Inebilizumab: A Comprehensive Monograph on a First-in-Class CD19-Directed Cytolytic Antibody

I. Inebilizumab: A Profile of a First-in-Class CD19-Directed Cytolytic Antibody

1.1. Nomenclature and Regulatory Identification

[Inebilizumab is a high-affinity, humanized monoclonal antibody that represents a significant advancement in the targeted therapy of specific B-cell-mediated autoimmune disorders. To ensure precise identification across clinical, research, and regulatory domains, the molecule is designated by several names and unique identifiers.]

[Its proprietary or brand name is UPLIZNA®.][1][ The United States Adopted Name (USAN) is formally designated as]

inebilizumab-cdon[.][4][ The four-letter, non-meaningful suffix "-cdon" is a convention established by the U.S. Food and Drug Administration (FDA) to distinguish the originator biologic from potential future biosimilars, a critical detail for ensuring accurate pharmacovigilance and attribution of clinical data. The International Nonproprietary Name (INN), recognized globally, is]

inebilizumab[.][5][ During its development, the compound was also known by the codes MEDI-551 and AMG 335.][4]

[For scientific and regulatory tracking, inebilizumab is assigned the following identifiers:]

• DrugBank ID:[ DB12530 ][1]
• CAS (Chemical Abstracts Service) Number:[ 1299440-37-1 ][1]
• Anatomical Therapeutic Chemical (ATC) Code:[ L04AG10, classifying it under the category of immunosuppressants and specifically as a monoclonal antibody.][1]
• KEGG (Kyoto Encyclopedia of Genes and Genomes) ID:[ D11757.][1]

1.2. Molecular Architecture and Physicochemical Characteristics

[Inebilizumab is a biologic, or biotech, therapeutic, specifically categorized as a protein-based therapy.][8][ The FDA considers it a]

first-in-class medication[ due to its novel mechanism of action in its approved indications.][1]