UPLIZNA (inebilizumab-cdon)
UPLIZNA is indicated for the treatment of 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.
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.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-06-11
- Patent Cliff
- 2027
- Revenue
- $233M (Q4-2025)
- 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 Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06570798 | 20240033 2024-514382-19 | Ph 2 | recruiting | A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases |
| NCT07222553 | 20240202 2025-520988-41-00 | Ph 2 | not yet recruiting | Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Pediatric Participants With IgG4-RD |
| NCT06987539 THYME | 20240236 2025-520993-20 | Ph 2 | recruiting | A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG) |
| NCT07010302 BEST-NMOSD | 40200 | Ph 4 | not yet recruiting | Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD |
| NCT04524273 MINT results posted | VIB0551.P3.S1 | Ph 3 | active not recruiting | Myasthenia Gravis Inebilizumab Trial |
| NCT04540497 results posted | VIB0551.P3.S2 2023-508290-81-00 | Ph 3 | active not recruiting | A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease |
| NCT05198557 | MT-0551-A-301 | Ph 3 | active not recruiting | A Study of MT-0551 in Patients With Systemic Sclerosis |
| NCT05549258 | VIB0551.P2.S2.NMO 2023-510007-22 | Ph 2 | recruiting | Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder |
| NCT06180278 N-MOmentum LT | HZNP-UPL-401 | Ph 4 | active not recruiting | Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD) |
| NCT04372615 ExTINGUISH | 143461 | Ph 2 | recruiting | The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis |
| NCT04174677 | VIB0551.P2.S1 | Ph 2 | withdrawn | Safety and Tolerability of Inebilizumab, VIB4920, or the Combination in Highly Sensitized Candidates Awaiting Kidney Transplantation From a Deceased Donor |
| NCT02200770 results posted | CD-IA-MEDI-551-1155 2014-000253-36 | Ph 2, Ph 3 | completed | N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders |
| NCT07598825 MERCURY | 20240237 2025-522393-37-00 | Ph 3 | not yet recruiting | A Trial of Inebilizumab in Participants With Autoimmune Hepatitis |
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
Indications & Usage
FDA Label (PDF)UPLIZNA is indicated for the treatment of 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.
Pro Intelligence Preview
Deep insights for UPLIZNA
Revenue Insights
- • Q4-2025: $233M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • Generic/biosimilar risk
Trial Analysis
- • 12 total trials
- • Stage: Growth
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment