phase 2 | NCT00240084 | Jul 2003 → Nov 2005 | heart failure | University of Rochester | Completed | No outcome recorded |
| Phase 2 | NCT00119691 | Apr 2003 → Nov 2005 | congestive heart failure, impaired renal function disease | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 312 trials · 1 met primary · 2 missed | ||||||
| Phase 3 | NCT00562692 | Sep 2007 → Jul 2009 | heart failure | The Alfred | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00475852 | May 2007 → Mar 2011 | heart failure | Scios, Inc. | Completed | Missed primary |
| Phase 3 | NCT00813202 | Oct 2006 → Jun 2007 | congestive heart failure | Xian-Janssen Pharmaceutical Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00110201 | Mar 2005 → Dec 2007 | acute kidney injury, cardiovascular disorder | Ejaz, Abulate A, MD | Unknown | Missed primary |
| Phase 3 | NCT00170183 | Mar 2003 → Jul 2007 | cardiomyopathy, congestive heart failure, kidney disorder | Mayo Clinic | Completed | No outcome recorded |
| Phase 3 | NCT00270361 | Dec 2001 → Jan 2003 | congestive heart failure | Scios, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00270387 | Jan 2001 → Jan 2002 | cardiomyopathy, congestive heart failure | Scios, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00270374 | Oct 1999 → Aug 2000 | congestive heart failure, symptomatic heart failure | Scios, Inc. | Completed | Met primary |
| Phase 3 | NCT00270400 | Aug 1998 → Feb 1999 | congestive heart failure | Scios, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00271557 | Jan → Dec 1997 | congestive heart failure | Scios, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00288730 | Oct 1996 → Aug 1997 | congestive heart failure | Scios, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00530361 | ? → Sep 2009 | congestive heart failure, coronary atherosclerosis, myocardial ischemia | Scios, Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 411 trials · 1 missed | ||||||
| Phase 4 | NCT07617675 | May 2026 → Jan 2028 expected | acute kidney injury | China National Center for Cardiovascular Diseases | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT01836809 | Apr 2013 → May 2014 | cardio-renal syndrome, congestive heart failure | Virginia Commonwealth University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00453453 | Mar → Sep 2007 | congestive heart failure | Emory University | Terminated | No outcome recorded |
| Phase 4 | NCT00842023 | Jul 2006 → Jul 2008 | heart failure | Western University of Health Sciences | Completed | No outcome recorded |
| Phase 4 | NCT00270829 | Dec 2005 → Jan 2007 | congestive heart failure | University of Maryland, Baltimore | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT00205426 | Aug 2005 → May 2006 | pulmonary hypertension | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 4 | NCT00262574 | Jul 2005 → Apr 2012 | coronary artery disorder | The Baruch Padeh Medical Center, Poriya | Unknown | No outcome recorded |
| Phase 4 | NCT00083772 | May 2004 → Apr 2006 | diastolic heart failure | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 4 | NCT00186329 | Mar 2004 → Oct 2006 | congestive heart failure, impaired renal function disease | Stanford University | Completed | Missed primary |
| Phase 4 | NCT00075179 | Dec 2003 → Mar 2006 | cancer, lung disorder, pulmonary hypertension | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00652652 | Mar 2003 → Jan 2004 | congestive heart failure | Scios, Inc. | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT03207295 | Jul 2017 → Jul 2020 | congenital heart disease | China National Center for Cardiovascular Diseases | Unknown | No outcome recorded |
| — | NCT00204984 | May 2005 → Dec 2006 | hypertensive disorder | University of Wisconsin, Madison | Completed | No outcome recorded |
| — | NCT00204945 | Feb 2005 → Jun 2007 | congestive heart failure | University of Wisconsin, Madison | Completed | No outcome recorded |
| — | NCT00166010 | Oct 2004 → Jun 2010 | cardiac ventricle disorder, congestive heart failure | Emory University | Withdrawn | No outcome recorded Stop: Enrollment |
| Comparator or background therapy14 trials | ||||||
| Phase 1 | NCT03234751 Comparator | Jul 2017 → Sep 2018 | diabetes mellitus | AdventHealth Translational Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT01977859 Comparator | Nov 2013 → Feb 2016 | diabetes mellitus, hypertensive disorder, obesity disorder | AdventHealth Translational Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT00818701 Comparator | Feb 2009 → Aug 2010 | congestive heart failure, impaired renal function disease | Mayo Clinic | Terminated | No outcome recorded |
| Phase 1/2 | NCT02608996 Comparator | Dec 2015 → Dec 2018 overdue | hypertensive disorder | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT00972569 Comparator | Oct 2009 → Jun 2019 | heart failure, impaired renal function disease | Mayo Clinic | Completed | No outcome recorded |
| Phase 1/2 | NCT00405639 Comparator | Jun 2006 → Apr 2011 | systolic heart failure | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT01132846 Comparator | Aug 2010 → May 2013 | symptomatic heart failure | Duke University | Completed | No outcome recorded |
