Drugs / Sivelestat
last change Jun 2026 re-read 2 minutes ago

Sivelestat

Small molecule targets ELANE via inhibition

Developed for
aortic disorder · acute respiratory distress syndrome · acute lung injury · adult acute respiratory distress syndrome · infectious disease with sepsis · blood coagulation disease · cerebral artery occlusion · coronary artery disorder
+6 more · ischemic stroke · multiple organ dysfunction syndrome · pneumonia · respiratory failure · viral respiratory tract infection · cardiovascular disorder
Investigated by
First Affiliated Hospital Xi'an Jiaotong University · Ono Pharmaceutical Co., Ltd. · Affiliated Hospital of Nantong University · Assistance Publique - Hôpitaux de Paris · Beijing Anzhen Hospital · Beijing Tiantan Hospital
+16 more · Changhai Hospital · Eli Lilly and Company · Fujian Provincial Hospital · Guangdong Provincial People's Hospital · Nanjing Medical University · Shanghai Zhongshan Hospital · Sichuan Provincial People's Hospital · Southeast University, China · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · The First Affiliated Hospital of Anhui Medical University · The First Affiliated Hospital with Nanjing Medical University · The First Hospital of Jilin University · The University of Hong Kong-Shenzhen Hospital · University Hospital, Strasbourg, France · Xiaotong Hou · Xuanwu Hospital, Beijing

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

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT00036062 Aug 2001 → Dec 2002 acute lung injury, adult acute respiratory distress syndrome Eli Lilly and Company Completed No outcome recorded
Phase 24 trials
Phase 2 NCT06381661 May 2026 → Jun 2028 expected infectious disease with sepsis Assistance Publique - Hôpitaux de Paris Not yet recruiting No outcome recorded
Phase 2 NCT07214103 Mar 2026 → Dec 2032 expected blood coagulation disease, infectious disease with sepsis University Hospital, Strasbourg, France Not yet recruiting No outcome recorded
Phase 2 NCT07118930 Aug 2025 → Jul 2027 expected coronary artery disorder Affiliated Hospital of Nantong University Recruiting No outcome recorded
Phase 2 NCT00417326 Dec 2006 → Aug 2009 pneumonia Ono Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 32 trials
Phase 3 NCT06276569 Feb 2024 → Apr 2025 heart disorder The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Completed No outcome recorded
Phase 3 NCT04973670 Oct 2021 → Sep 2023 acute respiratory distress syndrome Southeast University, China Unknown No outcome recorded
Phase 43 trials
Phase 4 NCT07156656 Sep 2025 → Sep 2028 expected aortic disorder, multiple organ dysfunction syndrome Shanghai Zhongshan Hospital Not yet recruiting No outcome recorded
Phase 4 NCT04909697 Apr 2022 → Sep 2025 acute respiratory distress syndrome Sichuan Provincial People's Hospital Completed No outcome recorded
Phase 4 NCT00219375 Jun 2004 → Jul 2007 acute lung injury Ono Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase not applicable6 trials
NCT07552610 Jun 2026 → May 2029 expected cerebral artery occlusion, ischemic stroke Xuanwu Hospital, Beijing Recruiting No outcome recorded
NCT06195267 Jul 2024 → Dec 2025 overdue aortic disorder Nanjing Medical University Recruiting No outcome recorded
NCT05874700 May → Dec 2023 aortic disorder Xiaotong Hou Unknown No outcome recorded
NCT05697016 Jan 2023 → Jan 2024 respiratory failure, viral respiratory tract infection Beijing Tiantan Hospital Unknown No outcome recorded
NCT05672472 Jan 2023 → Jan 2025 adult acute respiratory distress syndrome The First Hospital of Jilin University Unknown No outcome recorded
NCT05343338 Apr 2022 → Dec 2024 acute respiratory distress syndrome, aortic disorder First Affiliated Hospital Xi'an Jiaotong University Unknown No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
NCT06387823 Comparator Apr 2024 → Jun 2025 acute respiratory distress syndrome Peking Union Medical College Hospital Unknown No outcome recorded
NCT01170845 Comparator Mar 2007 → Mar 2009 esophageal cancer Yokohama City University Medical Center Completed No outcome recorded

Evidence & citations 18 cited values

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

FieldValueCited text
Known as sivelestat “the neutrophil elastase inhibitor, sivelestatPMID 23596346 Apr 2013
12

NCT01170845

NCT04909697

NCT06381661

NCT05343338

NCT06276569

NCT06195267

NCT05874700

NCT00036062

NCT07156656

NCT07214103

NCT05697016

NCT07118930

Known as EI-546 ChEMBL registry synonym — accepted as the source's own label CHEMBL76688
Known as Elaspol ChEMBL registry synonym — accepted as the source's own label CHEMBL76688
Known as LY-544349 ChEMBL registry synonym — accepted as the source's own label CHEMBL76688
Known as LY-544349 SODIUM HYDRATE ChEMBL registry synonym — accepted as the source's own label CHEMBL76688
Known as ONO-5046 ChEMBL registry synonym — accepted as the source's own label CHEMBL76688
Known as ONO-5046 SODIUM HYDRATE ChEMBL registry synonym — accepted as the source's own label CHEMBL76688
Known as ONO-5046Na ClinicalTrials.gov intervention name — accepted as the source's own label NCT00417326
Known as Sivelestat sodium “The total 24-hour dose of Sivelestat sodium (4.8mg/kg) was dissolved with 50 ml normal saline.” NCT06195267
4

NCT07552610

NCT04973670

NCT05672472

NCT06387823

Known as sivelestat sodium hydrate “Postischemic infusion of sivelestat sodium hydrate, a selective neutrophil elastase inhibitor, protects against myocardial stunning in swine.” PMID 20464430 May 2010
1

NCT00219375

Known as Sivelestat sodium salt tetrahydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL76688
Known as Sivelestat sodium tetrahydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL76688
Known as sodium N-\[2-\[4-(2,2-dimethylpropionyloxy) phenyl-sulfonylaminobenzoyl\]amino-acetate tetrahydrate\] “Sivelestat, a specific inhibitor of neutrophil elastase; sodium N-\[2-\[4-(2,2-dimethylpropionyloxy) phenyl-sulfonylaminobenzoyl\]amino-acetate tetrahydrate\]NCT05697016
Known as SSH “BACKGROUND: This study was undertaken to assess the value of administering perioperative sivelestat sodium hydrate (SSH), a selective neutrophil elastase inhibitor, after...” PMID 21557207 May 2011
1

“Sivelestat Sodium Hydrate (SSH) combined with Ulinastatin (UTI)” PMID 38886709 Jun 2024

Action Inhibit “a selective neutrophil elastase inhibitor” PMID 21557207 May 2011
1

“Leukocyte elastase inhibitor” CHEMBL76688

Modality Small molecule CHEMBL76688
Route Intravenous “0.2 mg/kg/hr continuous i.v. infusion - up to 14 days” NCT00219375
Target ELANE “Leukocyte elastase inhibitor” CHEMBL76688