RM-CVS / Coagulation and vascular signalling
Ecallantide
Also known as: Kalbitor · DX-88
Grade describes the published research on the molecule. It is not a quality score, a safety score, or a release state.
What this is
Ecallantide is a recombinant 60-amino-acid kallikrein inhibitor. It is a small protein biologic rather than a short synthetic research peptide.
Evidence position
The licensed biologic and human evidence support Grade A for the exact finished product.
What the record does not establish
The biologic license does not authenticate another recombinant material or transfer its expression, purification, sterility and formulation controls.
Sources
- 01Kalbitor prescribing informationDailyMed / U.S. National Library of Medicine
- Shows
- Current U.S. biologic label for a defined ecallantide injection
- Does not show
- Does not qualify another recombinant protein, concentration, vial or source
External database index
LIVE DATABASE INDEX / SEPARATE FROM CURATED EVIDENCE
Records below come directly from public scientific databases. They help find relevant material, but do not affect the evidence grade until they are matched to the molecule and added to the curated source list.
PUBMED / FOUND RECORDS
- Angioedema.Critical care medicine / 2017 AprPMID 28291095 / DOI 10.1097/CCM.0000000000002281
- Ecallantide. / 2006PMID 33497163
- Bradykinin-mediated diseases.Chemical immunology and allergy / 2014PMID 24925394 / DOI 10.1159/000358619
- Ecallantide (DX-88) for acute hereditary angioedema attacks: integrated analysis of 2 double-blind, phase 3 studies.The Journal of allergy and clinical immunology / 2011 JulPMID 21481442 / DOI 10.1016/j.jaci.2011.03.006
- Bradykinin-mediated angioedema.Polskie Archiwum Medycyny Wewnetrznej / 2016PMID 26842379 / DOI 10.20452/pamw.3273
CLINICALTRIALS.GOV / FOUND RECORDS
- Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary AngioedemaCOMPLETED / NO PHASE / ShireNCT01059526 / DIRECT intervention MATCH: Ecallantide
- EDEMA2: Evaluation of DX-88's Effect in Mitigating AngioedemaCOMPLETED / PHASE2 / ShireNCT01826916 / DIRECT intervention MATCH: Ecallantide
- Study to Assess the Tolerability and Safety of Ecallantide in Children and Adolescents With Hereditary AngioedemaWITHDRAWN / PHASE2 / NYU Langone HealthNCT01832896 / DIRECT intervention MATCH: Ecallantide
- Study to Assess the Safety and Tolerability of a Single Administration of FOV2302 (Ecallantide) in Patients With Macular Edema Associated With Central Retinal Vein OcclusionTERMINATED / PHASE1 / Fovea Pharmaceuticals SANCT00969293 / DIRECT intervention MATCH: Ecallantide
- Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema (HAE)COMPLETED / PHASE3 / ShireNCT00262080 / DIRECT intervention MATCH: Ecallantide