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
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| kalbitor | Biologic Licensing Application | 2025-07-01 |
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
13 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Angioedema | D000799 | EFO_0005532 | T78.3 | — | 5 | 4 | — | 1 | 9 |
| Hereditary angioedemas | D054179 | EFO_0004131 | — | — | 3 | 4 | — | 1 | 7 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Surgical blood loss | D016063 | — | — | — | 3 | — | — | — | 3 |
| Operative surgical procedures | D013514 | — | — | — | 2 | — | — | — | 2 |
| Hereditary angioedema types i and ii | D056829 | — | — | — | 1 | — | — | — | 1 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Macular edema | D008269 | — | — | 1 | — | — | — | — | 1 |
| Retinal vein occlusion | D012170 | EFO_1001157 | H34.81 | 1 | — | — | — | — | 1 |
| Edema | D004487 | — | R60.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
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 | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201837 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB05311 |
| UNII ID | 5Q6TZN2HNM (ChemIDplus, GSRS) |
Target
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Financial
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Trends
PubMed Central
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Additional graphs summarizing 622 documents
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Safety
Black-box Warning
Black-box warning for: Kalbitor
Adverse Events
Top Adverse Reactions
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1,425 adverse events reported
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