Identification

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Name
Alteplase
Accession Number
DB00009  (BTD00050, BIOD00050)
Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Thrombolytic agents
Description

Human tissue plasminogen activator, purified, glycosylated, 527 residues purified from CHO cells

Protein structure
Db00009
Protein chemical formula
C2569H3928N746O781S40
Protein average weight
59042.3 Da
Sequences
>Alteplase sequence
SYQVICRDEKTQMIYQQHQSWLRPVLRSNRVEYCWCNSGRAQCHSVPVKSCSEPRCFNGG
TCQQALYFSDFVCQCPEGFAGKCCEIDTRATCYEDQGISYRGTWSTAESGAECTNWNSSA
LAQKPYSGRRPDAIRLGLGNHNYCRNPDRDSKPWCYVFKAGKYSSEFCSTPACSEGNSDC
YFGNGSAYRGTHSLTESGASCLPWNSMILIGKVYTAQNPSAQALGLGKHNYCRNPDGDAK
PWCHVLKNRRLTWEYCDVPSCSTCGLRQYSQPQFRIKGGLFADIASHPWQAAIFAKHRRS
PGERFLCGGILISSCWILSAAHCFQERFPPHHLTVILGRTYRVVPGEEEQKFEVEKYIVH
KEFDDDTYDNDIALLQLKSDSSRCAQESSVVRTVCLPPADLQLPDWTECELSGYGKHEAL
SPFYSERLKEAHVRLYPSSRCTSQHLLNRTVTDNMLCAGDTRSGGPQANLHDACQGDSGG
PLVCLNDGRMTLVGIISWGLGCGQKDVPGVYTKVTNYLDWIRDNMRP
Download FASTA Format
Synonyms
  • Alteplasa
  • Alteplase (genetical recombination)
  • Alteplase, recombinant
  • Alteplase,recombinant
  • Plasminogen activator (human tissue-type protein moiety)
  • rt-PA
  • t-PA
  • t-plasminogen activator
  • Tissue plasminogen activator
  • Tissue plasminogen activator alteplase
  • Tissue plasminogen activator, recombinant
  • tPA
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
ActivaseKit100 mg/100mLIntravenousGenentech, Inc.1987-11-13Not applicableUs
ActivaseKit50 mg/50mLIntravenousGenentech, Inc.1987-11-13Not applicableUs
Activase RT-PA InjPowder, for solutionIntravenousHoffmann La Roche1987-12-311998-07-31Canada
Activase RT-PA InjPowder, for solutionIntravenousHoffmann La Roche1987-12-311998-07-31Canada
Activase RT-PA InjPowder, for solutionIntravenousHoffmann La Roche1987-12-311998-07-31Canada
CathfloPowder, for solutionHoffmann La Roche2002-09-26Not applicableCanada
Cathflo ActivaseInjection, powder, lyophilized, for solution2.2 mg/2mLIntravenousGenentech, Inc.2001-09-04Not applicableUs
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
Activase RT-PAAlteplase (50 mg) + Water (50 ml)Liquid; Powder, for solutionIntravenousHoffmann La Roche1998-04-12Not applicableCanada
Activase RT-PAAlteplase (100 mg) + Water (100 ml)Liquid; Powder, for solutionIntravenousHoffmann La Roche1996-12-31Not applicableCanada
Lysatec RT - PaAlteplase (50 mg) + Water (50 ml)Powder, for solutionIntravenousGenentech, Inc.1993-12-311997-08-26Canada
Categories
UNII
1RXS4UE564
CAS number
105857-23-6

Pharmacology

Indication

For management of acute myocardial infarction, acute ischemic strok and for lysis of acute pulmonary emboli

Associated Conditions
Pharmacodynamics

Alteplase binds to fibrin in a thrombus and converts the entrapped plasminogen to plasmin. It also produces limited conversion of plasminogen in the absence of fibrin.

