Inebilizumab
- Generic Name
- Inebilizumab
- Brand Names
- Uplizna 3 Vial Kit, Uplizna
- Drug Type
- Biotech
- CAS Number
- 1299440-37-1
- Unique Ingredient Identifier
- 74T7185BMM
- Background
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
AMG 335 Expanded Access Program for IgG4-Related Disease
- First Posted Date
- 2024-09-10
- Last Posted Date
- 2024-09-10
- Lead Sponsor
- Amgen
- Registration Number
- NCT06590051
A Phase 2a Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
- Conditions
- Systemic Lupus ErythematosusActive Refractory Rheumatoid Arthritis
- Interventions
- First Posted Date
- 2024-08-26
- Last Posted Date
- 2025-03-12
- Lead Sponsor
- Amgen
- Target Recruit Count
- 110
- Registration Number
- NCT06570798
- Locations
- 🇺🇸
Vitaly Clinical Research, Miami, Florida, United States
🇺🇸Northwell Health, Great Neck, New York, United States
🇺🇸Prolato Clinical Research Center, Houston, Texas, United States
A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders
- Conditions
- Neuromyelitis Optica Spectrum Disorders
- Interventions
- First Posted Date
- 2024-01-18
- Last Posted Date
- 2024-01-18
- Lead Sponsor
- Hansoh BioMedical R&D Company
- Target Recruit Count
- 33
- Registration Number
- NCT06212245
- Locations
- 🇨🇳
IRB of Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing, China
Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD)
- Conditions
- Neuromyelitis Optica Spectrum Disorder
- Interventions
- Other: Blood tests
- First Posted Date
- 2023-12-22
- Last Posted Date
- 2025-05-15
- Lead Sponsor
- Amgen
- Target Recruit Count
- 30
- Registration Number
- NCT06180278
- Locations
- 🇵🇱
Uniwersyteckie Centrum Kliniczne WUM, Warszawa, Mazowieckie, Poland
🇺🇸Baylor College of Medicine, Houston, Texas, United States
🇭🇺Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ, Szeged, Csongrád, Hungary
Inebilizumab and Rituximab in Neuromyelitis Optica Spectrum Disorders
- Conditions
- Neuromyelitis Optica Spectrum Disorders
- Interventions
- Drug: Rituximab(RTX)
- First Posted Date
- 2023-10-05
- Last Posted Date
- 2023-10-05
- Lead Sponsor
- Feng Jinzhou
- Target Recruit Count
- 80
- Registration Number
- NCT06068829
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
- Conditions
- Neuromyelitis Optica Spectrum DisorderPregnancy Related
- First Posted Date
- 2023-06-18
- Last Posted Date
- 2025-02-19
- Lead Sponsor
- Amgen
- Target Recruit Count
- 60
- Registration Number
- NCT05909761
- Locations
- 🇺🇸
University of Colorado Denver, Aurora, Colorado, United States
Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders
- Conditions
- Neuromyelitis Optica Spectrum Disorder
- Interventions
- Drug: oral immunosuppressant
- First Posted Date
- 2023-06-06
- Last Posted Date
- 2024-06-24
- Lead Sponsor
- Xuanwu Hospital, Beijing
- Target Recruit Count
- 50
- Registration Number
- NCT05891379
- Locations
- 🇨🇳
Xuanwu Hospital, Capital Medical University, Beijing, Beijing, China
Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder
- First Posted Date
- 2022-09-22
- Last Posted Date
- 2025-01-09
- Lead Sponsor
- Amgen
- Target Recruit Count
- 15
- Registration Number
- NCT05549258
- Locations
- 🇬🇧
Great Ormond Street Hospital, London, London, City Of, United Kingdom
🇺🇸Loma Linda University Children's Hospital, Loma Linda, California, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
A Study of MT-0551 in Patients With Systemic Sclerosis
- First Posted Date
- 2022-01-20
- Last Posted Date
- 2024-07-05
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Target Recruit Count
- 80
- Registration Number
- NCT05198557
- Locations
- 🇯🇵
University of Fukui Hospital, Yoshida-gun, Fukui, Japan
🇯🇵Kanazawa University Hospital, Kanazawa, Ishikawa, Japan
🇯🇵St. Marianna University Hospital, Kawasaki-shi, Kanagawa, Japan
A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease
- Conditions
- IgG4 Related Disease
- Interventions
- Other: Placebo
- First Posted Date
- 2020-09-07
- Last Posted Date
- 2025-04-02
- Lead Sponsor
- Amgen
- Target Recruit Count
- 135
- Registration Number
- NCT04540497
- Locations
- 🇬🇧
Viela Bio Investigative Site, Oxford, United Kingdom
🇪🇸Viela Bio Investigative Site 2, Barcelona, Spain
🇨🇳Viela Bio Investigative Site 1, Beijing, China
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.