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uplizna

Generic: inebilizumab-cdon

uplizna: sourced relationships with 1 company · 2 clinical trials tracked · 1 FDA decision.

uplizna evidence translation

What we can confirm

1 FDA record · 2 tracked trials

What it means

Source-backed records connect uplizna to VIE; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could uplizna → VIE affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 1 study sponsors

Related indications

Neuromyelitis optica spectrum disorder (NMOSD)
Dated Pipeline Records (1)
CompanyDated record stage
Viela Bio, Inc. (VIE)
developer · Reported 2021-03-01 · Current development: unknownSource
Neuromyelitis optica spectrum disorder (NMOSD)
Approved
Clinical Trial Registry Records (2)

AMG 335 Expanded Access Program for IgG4-Related Disease

NCT06590051Registry updated 2026-09-14·AMGN
Approved for marketing
Expanded AccessAmgen

An Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (Inebilizumab-cdon) During Pregnancy

NCT05909761Registry updated 2026-08-31·AMGN
Recruiting

Primary endpoint: Number of newborns with Major Congenital Malformations (MCMs)

Observational60 targetStarted 2026-10Completion 2032-101 site · United StatesAmgen
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE 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. ( 1.1 ) Immunoglobulin G4-related disease (IgG4-RD) in adult patients. ( 1.2 ) Generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive. ( 1.2 ) 1.1 Neuromyelitis Optica Spectru(VIE)FDA ↗
BLA761142Type 1 - New Molecular EntityOrphan DrugStandardOtherInjectable

Frequently asked questions

Which companies have sourced relationships with uplizna?

uplizna has dated SEC/FDA relationship records for Viela Bio, Inc..

How many clinical trials involve uplizna?

BioSniper tracks 2 clinical trials involving uplizna.

What is uplizna's latest FDA decision?

The most recent tracked FDA decision for uplizna is Approval for 1 INDICATIONS AND USAGE 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. ( 1.1 ) Immunoglobulin G4-related disease (IgG4-RD) in adult patients. ( 1.2 ) Generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive. ( 1.2 ) 1.1 Neuromyelitis Optica Spectru, dated June 11, 2020.