Drug intelligence / Profile preview

ozoralizumab

Development stage
Phase 3
Lead developer
Taisho Pharmaceutical
Modality
Recombinant Proteins and Enzymes, Nanobodies (VHH) → Antibody Fragments → Engineered Antibody Formats → Antibody-Based Therapeutics
Administration
Subcutaneous
01

Overview

Ozoralizumab is a next-generation anti-tumor necrosis factor alpha (TNFα) therapeutic, approved in Japan for the treatment of rheumatoid arthritis (RA) inadequately managed by existing therapies. It is the first Nanobody drug for RA and features a unique trivalent structure composed of two humanized anti-TNFα Nanobody variable heavy-chain domains (VHHs) and one humanized anti-human serum albumin (HSA) Nanobody VHH. This design allows it to bind bivalently to TNFα trimers, potently neutralizing both soluble and membrane-bound forms of TNFα, while also binding to serum albumin to extend its plasma half-life. Unlike conventional IgG antibodies, ozoralizumab lacks an Fc region, reducing Fcγ receptor-mediated immune responses and potentially lowering the risk of local acute inflammation or injection site reactions. Its molecular weight (~38 kDa) is significantly lower than typical IgG antibodies but its albumin-binding property prevents rapid renal clearance. Ozoralizumab was developed by Taisho Pharmaceutical under license from Ablynx (a Sanofi affiliate).

Brand names
Nanozora
Other names
ozoralizumab
02

Targets

TNFA (Tumor necrosis factor alpha (soluble))

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