UPLIZNA
UPLIZNA (inebilizumab-cdon) is a CD19-directed cytolytic antibody indicated for the treatment of specific autoimmune disorders in adult patients. It is used to treat neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody positive and generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive. The medication is also indicated for the treatment of adults with Immunoglobulin G4-related disease (IgG4-RD).
How UPLIZNA Works
Inebilizumab-cdon functions by binding to CD19, a cell surface antigen present on pre-B and mature B lymphocytes. Once the drug binds to these B lymphocytes, it induces antibody-dependent cellular cytolysis. This mechanism is presumed to provide therapeutic effects across its approved indications by targeting and depleting these specific immune cell populations.
Details
- Status
- Prescription
- First Approved
- 2020-06-11
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
UPLIZNA Approval History
What UPLIZNA Treats
3 indicationsUPLIZNA is approved for 3 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Neuromyelitis optica spectrum disorder (NMOSD) in anti-aquaporin-4 (AQP4) antibody positive adults
- Immunoglobulin G4-related disease (IgG4-RD) in adults
- Generalized myasthenia gravis (gMG) in anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive adults
UPLIZNA Target & Pathway
ProTarget
A protein expressed on B-cells throughout their development. CD19 is a key target for CAR-T cell therapies in B-cell leukemias and lymphomas, where engineered T-cells are directed to kill CD19-expressing cancer cells.
UPLIZNA Competitors
Pro3 other drugs also target CD19. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (CD19). Earlier expiry dates signal biosimilar/generic opportunities.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
UPLIZNA FDA Label Details
ProIndications & Usage
FDA Label (PDF)UPLIZNA is a CD19-directed cytolytic antibody indicated for the treatment of: Neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. Immunoglobulin G4-related disease (IgG4-RD) in adult patients. Generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive. 1.1 Neuromyelitis Optica Spectrum Disorder (NMOSD) UPLIZNA is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.