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UPLIZNA
UPLIZNA is a neonatal Fc receptor (FcRn) antagonist that blocks the recycling and extends the half-life of pathogenic immunoglobulins, leading to their increased clearance from circulation.
UPLIZNA is a neonatal Fc receptor (FcRn) antagonist that blocks the recycling and extends the half-life of pathogenic immunoglobulins, leading to their increased clearance from circulation. Used for Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) antibody positive.
At a glance
| Generic name | UPLIZNA |
|---|---|
| Also known as | inebilizumab-cdon |
| Sponsor | Amgen |
| Drug class | FcRn antagonist |
| Target | FcRn (neonatal Fc receptor) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
UPLIZNA binds to the neonatal Fc receptor (FcRn), which normally recycles immunoglobulins back into circulation to extend their lifespan. By blocking this recycling pathway, the drug promotes the degradation and clearance of circulating immunoglobulins, including autoantibodies and pathogenic antibodies. This mechanism reduces antibody-mediated autoimmune responses in conditions driven by pathogenic immunoglobulins.
Approved indications
- Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) antibody positive
Common side effects
- Infection (including serious infections)
- Infusion-related reactions
- Headache
- Fatigue
Key clinical trials
- A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG) (PHASE2)
- A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases (PHASE2)
- Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
- Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD) (PHASE4)
- The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis (PHASE2)
- AMG 335 Expanded Access Program for IgG4-Related Disease
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |