plasminogen
Trade name: Ryplazim
BiologicalapprovedOrphan Drug FDA
Approved
Jun 4, 2021
Plasmin is an important enzyme present in blood that degrades many blood plasma proteins, including fibrin clots. The degradation of fibrin is termed fibrinolysis. In humans, the plasmin protein is encoded by the PLG gene. — Wikipedia
Clinical trial activity
7 trials · 7 clinical orgs · 1 marketing orgs
Phase 1
1
Phase 2
1
Phase 3
3
Phase 4
0
Earliest trial started Sep 1, 2012 (NCT01554956)
Timeline
2010s
- Jan 1, 2012
Earliest Phase 2 Sponsor(trial)
- Mar 5, 2013
Orphan Drug Designation
- Jan 1, 2014
ProMetic Life Sciences — Earliest Phase 1 Sponsor(trial)
2020s
- Jan 1, 2020
Earliest Phase 3 Sponsor(trial)
- Jun 4, 2021
ProMetic Life Sciences — Earliest FDA Approval
- Jun 4, 2021
ProMetic Life Sciences — NDA Secondary Org
- Jun 4, 2021
ProMetic Life Sciences — NDA Organization
Indications
Approved for
Mechanism of action
- PlasminogenAGONIST
PLG agonist
- FibrinogenHYDROLYTIC ENZYME
Fibrinogen hydrolytic enzyme
Approval history
- approvedJun 4, 2021
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaPlasmin ↗
- NCATS1EF190B6M7 ↗
- ChEMBLCHEMBL2108131 ↗
Also known as
- plasminogen
- plasminogen
- plasminogen
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04275232 | Phase 3 | May 31, 2020 | Canadian Blood Services, Memorial University of Newfoundland |
| NCT02690714 | Phase 2/Phase 3 (Phase 3) | May 4, 2016 | Indiana Hemophilia & Thrombosis Center, ProMetic Life Sciences |
| NCT02312180 | Phase 1 | Dec 1, 2014 | ProMetic Life Sciences |
| NCT01554956 | Phase 2/Phase 3 (Phase 3) | Sep 1, 2012 | Kedrion SpA |
| NCT03265171 | N/A | — | Cedars-Sinai Medical Center, Indiana Hemophilia & Thrombosis Center, ProMetic Life Sciences, Vanderbilt University |
| NCT03642691 | N/A | — | ProMetic Life Sciences |
| NCT04586062 | N/A | — | Kedrion SpA |
Showing 7 of 7 trials
Page 1 / 1
Organizations
Research & Development (7)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| ProMetic Life Sciences | For profit | 4 | 4 | 3 | 2014 |
| Indiana Hemophilia & Thrombosis Center | Academic/Hospital | 2 | 0 | 2 | 2016 |
| Kedrion SpA | For profit | 2 | 2 | 2 | 2012 |
| Canadian Blood Services | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Cedars-Sinai Medical Center | Academic/Hospital | 1 | 0 | 1 | — |
| Memorial University of Newfoundland | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Vanderbilt University | Academic/Hospital | 1 | 0 | 1 | — |
7 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ProMetic Life Sciences | For profit | NDA2 | Jun 4, 2021 |
| ProMetic Life Sciences | For profit | NDA | Jun 4, 2021 |