Last reviewed 2026-04-20 · How we verify

ROZANOLIXIZUMAB

At a glance

Approved indications

No approved indications tracked.

Common side effects

• Headache
• Infections
• Upper respiratory tract infection
• COVID-19
• Urinary tract infections
• Herpes simplex
• Pyrexia
• Diarrhea
• Hypersensitivity reactions
• Nausea
• Administration site reactions
• Abdominal pain

Key clinical trials

• A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis (PHASE2, PHASE3)
• Phase 4 Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis (PHASE4)
• A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis (PHASE3)
• A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOG-AD) (PHASE3)
• A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis (PHASE3)
• An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis (PHASE3)
• A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis (PHASE3)
• A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG) (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• ROZANOLIXIZUMAB CI brief — competitive landscape report
• ROZANOLIXIZUMAB updates RSS · CI watch RSS