ecallantide

Trade name: Kalbitor

PeptideapprovedOrphan Drug FDA

Approved

Dec 1, 2009

Ecallantide (DX-88) is a potent and specific inhibitor of plasma kallikrein. Ecallantide is a recombinantly produced and engineered small protein based on the first Kunitz domain of human tissue factor pathway inhibitor. It was identified through phage display technology. Ecallantide binds to plasma kallikrein and blocks its binding site, inhibiting the conversion of HMW kininogen to bradykinin. Hereditary angioedema (HAE) resulting from the deficiency of the C1 inhibitor protein is a rare disease, characterized by paroxysms of edema formation in the subcutis and in the submucosa. Edema can cause obstruction of the upper airway, which may lead to suffocation. Prompt elimination of edema is necessary to save patients from this life-threatening condition. Essentially, these edematous attacks are related to the activation of the kinin-kallikrein system and the consequent release of bradykinin. Ecallantide (KALBITOR) is a plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older. — NCATS

Clinical trial activity

12 trials · 7 clinical orgs · 2 marketing orgs

Phase 1
1
Phase 2
10
Phase 3
4
Phase 4
0

Earliest trial started Nov 1, 2003 (NCT01826916)

Timeline

2000s

  1. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

  2. Feb 4, 2003

    Orphan Drug Designation

  3. Jan 1, 2005

    Earliest Phase 3 Sponsor(trial)

  4. Jan 1, 2009

    Earliest Phase 1 Sponsor(trial)

  5. Dec 1, 2009

    Earliest FDA Approval

  6. Dec 1, 2009

    Dyax — Marketing Organization

  7. Dec 1, 2009

    Takeda — NDA Secondary Org

Indications

Mechanism of action

Approval history

  • approvedDec 1, 2009

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • dx-88
  • dx-88
  • dx-88
  • dx-88 cpd
  • ecallantide
  • ecallantide
  • ecallantide
  • ecallantide
  • ecallantide
  • ecallantide
  • ecallantide
  • ecallantide
  • ecallantide
  • ecallantide
  • epi-kal-2
  • kalbitor
  • kalbitor
  • kalbitor
  • kalbitor

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT01832896Phase 2Aug 1, 2013Dyax, Winthrop University
NCT01253382Phase 2/Phase 3 (Phase 3)Jun 1, 2012Shire
NCT01343823Phase 2Jun 1, 2011Shire
NCT01036659Phase 2May 1, 2010Bernstein, Jonathan A., M.D., Dyax
NCT00969293Phase 1Sep 1, 2009Fovea Pharmaceuticals, University of Paris
NCT00888940Phase 2Jun 1, 2009Cubist
NCT00816023Phase 2Mar 1, 2009Cubist
NCT00448864Phase 2May 1, 2007Cubist, Dyax
NCT00457015Phase 3Apr 1, 2007Dyax, Shire
NCT00456508Phase 3Apr 1, 2007Dyax, Shire
NCT00262080Phase 3Dec 1, 2005Shire
NCT01826916Phase 2Nov 1, 2003Shire
Showing 12 of 12 trials
Page 1 / 1

Organizations

Research & Development (7)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
ShireFor profit6622003
DyaxFor profit5022007
CubistFor profit3312007
Bernstein, Jonathan A., M.D.Academic/Hospital1112010
Fovea PharmaceuticalsFor profit1112009
University of ParisAcademic/Hospital1012009
Winthrop UniversityAcademic/Hospital1112013
7 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
DyaxFor profitNDA
DyaxFor profitMKTGDec 1, 2009
TakedaFor profitNDA2Dec 1, 2009