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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 diseasesD002318
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Angiomax (generic drugs available since 2015-07-14)
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
bivalirudinNew Drug Application2023-04-30
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, 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
171 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471C61246137610129
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AdenocarcinomaD000230393—215
Covid-19D000086382U07.1111——3
Triple negative breast neoplasmsD064726111——2
Ovarian neoplasmsD010051EFO_0003893C56—21——2
Bone neoplasmsD001859EFO_0003820D16——1——1
Second primary neoplasmsD016609—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C5039———10
Castration-resistant prostatic neoplasmsD06412921———2
Salivary gland neoplasmsD012468EFO_0003826D11—1——12
NeoplasmsD009369C80—2———2
Lower urinary tract symptomsD059411EFO_000800811———2
Male breast neoplasmsD018567—1———1
SyndromeD01357711———1
Precocious pubertyD011629E22.8—1———1
Erectile dysfunctionD007172EFO_0004234F52.21—1———1
Sars-cov-2D000086402—1———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—7————7
HirsutismD006628HP_0001007L68.02————2
Myelodysplastic syndromesD009190D461————1
Myeloid leukemia acuteD015470C92.01————1
Hematologic neoplasmsD0193371————1
Pancreatic neoplasmsD010190EFO_0003860C251————1
Non-hodgkin lymphomaD008228C85.91————1
Primary myelofibrosisD055728D47.41————1
Multiple myelomaD009101C90.01————1
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.01————1
Show 10 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
OsteoporosisD010024EFO_0003882M81.0————11
Metabolic syndromeD024821EFO_0000195E88.81————11
Polycystic ovary syndromeD011085EFO_0000660E28.2————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)
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
RxCUI60819
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
Clinical Variant
No data
Financial
Bivalirudin - The Medicines Company
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,306 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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5,499 adverse events reported
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