Drugs / Defibrotide

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) DEFITELIO 2016-03-30 fda.gov
Approved EU (EMA) Defitelio 2013-10-18 europa.eu

Trials 21 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT04530604 Oct 2020 → Mar 2021 COVID-19, acute respiratory distress syndrome Gregory Yanik Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT00406978 Feb 2006 → Sep 2010 plasma cell myeloma Silvio Aime Completed No outcome recorded
Phase 213 trials
Phase 2 NCT06182410 Aug 2024 → May 2027 neuroblastoma, thrombotic microangiopathy University of California, San Francisco Withdrawn No outcome recorded
Phase 2 NCT05987124 Mar 2024 → Aug 2027 expected hepatic veno-occlusive disease New York Medical College Recruiting No outcome recorded
Phase 2 NCT04313036 Mar 2021 → May 2022 disease related to hematopoietic stem cell transplant, hepatic veno-occlusive disease Loyola University Unknown No outcome recorded
Phase 2 NCT04777422 Feb 2021 → Oct 2023 Kawasaki disease New York Medical College Unknown No outcome recorded
Phase 2 NCT04652115 Jan 2021 → Dec 2026 expected COVID-19 Brigham and Women's Hospital Recruiting No outcome recorded
Phase 2 NCT04335201 May 2020 → Apr 2021 IRCCS San Raffaele Completed No outcome recorded
Phase 2 NCT04348383 Apr 2020 → Feb 2023 COVID-19 Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia Completed No outcome recorded
Phase 2 NCT03954106 Oct 2019 → Sep 2020 diffuse large B-cell lymphoma, toxic encephalopathy Jazz Pharmaceuticals Terminated No outcome recorded
Phase 2 NCT03384693 May 2018 → Jul 2020 thrombotic microangiopathy University of California, San Francisco Completed No outcome recorded
Phase 2 NCT03339297 Feb 2018 → May 2020 acute graft versus host disease Jazz Pharmaceuticals Completed No outcome recorded
Phase 33 trials
Phase 3 NCT02851407 Sep 2016 → Oct 2020 hepatic veno-occlusive disease Jazz Pharmaceuticals Completed No outcome recorded
Phase 3 NCT00628498 Dec 2007 → Jul 2016 hepatic veno-occlusive disease Jazz Pharmaceuticals Completed No outcome recorded
Phase 3 NCT00358501 Jul 2006 → Sep 2008 hepatic veno-occlusive disease Jazz Pharmaceuticals Completed No outcome recorded
Phase 41 trial
Phase 4 NCT02876601 Apr 2017 → Feb 2018 Medical University of Vienna Completed No outcome recorded
Phase not stated2 trials
NCT00263978 Nov 2005 → Jun 2009 liver disorder Emory University No longer available No outcome recorded
NCT00143546 Nov 2003 → ? hepatic veno-occlusive disease St. Jude Children's Research Hospital No longer available No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2/31 trial
Phase 2/3 NCT00272948 Comparator Dec 2005 → Jan 2009 hepatic veno-occlusive disease European Society for Blood and Marrow Transplantation Completed No outcome recorded
Phase 41 trial
Phase 4 NCT01718288 Background Nov 2006 → Mar 2011 peripheral arterial disease Fadoi Foundation, Italy Completed No outcome recorded

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 23 sources stand behind the page.

FieldValueCited text
Known as Defibrotide “standard heparin / low molecular weight heparin, hemorheological / vasodilators such as pentoxifylline / buflomedil, propionyl-L-carnitine, Defibrotide) but not prostanoids” NCT01718288
22

Defibrotide (DF) is a novel orally bioavailable polydisperse oligonucleotide with anti-thrombotic and anti-adhesive effects” NCT00406978

NCT00358501

NCT00272948

NCT02876601

NCT02851407

NCT03954106

NCT00003966

NCT03384693

NCT05987124

NCT04777422

NCT02675959

NCT00263978

NCT04335201

NCT00628498

NCT04652115

NCT04530604

NCT04348383

NCT03805581

NCT00143546

NCT04313036

NCT03339297

NCT06182410

Known as Defitelio “Protection of endothelial dysfunction by intravenous infusion of Defibrotide (Defitelio), expected to decrease inflammation and expression of adhesion molecules in the endothelium” NCT04348383
Action Inhibit “It is a polydeoxyribonucleotide salt that blocks plasminogen activator inhibitor-1 (PAI-1)” NCT03384693
Modality Oligonucleotide (other) “Defibrotide (DF) is a novel orally bioavailable polydisperse oligonucleotide” NCT00406978
Route Intravenous “defibrotide IV over 2 hours every 6 hours” NCT00003966