Mechanism of action

Alteplase binds to fibrin rich clots via the fibronectin finger-like domain and the Kringle 2 domain. The protease domain then cleaves the Arg/Val bond in plasminogen to form plasmin. Plasmin in turn degrades the fibrin matrix of the thrombus, thereby exerting its thrombolytic action.

TargetActionsOrganism
APlasminogen
activator
Humans
AFibrinogen alpha chainNot AvailableHumans
UUrokinase plasminogen activator surface receptorNot AvailableHumans
UPlasminogen activator inhibitor 1Not AvailableHumans
Additional Data Available
Adverse Effects

Comprehensive structured data on known drug adverse effects with statistical prevalence. MedDRA and ICD10 ids are provided for adverse effect conditions and symptoms.

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Additional Data Available
Contraindications

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

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Additional Data Available
Blackbox Warnings

Structured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.

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Absorption
Not Available
Volume of distribution
Not Available
Protein binding
Not Available
Metabolism
Not Available
Route of elimination
Not Available
Half life
Not Available
Clearance
Not Available
Toxicity
Not Available
Affected organisms
  • Humans and other mammals
Pathways
PathwayCategory
Alteplase Action PathwayDrug action
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
(1,2,6,7-3H)Testosterone(1,2,6,7-3H)Testosterone may increase the anticoagulant activities of Alteplase.
(R)-warfarinThe risk or severity of bleeding can be increased when Alteplase is combined with (R)-warfarin.
(S)-WarfarinThe risk or severity of bleeding can be increased when Alteplase is combined with (S)-Warfarin.
1-Testosterone1-Testosterone may increase the anticoagulant activities of Alteplase.
18-methyl-19-nortestosterone18-methyl-19-nortestosterone may increase the anticoagulant activities of Alteplase.
3,5-Diiodotyrosine3,5-Diiodotyrosine may increase the anticoagulant activities of Alteplase.
4-hydroxycoumarinThe risk or severity of bleeding can be increased when Alteplase is combined with 4-hydroxycoumarin.
4-Hydroxytestosterone4-Hydroxytestosterone may increase the anticoagulant activities of Alteplase.
5beta-dihydrotestosterone5beta-dihydrotestosterone may increase the anticoagulant activities of Alteplase.
7,8-Dichloro-1,2,3,4-tetrahydroisoquinolineThe risk or severity of bleeding and hemorrhage can be increased when 7,8-Dichloro-1,2,3,4-tetrahydroisoquinoline is combined with Alteplase.
Additional Data Available
  • Extended Description
    Extended Description

    Extended description of the mechanism of action and particular properties of each drug interaction.

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  • Severity
    Severity

    A severity rating for each drug interaction, from minor to major.

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  • Evidence Level
    Evidence Level

    A rating for the strength of the evidence supporting each drug interaction.

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  • Action
    Action

    An effect category for each drug interaction. Know how this interaction affects the subject drug.

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Food Interactions
Not Available

