Angiomax, Angiox(bivalirudin)
Angiomax, Angiox (bivalirudin) is a protein pharmaceutical. Bivalirudin was first approved as Angiomax on 2000-12-15. It is used to treat unstable angina in the USA. It has been approved in Europe to treat acute coronary syndrome. The pharmaceutical is active against prothrombin.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Angiomax, Bivalirudin (discontinued: Bivalirudin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Bivalirudin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ANGIOMAX RTU | MAIA Biotechnology | N-211215 RX | 2019-07-25 | 1 products, RLD, RS |
| ANGIOMAX | Sandoz | N-020873 RX | 2000-12-15 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bivalirudin | NDA authorized generic | 2025-09-10 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| unstable angina | EFO_1000985 | D000789 | I20.0 |
Agency Specific
FDA
EMA
No data
HCPCS
Code | Description |
|---|---|
| J0583 | Injection, bivalirudin, 1 mg |
Clinical
Clinical Trials
89 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thrombosis | D013927 | — | — | — | 1 | 2 | 1 | — | 4 |
| Syndrome | D013577 | — | — | — | — | 1 | 1 | 1 | 3 |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | — | — | 2 | 1 | — | 3 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | — | 1 | 1 | 2 |
| Coronary disease | D003327 | — | — | — | — | — | 1 | — | 1 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | 4 | — | — | 4 |
| Infarction | D007238 | EFO_0009463 | — | — | — | 4 | — | — | 4 |
| Coronary artery bypass | D001026 | EFO_0003776 | — | — | — | 4 | — | — | 4 |
| Acute coronary syndrome | D054058 | EFO_0005672 | — | — | — | 2 | — | 1 | 3 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 2 | — | — | 2 |
| Unstable angina | D000789 | EFO_1000985 | I20.0 | — | — | 1 | — | — | 1 |
| Acute disease | D000208 | — | — | — | — | 1 | — | — | 1 |
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | — | — | 1 | — | — | 1 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | 1 | — | — | 1 |
| Endovascular procedures | D057510 | — | — | — | — | 1 | — | — | 1 |
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Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stable angina | D060050 | — | I20.89 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Bivalirudin |
| INN | bivalirudin |
| Description | Bivalirudin is a synthetic peptide of 20 amino acids, comprising D-Phe, Pro, Arg, Pro, Gly, Gly, Gly, Gly, Asn, Gly, Asp, Phe, Glu, Glu, Ile, Pro, Glu, Glu, Tyr, and Leu in sequence. A congener of hirudin (a naturally occurring drug found in the saliva of the medicinal leech), it a specific and reversible inhibitor of thrombin, and is used as an anticoagulant. It has a role as an anticoagulant and an EC 3.4.21.5 (thrombin) inhibitor. |
| Classification | Protein |
| Drug class | anticoagulants (hirudin type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC[C@H](C)[C@H](NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(=O)O)NC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)CNC(=O)CNC(=O)CNC(=O)CNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H]1CCCN1C(=O)[C@H](N)Cc1ccccc1)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1ccc(O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 128270-60-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2103749 |
| ChEBI ID | 59173 |
| PubChem CID | 16129704 |
| DrugBank | DB00006 |
| UNII ID | TN9BEX005G (ChemIDplus, GSRS) |
Target
Variants
No data
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Bivalirudin – The Medicines Company
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,195 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,623 adverse events reported
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