Overview
Inappropriate growth of or self-directed antibody production by B-cells is the etiological underpinning of a variety of conditions, including the multiple sclerosis-like neurological condition neuromyelitis optica spectrum disorder (NMOSD). Inebilizumab is a humanized afucosylated monoclonal IgG1 antibody directed against the broadly expressed B-cell surface antigen CD19. Inebilizumab is cytolytic, resulting in B-cell depletion and offering therapeutic benefit to patients suffering from NMOSD. Compared to the anti-CD20 antibody rituximab, which is also used to treat NMOSD, inebilizumab has broader specificity. Inebilizumab was granted FDA approval on June 11, 2020, for the treatment of anti-aquaporin 4 positive NMOSD patients. Given its mechanism of action and good safety profile, it may prove useful in the treatment of other conditions linked to autoimmune antibody production or B-cell malignancies.
Indication
Inebilizumab is indicated for the treatment of aquaporin-4 (AQP4) immunoglobulin-positive (AQP4-IgG) neuromyelitis optica spectrum disorder (NMOSD) in adult patients.
Associated Conditions
- Neuromyelitis Optica Spectrum Disorders
Research Report
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]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/08 | Phase 4 | Not yet recruiting | |||
2025/05/23 | Phase 2 | Not yet recruiting | |||
2024/09/10 | N/A | AVAILABLE | |||
2024/08/26 | Phase 2 | Recruiting | |||
2024/01/18 | Phase 4 | Not yet recruiting | Hansoh BioMedical R&D Company | ||
2023/12/22 | Phase 4 | Active, not recruiting | |||
2023/10/05 | N/A | Not yet recruiting | Feng Jinzhou | ||
2023/06/18 | N/A | Recruiting | |||
2023/06/06 | N/A | Not yet recruiting | |||
2022/09/22 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Horizon Therapeutics USA, Inc. | 75987-150 | INTRAVENOUS | 10 mg in 1 mL | 7/27/2021 | |
| Viela Bio, Inc. | 72677-551 | INTRAVENOUS | 10 mg in 1 mL | 12/23/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/25/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| UPLIZNA inebilizumab 100 mg/10 mL concentrated injection vial | 446050 | Medicine | A | 3/12/2025 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| UPLIZNA | Amgen Canada Inc | 02543931 | Solution - Intravenous | 10 MG / ML | 6/18/2024 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| UPLIZNA 100 MG CONCENTRADO PARA SOLUCION PARA PERFUSION | 1211602001 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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