Overview
Plasminogen is a pro-enzyme (i.e. a zymogen) which is cleaved to form plasmin - also known as fibrinolysin - as part of the fibrinolytic pathway that breaks down fibrin blood clots. This pathway is activated when a clot is no longer needed or to prevent a clot from extending beyond the site of injury. In June 2021, the FDA approved a plasma-derived plasminogen (Ryplazim, human plasminogen-tvmh) for the treatment of type 1 plasminogen deficiency (hypoplasminogenemia). It is the first and only FDA-approved treatment for this condition, which causes wood-like lesions to form on the mucous membranes of patients, providing an unmet medical need for patients with this rare congenital disease.
Background
Plasminogen is a pro-enzyme (i.e. a zymogen) which is cleaved to form plasmin - also known as fibrinolysin - as part of the fibrinolytic pathway that breaks down fibrin blood clots. This pathway is activated when a clot is no longer needed or to prevent a clot from extending beyond the site of injury. In June 2021, the FDA approved a plasma-derived plasminogen (Ryplazim, human plasminogen-tvmh) for the treatment of type 1 plasminogen deficiency (hypoplasminogenemia). It is the first and only FDA-approved treatment for this condition, which causes wood-like lesions to form on the mucous membranes of patients, providing an unmet medical need for patients with this rare congenital disease.
Indication
Plasma-derived human plasminogen, marketed under the brand name Ryplazim, is indicated for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia).
Associated Conditions
- Type I Plasminogen Deficiency
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/08/23 | N/A | UNKNOWN | |||
2022/01/12 | Phase 2 | Completed | General Hospital of Shenyang Military Region | ||
2021/12/13 | Phase 4 | Completed | |||
2020/10/14 | N/A | AVAILABLE | Kedrion S.p.A. | ||
2019/11/20 | N/A | UNKNOWN | University of Medicine and Pharmacy at Ho Chi Minh City | ||
2019/05/29 | Phase 3 | Completed | |||
2016/05/10 | Phase 3 | Withdrawn | |||
2012/09/05 | Phase 2 | Completed | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | ||
2012/02/13 | Phase 4 | UNKNOWN | Beijing Chao Yang Hospital | ||
2012/01/20 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Fibrinogenase for Injection | 国药准字H11022110 | 化学药品 | 注射剂(冻干粉针剂) | 10/16/2020 | |
| Fibrinogenase Injection | 国药准字H22026138 | 化学药品 | 注射剂 | 2/20/2021 | |
| Fibrinogenase Injection | 国药准字H11022157 | 化学药品 | 注射剂(小容量注射剂) | 10/16/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||