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
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 |
|---|---|---|---|---|---|
| Kalbitor | ecallantide | Takeda | N-125277 RX | 2009-12-01 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| kalbitor | Biologic Licensing Application | 2021-01-06 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hereditary angioedemas | EFO_0004131 | D054179 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ecallantide, Kalbitor, Takeda Pharmaceuticals U.S.A., Inc. | |||
| 2121-03-28 | Orphan excl. | ||
Patent Expiration
No data
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 hyperplasia | D011470 | EFO_0000284 | N40 | 13 | 1 | 7 | 11 | 6 | 38 |
| Prostatic neoplasms | D011471 | C61 | 2 | 17 | 5 | 4 | 7 | 33 | |
| Hypogonadism | D007006 | E23.0 | 1 | 2 | 1 | 2 | — | 6 | |
| Healthy volunteers/patients | — | 2 | 2 | 1 | 1 | — | 5 | ||
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | 1 | 1 | 2 | 2 | 5 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alopecia | D000505 | HP_0002293 | L64 | 2 | 1 | 4 | — | 1 | 8 |
| Transsexualism | D014189 | F64.0 | — | — | 2 | — | — | 2 | |
| Covid-19 | D000086382 | U07.1 | — | 1 | 1 | — | — | 1 | |
| Physiological sexual dysfunction | D012735 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Eunuchism | D005058 | EFO_0007266 | E29.1 | 1 | 1 | — | — | — | 2 |
| Neoplasms | D009369 | C80 | — | 1 | — | — | 1 | 2 | |
| Lower urinary tract symptoms | D059411 | EFO_0008008 | — | 1 | — | — | 1 | 2 | |
| Contraception | D003267 | 1 | 2 | — | — | — | 2 | ||
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | — | 1 | — | — | — | 1 |
| X-linked bulbo-spinal atrophy | D055534 | — | 1 | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alcohol-related disorders | D019973 | F10 | — | — | — | — | 2 | 2 | |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Insulin resistance | D007333 | EFO_0002614 | — | — | — | — | 1 | 1 | |
| Urinary retention | D016055 | HP_0000016 | R33 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ECALLANTIDE |
| INN | ecallantide |
| 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 class | peptides |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 460738-38-9 |
| RxCUI | 658708 |
| ChEMBL ID | CHEMBL1201837 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB05311 |
| UNII ID | 5Q6TZN2HNM (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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