ecallantide
Trade name: Kalbitor
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
Earliest trial started Nov 1, 2003 (NCT01826916)
Timeline
Indications
Approved for
Mechanism of action
- Plasma kallikreinINHIBITOR
KLKB1 inhibitor
- Kallikrein 1INHIBITOR
KLK1 inhibitor
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
Sources
- WikipediaEcallantide ↗
- NCATS5Q6TZN2HNM ↗
- ChEMBLCHEMBL1201837 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT01832896 | Phase 2 | Aug 1, 2013 | Dyax, Winthrop University |
| NCT01253382 | Phase 2/Phase 3 (Phase 3) | Jun 1, 2012 | Shire |
| NCT01343823 | Phase 2 | Jun 1, 2011 | Shire |
| NCT01036659 | Phase 2 | May 1, 2010 | Bernstein, Jonathan A., M.D., Dyax |
| NCT00969293 | Phase 1 | Sep 1, 2009 | Fovea Pharmaceuticals, University of Paris |
| NCT00888940 | Phase 2 | Jun 1, 2009 | Cubist |
| NCT00816023 | Phase 2 | Mar 1, 2009 | Cubist |
| NCT00448864 | Phase 2 | May 1, 2007 | Cubist, Dyax |
| NCT00457015 | Phase 3 | Apr 1, 2007 | Dyax, Shire |
| NCT00456508 | Phase 3 | Apr 1, 2007 | Dyax, Shire |
| NCT00262080 | Phase 3 | Dec 1, 2005 | Shire |
| NCT01826916 | Phase 2 | Nov 1, 2003 | Shire |
Organizations
Research & Development (7)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Shire | For profit | 6 | 6 | 2 | 2003 |
| Dyax | For profit | 5 | 0 | 2 | 2007 |
| Cubist | For profit | 3 | 3 | 1 | 2007 |
| Bernstein, Jonathan A., M.D. | Academic/Hospital | 1 | 1 | 1 | 2010 |
| Fovea Pharmaceuticals | For profit | 1 | 1 | 1 | 2009 |
| University of Paris | Academic/Hospital | 1 | 0 | 1 | 2009 |
| Winthrop University | Academic/Hospital | 1 | 1 | 1 | 2013 |