Clinical Trials

Numerous clinical trials evaluate the therapeutic potential of sivelestat in critical care and inflammatory conditions, including acute respiratory distress syndrome, acute lung injury, systemic inflammatory response syndrome, sepsis, aortic dissection, and acute ischemic stroke. Ranging from Phase 1 through Phase 4, these studies are predominantly sponsored by academic medical institutions, such as Peking Union Medical College Hospital and Shanghai Zhongshan Hospital. Across these protocols, trial recruitment statuses encompass actively recruiting and upcoming studies alongside completed and unknown statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07214103 NOT_YET_RECRUITING
Septic Shock; Coagulopathy
University Hospital, Strasbourg, France
 2027-08-01 PHASE2
NCT07552610 RECRUITING
Acute Ischemic Stroke; Large Vessel Occlusion; Thrombectomy; Neutrophil Extracellular Trap Formation
Xuanwu Hospital, Beijing
 2026-06-22
NCT07156656 NOT_YET_RECRUITING
Type A Aortic Dissection; Organ Failure, Multiple
Shanghai Zhongshan Hospital
 2025-09-01 PHASE4
NCT06381661 RECRUITING
Sepsis
Assistance Publique - Hôpitaux de Paris
 2026-07-09 PHASE2
NCT07738952 NOT_YET_RECRUITING
Neuromyelitis Optica Spectrum Disorder Attack
Kyushu University
 2026-08-17 PHASE1; PHASE2
NCT07118930 RECRUITING
Coronary Heart Disease; Coronary Artery Disease; Coronary Arterial Disease (CAD)
Affiliated Hospital of Nantong University
 2025-08-01 PHASE2
NCT07196605 COMPLETED
Acute Ischemic Stroke; Neutrophil Extracellular Traps Formation; Large Vessel Occlusion; Thrombectomy
Xuanwu Hospital, Beijing
 2025-10-28
NCT06195267 RECRUITING
Aortic Dissection; Systemic Inflammatory Response Syndrome; Cardiovascular Diseases (CVD)
Nanjing Medical University
 2024-07-01
NCT04909697 COMPLETED
Acute Respiratory Distress Syndrome
Sichuan Provincial People's Hospital
 2022-04-18 PHASE4
NCT06387823 UNKNOWN
Acute Respiratory Distress Syndrome
Peking Union Medical College Hospital
 2024-04-15
NCT06276569 COMPLETED
Cardiac Disease
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
 2024-02-18 PHASE3
NCT05672472 UNKNOWN
Acute Respiratory Distress Syndrome
The First Hospital of Jilin University
 2023-01-10
NCT05343338 UNKNOWN
Aortic Dissection; Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
First Affiliated Hospital Xi'an Jiaotong University
 2022-04-20
NCT05697016 UNKNOWN
Respiratory Infection Virus; Respiratory Failure
Beijing Tiantan Hospital
 2023-01-31
NCT05874700 UNKNOWN
Acute Aortic Dissection
Xiaotong Hou
 2023-05
NCT04973670 UNKNOWN
ARDS
Southeast University, China
 2021-10-11 PHASE3
NCT01170845 COMPLETED
Esophageal Cancer
Yokohama City University Medical Center
 2007-03
NCT00219375 COMPLETED
Acute Lung Injury; Systemic Inflammatory Response Syndrome
Ono Pharmaceutical Co., Ltd.
 2004-06 PHASE4
NCT00036062 COMPLETED
Respiratory Distress Syndrome, Adult; Acute Lung Injury
Eli Lilly and Company
 2001-08 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-20)

Check the Sivelestat (Ono-5046) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sivelestat is a potent and selective inhibitor of neutrophil elastase with an IC50 of 44 nM that binds the catalytic site to block enzymatic degradation of extracellular matrix proteins and attenuate neutrophil-mediated cleavage cascades. By suppressing endothelial hyperpermeability and local tissue destruction, sivelestat alleviates vascular inflammatory injury, which provides clinical rationale for its application in conditions such as acute respiratory distress syndrome, systemic inflammatory response syndrome, and sepsis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.