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Drug

Inebilizumab

Approved · EMA
Emerging researchLate-stage development

Also known as Uplizna.

RxNorm2373951UNII74T7185BMM
1
Research papers
11
Active clinical trials
1
Regulatory events
Latest activity
beta

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

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

A Phase 3, Randomized, Double-blind, Multicenter, Placebo Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease

Clinical trial2025-12-11Results posted · ClinicalTrials.gov

An Open-Label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder

Clinical trial2025-12-05Results expected Q2 2027 · ClinicalTrials.gov

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

Clinical trial2025-11-21Results expected Q2 2028 · ClinicalTrials.gov

Phase 3 Study of MT-0551 in Patients With Systemic Sclerosis (Placebo-Controlled Double-Blind Study)

Clinical trial2025-07-31Primary completion · ClinicalTrials.gov

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
UNII
74T7185BMM
Regulatory jurisdictions
ema

Regulatory timeline

1 event

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.

Earliest approval
2022-04-25
Latest approval
2022-04-25
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2022-04-25Approval
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 ↗

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
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.