eculizumab   Click here for help

GtoPdb Ligand ID: 6884

Synonyms: h5G1.1 | h5G1.1VHC | Soliris®
Approved drug Immunopharmacology Ligand
eculizumab is an approved drug (FDA (2011), EMA (2007))
Compound class: Antibody
Comment: Eculizumab is a humanized monoclonal antibody targeting terminal complement activation, by binding to complement component C5 and inhibiting the production of C5a [4]. It is the first approved therapy for paroxysmal nocturnal hemoglobinuria.
Eculizumab's developers, Alexion Pharmaceuticals have developed a next-generation version of eculizumab called ravulizumab (ALXN1210; FDA approved in December 2018), that has a longer circulating half-life than the originator, which allows for monthly dosing.
The evidence confirming C5, C5a and the C5a receptor as anti-inflammatory and anti-cancer drug targets is reviewed by Horiuchi and Tsukamoto (2016) [2].

Biosimilars:
ABP 959 (Amgen) is in Phase 3 development under the jurisdiction of the Australian New Zealand Clinical Trials Registry (trial ID ACTRN12616000509460).
BOW080 (Epirus Biopharmaceuticals) is in preclinical development- see
None of these biosimilars can be FDA approved until Alexion's exclusivity period (due to protection as an orphan drug) expires in March 2019. Eculizumab's patent protection ends in May 2020 (Europe) and March 2021 (US). Hence, Alexion developed the improved agent ravulizumab as a replacement product.
Classification Click here for help
Compound class Antibody
Approved drug? Yes (FDA (2011), EMA (2007))
International Nonproprietary Names Click here for help
INN number INN
8231 eculizumab
Synonyms Click here for help
h5G1.1 | h5G1.1VHC | Soliris®
Database Links Click here for help
Specialist databases
IMGT/mAb-DB 37
Other databases
GtoPdb PubChem SID 178103466
PubChem SID 178103466
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Wikipedia Eculizumab