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Cablivi(caplacizumab)
Cablivi (caplacizumab) is an antibody pharmaceutical. Caplacizumab was first approved as Cablivi on 2018-08-30. It has been approved in Europe to treat thrombotic thrombocytopenic purpura. The pharmaceutical is active against von Willebrand factor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hemic and lymphatic diseasesD006425
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Cablivi
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Caplacizumab
Tradename
Proper name
Company
Number
Date
Products
Cablivicaplacizumab-yhdpAblynxN-761112 RX2019-02-06
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
cabliviBiologic Licensing Application2020-09-18
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
caplacizumab, Cablivi, Ablynx NV
2026-02-06Orphan excl.
Patent Expiration
No data
ATC Codes
B: Blood and blood forming organ drugs
— B01: Antithrombotic agents
— B01A: Antithrombotic agents
— B01AX: Other antithrombotic agents in atc
— B01AX07: Caplacizumab
HCPCS
Code
Description
C9047
Injection, caplacizumab-yhdp, 1 mg
Clinical
Clinical Trials
13 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Thrombotic thrombocytopenic purpuraD011697M31.19—12——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Stable anginaD060050I20.8—1———1
Unstable anginaD000789EFO_1000985I20.0—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—2————2
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Thrombocytopenic purpura idiopathicD016553EFO_0007160D69.3————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCAPLACIZUMAB
INNcaplacizumab
Description
Caplacizumab (humanized mab)
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)CAPLACIZUMAB
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB7EOW
CAS-ID915810-67-2
RxCUI2110605
ChEMBL IDCHEMBL2109624
ChEBI ID—
PubChem CID—
DrugBankDB06081
UNII ID2R27AB6766 (ChemIDplus, GSRS)
Target
Agency Approved
VWF
VWF
Organism
Homo sapiens
Gene name
VWF
Gene synonyms
F8VWF
NCBI Gene ID
7450
Protein name
von Willebrand factor
Protein synonyms
coagulation factor VIII VWF, Factor VIII related antigen
Uniprot ID
Q99806
Mouse ortholog
Vwf (22371)
von Willebrand factor (Q8CIZ8)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 746 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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73,463 adverse events reported
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