Abstract
NanozoraⓇ（generic name: ozoralizumab（genetic recombination））is a humanized bispecific NANOBODYⓇ compound consisting of two anti-human TNFα NANOBODYⓇ molecules and one anti-human serum albumin NANOBODYⓇ molecule. It bivalently binds to soluble and membrane-bound human TNFα and strongly inhibits the activity of soluble TNFα. Animal studies of ozoralizumab demonstrated an extended plasma half-life by binding to serum albumin, and its rapid transfer into systemic circulation and distribution to inflamed tissues after subcutaneous injection. The efficacy and safety of NanozoraⓇ have been confirmed in clinical trials. NanozoraⓇ 30 mg subcutaneous injection syringe was approved for manufacturing and marketing in September 2022 in Japan, followed by the approval of NanozoraⓇ 30 mg subcutaneous injection auto-injector in July 2023, which is expected to enhance safety and user convenience. This article reviews the structural characteristics of ozoralizumab, preclinical and clinical findings, and the development history of its formulation.
