Plasmin

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.

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
Reduced Dose Thrombolytic in Intermediate/High Risk Pulmonary Thromboembolism	2022/08/23	NCT05512702	N/A	UNKNOWN	Ege University
EXtending the tIme Window of Thrombolysis by ButyphThalide up to 6 Hours After Onset (EXIT-BT)	2022/01/12	NCT05189509	Phase 2	Completed	General Hospital of Shenyang Military Region
Direct Mechanical Thrombectomy Versus Bridging Therapy	2021/12/13	NCT05155540	Phase 4	Completed	Alexandria University
Sponsor Initiated Expanded Access Protocol, Intermediate-Size Patient Population	2020/10/14	NCT04586062	N/A	AVAILABLE	Kedrion S.p.A.
Efficacy of Intravenous Tissue-type Plasminogen Activator on Acute Ischemic Stroke Patients With Large Vessel Occlusions	2019/11/20	NCT04170647	N/A	UNKNOWN	University of Medicine and Pharmacy at Ho Chi Minh City
Thrombolysis Endovascular Treatment of Pulmonary Embolism	2019/05/29	NCT03966079	Phase 3	Completed	Beijing Tsinghua Chang Gung Hospital
Pediatric High-Risk Deep Venous Thrombosis Lytic Outcomes Trial	2016/05/10	NCT02767232	Phase 3	Withdrawn	University of Colorado, Denver
Sonothrombolysis Potentiated by Microbubbles for Acute Ischemic Stroke	2012/09/05	NCT01678495	Phase 2	Completed	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Low Dose Rt-PA for Acute Normotensive Pulmonary Embolism With RVD	2012/02/13	NCT01531829	Phase 4	UNKNOWN	Beijing Chao Yang Hospital
Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy	2012/01/20	NCT01513759	Phase 3	Completed	Boston Scientific Corporation

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
No NMPA approvals found for this drug.

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.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
TISSEEL KIT VH 5.0	osterreichisches institut fur haemoderivate ges m.b.h.	01974327	Powder For Solution - Topical	120 MCG / ML	12/31/1992
TISSEEL KIT VH 2.0	osterreichisches institut fur haemoderivate ges m.b.h.	01949012	Powder For Solution - Topical	120 MCG / ML	12/31/1992
TISSEEL KIT VH	osterreichisches institut fur haemoderivate ges m.b.h.	00677558	Jelly - Topical	120 MCG / PCK	12/31/1986
TISSEEL KIT VH 5.0	Baxter AG	02233275	Liquid , Kit , Powder For Solution - Topical	600 MCG / 5 ML	10/13/1998
TISSEEL KIT VH 1.0	Baxter AG	02233273	Kit , Liquid , Powder For Solution - Topical	120 MCG / 1 ML	10/13/1998
TISSEEL KIT VH 1.0	osterreichisches institut fur haemoderivate ges m.b.h.	01949020	Powder For Solution , Liquid - Topical	120 MCG / ML	12/31/1992
TISSEEL KIT VH 0.5	osterreichisches institut fur haemoderivate ges m.b.h.	02017229	Powder For Solution , Liquid - Topical	120 MCG / ML	12/31/1992
TISSEEL KIT VH 0.5	Baxter AG	02233272	Powder For Solution , Liquid , Kit - Topical	60 MCG / VIAL	1/20/1998
TISSEEL KIT VH 2.0	Baxter AG	02233274	Liquid , Kit , Powder For Solution - Topical	240 MCG / 2 ML	10/13/1998

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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