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Drug

Inebilizumab

Approved medicine
ClassB-lymphocyte antigen CD19 binding agentResearchActive indication expansion

Also known as Uplizna.

RxNorm2373951ChEMBLCHEMBL2109334ATCL04AG10UNII74T7185BMM
1
Research papers
11
Active clinical trials
B-lymphocyte antigen CD19
Primary target
5
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: INEBILIZUMAB (BLA761142)

Regulatory2026-09-03FDA

Inebilizumab-cdon reduces exacerbations in gMG patients

Industry2026-08-21Healio Neurology

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 Generalized Myasthenia Gravis (gMG)

Clinical trial2026-07-09Results expected Q1 2030 · ClinicalTrials.gov

A Comparative Clinical Effectiveness Trial of Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab and Eculizumab To Prevent Relapses in Neuromyelitis Optica Spectrum Disorder

Clinical trial2026-06-24Results expected Q1 2030 · ClinicalTrials.gov

A Phase 2/3, Randomized, Double-blind, Multicenter, Placebo-controlled Study of Inebilizumab in Participants With Autoimmune Hepatitis

Clinical trial2026-05-20Results expected Q3 2031 · ClinicalTrials.gov

A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study With Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia Gravis

Clinical trial2026-05-15Results posted · ClinicalTrials.gov

A Phase 2, Open Label, Multicenter, Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Autoimmune Diseases

Clinical trial2026-05-07Results expected Q3 2028 · ClinicalTrials.gov

Open-label, Uncontrolled, Multicenter Trial to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Children From 2 Years to Less Than 18 Years of Age With Immunoglobulin G4-related Disease (IgG4-RD)

Clinical trial2026-05-04Results expected Q2 2031 · ClinicalTrials.gov

Indication expansion: INEBILIZUMAB (BLA761142)

Regulatory2025-12-11FDA

Indication expansion: INEBILIZUMAB (BLA761142)

Regulatory2025-04-03FDA

Approval: Uplizna (EMA)

Regulatory2022-04-25EMA

Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised placebo-controlled phase 2/3 trial.

Research2019-09-05Lancet (London, England)

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Inebilizumab
Aliases & brands
Uplizna
RxNorm CUI
2373951
ChEMBL ID
CHEMBL2109334
ATC codes
L04AG10
UNII
74T7185BMM
Primary mechanism
B-lymphocyte antigen CD19 binding agent
Regulatory jurisdictions
emafda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

B-lymphocyte antigen CD19
CD19 · P15391
BINDING AGENTB-lymphocyte antigen CD19 binding agent

Regulatory timeline

5 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2020-06-11 → 2022-04-25)
Earliest approval
2020-06-11
Latest approval
2025-12-11
Authorities
FDA · EMA
Total events
5
fdaU.S. Food and Drug Administration· 4 events
2026-09-03Label change
Label change: INEBILIZUMAB (BLA761142)
Evidence ↗
2025-12-11Indication expansion
Indication expansion: INEBILIZUMAB (BLA761142)
Evidence ↗
2025-04-03Indication expansion
Indication expansion: INEBILIZUMAB (BLA761142)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2022-04-25ApprovalMulti-authority
Approval: Uplizna (EMA)
Indication: Uplizna is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin 4 immunoglobulin G (AQP4-IgG)… Show full indication

Uplizna is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin 4 immunoglobulin G (AQP4-IgG) seropositive (see section 5.1).

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

14 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
14
registered trials across all phases
LATEST COMPLETION 2020
11
Active studies
7
Recruiting
8
Late-stage (III+)
1
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 14
Phase 26Phase 2 / 31Phase 34Phase 43

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Comparative Clinical Effectiveness Trial of Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab and Eculizumab To Prevent Relapses in Neuromyelitis Optica Spectrum Disorder

Not yet recruitingPH IVMassachusetts General Hospitaln=5402030

A Long-term, Open-label, Low-interventional Safety Study of Inebilizumab in the Treatment of NMOSD (N-MOmentum LT)

Active, not recruitingPH IVAmgenn=322028

An Open-label Single-arm Clinical Study to Assess the Efficacy and Safety of Inebilizumab in Chinese Adult Patients With Neuromyelitis Optica Spectrum Disorders (NMOSD)

Unknown statusPH IVHansoh BioMedical R&D Companyn=332025

A Phase 2/3, Randomized, Double-blind, Multicenter, Placebo-controlled Study of Inebilizumab in Participants With Autoimmune Hepatitis

Not yet recruitingPH IIIAmgenn=1802034

A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study With Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia Gravis

Active, not recruitingPH IIIAmgenn=2382029

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • Lancet (London, England)1
Leading researchers
  • Aktas O1
  • Barron G1
  • Bennett JL1
  • Cimbora D1
  • Cree BAC1
  • Cutter GR1
  • Drappa J1
  • Fujihara K1
Leading institutions
free-text, unnormalised
  • Experimental and Clinical Research Center1
  • Fukushima Medical University1
  • Heinrich Heine University1
  • Icahn School of Medicine at Mount Sinai1
  • Lyon University Hospital1
  • Mayo Clinic1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.