MedPath

Ecallantide

Generic Name
Ecallantide
Brand Names
Kalbitor
Drug Type
Biotech
CAS Number
460738-38-9
Unique Ingredient Identifier
5Q6TZN2HNM

Overview

Ecallantide is a potent and selective human plasma kallikrein inhibitor that is indicated for the symptomatic treatment of hereditary angioedema. Ecallantide is a recombinant 60-amino-acid protein produced in Pichia pastoris yeast cells that contains three intramolecular disulfide bonds . It was discovered by phage display technology . It shares sequence similarities with the naturally occurring human protein tissue-factor pathway inhibitor (TFPI), which is also known lipoprotein-associated coagulation inhibitor (LACI) . The amino acid sequence of two compounds differ by seven amino acids . Ecallantide works by blocking kallikrein to participate in the kallikrein-kinin system, which is a complex proteolytic cascade that initiates inflammatory and coagulation pathways . The protease plasma kallikerin facilitates the conversion of kininogen to bradykinin, which is a pro-inflammatory vasodilator that increases vascular permeability and induces pain . Hereditary angioedema is a rare autosomal dominant disorder with mutations to C1-esterase-inhibitor (C1-INH) located on Chromosome 11q, resulting in substantially lower levels of C4 and C1-INH activity . The disorder is associated with recurrent attacks of severe swelling and is thought to be caused by unregulated activity of kallikrein and excessive bradykinin production . By reversibly binding to plasma kallikrein, ecallantide displays a rapid on-rate and a slow off-rate that results in high affinity inhibition in the picomolar range . Ecallantide is marketed by FDA and EMA under the trade name Kalbitor for subcutaneous injection. Apart from its FDA and EMA indication, ecallantide has been used off label in the management of nonhistaminergic angioedema, not due to HAE .

Indication

Indicated for the symptomatic treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older .

Associated Conditions

  • Acute attacks of hereditary angioedema

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2013/04/16
Phase 2
Withdrawn
2011/04/28
Phase 2
Terminated
2010/02/01
N/A
Completed
2009/12/21
Phase 2
UNKNOWN
Bernstein, Jonathan A., M.D.
2009/04/28
Phase 2
Completed
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
2008/12/31
Phase 2
Completed
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
2007/04/05
Phase 3
Completed
2007/04/05
Phase 3
Completed
2007/03/19
Phase 2
Terminated
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
2005/12/06
Phase 3
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Takeda Pharmaceuticals America, Inc.
47783-101
SUBCUTANEOUS
10 mg in 1 mL
11/17/2021

EMA Drug Approvals

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No EMA approvals found for this drug.

HSA Drug Approvals

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No HSA approvals found for this drug.

NMPA Drug Approvals

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No NMPA approvals found for this drug.

PPB Drug Approvals

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No PPB approvals found for this drug.

TGA Drug Approvals

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No TGA approvals found for this drug.

Health Canada Drug Approvals

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No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

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No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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MA Holder
MA Number
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Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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