References

General References
Not Available
External Links
UniProt
P00750
Genbank
L00153
KEGG Drug
D02837
PubChem Substance
46507035
ChEMBL
CHEMBL1201593
Therapeutic Targets Database
DAP000203
PharmGKB
PA164776730
RxList
RxList Drug Page
Drugs.com
Drugs.com Drug Page
Wikipedia
Alteplase
ATC Codes
B01AD02 — AlteplaseS01XA13 — Alteplase
AHFS Codes
  • 20:12.20 — Thrombolytic Agents
FDA label
Download (1.98 MB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1Active Not RecruitingTreatmentPeritoneal dialysis therapy / Peritoneal Dialysis, Continuous Ambulatory1
1CompletedTreatmentCentral Retinal Vein Occlusion (CRVO)1
1CompletedTreatmentStroke1
1CompletedTreatmentSystemic Embolism / Thrombophlebitis1
1Not Yet RecruitingTreatmentCentral Retinal Vein Occlusion (CRVO)1
1RecruitingTreatmentLoculated or Non-draining Malignant Pleural Effusions1
1TerminatedHealth Services ResearchChemotherapy, Adjuvant / Port-A-Cath / Tumors, Solid1
1TerminatedTreatmentStroke1
1TerminatedTreatmentThrombotic events1
1WithdrawnTreatmentStroke, Ischemic1
1, 2CompletedTreatmentStroke1
1, 2CompletedTreatmentUnspecified Adult Solid Tumor, Protocol Specific1
1, 2WithdrawnPreventionCerebral Aneurysms / Cerebral Vasospasm / Hydrocephaly / Subarachnoid Hemorrhage1
2Active Not RecruitingTreatmentHypertensive Intracerebral Hemorrhage1
2Active Not RecruitingTreatmentStroke, Acute1
2Active Not RecruitingTreatmentStroke, Ischemic1
2CompletedTreatmentAbdominal Abscess / Pelvic Abscess1
2CompletedTreatmentAcute Deep Venous Thrombosis of the Lower Extremity1
2CompletedTreatmentAcute Ischemic Stroke (AIS)1
2CompletedTreatmentAcute Peripheral Arterial Occlusion1
2CompletedTreatmentBrain Infarction / Stroke / Stroke, Ischemic1
2CompletedTreatmentCerebral Hemorrhage2
2CompletedTreatmentCerebrovascular Stroke1
2CompletedTreatmentIntraventricular Hemorrhage1
2CompletedTreatmentMyocardial Infarction1
2CompletedTreatmentStroke3
2CompletedTreatmentStroke, Ischemic1
2Not Yet RecruitingTreatmentAcute Ischemic Stroke (AIS)1
2Not Yet RecruitingTreatmentCentral Venous Catheterization / Malignancies1
2Not Yet RecruitingTreatmentIschemic Cerebrovascular Accident1
2Not Yet RecruitingTreatmentLung Cancers / Pleural Effusions1
2Not Yet RecruitingTreatmentPulmonary Embolism1
2RecruitingPreventionCentral Venous Catheter Associated Bloodstream Infection / Central Venous Catheter Thrombosis1
2RecruitingTreatmentAcute Pulmonary Embolism1
2RecruitingTreatmentHealthy Volunteers / Plastic Bronchitis / Protein-Losing Enteropathies1
2RecruitingTreatmentStroke, Acute1
2RecruitingTreatmentStroke, Acute, Stroke Ischemic1
2RecruitingTreatmentStroke, Ischemic1
2TerminatedTreatmentDamage in the Anterior Spinal Artery (ASA) / Motor Weakness in Two or Four Limbs / Temperature and Superficial Sensation / Urinary Retention or Bowel Disorder1
2TerminatedTreatmentStroke1
2Unknown StatusTreatmentAneurysmal Subarachnoid Hemorrhage / Intraventricular Hemorrhage1
2Unknown StatusTreatmentStroke2
2WithdrawnTreatmentCerebral Artery / Nervous System Disorders1
2WithdrawnTreatmentStroke1
2, 3Active Not RecruitingTreatmentExudative Macular Degeneration / Retinal Hemorrhage1
2, 3RecruitingTreatmentStroke, Ischemic1
