Drugs / Serelaxin

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Refused (EMA) EU (EMA) Reasanz 2014-08-05 europa.eu

Trials 16 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT01875523 Aug → Dec 2013 chronic renal failure syndrome, end stage renal failure Novartis Pharmaceuticals Completed No outcome recorded
Phase 1 NCT01433458 Jul → Dec 2011 Novartis Pharmaceuticals Completed No outcome recorded
Phase 211 trials
Phase 2 NCT02625922 Feb 2016 → Jan 2017 heart failure Novartis Pharmaceuticals Terminated No outcome recorded
Phase 2 NCT02151383 Sep 2014 → Apr 2017 heart failure Novartis Pharmaceuticals Terminated No outcome recorded
Phase 2 NCT01982292 May 2014 → Sep 2015 heart failure Novartis Pharmaceuticals Completed No outcome recorded
Phase 2 NCT01979614 Feb 2014 → Aug 2016 coronary artery disorder Novartis Pharmaceuticals Completed No outcome recorded
Phase 2 NCT02002702 Jan → Aug 2014 heart failure Novartis Pharmaceuticals Completed No outcome recorded
Phase 2 NCT01566630 May 2013 → Aug 2014 preeclampsia Novartis Pharmaceuticals Terminated No outcome recorded
Phase 2 NCT01640964 Apr 2013 → Dec 2014 portal hypertension Novartis Pharmaceuticals Completed No outcome recorded
Phase 2 NCT01543854 Mar 2012 → Jan 2013 heart failure Novartis Pharmaceuticals Completed No outcome recorded
Phase 2 NCT01546532 Feb → Dec 2012 heart failure Novartis Pharmaceuticals Completed No outcome recorded
Phase 2 NCT00406575 Nov 2006 → Jan 2007 congestive heart failure Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies Terminated No outcome recorded
Phase 33 trials
Phase 3 NCT02007720 Mar 2014 → Mar 2017 heart failure Novartis Pharmaceuticals Terminated No outcome recorded
Phase 3 NCT02064868 Jan 2014 → Mar 2017 heart failure Novartis Pharmaceuticals Terminated No outcome recorded
Phase 3 NCT01870778 Oct 2013 → Jan 2017 heart failure Novartis Pharmaceuticals Completed No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT02669875 Comparator Oct 2017 → Aug 2018 cirrhosis of liver, portal hypertension University of Edinburgh Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2017-03-22 Novartis Pharmaceuticals Novartis provides update on Phase III study of RLX030 (serelaxin) in patients with acute heart failure novartis.com

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 21 sources stand behind the page.

FieldValueCited text
Known as Serelaxin Serelaxin is a recombinant form of human relaxin-2, a vasodilator hormone that contributes to cardiovascular and renal adaptations during pregnancy.” PMID 31433919 Aug 2019
13

“Renal hemodynamic effects of serelaxin in patients with chronic heart failure: a randomized, placebo-controlled study.” PMID 25286914 Oct 2014

“AIMS: Serelaxin is a recombinant form of human relaxin-2 in development for treatment of acute heart failure.” PMID 25511105 Jun 2015

NCT01875523

NCT02151383

NCT02669875

NCT02625922

NCT02064868

NCT01982292

NCT01640964

NCT02007720

NCT02002702

NCT01979614

NCT00259103

Known as Human relaxin 2 (relaxin h2) ChEMBL registry synonym — accepted as the source's own label CHEMBL2108358
Known as Human relaxin recombinant ChEMBL registry synonym — accepted as the source's own label CHEMBL2108358
Known as recombinant human relaxin “24-h intravenous infusion of serelaxin (recombinant human relaxin) or placebo for cervical ripening in 72 healthy, primiparous women.” PMID 27596360 Sep 2016
1

NCT00406575

Known as recombinant human relaxin-2 “Serelaxin (recombinant human relaxin-2) is a peptide molecule with anti-fibrotic and vasoprotective properties that binds to relaxin family peptide receptor-1 (RXFP1) and has...” PMID 28245243 Feb 2017
Known as rhRlx “Recombinant human relaxin (rhRlx) diluted for continuous IV infusion.” NCT00406575
Known as RLX030 RLX030 (serelaxin) was administered according to a weight-range adjusted dosing regimen at a nominal dose of 30 μg/kg/day as a continuous IV infusion for 48 hours.” NCT01982292
4

“Serelaxin (RLX030) in Patients With Compensated Cirrhosis and Portal Hypertension” NCT01640964

“Serelaxin (RLX030)” NCT01870778

NCT01543854

NCT01566630

Known as Serelaxina ChEMBL registry synonym — accepted as the source's own label CHEMBL2108358
Known as Serelaxine ChEMBL registry synonym — accepted as the source's own label CHEMBL2108358
Action Activate “Relaxin receptor 2 activator” CHEMBL2108358
1

“Relaxin receptor 1 activator” CHEMBL2108358

Modality Protein / enzyme biologic “24-h intravenous infusion of serelaxin (recombinant human relaxin) or placebo for cervical ripening in 72 healthy, primiparous women.” PMID 27596360 Sep 2016
Route Intravenous “24-h intravenous infusion of serelaxin (recombinant human relaxin) or placebo for cervical ripening in 72 healthy, primiparous women.” PMID 27596360 Sep 2016
Target RXFP1 “Relaxin receptor 1 activator” CHEMBL2108358
Target RXFP2 “Relaxin receptor 2 activator” CHEMBL2108358