Enspryng (satralizumab-mwge) / Roche, Chugai Pharmaceutical - LARVOL DELTA

BEST-NMOSD: Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD (clinicaltrials.gov) - P4 | N=540 | Recruiting | Sponsor: Massachusetts General Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

Autoimmune inflammatory diseases of the central nervous system: advances in clinical trials and immunotherapeutic strategies. (PubMed, Reumatologia) - "In AE, first-line immunotherapies (high-dose glucocorticoids, intravenous immunoglobulin, and plasma exchange) remain based mainly on observational data, while second-line therapies such as rituximab and cyclophosphamide are increasingly used despite limited comparative trial data. Recent systematic reviews and individual patient data meta-analyses have highlighted both the potential and the limitations of existing observational evidence, and several randomized phase II-III trials are now underway evaluating agents including bortezomib, satralizumab, and inebilizumab. In NMOSD, the therapeutic landscape has advanced more rapidly, with multiple pivotal randomized controlled trials of targeted biologics (e.g. complement inhibition with eculizumab, B-cell depletion with inebilizumab, interleukin-6 [IL-6] receptor blockade with satralizumab) demonstrating large reductions in relapse risk and leading to regulatory approvals...Emerging strategies include use of adaptive and..."

Journal • Review • CNS Disorders • Immunology • Inflammation • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Pediatrics • Psychiatry • Rare Diseases • Solid Tumor • IL6

Efficacy and safety of interleukin-6 receptor inhibitors in myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD): A systematic review and meta-analysis. (PubMed, Ther Adv Neurol Disord) - "To evaluate the efficacy and safety of tocilizumab and satralizumab in patients with MOGAD. IL-6R inhibition was associated with substantial relapse control in selected patients with MOGAD, supporting its potential role as a maintenance therapy. However, the evidence remains limited by observational designs, heterogeneous treatment regimens and follow-up, concomitant therapies, and the influence of one large cohort."

Journal • Retrospective data • CNS Disorders • Solid Tumor

Satralizumab For Patients With Thyroid Eye Disease: First Report of Week 48 Outcomes from the Phase 3 SatraGO-1 and SatraGO-2 Trials (ATA 2026) - No abstract available

Clinical • P3 data • Ophthalmology • Thyroid Eye Disease

HANDLE-a Real World Study on Satralizumab in NMOSD (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: Huashan Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Real-world evidence • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

U.S. FDA grants Priority Review for Roche’s Enspryng for MOGAD, an autoimmune disease with no approved treatments (Roche Press Release) - "The filing acceptance is based on positive results from the Phase III METEOROID study, which showed that Enspryng provided consistent, clinically meaningful improvements for people living with MOGAD.... The FDA is expected to make a decision on approval in MOGAD by 10 January 2027....Additionally, the European Medicines Agency (EMA) has validated the application for Enspryng for MOGAD in Europe. The decision by the European Commission is expected in the third quarter of 2027."

EMA approval • EMA filing • FDA filing • PDUFA • Priority review • Neuromyelitis Optica Spectrum Disorder

Efficacy and Safety of Satralizumab for Thyroid Eye Disease: Week 24 Results from the Phase 3 SatraGO-1 and SatraGO-2 Randomized Trials. (PubMed, Ophthalmology) - P3 | "Satralizumab demonstrated clinically meaningful improvements in proptosis, CAS, and diplopia, and had a favorable safety profile in participants with TED. Interleukin-6 pathway inhibition with subcutaneous satralizumab represents an efficacious and well-tolerated treatment option for patients with TED."

Journal • P3 data • Infectious Disease • Ophthalmology • Thyroid Eye Disease • IL6R

SATURN: A Multicenter Prospective Real-World Effectiveness and Safety of Satralizumab in the Early Treatment of Attacks in NMOSD (clinicaltrials.gov) - P=N/A | N=50 | Recruiting | Sponsor: Junwei Hao, MD

New trial • Real-world evidence • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

AQP4-IgG-positive myelitis occurring in a patient with small cell lung cancer: a case report. (PubMed, Front Oncol) - "The patient received high-dose intravenous methylprednisolone followed by adjunctive intravenous immunoglobulin (IVIG)...Satralizumab was initiated during corticosteroid tapering for maintenance immunotherapy...This case highlights that AQP4-IgG-positive myelitis can occur in patients with SCLC. In patients presenting with non-compressive longitudinally extensive transverse myelitis (LETM), particularly when imaging shows no evidence of compression and CSF cytology is negative for malignant cells, prompt AQP4-IgG testing is critical to prevent misdiagnosis and enable early initiation of appropriate immunotherapy."

Journal • CNS Disorders • Lung Cancer • Neuromyelitis Optica Spectrum Disorder • Oncology • Rare Diseases • Small Cell Lung Cancer • Solid Tumor

Clinical Use of Interleukin-6 Blockade in Neuroimmunological Disorders. (PubMed, Noro Psikiyatr Ars) - "It focuses on the therapeutic potential and safety profile of IL-6 inhibitors, particularly tocilizumab and satralizumab. Future research should focus on large-scale randomized controlled trials and the development of IL-6 inhibitors capable of crossing the BBB to enhance CNS-specific efficacy. Cost-related accessibility also remains a major challenge for broader clinical application."

