Ulinastatin

Summary

Ulinastatin (CHEMBL2108163) is a phase-3 clinical-stage unknown (ATC B02AB05); indicated across 6 conditions including stomatitis and injury.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Unknown
• ATC class: B02AB05
• Indications: 6 conditions
• Clinical trials: 31

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2108163
Name	Ulinastatin
Type	Unknown
Max phase	3
ATC	B02AB05

Also known as: AER-002, Bikunin, Estotin, Mingin, Miraclid, Trypsin inhibitor uti-1, Ulinastatin, Ulinastatina, Ulinastatine, Urinary trypsin inhibitor 1, Urinastatin, Uristatin

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

4 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
stomatitis	3	MONDO:0004842	EFO:1001904
injury	2	MONDO:0021178	EFO:0000546
acute respiratory distress syndrome	2	MONDO:0006502	EFO:1000637
severe acute respiratory syndrome	1	MONDO:0005091	MONDO:0100096

2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 31.

Phase distribution

Phase	Trials
Not specified	18
PHASE4	8
PHASE3	2
PHASE2	2
PHASE1/PHASE2	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT00944385	PHASE4	COMPLETED	Effects of Ulinastatin on Myocardial Protection and Blood Loss in Patients Undergoing Aortic Valve Replacement
NCT01084044	PHASE4	COMPLETED	Effects of Ulinastatin on Coagulation in High Risk Patients Undergoing Off Pump Coronary Artery Bypass Graft Surgery
NCT01132521	PHASE4	SUSPENDED	Ulinastatin in Severe Acute Pancreatitis
NCT01518569	PHASE4	COMPLETED	Ulinastatin’s Anti-inflammatory Reaction in Cardiac Surgery
NCT02527811	PHASE4	UNKNOWN	Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery
NCT02647554	PHASE4	COMPLETED	Ulinastatin Treatment in Adult Patients With Sepsis and Septic Shock in China
NCT03154814	PHASE4	COMPLETED	Ulinastatin Improves Postoperative Oxygenation After Cardiopulmonary Bypass
NCT05895240	PHASE4	UNKNOWN	Role of Ulinastatin in Preventing Severe Sepsis and Consequent Morbidities and Mortality
NCT03387774	PHASE3	COMPLETED	Efficacy of Ulinastatin for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients
NCT05391789	PHASE3	UNKNOWN	Clinical Efficacy of Ulinastatin for Treatment of Sepsis With Systemic Inflammatory Response Syndrome
NCT01287806	PHASE2	UNKNOWN	Ulinastatin in Inhalation Lung Injury
NCT02895191	PHASE2	UNKNOWN	The Safety and Dose Response Relationship of Ulinastatin for Acute Respiratory Distress Syndrome(ARDS)
NCT04393311	PHASE1/PHASE2	WITHDRAWN	Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients
NCT06966687	Not specified	ENROLLING_BY_INVITATION	Protective Effect of Ulinastatin and Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA XI)
NCT07382375	Not specified	NOT_YET_RECRUITING	AI-assisted Subtyping-directed Precision Treatment in Acute Aortic Dissection
NCT07520370	Not specified	NOT_YET_RECRUITING	Effect of Perioperative Ulinastatin on Postoperative Stroke in Patients With Brain Tumor
NCT07583290	Not specified	ACTIVE_NOT_RECRUITING	Artificial Intelligence for Ulinastatin Responder Outcome & Risk Assessment in CPB
NCT01060189	Not specified	COMPLETED	Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery
NCT01643447	Not specified	COMPLETED	Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular Carcinoma (HCC)
NCT01894334	Not specified	UNKNOWN	Mechanism and Early Intervention Research on ALI During Emergence Surgery of Acute Stanford A Aortic Dissection
NCT02258906	Not specified	COMPLETED	Effect of Ulinastatin on Postoperative Renal Function in Patients Undergoing Robot-assisted Laparoscopic Partial Nephrectomy
NCT02520570	Not specified	UNKNOWN	Post-market Safety Reassessment of Ulinastatin for Injection
NCT03089957	Not specified	COMPLETED	Prevention of Ulinastatin on Acute Respiratory Distress Syndrome (ARDS)
NCT04028024	Not specified	UNKNOWN	Protective Effect in Cardiac Surgery Patients
NCT04473144	Not specified	UNKNOWN	The Effect of Ulistin on Acute Renal Injury in Patients Undergoing OPCAB (Off Pump Coronary Artery Bypass): a Propensity Score Matched Study
NCT04711889	Not specified	COMPLETED	Protective Effect of Ulinastatin Against Negative Inflammatory Response and Organ Dysfunction After Acute Type a Aortic Dissection Surgery (PANDA I)
NCT04990752	Not specified	UNKNOWN	Effects of Ulinastatin on Inflammatory Response During ECMO Support
NCT05534802	Not specified	COMPLETED	Ulinastatin Improves and Prevents Cardiac Dysfunction Induced by Cardiopulmonary Bypass
NCT05716256	Not specified	UNKNOWN	Effect of Ulinastatin on the Action of NDMRs (Rocuronium / Cisatracurium)
NCT06268249	Not specified	COMPLETED	Ulinastatin Improves Post-Cardiac Surgery Cognitive Dysfunction
NCT07090278	Not specified	COMPLETED	Ulinastatin Treatment Reduces the Incidence of Sepsis-associated Encephalopathy

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).