Satralizumab-mwge is marketed as ENSPRYNG, an interleukin-6 receptor antagonist for adults with anti-aquaporin-4 antibody positive neuromyelitis optica spectrum disorder. It is a recombinant humanized anti-IL-6 receptor monoclonal antibody, with therapeutic effect presumed to involve inhibition of IL-6 signaling. U.S. initial approval was in 2020.
Over 10 companies are developing 12+ pipeline therapies for Neuromyelitis Optica Spectrum Disorder, including Roche's satralizumab Phase III pediatric trial and multiple anti-CD20 monoclonal antibody candidates.
Industry leaders highlight advances in AI-enabled trial monitoring, real-world data interoperability, and protocol-driven eSource systems, while emphasizing the need for community engagement in diversity efforts and addressing operational risks in rare disease trials.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07010302 |
Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD |
NOT_YET_RECRUITING | PHASE4 |
| NCT06829524 |
HANDLE-a Real World Study on Satralizumab in NMOSD |
NOT_YET_RECRUITING | |
| NCT06450639 |
A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD) |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT06106828 |
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05987423 |
Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05727657 |
Satralizumab in Aneurysmal Subarachnoid Hemorrhage |
WITHDRAWN | EARLY_PHASE1 |
| NCT05503264 |
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Satralizumab in Participants With Anti-N-methyl-D-aspartic Acid Receptor (NMDAR) or Anti-leucine-rich Glioma-inactivated 1 (LGI1) Encephalitis |
RECRUITING | PHASE3 |
| NCT05271409 |
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease |
RECRUITING | PHASE3 |
| NCT05199688 |
A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD) |
RECRUITING | PHASE3 |
| NCT04963270 |
A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis |
TERMINATED | PHASE3 |
