Ecallantide
Highest phase reached
Approved
Drug type
Protein
First approval year
2009
- First approval year
- 2009
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Ecallantide
- (GLU(SUP 20),ALA(SUP 21),ARG(SUP 36),ALA(SUP 38),HIS(SUP 39),PRO(SUP 40),TRP(SUP 42))TISSUE FACTOR PATHWAY INHIBITOR (HUMAN)-(20 79)-PEPTIDE (MODIFIED ON REACTIVE BOND REGION KUNITZ INHIBITOR 1 DOMAIN CONTAINING FRAGMENT)
- dx 88
- dx 88 ecallantide
- DX-88
- DX-88 (ecallantide)
- ecalantida
- Ecalantida
- ecallantide
- Ecallantide
- ecallantide [INN]
- ECALLANTIDE [JAN]
- ECALLANTIDE [MART.]
- ECALLANTIDE [MI]
- ECALLANTIDE [PURPLE BOOK CDER]
- ECALLANTIDE [USAN]
- ECALLANTIDE [VANDF]
- Ecallantide [WHO-DD]
- ecallantide 10 mg
- ecallantide 30 mg
- ecallantide 60 mg
- ecallantide inn
- ecallantide jan
- ecallantide mart
- ecallantide mi
- ecallantide purple book cder
And 9 more, listed on the interactive page.
- ATC classification codes
- B06AC03
Sources for recorded values
- CAS registry numbers
- 460738-38-9
- ChEMBL ID
- CHEMBL1201837
- PubChem compound IDs
- 118984459
- RxNorm IDs (RxCUI)
- 658708
- FDA ingredient codes (UNII)
- 5Q6TZN2HNM
- Applicant
- DYAX CORP.
- Approval date
- 1 Dec 2009
- Application number
- BLA125277
- Patents
- 0
- Designations
- 3
- Earliest recorded loss of exclusivity
- 28 Mar 2021
- First in class
- No
- Fast track
- Yes
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- ecallantide
- Type
- Peptide
- Drug name stem
- -tide
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
Mechanisms of action
- Mechanism
- Plasma kallikrein inhibitor
- Action type
- Inhibitor
- Target
- Plasma kallikrein
- Protein identifier
- P03952
Open Targets mechanisms
- Mechanism
- Plasma kallikrein inhibitor
- Action type
- Inhibitor
- Target
- Plasma kallikrein
- Condition
- Angioedema
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005532
- Subject identifier
- D000799
- Condition
- Angioedemas, Hereditary
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0019623
- Subject identifier
- D054179
- Condition identifier
- EFO_0005532
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0003005
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005010
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0010481
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0019623
- Condition identifier
- MONDO_0019623
- Highest recorded phase
- 4
Warnings
- Warning
- Black Box Warning
- Effect
- immune system toxicity
Open Targets warnings
- Warning
- Black Box Warning
- Effect
- immune system toxicity
- Country
- United States
- Event
- anaphylactic reaction
- Reports
- 38
- Reporting signal score
- 74.1218
- Event
- extra dose administered
- Reports
- 7
- Reporting signal score
- 15.3664
- Event
- fibrinolysis decreased
- Reports
- 1
- Reporting signal score
- 8.27464
- Event
- hereditary angioedema
- Reports
- 199
- Reporting signal score
- 1,232.61
- Event
- hypersensitivity
- Reports
- 29
- Reporting signal score
- 29.5223
- Event
- infusion site urticaria
- Reports
- 2
- Reporting signal score
- 7.65859
- Event
- migraine
- Reports
- 11
- Reporting signal score
- 10.3718
- Event
- pharyngeal oedema
- Reports
- 14
- Reporting signal score
- 32.0714
- Event
- swelling
- Reports
- 13
- Reporting signal score
- 11.6501
- Event
- swollen tongue
- Reports
- 7
- Reporting signal score
- 7.36116
- Event
- therapeutic response decreased
- Reports
- 21
- Reporting signal score
- 33.08
- NCT00262080
- NCT00456508
- NCT00457015
- NCT01253382
- NCT01826916
- NCT01832896
- NCT01036659
- NCT01343823
- Dose
- 30 mg
- Route
- Subcutaneous
- How often
- Every 24 hours as needed
- Administered by healthcare professional
- Do not use if particulate matter or discoloration
- Refrigerate and protect from light
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
Sequences
- Component
- Sequence
- Type
- Protein
- Organism
- Homo sapiens
- Sequence
- EAMHSFCAFKADDGPCRAAHPRWFFNIFTRQCEEFIYGGCEGNQNRFESLEECKKMCTRD
- 47783-101
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Approved for (1)
- Hereditary angioedema
In development for (1)
- Angioedema Phase 2
Targets (1)
- KLKB1 Plasma kallikrein inhibitor