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Drug ReportsArgatroban
Argatroban
Argatroban (argatroban) is a small molecule pharmaceutical. Argatroban was first approved as Argatroban on 2000-06-30. It is used to treat thrombocytopenia and thromboembolism in the USA. The pharmaceutical is active against prothrombin.
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Financial
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Events Timeline
5D
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YTD
1Y
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FDA approval date
EMA approval date
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Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
hemic and lymphatic diseasesD006425
Trade Name
FDA
EMA
Argatroban (discontinued: Argatroban)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Argatroban
Tradename
Company
Number
Date
Products
ARGATROBAN IN SODIUM CHLORIDEAccord HealthcareN-212035 RX2021-06-07
1 products, RLD, RS
ARGATROBAN IN SODIUM CHLORIDEEugia Pharma SpecialtiesN-209552 RX2018-11-27
1 products
ARGATROBANFresenius KabiN-201811 RX2015-03-23
1 products
ARGATROBANHikma PharmaceuticalsN-203049 RX2012-01-05
2 products, RLD, RS
ARGATROBAN IN SODIUM CHLORIDESandozN-022485 RX2011-05-09
1 products, RLD, RS
Show 4 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
argatrobanNew Drug Application2024-10-11
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
thromboembolismHP_0001907D013923—
thrombocytopeniaHP_0001873D013921D69.6
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Argatroban, Argatroban In Sodium Chloride, Cipla
75891062027-09-26DPU-1163
76875162027-09-26DPU-1164
ATC Codes
B: Blood and blood forming organ drugs
— B01: Antithrombotic agents
— B01A: Antithrombotic agents
— B01AE: Direct thrombin inhibitors
— B01AE03: Argatroban
HCPCS
Code
Description
J0883
Injection, argatroban, 1 mg (for non-esrd use)
J0884
Injection, argatroban, 1 mg (for esrd on dialysis)
J0891
Injection, argatroban (accord), not therapeutically equivalent to j0883, 1 mg (for non-esrd use)
J0892
Injection, argatroban (accord), not therapeutically equivalent to j0884, 1 mg (for esrd on dialysis)
J0898
Injection, argatroban (auromedics), not therapeutically equivalent to j0883, 1 mg (for non-esrd use)
J0899
Injection, argatroban (auromedics), not therapeutically equivalent to j0884, 1 mg (for esrd on dialysis)
Clinical
Clinical Trials
36 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ThrombocytopeniaD013921HP_0001873D69.61124311
StrokeD020521EFO_0000712I63.9131419
Ischemic strokeD000083242——121317
IschemiaD007511EFO_0000556————213
Coronary artery diseaseD003324—I25.1—2—1—3
Cerebral infarctionD002544—I63—1—113
ThrombosisD013927———1—2—3
Unstable anginaD000789EFO_1000985I20.0—1—1—2
Covid-19D000086382—————112
ThromboembolismD013923HP_0001907———11—2
Show 9 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Venous thromboembolismD054556EFO_0004286I74——1——1
Female genital neoplasmsD005833————1——1
Blood coagulation disordersD001778EFO_0009314D68.9—11——1
Hemostatic disordersD020141———11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Staphylococcal infectionsD013203—A49.01—1———1
BacteremiaD016470EFO_0003033R78.81—1———1
Staphylococcus aureusD013211NCBITaxon_1280——1———1
Brain ischemiaD002545EFO_0003883I67.82—1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameArgatroban
INNargatroban
Description
Argatroban is an anticoagulant that is a small molecule direct thrombin inhibitor. In 2000, argatroban was licensed by the Food and Drug Administration (FDA) for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia (HIT). In 2002, it was approved for use during percutaneous coronary interventions in patients who have HIT or are at risk for developing it. In 2012, it was approved by the MHRA in the UK for anticoagulation in patients with heparin-induced thrombocytopenia Type II (HIT) who require parenteral antithrombotic therapy.
Classification
Small molecule
Drug classantithrombotics (thromboxane A2 receptor antagonists)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC1CNc2c(cccc2S(=O)(=O)N[C@@H](CCCNC(=N)N)C(=O)N2CC[C@@H](C)C[C@@H]2C(=O)O)C1
Identifiers
PDB—
CAS-ID74863-84-6
RxCUI—
ChEMBL IDCHEMBL1166
ChEBI ID—
PubChem CID440542
DrugBankDB00278
UNII IDOCY3U280Y3 (ChemIDplus, GSRS)
Target
Agency Approved
F2
F2
Organism
Homo sapiens
Gene name
F2
Gene synonyms
NCBI Gene ID
2147
Protein name
prothrombin
Protein synonyms
Coagulation factor II, prepro-coagulation factor II, prothrombin B-chain, thrombin factor II
Uniprot ID
Q9UCA1
Mouse ortholog
F2 (14061)
prothrombin (P19221)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,708 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,324 adverse events reported
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