ulinastatin
Recombinant proteinexperimental
Ulinastatin is a glycoprotein that is isolated from healthy human urine or synthetically produced and has molecular weight of 25 - 40kDa. It acts as a urinary trypsin inhibitor (UTI). Highly purified ulinastatin has been clinically used for the treatment of acute pancreatitis, chronic pancreatitis, Stevens–Johnson syndrome, burns, septic shock, and toxic epidermal necrolysis (TEN). — Wikipedia
Clinical trial activity
26 trials · 30 clinical orgs · 0 marketing orgs
Phase 1
2
Phase 2
5
Phase 3
3
Phase 4
8
Earliest trial started Mar 1, 2008 (NCT01518569)
Timeline
Indications
Approved for
Studied for
- Aortic Valve Disease · Phase 4
- Cardiopulmonary Bypass · Phase 4
- Cardiovascular Diseases · Phase 4
- Coronary Artery Disease · Phase 4
- COVID-19 · Phase 1/Phase 2
- Healthy Volunteers · Phase 1
- Heart Defects, Congenital · Phase 4
- Inhalation Exposure · Phase 2
- Mucositis · Phase 3
- Multiple Organ Failure · Phase 4
- Pancreatitis · Phase 4
- Pneumonia, Ventilator-Associated · Phase 2/Phase 3
- Respiratory Distress Syndrome · Phase 2
- Sepsis · Phase 4
- Shock, Septic · Phase 4
- Thoracic Surgery · Phase 4
- Ventilators, Mechanical · Phase 2/Phase 3
Mechanism of action
- TrypsinINHIBITOR
Trypsin inhibitor
- Coagulation factor IXINHIBITOR
F9 inhibitor
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaUlinastatin ↗
- ChEMBLCHEMBL2108163 ↗
Also known as
- acid-stable protease inhibitor
- miraclid
- mr 20
- mr-20 (magnetic powder)
- mr 20 (magnetic powder) of urinastatin
- trypsin inhibitor mr-20
- ulinastatin
- ulinastatin
- ulinastatin
- ulinastatin
- ulinastatin
- urinary trypsin inhibitor
- urinary trypsin inhibitor (68)
- urinary trypsin inhibitor-like inhibitor (43)
- urinastatin
- uti68
- uti(68)
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06966687 | N/A | Apr 1, 2025 | Capital Medical University, Guangzhou Medical University, Huazhong University of Science and Technology, Nanjing Medical University, Sichuan University |
| NCT05895240 | Phase 4 | May 1, 2023 | Jinnah Postgraduate Medical Centre |
| NCT05716256 | N/A | Feb 15, 2023 | Huazhong University of Science and Technology |
| NCT05534802 | N/A | Sep 16, 2022 | Huazhong University of Science and Technology |
| NCT05391789 | Phase 3 | Jul 31, 2022 | Fudan University |
| NCT04711889 | N/A | Jan 1, 2021 | Capital Medical University, Nanjing Medical University |
| NCT04473144 | N/A | Aug 1, 2020 | Ajou University |
| NCT04393311 | Phase 1/Phase 2 (Phase 2) | Jun 30, 2020 | Stanford University |
| NCT04028024 | N/A | Aug 1, 2019 | Fudan University |
| NCT03630627 | Phase 1 | Aug 21, 2018 | Parexel, Samsung |
| NCT03387774 | Phase 3 | Jan 30, 2018 | First People's Hospital of Foshan, Guangzhou Medical University, People's Hospital of Zhongshan, Sun Yat-Sen University |
| NCT03089957 | N/A | Apr 1, 2017 | Central Hospital, Zibo, Henan Medical University, Peking University, People's Liberation Army of China, Zhengzhou University |
| NCT02647554 | Phase 4 | Dec 1, 2016 | Techpool Bio-Pharma Co., Ltd., Tsinghua University |
| NCT02895191 | Phase 2 | Aug 1, 2016 | Bengbu Medical College, Capital Medical University, Guangzhou Medical University, Sichuan University, Techpool Bio-Pharma Co., Ltd., Zhejiang University |
| NCT03154814 | Phase 4 | Jan 1, 2016 | Konkuk University |
| NCT02527811 | Phase 4 | Apr 1, 2015 | Fudan University, Guangzhou Medical University, Jiao Tong University, Nanjing Medical University, People's Liberation Army of China, Techpool Bio-Pharma Co., Ltd. |
| NCT02258906 | N/A | Oct 1, 2014 | Yonsei University |
| NCT01865266 | Phase 2/Phase 3 (Phase 3) | Jan 1, 2014 | Fudan University, Jiao Tong University |
| NCT01894334 | N/A | Apr 1, 2013 | Capital Medical University |
| NCT01643447 | N/A | May 1, 2012 | Eastern Hepatobiliary Surgery Hospital, People's Liberation Army of China |
Showing 20 of 26 trials
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Organizations
Research & Development (30)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Capital Medical University | Academic/Hospital | 4 | 1 | 2 | 2013 |
| Fudan University | Academic/Hospital | 4 | 3 | 3 | 2014 |
| Guangzhou Medical University | Academic/Hospital | 4 | 0 | 4 | 2015 |
| Huazhong University of Science and Technology | Academic/Hospital | 4 | 2 | 2 | 2010 |
| Nanjing Medical University | Academic/Hospital | 4 | 2 | 2 | 2010 |
| People's Liberation Army of China | Government | 4 | 1 | 3 | 2011 |
| Techpool Bio-Pharma Co., Ltd. | For profit | 4 | 3 | 2 | 2010 |
| Sichuan University | Academic/Hospital | 3 | 0 | 3 | 2010 |
| Yonsei University | Academic/Hospital | 3 | 3 | 2 | 2009 |
| Jiao Tong University | Academic/Hospital | 2 | 0 | 2 | 2014 |
| Konkuk University | Academic/Hospital | 2 | 2 | 1 | 2008 |
| Sun Yat-Sen University | Academic/Hospital | 2 | 1 | 2 | 2010 |
| Tsinghua University | Academic/Hospital | 2 | 1 | 1 | 2010 |
| Ajou University | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Bengbu Medical College | Academic/Hospital | 1 | 0 | 1 | 2016 |
| Central Hospital, Zibo | Academic/Hospital | 1 | 0 | 1 | 2017 |
| Changhai Hospital | Academic/Hospital | 1 | 0 | 1 | 2011 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 1 | 1 | 1 | 2008 |
| Eastern Hepatobiliary Surgery Hospital | Academic/Hospital | 1 | 1 | 1 | 2012 |
| First People's Hospital of Foshan | Academic/Hospital | 1 | 0 | 1 | 2018 |
30 organizations
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