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Drug ReportsBivalirudin
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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Target
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Financial
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
signs and symptoms pathological conditionsD013568
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 RTUMAIA BiotechnologyN-211215 RX2019-07-25
1 products, RLD, RS
ANGIOMAXSandozN-020873 RX2000-12-15
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
angiomaxNew Drug Application2019-06-30
bivalirudinANDA2024-12-23
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
unstable anginaEFO_1000985D000789I20.0
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Bivalirudin, Angiomax Rtu, Maia Pharms Inc
119039932039-05-20U-3817
119186222039-05-20U-3817
Bivalirudin, Angiomax, Sandoz
75827272028-07-27DP
75983432028-07-27DP
ATC Codes
B: Blood and blood forming organ drugs
— B01: Antithrombotic agents
— B01A: Antithrombotic agents
— B01AE: Direct thrombin inhibitors
— B01AE06: Bivalirudin
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
Myocardial infarctionD009203EFO_0000612I21—1816530
InfarctionD007238EFO_0009463——1716529
Coronary artery diseaseD003324—I25.1—1211519
St elevation myocardial infarctionD000072657———119314
Acute coronary syndromeD054058EFO_0005672———56112
Coronary diseaseD003327———117312
Myocardial ischemiaD017202EFO_1001375I20-I25—11529
Percutaneous coronary interventionD062645————24—6
SyndromeD013577————2316
Inferior wall myocardial infarctionD056989EFO_1000983———2136
Show 13 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Coronary artery bypassD001026EFO_0003776———4——4
NecrosisD009336————2——2
Heart failureD006333EFO_0003144I50——1—12
Cardiovascular diseasesD002318EFO_0000319I98——2——2
Acute diseaseD000208————1——1
Subarachnoid hemorrhageD013345EFO_0000713I60——1——1
AneurysmD000783—I72.9——1——1
Intracranial aneurysmD002532EFO_0003870I67.1——1——1
Endovascular proceduresD057510————1——1
Aortic valve stenosisD001024EFO_0000266———1——1
Show 5 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Carotid artery diseasesD002340EFO_0003781——1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Venous thrombosisD020246—I82.401————1
Healthy volunteers/patients———1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Stable anginaD060050—I20.89————22
AtherosclerosisD050197EFO_0003914I25.1————11
Carotid stenosisD016893——————11
Microvascular anginaD017566——————11
Respiratory insufficiencyD012131—J96.9————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBivalirudin
INNbivalirudin
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 classanticoagulants (hirudin type)
Image (chem structure or protein)Loading
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-ID128270-60-0
RxCUI—
ChEMBL IDCHEMBL2103749
ChEBI ID59173
PubChem CID16129704
DrugBankDB00006
UNII IDTN9BEX005G (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
Revenue by drug
$
€
£
₣
Bivalirudin – The Medicines Company
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,956 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,576 adverse events reported
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