2, 3TerminatedTreatmentAbscesses1
2, 3TerminatedTreatmentSinus Thrombosis, Intracranial1
2, 3WithdrawnTreatmentStroke, Ischemic1
3Active Not RecruitingTreatmentMyocardial Infarction / Percutaneous Coronary Intervention1
3Active Not RecruitingTreatmentStroke1
3CompletedTreatmentAcute Pulmonary Embolism / Massive Pulmonary Embolism / Pulmonary Embolism / Pulmonary Thromboembolism / Sub-massive Pulmonary Embolism1
3CompletedTreatmentAngina Pectoris / Cardiovascular Heart Disease / Coronary Heart Disease (CHD) / Heart Diseases / Myocardial Infarction / Myocardial Ischemia1
3CompletedTreatmentCardiovascular Heart Disease / Coronary Heart Disease (CHD) / Heart Diseases / Myocardial Infarction / Myocardial Ischemia2
3CompletedTreatmentCerebral Hemorrhage1
3CompletedTreatmentCerebral Infarctions / Ischemia, Brain1
3CompletedTreatmentCerebrovascular Accident / Stroke2
3CompletedTreatmentDeep Vein Thrombosis / Post Thrombotic Syndrome / Postphlebitic Syndrome / Thrombosis, Venous / Venous Thromboembolism1
3CompletedTreatmentIntraventricular Hemorrhage1
3CompletedTreatmentMyocardial Infarction2
3CompletedTreatmentPleural Empyema1
3CompletedTreatmentStroke4
3CompletedTreatmentStroke, Ischemic1
3Not Yet RecruitingTreatmentCatheter Occlusion / Thrombotic events1
3Not Yet RecruitingTreatmentPulmonary Embolism1
3Not Yet RecruitingTreatmentStroke, Ischemic1
3RecruitingTreatmentAcute Ischaemic Stroke1
3RecruitingTreatmentAcute Pulmonary Embolism / Pulmonary Embolism1
3RecruitingTreatmentCentral Retinal Artery Occlusion1
3RecruitingTreatmentCerebrovascular Diseases / Stroke, Acute / Stroke, Ischemic1
3RecruitingTreatmentPulmonary Embolism1
3RecruitingTreatmentST Segment Elevation Myocardial Infarction (STEMI)1
3RecruitingTreatmentStroke, Acute / Thromboses, Intracranial1
3RecruitingTreatmentStroke, Ischemic1
3RecruitingTreatmentSubarachnoid Hemorrhage1
3TerminatedTreatmentAbscess, Intra-Abdominal1
3TerminatedTreatmentAcute Ischemic Stroke (AIS)1
3TerminatedTreatmentIschemia, Brain / Stroke1
3TerminatedTreatmentStroke1
3WithdrawnTreatmentDeep Vein Thrombosis / Post-Thrombotic Syndrome / Thrombosis, Venous1
3WithdrawnTreatmentEmpyema1
4Active Not RecruitingTreatmentPulmonary Embolism and Thrombosis1
4Active Not RecruitingTreatmentST Elevation Acute Myocardial Infarction1
4Active Not RecruitingTreatmentStroke, Ischemic1
4CompletedTreatmentAcute ST-segment Elevation Myocardial Infarction1
4CompletedTreatmentDysfunctional Central Venous Access Devices (CVADS)1
4CompletedTreatmentPleural Diseases / Pleural Effusions / Pleural Empyema1
4CompletedTreatmentPulmonary Embolism / Thromboembolism1
4CompletedTreatmentStroke1
4Not Yet RecruitingTreatmentPulmonary Embolism / Pulmonary Embolism Subacute Massive / Pulmonary Embolism With Acute Cor Pulmonale / Pulmonary Embolism With Pulmonary Infarction / Right Ventricular Dysfunction / Right Ventricular Failure1
4RecruitingTreatmentEmpyema / Parapneumonic Effusion / Pleural Diseases / Pleural space infections1
4RecruitingTreatmentPleural Diseases1
4RecruitingTreatmentPulmonary Embolism / Pulmonary Hypertension (PH) / Right Ventricular Dysfunction / Thromboembolism1
4RecruitingTreatmentStroke2
4TerminatedTreatmentArgatroban, Rt-PA1
4TerminatedTreatmentMiddle Cerebral Artery Infarction1
4TerminatedTreatmentThrombotic events1
4Unknown StatusNot AvailableThis Study Will Provide Data Comparing Safety of LMWH Versus UFH in the Treatment of Acute PE Cases Who Require Thrombolytic Treatment1
4Unknown StatusTreatmentMalfunction; Catheter / Mechanical Complication of Hemodialysis Catheter / Thrombotic events1
4Unknown StatusTreatmentPulmonary Embolism / Pulmonary Thromboembolism1
Not AvailableActive Not RecruitingTreatmentRenal Insufficiency,Chronic1
Not AvailableCompletedNot AvailableBrain Injury / Hypertensive Intracerebral Hemorrhage / Intraventricular Hemorrhage1
Not AvailableCompletedNot AvailableStroke3
Not AvailableCompletedNot AvailableStroke, Ischemic1
Not AvailableCompletedDiagnosticMyocardial Infarction / Myocardial Injury / Myocardial Necrosis / ST Elevation Myocardial Infarction (STEMI)1
Not AvailableCompletedPreventionTransplantation, Kidney / Transplantation, Liver1
Not AvailableCompletedTreatmentAcute Ischemic Stroke (AIS)1
Not AvailableCompletedTreatmentBacterial Pleural Effusion Other Than Tuberculosis / Pleural Effusion Associated With Pulmonary Infection1
Not AvailableCompletedTreatmentProsthetic Valve Thrombosis1
Not AvailableCompletedTreatmentRuptured Retinal Arterial Macro Aneurysms / Submacular Hemorrhage1
Not AvailableCompletedTreatmentStroke, Ischemic2
Not AvailableNot Yet RecruitingTreatmentAll Patients With Ischemic Cerebrovascular Stroke Aged ≥18 Years of Both Sex1
Not AvailableRecruitingNot AvailableStroke1
Not AvailableRecruitingOtherCollateral Circulation, Any Site1
Not AvailableRecruitingTreatmentIschemia, Brain / Stroke1
Not AvailableRecruitingTreatmentKidney Diseases1
Not AvailableTerminatedNot AvailableMyocardial Infarction1
Not AvailableTerminatedNot AvailableStroke, Ischemic / Transient Ischaemic Attack (TIA)1
Not AvailableTerminatedTreatmentAcute Ischaemic Stroke1
Not AvailableTerminatedTreatmentCatheter Malfunction / Clotted Dialysis Catheter / Dialysis Catheter Fibrin Sheath1
Not AvailableTerminatedTreatmentCerebral Stroke / Cerebrovascular Accident1
Not AvailableTerminatedTreatmentDiabetic Macular Edema (DME)1
Not AvailableTerminatedTreatmentStroke, Acute1
Not AvailableUnknown StatusNot AvailableStroke1
Not AvailableUnknown StatusNot AvailableStroke, Ischemic1
Not AvailableUnknown StatusTreatmentEmpyema / Pleural Effusions1
Not AvailableWithdrawnNot AvailableAcute Coronary Syndromes (ACS) / Non ST Elevation Myocardial Infarction / ST Elevation Myocardial Infarction / Unstable Angina Pectoris1
Not AvailableWithdrawnNot AvailableStroke, Ischemic1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
  • Genentech Inc.
Dosage forms
FormRouteStrength
KitIntravenous100 mg/100mL
KitIntravenous50 mg/50mL
Liquid; powder, for solutionIntravenous
Powder, for solutionIntravenous
Powder, for solution
Injection, powder, lyophilized, for solutionIntravenous2.2 mg/2mL
Powder, for solutionIntravenous
Prices
Unit descriptionCostUnit
Activase 100 mg vial4779.71USD vial
Activase 50 mg vial2389.85USD vial
Cathflo activase 2 mg vial106.33USD vial
DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.
Patents
Not Available

Properties

State
Liquid
Experimental Properties
PropertyValueSource
melting point (°C)60 °CNovokhatny, V.V. et al., J. Biol. Chem. 266:12994-123002 (1991)
hydrophobicity-0.516Not Available
isoelectric point7.61Not Available

Taxonomy

Description
Not Available
Kingdom
Organic Compounds
Super Class
Organic Acids
Class
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Peptides
Alternative Parents
Not Available
Substituents
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available

Targets

Kind
Protein
Organism
Humans
Pharmacological action
Yes
Actions
Activator
General Function
Serine-type peptidase activity
Specific Function
Plasmin dissolves the fibrin of blood clots and acts as a proteolytic factor in a variety of other processes including embryonic development, tissue remodeling, tumor invasion, and inflammation. In...
Gene Name
PLG
Uniprot ID
P00747
Uniprot Name
Plasminogen
Molecular Weight
90568.415 Da
References
  1. Longstaff C, Williams S, Thelwell C: Fibrin binding and the regulation of plasminogen activators during thrombolytic therapy. Cardiovasc Hematol Agents Med Chem. 2008 Jul;6(3):212-23. [PubMed:18673235]
  2. Melandri G, Vagnarelli F, Calabrese D, Semprini F, Nanni S, Branzi A: Review of tenecteplase (TNKase) in the treatment of acute myocardial infarction. Vasc Health Risk Manag. 2009;5(1):249-56. Epub 2009 Apr 8. [PubMed:19436656]
  3. Hilleman DE, Tsikouris JP, Seals AA, Marmur JD: Fibrinolytic agents for the management of ST-segment elevation myocardial infarction. Pharmacotherapy. 2007 Nov;27(11):1558-70. [PubMed:17963464]
  4. Chen X, Ji ZL, Chen YZ: TTD: Therapeutic Target Database. Nucleic Acids Res. 2002 Jan 1;30(1):412-5. [PubMed:11752352]
Kind
Protein
Organism
Humans
Pharmacological action
Yes
General Function
Structural molecule activity
Specific Function
Cleaved by the protease thrombin to yield monomers which, together with fibrinogen beta (FGB) and fibrinogen gamma (FGG), polymerize to form an insoluble fibrin matrix. Fibrin has a major function ...
Gene Name
FGA
Uniprot ID
P02671
Uniprot Name
Fibrinogen alpha chain
Molecular Weight
94972.455 Da
References
  1. Longstaff C, Williams S, Thelwell C: Fibrin binding and the regulation of plasminogen activators during thrombolytic therapy. Cardiovasc Hematol Agents Med Chem. 2008 Jul;6(3):212-23. [PubMed:18673235]
  2. Melandri G, Vagnarelli F, Calabrese D, Semprini F, Nanni S, Branzi A: Review of tenecteplase (TNKase) in the treatment of acute myocardial infarction. Vasc Health Risk Manag. 2009;5(1):249-56. Epub 2009 Apr 8. [PubMed:19436656]
  3. Hilleman DE, Tsikouris JP, Seals AA, Marmur JD: Fibrinolytic agents for the management of ST-segment elevation myocardial infarction. Pharmacotherapy. 2007 Nov;27(11):1558-70. [PubMed:17963464]
Kind
Protein
Organism
Humans
Pharmacological action
Unknown
General Function
Urokinase plasminogen activator receptor activity
Specific Function
Acts as a receptor for urokinase plasminogen activator. Plays a role in localizing and promoting plasmin formation. Mediates the proteolysis-independent signal transduction activation effects of U-...
Gene Name
PLAUR
Uniprot ID
Q03405
Uniprot Name
Urokinase plasminogen activator surface receptor
Molecular Weight
36977.62 Da
References
  1. Overington JP, Al-Lazikani B, Hopkins AL: How many drug targets are there? Nat Rev Drug Discov. 2006 Dec;5(12):993-6. [PubMed:17139284]
  2. Imming P, Sinning C, Meyer A: Drugs, their targets and the nature and number of drug targets. Nat Rev Drug Discov. 2006 Oct;5(10):821-34. [PubMed:17016423]
Kind
Protein
Organism
Humans
Pharmacological action
Unknown
General Function
Serine-type endopeptidase inhibitor activity
Specific Function
Serine protease inhibitor. This inhibitor acts as 'bait' for tissue plasminogen activator, urokinase, protein C and matriptase-3/TMPRSS7. Its rapid interaction with PLAT may function as a major con...
Gene Name
SERPINE1
Uniprot ID
P05121
Uniprot Name
Plasminogen activator inhibitor 1
Molecular Weight
45059.695 Da
References
  1. Hilleman DE, Tsikouris JP, Seals AA, Marmur JD: Fibrinolytic agents for the management of ST-segment elevation myocardial infarction. Pharmacotherapy. 2007 Nov;27(11):1558-70. [PubMed:17963464]

Drug created on June 13, 2005 07:24 / Updated on January 19, 2020 23:38