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Sivelestat

Alternative Names: sivelestat
Clinical Status: Inactive
Latest Update: 2025-10-09
Latest Update Note: Clinical Trial Update

Product Description

Mechanisms of Action: ELA Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Intravenous

FDA Designation: *

Approval Status: Not Approved

Approved Countries: China | Korea

Approved Indications: None

Known Adverse Events: None

Company: ONO Pharm
Company Location: CHUO-KU OSAKA 541 JA M0
Company CEO:
Additional Commercial Interests: None

Clinical Description

Countries in Clinic:

Active Clinical Trial Count:

Recent & Upcoming Milestones

Highest Development Phases

Phase 4: Acute Lung Injury|Acute Respiratory Distress Syndrome|Other|Respiratory Distress Syndrome, Newborn

Phase 3: Acute Respiratory Distress Syndrome|Respiratory Distress Syndrome, Newborn|Acute Lung Injury|Sepsis

Phase 2: Acute Respiratory Distress Syndrome|Respiratory Distress Syndrome, Newborn|Acute Lung Injury|Shock, Septic|Hemostatic Disorders|Coronary Artery Disease|Myocardial Ischemia

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

ChiCTR2500108967

ChiCTR2500108967

N/A

Not yet recruiting

Chronic Obstructive Pulmonary Disease|Respiratory Insufficiency

2028-08-31

ChiCTR2500099241

ChiCTR2500099241

N/A

Not yet recruiting

Pneumonia|Respiratory Insufficiency

2027-12-31

ChiCTR2500106233

ChiCTR2500106233

N/A

Not yet recruiting

Pancreatitis, Acute

2027-12-31

ChiCTR2500105020

ChiCTR2500105020

N/A

Not yet recruiting

Sepsis

2027-07-01

ChiCTR2500110021

ChiCTR2500110021

N/A

Not yet recruiting

Unknown

2027-06-30

ChiCTR2400086632

ChiCTR2400086632

N/A

Not yet recruiting

Unknown

2027-04-24

2024-07-08

Treatments

ChiCTR2500107626

ChiCTR2500107626

N/A

Not yet recruiting

Acute Respiratory Distress Syndrome

2027-03-31

ChiCTR2200059102

ChiCTR2200059102

N/A

Not yet recruiting

Acute Lung Injury

2027-03-01

ChiCTR2400086486

ChiCTR2400086486

N/A

Not yet recruiting

Acute Respiratory Distress Syndrome

2026-12-31

2024-07-03

Treatments

ChiCTR2500098962

ChiCTR2500098962

N/A

Not yet recruiting

Acute Lung Injury

2026-12-31

ChiCTR2500101095

ChiCTR2500101095

N/A

Not yet recruiting

Acute Respiratory Distress Syndrome

2026-11-30

NCT07196605

IAT-TOP 2

N/A

Not yet recruiting

Ischemic Stroke

2026-03-01

2025-09-30

Primary Endpoints|Treatments

NCT06195267

PANDA

N/A

Recruiting

Aortic Diseases

2025-12-31

2024-11-21

Patient Enrollment|Primary Endpoints|Start Date|Treatments|Trial Status

ChiCTR2400092841

ChiCTR2400092841

N/A

Not yet recruiting

Unknown

2025-06-30

NCT06387823

STAR

N/A

Recruiting

Acute Lung Injury|Respiratory Distress Syndrome, Newborn|Acute Respiratory Distress Syndrome

2025-06-01

2024-05-14

NCT05672472

Yuting Li1

N/A

Unknown status

Sepsis|Acute Respiratory Distress Syndrome|Acute Lung Injury|Respiratory Distress Syndrome, Newborn

2025-01-10

2025-02-12

Primary Endpoints

NCT05343338

IPIADSS

N/A

Unknown status

Acute Lung Injury|Respiratory Distress Syndrome, Newborn|Acute Respiratory Distress Syndrome|Respiratory Insufficiency

2024-12-31

2025-01-03

Primary Endpoints|Treatments|Trial Status

ChiCTR2400083364

ChiCTR2400083364

N/A

Not yet recruiting

Lung Diseases, Interstitial

2024-10-31

2024-04-23

ChiCTR2300074438

ChiCTR2300074438

N/A

Recruiting

Acute Lung Injury

2024-07-31

2023-08-08

Treatments

NCT05697016

HX-B-2022083

N/A

Unknown status

Respiratory Insufficiency|Acute Respiratory Distress Syndrome|Acute Lung Injury|Respiratory Distress Syndrome, Newborn|Respiratory Tract Infections|COVID-19

2024-01-03

2025-01-03

NCT07214103

SivelSep

P2

Not yet recruiting

Shock, Septic|Hemostatic Disorders

2032-12-31

2025-10-10

Primary Endpoints|Treatments

NCT07118930

2025-K171-01

P2

Recruiting

Myocardial Ischemia|Coronary Artery Disease

2027-07-31

2025-08-13

Primary Endpoints|Treatments

NCT06276569

2023-LCYJ-MS-26

P3

Completed

Acute Respiratory Distress Syndrome|Respiratory Distress Syndrome, Newborn|Acute Lung Injury

2025-04-30

2025-08-07

Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status

NCT07156656

STOP

P4

Not yet recruiting

Other

2028-09-30

2025-09-06

Primary Endpoints|Treatments

NCT04909697

TOAWSS

P4

Recruiting

Acute Lung Injury|Acute Respiratory Distress Syndrome|Respiratory Distress Syndrome, Newborn

2026-03-30

2025-05-03