UPLIZNA
PeakmAbinebilizumab
BLAINJECTIONINJECTABLE
Approved
Jun 2020
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
11
Data completeness
4/8 — Partial
UPLIZNA (inebilizumab) is cd19-directed antibody interactions [moa]. First approved in 2020.
Drug data last refreshed 32m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
UPLIZNA (inebilizumab) is a CD19-directed cytolytic monoclonal antibody approved in 2020 for treating neuromyelitis optica spectrum disorder (NMOSD) by depleting B cells. It works by binding to CD19 on B lymphocytes and inducing their destruction, reducing pathogenic autoantibodies and neuroinflammation.
$13MPart D
PeakThe drug is in peak commercial phase with modest Medicare Part D uptake (82 claims in 2023), indicating a mature but niche specialty biologic supported by focused commercial teams.
Mechanism of Action
CD19-directed Antibody Interactions
Pharmacologic Class:
CD19-directed Cytolytic Antibody
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (11)
A Trial of Inebilizumab in Participants With Autoimmune Hepatitis
Started Sep 2026
180 enrolled
Autoimmune HepatitisAIH
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG)
Started Aug 2026
15 enrolled
Generalized Myasthenia Gravis
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Pediatric Participants With IgG4-RD
Started Jul 2026
15 enrolled
Immunoglobulin G4-related Disease
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
Started Apr 2026
60 enrolled
Neuromyelitis Optica Spectrum DisorderPregnancy Related
A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
Started Jul 2025
220 enrolled
Systemic Lupus ErythematosusActive Refractory Rheumatoid Arthritis
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.