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Drug ReportsAlteplase
Alteplase
Activase (alteplase) is an enzyme pharmaceutical. Alteplase was first approved as Activase on 1987-11-13. It is used to treat arterial occlusive diseases, intracranial embolism and thrombosis, myocardial infarction, pulmonary embolism, and stroke in the USA.
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FDA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
nervous system diseasesD009422
cardiovascular diseasesD002318
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Cathflo activase
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Alteplase
Tradename
Proper name
Company
Number
Date
Products
ActivasealteplaseGenentechN-103172 RX1987-11-13
2 products
Cathflo ActivasealteplaseGenentechN-103172 RX2001-09-04
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
activaseBiologic Licensing Application2025-05-08
cathflo activaseBiologic Licensing Application2024-11-19
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
B: Blood and blood forming organ drugs
— B01: Antithrombotic agents
— B01A: Antithrombotic agents
— B01AD: Enzymes, antithrombotic
— B01AD02: Alteplase
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01X: Other ophthalmologicals in atc
— S01XA: Other ophthalmologicals in atc
— S01XA13: Alteplase
HCPCS
Code
Description
J2997
Injection, alteplase recombinant, 1 mg
Clinical
Clinical Trials
511 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
StrokeD020521EFO_0000712I63.92162611897239
Ischemic strokeD000083242——1852521969194
IschemiaD007511EFO_0000556—82532744108
Cerebral infarctionD002544—I635202142466
EmbolismD004617——231191540
ThrombosisD013927——339101640
Pulmonary embolismD011655EFO_0003827I26131091235
HemorrhageD006470MP_0001914R5838811532
InfarctionD007238EFO_0009463——3139631
Myocardial infarctionD009203EFO_0000612I21—1124522
Show 36 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cerebral hemorrhageD002543——243—615
Arterial occlusive diseasesD001157EFO_0009085——25—713
Brain ischemiaD002545EFO_0003883I67.82122—48
Cerebral intraventricular hemorrhageD000074042——121—37
Covid-19D000086382—U07.1—21—36
Cardiovascular diseasesD002318EFO_0000319I98113—16
Myocardial ischemiaD017202EFO_1001375I20-I251—3—26
Intracranial hemorrhagesD020300EFO_0000551I621—1—35
Retinal artery occlusionD015356EFO_1001154H34.1——2—24
Macular degenerationD008268EFO_0001365H35.30—12—24
Show 40 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InflammationD007249MP_0001845——2——24
SepsisD018805EFO_0001420A41.9—1——34
AdenocarcinomaD000230——11——13
LeukemiaD007938—C9522———3
NeoplasmsD009369—C8022———3
Alzheimer diseaseD000544EFO_0000249F03—1——23
Malignant pleural effusionD016066—J91.011———2
Respiratory insufficiencyD012131—J96.9—2———2
Myelodysplastic syndromesD009190—D4621———2
PreleukemiaD011289——21———2
Show 39 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Retinal vein occlusionD012170EFO_1001157H34.812————2
FlushingD005483—R23.21———12
Renal cell carcinomaD002292EFO_0000376—1————1
Rectal neoplasmsD012004——1————1
Squamous cell carcinoma of head and neckD000077195——1————1
ThrombophlebitisD013924——1————1
GlaucomaD005901EFO_0000516H401————1
Open-angle glaucomaD005902EFO_0004190H40.11————1
Adjuvant chemotherapyD017024——1————1
GallstonesD042882EFO_0004210—1————1
Show 16 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Blood coagulation disordersD001778EFO_0009314D68.9————44
Hemostatic disordersD020141——————44
Thrombotic strokeD000083244——————44
Vascular diseasesD014652EFO_0004264I77————33
FibrinolysisD005342——————33
ToxemiaD014115——————33
Thrombolytic therapyD015912——————33
Basal ganglia hemorrhageD020145——————33
Transient ischemic attackD002546EFO_0003764G45.9————33
ObesityD009765EFO_0001073E66.9————33
Show 78 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAlteplase
INNalteplase
Description
Alteplase (t-PA) is a thrombolytic medication, used to treat acute ischemic stroke, acute ST-elevation myocardial infarction (a type of heart attack), pulmonary embolism associated with low blood pressure, and blocked central venous catheter. It is given by injection into a vein or artery. Alteplase is the same as the normal human plasminogen activator produced in vascular endothelial cells and is synthesized via recombinant DNA technology in Chinese hamster ovary cells (CHO). Alteplase causes the breakdown of a clot by inducing fibrinolysis.
Classification
Enzyme
Drug classenzymes: tissue-type plasminogen activators
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB2MD9, 3T15, 3THG, 3ZUH, 3ZW6, 4MRT, 4W5W, 6HAS, 6L1Q, 6Z1D, 6Z1E, 6Z1F, 6Z1G, 7YYL, 7YZM, 7YZQ
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL1201593
ChEBI ID—
PubChem CID—
DrugBankDB00009
UNII ID1RXS4UE564 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 71,752 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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19,972 adverse events reported
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