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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Abbreviated New Drug Application (ANDA)
Argatroban
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ARGATROBAN IN SODIUM CHLORIDE | ACCORD HLTHCARE | N-212035 RX | 2021-06-07 | 1 products, RLD, RS |
| ARGATROBAN IN SODIUM CHLORIDE | Eugia Pharma Specialties | N-209552 RX | 2018-11-27 | 1 products |
| ARGATROBAN | Fresenius Kabi | N-201811 RX | 2015-03-23 | 1 products |
| ARGATROBAN | Hikma Pharmaceuticals | N-203049 RX | 2012-01-05 | 2 products, RLD, RS |
| ARGATROBAN | Sandoz | N-020883 RX | 2000-06-30 | 1 products, RLD, RS |
| ARGATROBAN IN SODIUM CHLORIDE | Sandoz | N-022485 RX | 2011-05-09 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| argatroban | ANDA | 2018-12-31 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| thrombocytopenia | HP_0001873 | D013921 | D69.6 |
| thromboembolism | HP_0001907 | D013923 | — |
Agency Specific
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Clinical
Clinical Trials
3 clinical trials
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Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myasthenia gravis | D009157 | EFO_0004991 | G70.0 | — | 1 | — | — | — | 1 |
Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ocular hypertension | D009798 | EFO_1001069 | H40.0 | — | — | — | — | 1 | 1 |
| Glaucoma | D005901 | EFO_0000516 | H40 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ARGATROBAN |
| INN | argatroban |
| 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.
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| Classification | Small molecule |
| Drug class | antithrombotics (thromboxane A2 receptor antagonists) |
| Image (chem structure or protein) | |
| 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-ID | 74863-84-6 |
| RxCUI | 15202 |
| ChEMBL ID | CHEMBL1166 |
| ChEBI ID | — |
| PubChem CID | 152951 |
| DrugBank | DB00278 |
| UNII ID | OCY3U280Y3 (ChemIDplus, GSRS) |
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Safety
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153 adverse events reported
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