Dr. Grey AI

Ecallantide (Kalbitor)

Peptide

Ecallantide is a 60-amino acid recombinant polypeptide kallikrein inhibitor for hereditary angioedema. FDA-approved December 2009. First subcutaneous HAE treatment approved. EDEMA3 & EDEMA4 Phase 3 (n=168): Significantly greater symptom improvement at 4h vs placebo (P<0.01). Treatment outcome score 53.4 vs 8.1 placebo (P=0.003). Effect apparent within 2h and maintained through 24h. SAFETY CONCERN: Anaphylaxis risk 3.9% - must be administered by healthcare professional with anaphylaxis treatment available.

Quick Answer

What it is

Ecallantide is a 60-amino acid recombinant polypeptide kallikrein inhibitor for hereditary angioedema. FDA-approved December 2009.

Key findings

  • Grade A: Symptom Improvement at 4 Hours (Hereditary Angioedema)
  • Grade A: Time to Symptom Relief (Hereditary Angioedema)
  • Grade A: Anaphylaxis Risk (Hereditary Angioedema)

Safety

  • SAFETY CONCERN: Anaphylaxis risk 3.9% - must be administered by healthcare professional with anaphylaxis treatment available.
  • Black box warning.
⚠ī¸ Research Notice

This peptide information is for educational and research purposes only. Peptides may not be FDA-approved for human use and may only be legally available for research purposes. Consult qualified healthcare professionals before considering any peptide compounds.

ℹī¸ Quick Facts: Ecallantide (Kalbitor)

Quick Facts: Ecallantide (Kalbitor)

  • Best Evidence:Grade A
  • Conditions Studied:1
  • Research Outcomes:6
  • Grade A Findings:3
  • Grade B Findings:1
  • Key Effect:Hereditary Angioedema
A3
B1
C0
D2
1 conditions ¡ 6 outcomes

Detailed Outcomes

A
Symptom Improvement at 4 Hours
EDEMA3 & EDEMA4 Phase 3 (n=168): Treatment outcome score at 4h significantly greater with ecallantide vs placebo (53.4 vs 8.1, P=0.003 in EDEMA4). Mean symptom complex severity score change -0.8 vs -0.4 placebo (P=0.01). Led to FDA approval.
large↑Improves
A
Time to Symptom Relief
EDEMA3+4 pooled analysis: Benefit apparent within 2 hours of dosing. Maintained through 24 hours. Need for rescue intervention: 14% ecallantide vs 36% placebo within 24h. Earlier treatment associated with better outcomes.
moderate↑Worsens
A
Anaphylaxis Risk
SAFETY CONCERN: Anaphylaxis in 3.9% of patients (10/255) in clinical trials. Most within first hour after injection. Black box warning. Must be administered by healthcare professional. Have anaphylaxis treatment available. Self-administration not recommended.
small↑Worsens
B
Laryngeal Attack Efficacy
Subset analysis of laryngeal attacks: Significant improvement in treatment outcome scores. Potential life-saving for airway-threatening attacks. Limited patient numbers in trials - use with close monitoring for severe attacks.
moderate↑Improves
D
Safety/Tolerability
2 preclinical studies support this finding. Primarily preclinical evidence.
small↑Improves
D
Immune Function
2 preclinical studies support this finding. Primarily preclinical evidence.
small↑Improves

Research Citations (16)

Short review of SEC, a potential dexamethasone-sparing regimen for glioblastoma: Spironolactone, ecallantide, clotrimazole.
(2021)
PMID: 33450263
Immunotargeting and therapy of cancer by advanced multivalence antibody scaffolds.
(2020)
PMID: 32434407
Novel Therapies for Angiotensin-Converting Enzyme Inhibitor-Induced Angioedema: A Systematic Review of Current Evidence.
(2017)
PMID: 28939396
Outcomes after ecallantide treatment of laryngeal hereditary angioedema attacks
(2015)
PMID: 23548529
Management of acute attacks of hereditary angioedema: role of ecallantide
(2015)
PMID: 25770240
Hereditary angioedema therapy: kallikrein inhibition and bradykinin receptor antagonism
(2013)
PMID: 23609142
Efficacy and safety of ecallantide in treatment of recurrent attacks of hereditary angioedema: open-label continuation study.
(2013)
PMID: 23484891
Ecallantide for treatment of acute hereditary angioedema attacks: analysis of efficacy by patient characteristics
(2012)
PMID: 22525395
Immunotherapy for primary immunodeficiency diseases.
(2012)
PMID: 22703850
A phase 2 prospective, randomized, double-blind trial comparing the effects of tranexamic acid with ecallantide on blood loss from high-risk cardiac surgery with cardiopulmonary bypass (CONSERV-2 Trial).
(2012)
PMID: 21724197

Related Peptides

Icatibant (Firazyr)

Peptide

1 shared condition ¡ 7 outcomes

Icatibant is a synthetic decapeptide and selective bradykinin B2 receptor antagonist. FDA-approved in 2011 for acute hereditary angioedema (HAE) attacks. Phase III FAST trials showed median symptom relief in 2 hours vs 12-19.8 hours placebo/comparator. Administered as 30mg subcutaneous injection, self-injectable by patients.