| Phase 2 | NCT01440881 Comparator | Apr 2010 → Dec 2012 | kidney failure | University of Florida | Completed | No outcome recorded |
| Phase 2 | NCT00573144 Comparator | Sep 2006 → Nov 2012 | acute myocardial infarction | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT00505791 Comparator | Aug 2007 → Aug 2008 | congestive heart failure, pulmonary edema | University of Medicine and Dentistry of New Jersey | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00559338 Comparator | Dec 2003 → Apr 2005 | cardiomyopathy, congestive heart failure | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| — | NCT02269072 Comparator | Feb 2015 → Feb 2016 | hypertensive disorder | Massachusetts General Hospital | Withdrawn | No outcome recorded Stop: Business |
| — | NCT01324739 Comparator | May → Oct 2010 | cardiomyopathy, diabetes mellitus | Medical University of Vienna | Completed | No outcome recorded |
| — | NCT00709163 Comparator | Dec 2003 → Nov 2005 | dilated cardiomyopathy | University of California, Los Angeles | Completed | No outcome recorded |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 59 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | nesiritide | “This study is being done to determine the effects (good and bad) of intravenous infusion of a human brain natriuretic peptide (BNP), Natrecor (nesiritide), a hormone produced...” NCT00252213 ↗54“standard therapy plus Natrecor® (nesiritide, a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure)” NCT00270387 ↗ “Recombinant human brain natriuretic peptide (rhBNP, generic name: nesiritide) shares structural and biological activity highly similar to endogenous BNP.” NCT07617675 ↗ “The intravenous infusion of nesiritide consisted of a bolus dose of 2mcg/kg followed by the infusion rate of 0.01 mcg/kg/min for up to eight hours.” NCT00559338 ↗ “Natrecor (Nesiritide) is a human recombinant form of BNP approved for use in the treatment of acute decompensated HF.” NCT00338455 ↗ “BNP (Nesiritide) will be infused starting at 0.0025 g/Kg/min IV for 3 hours” NCT00972569 ↗ “Dose of Nesiritide infusion will be 0.005 ug/Kg/min” NCT00252200 ↗ “infusion of nesiritide for 24 hours” NCT00309868 ↗ |
| Known as | BNP | “human B-type natriuretic factor (BNP), Natrecor (nesiritide), a hormone produced by the heart” NCT01544998 ↗3“Nesiritide (Brain Natriuretic Peptide, BNP) for the Prevention of Acute Renal Failure” NCT00110201 ↗ “recombinant human b-type natriuretic peptide (BNP) (Nesiritide)” NCT02642523 ↗ “Nesiritide (BNP)” NCT01514357 ↗ |
| Known as | BNP, Nesiritide | “BNP, Nesiritide” NCT00252200 ↗ |
| Known as | BNP-32 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01324739 ↗ |
| Known as | Brain Natriuretic Peptide | “Nesiritide (Brain Natriuretic Peptide, BNP) for the Prevention of Acute Renal Failure” NCT00110201 ↗ |
| Known as | fhBNP | “Nesiritide (fhBNP) administered by continuous IV infusion during 48 hours.” NCT03234751 ↗ |
| Known as | human B-type natriuretic factor | “human B-type natriuretic factor (BNP), Natrecor (nesiritide), a hormone produced by the heart” NCT01544998 ↗ |
| Known as | human b-type natriuretic peptide | “The goal of this study was to further define the role of nesiritide (human b-type natriuretic peptide) in the therapy of decompensated heart failure (HF)” PMID 10400005 ↗ Jul 1999 |
| Known as | JNS004 | “An Exploratory Study of JNS004 (Nesiritide) in Patients With Acute Heart Failure (J2)” NCT00490724 ↗ |
| Known as | NATRECOR | “This study is being done to determine the effects (good and bad) of intravenous infusion of a human brain natriuretic peptide (BNP), Natrecor (nesiritide), a hormone produced...” NCT00252213 ↗10“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...” NCT00075179 ↗ “Recombinant human BNP (Natrecor) is approved by the FDA for treatment of decompensated CHF as it has been demonstrated to lower filling pressures and improve symptoms.” NCT00170183 ↗ “FUSION I Assesses Safety and Tolerability of Two Doses of NATRECOR (Nesiritide) Administered to Patients With Worsening Congestive (Decompensated) Heart Failure” NCT00270361 ↗ “Natrecor (nesiritide) is the proprietary name for the IV formulation of human B-type natriuretic peptide (hBNP).” NCT00270374 ↗ “Nesiritide (Natrecor) is a man-made version of a human hormone that dilates veins and arteries.” NCT00145873 ↗ “human B-type natriuretic factor (BNP), Natrecor (nesiritide), a hormone produced by the heart” NCT01544998 ↗ |
| Known as | NATRECOR hBNP | “A Study to Develop Additional Safety and Clinical Experience With NATRECOR hBNP (Nesiritide) in the Treatment of Patients With Worsening Congestive Heart Failure” NCT00271557 ↗ |
| Known as | Natrecor(TM) | “investigates the potential benefit of nesiritide (brand name is Natrecor(TM))in improving exercise capacity in patients with heart failure (HF).” NCT00240084 ↗ |
| Known as | Nesiritide (Natrecor) | “Nesiritide (Natrecor)” NCT00972569 ↗ |
| Action | Inhibit | “neurohormonal effects of nesiritide favorably inhibit the renin-angiotension-aldosterone system” NCT00166010 ↗ |
| Modality | Protein / enzyme biologic | “Nesiritide (human recombinant B-type natriuretic peptide)” NCT00166010 ↗ |
| Route | Intravenous | “Nesiritide will be given by vein over 30 minutes.” NCT00075179 ↗ |