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UPLIZNA (INEBILIZUMAB-CDON)
UPLIZNA (generic name: INEBILIZUMAB-CDON) is a CD19-directed Cytolytic Antibody [EPC] drug developed by VIELA BIO. It is currently FDA-approved for Neuromyelitis optica.
At a glance
| Generic name | INEBILIZUMAB-CDON |
|---|---|
| Sponsor | VIELA BIO |
| Drug class | CD19-directed Cytolytic Antibody [EPC] |
| Target | Low affinity immunoglobulin gamma Fc region receptor III-A, B-lymphocyte antigen CD19 |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Approved indications
- Neuromyelitis optica
Common side effects
- Urinary tract infection
- Nasopharyngitis
- Infusion reaction
- Arthralgia
- Headache
Key clinical trials
- A Long-term, Open-label, Low-interventional Safety Study of Inebilizumab in the Treatment of NMOSD (N-MOmentum LT) (Phase 4)
- A Phase-2b, Double-Blind, Randomized Controlled Trial to Evaluate the Activity and Safety of Inebilizumab in Anti-Nmda Receptor Encephalitis and Assess Markers of Disease (Phase 2)
- An Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (Inebilizumab-cdon) During Pregnancy (N/A)
- A Phase 2, Open Label, Multicenter, Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Autoimmune Diseases (Phase 2)
- NCT06590051 (N/A)
- A Phase 2 Open-label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children From 2 Years to Less Than 18 Years of Age With Generalize (Phase 2)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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
Frequently asked questions about UPLIZNA
What is UPLIZNA?
UPLIZNA (INEBILIZUMAB-CDON) is a CD19-directed Cytolytic Antibody [EPC] drug developed by VIELA BIO, indicated for Neuromyelitis optica.
What is UPLIZNA used for?
UPLIZNA is indicated for Neuromyelitis optica.
Who makes UPLIZNA?
UPLIZNA is developed and marketed by VIELA BIO (see full VIELA BIO pipeline at /company/viela-bio).
What is the generic name of UPLIZNA?
INEBILIZUMAB-CDON is the generic (nonproprietary) name of UPLIZNA.
What drug class is UPLIZNA in?
UPLIZNA belongs to the CD19-directed Cytolytic Antibody [EPC] class. See all CD19-directed Cytolytic Antibody [EPC] drugs at /class/cd19-directed-cytolytic-antibody-epc.
What development phase is UPLIZNA in?
UPLIZNA is FDA-approved (marketed).
What are the side effects of UPLIZNA?
Common side effects of UPLIZNA include Urinary tract infection, Nasopharyngitis, Infusion reaction, Arthralgia, Headache.
What does UPLIZNA target?
UPLIZNA targets Low affinity immunoglobulin gamma Fc region receptor III-A, B-lymphocyte antigen CD19 and is a CD19-directed Cytolytic Antibody [EPC].
Related
- Drug class: All CD19-directed Cytolytic Antibody [EPC] drugs
- Target: All drugs targeting Low affinity immunoglobulin gamma Fc region receptor III-A, B-lymphocyte antigen CD19
- Manufacturer: VIELA BIO — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Neuromyelitis optica
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing