Rozanolixizumab: A Review in AChR or MuSK Autoantibody-Positive Generalised Myasthenia Gravis
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Abstract
Rozanolixizumab (rozanolixizumab-noli; RYSTIGGO®), a humanised immunoglobulin G4P monoclonal antibody, is a subcutaneously administered neonatal Fc receptor (FcRn) inhibitor approved for the treatment of both acetylcholine receptor (AChR) and muscle-specific kinase (MuSK) autoantibody-positive (Ab+) generalised myasthenia gravis (gMG) in adults. The pivotal, randomised, placebo-controlled phase III MycarinG trial demonstrated that a 6-week cycle of once-weekly rozanolixizumab ≈ 7 mg/kg or ≈ 10 mg/kg resulted in statistically significant and clinically meaningful improvements across all myasthenia gravis-specific scales assessed at day 43 versus placebo. Treatment benefits were rapid, sustained and consistent across repeated symptom-driven rozanolixizumab cycles. In a randomised, open-label, phase III crossover trial, self-administered rozanolixizumab improved MG symptoms regardless of whether manual push or infusion pump method was used. Rozanolixizumab was generally well tolerated with an acceptable safety profile; the most common adverse events were headache, diarrhoea, pyrexia and nausea. Thus, rozanolixizumab is an efficacious and generally well tolerated therapy for adults with AChR or MuSK Ab+ gMG, representing a convenient and valuable additional treatment option for these patients.
Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s40263-026-01335-3.
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BibTeX
@article{mcguigan2026rozanolixizumab,
title = {{Rozanolixizumab: A Review in AChR or MuSK Autoantibody-Positive Generalised Myasthenia Gravis}},
author = {Aisling McGuigan and Hannah A. Blair},
journal = {CNS Drugs},
year = {2026},
month = sep,
doi = {10.1007/s40263-026-01335-3},
url = {https://doi.org/10.1007/s40263-026-01335-3},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Rozanolixizumab: A Review in AChR or MuSK Autoantibody-Positive Generalised Myasthenia Gravis
AU - Aisling McGuigan
AU - Hannah A. Blair
PY - 2026
DA - 2026/09/30
JO - CNS Drugs
DO - 10.1007/s40263-026-01335-3
UR - https://doi.org/10.1007/s40263-026-01335-3
AB - Rozanolixizumab (rozanolixizumab-noli; RYSTIGGO®), a humanised immunoglobulin G4P monoclonal antibody, is a subcutaneously administered neonatal Fc receptor (FcRn) inhibitor approved for the treatment of both acetylcholine receptor (AChR) and muscle-specific kinase (MuSK) autoantibody-positive (Ab+) generalised myasthenia gravis (gMG) in adults. The pivotal, randomised, placebo-controlled phase III MycarinG trial demonstrated that a 6-week cycle of once-weekly rozanolixizumab ≈ 7 mg/kg or ≈ 10 mg/kg resulted in statistically significant and clinically meaningful improvements across all myasthenia gravis-specific scales assessed at day 43 versus placebo. Treatment benefits were rapid, sustained and consistent across repeated symptom-driven rozanolixizumab cycles. In a randomised, open-label, phase III crossover trial, self-administered rozanolixizumab improved MG symptoms regardless of whether manual push or infusion pump method was used. Rozanolixizumab was generally well tolerated with an acceptable safety profile; the most common adverse events were headache, diarrhoea, pyrexia and nausea. Thus, rozanolixizumab is an efficacious and generally well tolerated therapy for adults with AChR or MuSK Ab+ gMG, representing a convenient and valuable additional treatment option for these patients. Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s40263-026-01335-3.
SN - 1172-7047
SN - 1179-1934
ER -