Plasmin

Generic Name: Plasmin

Brand Names: Ryplazim

Drug Type: Biotech

CAS Number: 9001-91-6

Unique Ingredient Identifier: 1EF190B6M7

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

Reduced Dose Thrombolytic in Intermediate/High Risk Pulmonary Thromboembolism

Conditions: Pulmonary Embolism

Interventions: Drug: Low-molecular weight heparin
Drug: Tissue Plasminogen Activator, Alteplase

First Posted Date: 2022-08-23

Last Posted Date: 2022-09-01

Lead Sponsor: Ege University

Target Recruit Count: 100

Registration Number: NCT05512702

Locations: 🇹🇷
Ege University, İzmir, Bornova/İzmir, Turkey

EXtending the tIme Window of Thrombolysis by ButyphThalide up to 6 Hours After Onset (EXIT-BT)

Phase 2

Completed

Conditions: Stroke, Ischemic

Interventions: Drug: TNK-Tissue Plasminogen Activator

First Posted Date: 2022-01-12

Last Posted Date: 2023-01-13

Lead Sponsor: General Hospital of Shenyang Military Region

Target Recruit Count: 100

Registration Number: NCT05189509

Locations: 🇨🇳
Department of Neurology, General Hospital of Northern Theater Command, Shenyang, China

Direct Mechanical Thrombectomy Versus Bridging Therapy

Phase 4

Completed

Conditions: Thrombectomy
Large-Artery Atherosclerosis (Embolus/Thrombosis)
Ischemic Stroke

Interventions: Device: Trevo and or Merci devices for stent retreival
Device: Penumbra system for stent aspiration
Drug: recombinant tissue plasminogen activator

First Posted Date: 2021-12-13

Last Posted Date: 2022-01-03

Lead Sponsor: Alexandria University

Target Recruit Count: 51

Registration Number: NCT05155540

Locations: 🇪🇬
Alexandria University Faculty of Medicine, Alexandria, Egypt

Sponsor Initiated Expanded Access Protocol, Intermediate-Size Patient Population

Conditions: Ligneous Conjunctivitis

First Posted Date: 2020-10-14

Last Posted Date: 2023-10-05

Lead Sponsor: Kedrion S.p.A.

Registration Number: NCT04586062

Efficacy of Intravenous Tissue-type Plasminogen Activator on Acute Ischemic Stroke Patients With Large Vessel Occlusions

Conditions: Stroke, Ischemic
Stroke, Acute

First Posted Date: 2019-11-20

Last Posted Date: 2019-11-20

Lead Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City

Target Recruit Count: 81

Registration Number: NCT04170647

Locations: 🇻🇳
115 People's Hospital, Ho Chi Minh City, Vietnam

Thrombolysis Endovascular Treatment of Pulmonary Embolism

Phase 3

Completed

Conditions: Acute Pulmonary Embolism
Pulmonary Embolism

Interventions: Drug: recombinant tissue plasminogen activator

First Posted Date: 2019-05-29

Last Posted Date: 2020-11-30

Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

Target Recruit Count: 50

Registration Number: NCT03966079

Locations: 🇨🇳
Beijing Tsinghua Chang Gung Hospital, Beijing, Beijing, China

Pediatric High-Risk Deep Venous Thrombosis Lytic Outcomes Trial

Phase 3

Withdrawn

Conditions: Deep Vein Thrombosis
Post-Thrombotic Syndrome
Venous Thrombosis

Interventions: Drug: Standard Anticoagulation Therapy
Drug: Recombinant tissue plasminogen activator (rt-PA)

First Posted Date: 2016-05-10

Last Posted Date: 2018-08-10

Lead Sponsor: University of Colorado, Denver

Registration Number: NCT02767232

Sonothrombolysis Potentiated by Microbubbles for Acute Ischemic Stroke

Phase 2

Completed

Conditions: Cerebrovascular Stroke

Interventions: Other: Sulfur hexafluoride + ultrasounds
Drug: Recombinant tissue plasminogen activator

First Posted Date: 2012-09-05

Last Posted Date: 2015-08-10

Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Target Recruit Count: 24

Registration Number: NCT01678495

Locations: 🇪🇸
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

Low Dose Rt-PA for Acute Normotensive Pulmonary Embolism With RVD

Phase 4

Conditions: Pulmonary Thromboembolisms
Pulmonary Embolism

Interventions: Drug: Low Molecular Weight Heparin
Drug: Recombinant tissue plasminogen activator (rt-PA)

First Posted Date: 2012-02-13

Last Posted Date: 2012-02-14

Lead Sponsor: Beijing Chao Yang Hospital

Target Recruit Count: 460

Registration Number: NCT01531829

Locations: 🇨🇳
Beijing Chao Yang Hospial, Bejing, Beijing, China
🇨🇳
Beijing Daxing People's Hospital, Beijing, Beijing, China
🇨🇳
Beijing Fuwai Hospital, Beijing, Beijing, China

and more 32 locations

Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy

Phase 3

Completed

Conditions: Sub-massive Pulmonary Embolism
Massive Pulmonary Embolism
Pulmonary Thromboembolism
Pulmonary Embolism
Acute Pulmonary Embolism

Interventions: Drug: recombinant tissue plasminogen activator
Device: EKOS EkoSonic Endovascular System

First Posted Date: 2012-01-20

Last Posted Date: 2021-07-19

Lead Sponsor: Boston Scientific Corporation

Target Recruit Count: 150

Registration Number: NCT01513759

Locations: 🇺🇸
Orlando Regional Medical Center, Orlando, Florida, United States
🇺🇸
Florida Hospital, Orlando, Florida, United States
🇺🇸
Christiana Hospital, Newark, Delaware, United States

and more 19 locations

Drug Development Updates

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