Journal • Review • Alzheimer's Disease • CNS Disorders • Epilepsy • Immunology • Infectious Disease • Inflammation • Multiple Sclerosis • Myasthenia Gravis • Neuromyelitis Optica Spectrum Disorder • Rare Diseases • Solid Tumor • IL6

SatraGO-2: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=127 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed

Trial completion • Ophthalmology • Thyroid Eye Disease

Neuroimmunological overlap syndromes in optic neuritis, myelitis, and connective tissue diseases. (PubMed, Front Neurol) - "Four biologics inebilizumab (B-cell depletion), satralizumab (IL-6 blockade), and eculizumab/ravulizumab (complement inhibition) are approved for AQP4-IgG-positive NMOSD. Neuroimmunological overlap syndromes should be conceptualized as a unified neuroimmune continuum rather than discrete diseases. Priority research includes biomarker validation, head-to-head comparative cohorts, and randomized trials for MOGAD and CTD-associated neuroinflammation."

Journal • Review • CNS Disorders • Immunology • Inflammation • Neuromyelitis Optica Spectrum Disorder • Ocular Inflammation • Ophthalmology • Optic Neuritis • Rheumatology • GFAP • IFNG • IL17A • TNFA

SatraGO-1: Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=131 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed

Trial completion • Ophthalmology • Thyroid Eye Disease

Satralizumab in the Treatment of Pulmonary Arterial Hypertension (SATISFY-JP Trial) (clinicaltrials.gov) - P2 | N=20 | Completed | Sponsor: International University of Health and Welfare | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Comparative Evaluation of Rituximab Versus Approved Therapies in Aquaporin-4-IgG-Positive Neuromyelitis Optica Spectrum Disorder: A Systematic Review and Network Meta-analysis. (PubMed, Neurol Ther) - "This NMA showed hazard ratio point estimates favoring eculizumab and ravulizumab over rituximab. However, wide, overlapping confidence intervals and between-study heterogeneity indicate substantial uncertainty. Head-to-head trials or registry-based studies are needed to determine the most effective treatment for AQP4-IgG-positive NMOSD."

Journal • Retrospective data • Review • CNS Disorders • Immunology • Neuromyelitis Optica Spectrum Disorder • Rare Diseases • CD20 • IL6R

SAkuraSun: 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) (clinicaltrials.gov) - P3 | N=8 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Feb 2027 ➔ Sep 2029

Trial completion date • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Pediatrics • Rare Diseases

SAkuraSun: 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) (clinicaltrials.gov) - P3 | N=8 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Dec 2029 ➔ Sep 2029 | Trial primary completion date: Dec 2026 ➔ Mar 2027

Trial completion date • Trial primary completion date • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Pediatrics • Rare Diseases

Cielo: A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Anti-N-Methyl-D-Aspartic Acid Receptor (NMDAR) Or Anti-Leucine-Rich Glioma-Inactivated 1 (LGI1) Encephalitis (clinicaltrials.gov) - P3 | N=152 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Dec 2027 ➔ Dec 2028 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Pan tumor • Trial completion date • Trial primary completion date • Brain Cancer • CNS Disorders • CNS Tumor • Glioma • Immunology • Oncology • Solid Tumor

Satralizumab for the treatment of neuromyelitis optica spectrum disorders: a single center real life experience. (EAN 2026) - "Background and aims: Neuromyelitis optica spectrum disorders (NMOSD) is a rare, inflammatory, central nervous system disease historically treated with rituximab (RTX)...Prior therapy was tocilizumab (TOCI) in 5/11 patients and RTX in 6/11... In our small cohort, SATRA has proven to be effective and well tolerated, including long-term anti-IL-6R treated patients. Those who switched to SATRA to change mechanism of action stopping B-cell depletion because of worsening hypogammaglobulinemia all experienced a reduction of adverse events in both frequency and severity."

Clinical • Bone Marrow Transplantation • CNS Disorders • Infectious Disease • Neuromyelitis Optica Spectrum Disorder • Rare Diseases

SAkuraSun: 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) (clinicaltrials.gov) - P3 | N=8 | Recruiting | Sponsor: Hoffmann-La Roche | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Pediatrics • Rare Diseases

Interleukin 6 Receptor Blockade for Relapse Prevention in Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease. (PubMed, JAMA Neurol) - "Tocilizumab or satralizumab. Relapse rates were lower than the group who underwent IVIG less than 1 g/kg every 4 weeks but not significantly different from the group who underwent IVIG 1 g/kg or more every 4 weeks. This supports IL-6RB as a potential relapse-prevention therapy in MOGAD; the wide availability and relative affordability of tocilizumab may enable broad global use."

Journal • CNS Disorders • Infectious Disease • Solid Tumor • IL6R • IL6ST

Cielo: 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 (clinicaltrials.gov) - P3 | N=120 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Dec 2029 ➔ Dec 2028

Pan tumor • Trial completion date • Brain Cancer • CNS Disorders • Glioma • Immunology • Oncology • Solid Tumor

SAkuraSun: 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) (clinicaltrials.gov) - P3 | N=8 | Recruiting | Sponsor: Hoffmann-La Roche | Trial primary completion date: Sep 2024 ➔ Feb 2027

Trial primary completion date • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Pediatrics • Rare Diseases

SAkuraSun: 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) (clinicaltrials.gov) - P3 | N=8 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Sep 2029 ➔ Dec 2029 | Trial primary completion date: Mar 2027 ➔ Dec 2026

Trial completion date • Trial primary completion date • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Pediatrics • Rare Diseases

SAkuraSun: 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) (clinicaltrials.gov) - P3; N=8; Not yet recruiting; Sponsor: Hoffmann-La Roche

Clinical • New P3 trial • CNS Disorders • Neuromyelitis Optica Spectrum Disorder • Pediatrics • Rare Diseases