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Uplizna (INEBILIZUMAB)
Uplizna works by binding to CD19 on B-lymphocytes, marking them for destruction.
At a glance
| Generic name | INEBILIZUMAB |
|---|---|
| Sponsor | Viela Bio |
| Drug class | CD19-directed Cytolytic Antibody [EPC] |
| Target | B-lymphocyte antigen CD19 |
| Modality | Monoclonal antibody |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2020 |
Mechanism of action
The precise mechanism by which inebilizumab-cdon exerts its therapeutic effects in NMOSD is unknown but is presumed to involve binding to CD19, cell surface antigen presents on pre-B and mature lymphocytes. Following cell surface binding to lymphocytes, inebilizumab-cdon results in antibody-dependent cellular cytolysis.
Approved indications
- Neuromyelitis optica
Common side effects
- Urinary tract infection
- Nasopharyngitis
- Infusion reaction
- Arthralgia
- Headache
- Decreased Immunoglobulins
- Decreased Neutrophil Counts (1.0-1.5 x10^9/L)
- Decreased Neutrophil Counts (0.5-1.0 x10^9/L)
- Decreased Lymphocyte Counts
- Treatment-emergent antibodies
- Back pain
- IgG levels below the lower limit of normal
Key clinical trials
- A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG) (PHASE2)
- Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD (PHASE4)
- Myasthenia Gravis Inebilizumab Trial (PHASE3)
- A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases (PHASE2)
- Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
- Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Pediatric Participants With IgG4-RD (PHASE2)
- A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease (PHASE3)
- A Study of MT-0551 in Patients With Systemic Sclerosis (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Uplizna CI brief — competitive landscape report
- Uplizna updates RSS · CI watch RSS
- Viela Bio portfolio CI