Turoctocog Alfa Pegol (Esperoct®): A Comprehensive Monograph on a GlycoPEGylated Recombinant Factor VIII for Hemophilia A

Executive Summary

Turoctocog alfa pegol, marketed under the brand name Esperoct®, is a third-generation, extended half-life (EHL) recombinant human coagulation Factor VIII (rFVIII) concentrate developed by Novo Nordisk for the management of hemophilia A.[1] As a biotech product, it represents a significant advancement in replacement therapy for this congenital bleeding disorder, which is characterized by a deficiency of functional Factor VIII. The core innovation of turoctocog alfa pegol lies in its sophisticated molecular design: the site-specific covalent conjugation of a 40 kDa polyethylene glycol (PEG) molecule to a B-domain truncated rFVIII, a process known as glycoPEGylation.[3] This modification strategically increases the molecule's hydrodynamic size, thereby reducing its clearance from the circulation and extending its plasma half-life by approximately 1.6-fold in adults and 1.9-fold in children compared to standard half-life (SHL) FVIII products.[3] The clinical benefit of this pharmacokinetic enhancement is a reduction in the frequency of intravenous infusions required for prophylactic treatment, lessening the significant treatment burden for patients.[2]