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Drug

Satralizumab

Approved · FDA / EMA
Late-stage development

Also known as Enspryng, Sapelizumab.

RxNorm2391541UNIIYB18NF020M
8
Active clinical trials
5
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Basket 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

Clinical trial2026-07-10Results expected Q4 2026 · ClinicalTrials.gov

A Phase III, Multicenter, Open-Label, Uncontrolled Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)

Clinical trial2026-07-09Results expected Q1 2027 · ClinicalTrials.gov

Satralizumab,an Anti-IL-6 Receptor Antibody, in the Treatment of Pulmonary Arterial Hypertension; Safety and Efficacy Evaluation in Japan -Multicenter, Investigator-sponsored Trial-

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

A Comparative Clinical Effectiveness Trial of Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab and Eculizumab To Prevent Relapses in Neuromyelitis Optica Spectrum Disorder

Clinical trial2026-06-24Results expected Q1 2030 · ClinicalTrials.gov

Supplemental approval: SATRALIZUMAB (BLA761149)

Regulatory2026-06-10FDA

A Phase II Multicenter, Open-label Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Pediatric Patients With Duchenne Muscular Dystrophy (SHIELD DMD)

Clinical trial2026-05-15Results expected Q3 2026 · ClinicalTrials.gov

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab as Monotherapy or in Addition to Baseline Therapy in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD)

Clinical trial2025-11-20Primary completion · ClinicalTrials.gov

A Phase III, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Moderate-to-Severe Thyroid Eye Disease

Clinical trial2025-07-24Primary completion · ClinicalTrials.gov

A Phase III, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Moderate-to-Severe Thyroid Eye Disease

Clinical trial2025-07-08Primary completion · ClinicalTrials.gov

Label change: SATRALIZUMAB (BLA761149)

Regulatory2022-09-14FDA

Approval: Enspryng (EMA)

Regulatory2021-06-24EMA

Label change: SATRALIZUMAB (BLA761149)

Regulatory2021-05-03FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Satralizumab
Aliases & brands
EnspryngSapelizumab
RxNorm CUI
2391541
UNII
YB18NF020M
Regulatory jurisdictions
emafda

Regulatory timeline

5 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2020-08-14 → 2021-06-24)
Earliest approval
2020-08-14
Latest approval
2026-06-10
Authorities
FDA · EMA
Total events
5
fdaU.S. Food and Drug Administration· 4 events
2026-06-10Supplemental approval
Supplemental approval: SATRALIZUMAB (BLA761149)
Evidence ↗
2022-09-14Label change
Label change: SATRALIZUMAB (BLA761149)
Evidence ↗
2021-05-03Label change
Label change: SATRALIZUMAB (BLA761149)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2021-06-24ApprovalMulti-authority
Approval: Enspryng (EMA)
Indication: Satralizumab (Enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD)… Show full indication

Satralizumab (Enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

14 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
14
registered trials across all phases
LATEST COMPLETION 2024
8
Active studies
2
Recruiting
11
Late-stage (III+)
3
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 14
Early Phase 11Phase 22Phase 39Phase 42

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Comparative Clinical Effectiveness Trial of Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab and Eculizumab To Prevent Relapses in Neuromyelitis Optica Spectrum Disorder

Not yet recruitingPH IVMassachusetts General Hospitaln=5402030

SAkuraBonsai: Clinical, Imaging And Biomarker Open-Label Study In Neuromyelitis Optica Spectrum Disorder (NMOSD) With Satralizumab As An Intervention

TerminatedPH IVHoffmann-La Rochen=42023

A Phase III, Multicenter, Open-Label, Uncontrolled Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric Patients With AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)

RecruitingPH IIIHoffmann-La Rochen=82029

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Basket 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

Active, not recruitingPH IIIHoffmann-La Rochen=1222028

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab as Monotherapy or in Addition to Baseline Therapy in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD)

Active, not recruitingPH IIIHoffmann-La Rochen=1522028

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Multicenter, Single Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Satralizumab in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)

CompletedPH IIIHoffmann-La Rochen=1192024

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)

CompletedPH IIIHoffmann-La Rochen=952022

A Multicenter, Randomized, Addition to Baseline Treatment, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) in Patients With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)

CompletedPH IIIHoffmann-La Rochen=852021
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.