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Praxbind(idarucizumab)
Praxbind (idarucizumab) is an antibody pharmaceutical. Idarucizumab was first approved as Praxbind on 2015-10-16. It has been approved in Europe to treat hemorrhage.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Praxbind
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)
Idarucizumab
Tradename
Proper name
Company
Number
Date
Products
PraxbindidarucizumabBoehringer Ingelheim Pharmaceuticals, Inc.N-761025 RX2015-10-16
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
praxbindBiologic Licensing Application2020-01-01
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
idarucizumab, Praxbind, Boehringer Ingelheim Pharmaceuticals, Inc.
2122-10-16Orphan excl.
Patent Expiration
No data
ATC Codes
V: Various drug classes in atc
— V03: All other therapeutic products
— V03A: All other therapeutic products
— V03AB: Antidotes
— V03AB37: Idarucizumab
HCPCS
No data
Clinical
Clinical Trials
10 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
HemorrhageD006470MP_0001914R581—4—16
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—3————3
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Intracranial hemorrhagesD020300EFO_0000551I62————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameIDARUCIZUMAB
INNidarucizumab
Description
Idarucizumab, sold under the brand name Praxbind, is a monoclonal antibody used as a reversal agent for dabigatran.
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1362509-93-0
RxCUI1716191
ChEMBL IDCHEMBL3544996
ChEBI ID—
PubChem CID—
DrugBankDB09264
UNII ID97RWB5S1U6 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,149 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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45,004 adverse events reported
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