Inebilizumab
How it works: Removing B cells →
Uplizna
EU: Approved in the EU since 2022US: FDA approved 2020
- Molecule type
- Antibody
- Mechanism (ChEMBL)
- B-lymphocyte antigen CD19 binding agent
- Targets
- B-lymphocyte antigen CD19
- Availability
- Authorised in all EU and EEA countries. Reimbursement is decided by each country.
Approvals
Safety communications
None recorded.
Most-reported side effects (FDA reports)
Reports to the FDA's adverse event system (FAERS) show what people and doctors reported while taking the medicine. They do not prove the medicine caused it, and they are not rates.
122 reports in total, 109 marked serious.
- Off label use36
- Neuromyelitis optica spectrum disorder35
- Urinary tract infection13
- Pneumocystis jirovecii pneumonia9
- Pneumonia9
- Pyrexia9
- Infection8
- Infusion related reaction7
- Anaemia6
- Upper respiratory tract infection6
Trials
Key trials
Large trials with a reported result on their main goal.
- N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis
Completed · Phase 2 / Phase 3 · NMOSD · Met its main goal
Running now
- Observational Safety Study in Women With Neuromyelitis Optica Spectrum
Recruiting · NMOSD · Still running
- Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizum
Recruiting · Phase 4 · NMOSD · Still running
- Slow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD
Not yet recruiting · Phase 3 · NMOSD · Still running
- Inectolizumab With Steroid Optimization in Newly Treated NMOSD
Not yet recruiting · Not a drug-phase study · NMOSD · Still running
- Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis O
Running, not recruiting · Phase 4 · NMOSD · Still running
- Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica
Recruiting · Phase 2 · NMOSD · Still running
Other trials (5)
Completed small trials, dose-finding studies and trials in other diseases.
- Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders
Status unknown · NMOSD · No results found
- A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spec
Status unknown · Phase 4 · NMOSD · No results found
- Inebilizumab and Rituximab in Neuromyelitis Optica Spectrum Disorders
Status unknown · NMOSD · No results found
- Neuromyelitis Optica Spectrum Disorder Inebilizumab Study in Children
Moved to EU CTIS registry · Phase 2 · NMOSD
- Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, t
Completed · Phase 1 · Relapsing and progressive · Results posted, not judged
For information only, not medical advice. Talk to your neurologist before changing treatment.
Hypotheses involving this medicine
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Lab studies
Lab studies in animals or cells. Results in animals often do not hold in people, and these studies never change the status of an idea.
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