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Ecallantide
Kalbitor (ecallantide) is a protein pharmaceutical. Ecallantide was first approved as Kalbitor on 2009-12-01. It is used to treat hereditary angioedemas in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
immune system diseasesD007154
Trade Name
FDA
EMA
Kalbitor
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)
Ecallantide
Tradename
Proper name
Company
Number
Date
Products
KalbitorecallantideTakedaN-125277 RX2009-12-01
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
kalbitorBiologic Licensing Application2021-01-06
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hereditary angioedemasEFO_0004131D054179
Agency Specific
FDA
EMA
Expiration
Code
ecallantide, Kalbitor, Takeda Pharmaceuticals U.S.A., Inc.
2121-03-28Orphan excl.
Patent Expiration
No data
ATC Codes
B: Blood and blood forming organ drugs
B06: Other hematological agents in atc
B06A: Other hematological agents in atc
B06AC: Drugs used in hereditary angioedema
B06AC03: Ecallantide
HCPCS
Code
Description
J1290
Injection, ecallantide, 1 mg
Clinical
Clinical Trials
104 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic hyperplasiaD011470EFO_0000284N40131711638
Prostatic neoplasmsD011471C6121754733
HypogonadismD007006E23.012126
Healthy volunteers/patients22115
AlcoholismD000437EFO_0003829F10.111225
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AlopeciaD000505HP_0002293L6421418
TranssexualismD014189F64.022
Covid-19D000086382U07.1111
Physiological sexual dysfunctionD01273511
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EunuchismD005058EFO_0007266E29.1112
NeoplasmsD009369C80112
Lower urinary tract symptomsD059411EFO_0008008112
ContraceptionD003267122
Erectile dysfunctionD007172EFO_0004234F52.2111
X-linked bulbo-spinal atrophyD05553411
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Urologic diseasesD014570N39.922
AgingD000375GO_0007568R41.8111
Premenstrual syndromeD011293N94.311
DepressionD003863F33.911
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Alcohol-related disordersD019973F1022
ObesityD009765EFO_0001073E66.911
Insulin resistanceD007333EFO_000261411
Urinary retentionD016055HP_0000016R3311
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameECALLANTIDE
INNecallantide
Description
Ecallantide (trade name Kalbitor) is a drug used for the treatment of hereditary angioedema (HAE) and in the prevention of blood loss in cardiothoracic surgery. It is an inhibitor of the protein kallikrein and a 60-amino acid polypeptide which was developed from a Kunitz domain through phage display to mimic antibodies inhibiting kallikrein.
Classification
Protein
Drug classpeptides
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID460738-38-9
RxCUI658708
ChEMBL IDCHEMBL1201837
ChEBI ID
PubChem CID
DrugBankDB05311
UNII ID5Q6TZN2HNM (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Kalbitor - Shire
$
£
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Kalbitor - Takeda
$
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 458 documents
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Safety
Black-box Warning
Black-box warning for: Kalbitor
Adverse Events
Top Adverse Reactions
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9,146 adverse events reported
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