ENSPRYNG

(Satralizumab)

ApprovedMonoclonal antibody

Roche

ENSPRYNG is one of 42 small molecule programs targeting Autoimmune Encephalitis. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Autoimmune EncephalitisActive, not recruiting

Duchenne Muscular DystrophyActive, not recruiting

Neuromyelitis Optica Spectrum DisorderRecruiting

Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)Active, not recruiting

NMOSDNot yet recruiting

Autoimmune EncephalitisPhase 3

Active, not recruiting

Duchenne Muscular DystrophyPhase 2

Active, not recruiting

Neuromyelitis Optica Spectrum DisorderPhase 3

Recruiting

Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)Phase 3

Active, not recruiting

NMOSDApproved

Not yet recruiting

Competition

Competitive Landscape

40 competitors in Duchenne Muscular Dystrophy

#DrugCompanyPhaseTrials

Isordil

AstraZeneca

Approved

—2

Deltasone

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

2 3

ENSPRYNG

Roche

Approved

1 4

Coreg

Akero Therapeutics

Approved

1 5

Rapamune

PPrism Pharmaceuticals

Approved

1 6

Garamycin

Advil

Rifadin

1 9

Duvyzat

Italfarmaco

Phase 3

2 10

Vyondys 53

Sarepta Therapeutics

Approved

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Duchenne Muscular Dystrophy

NCT06450639

Q2 2027

Recruiting

Neuromyelitis Optica Spectrum Disorders (NMOSD)

NCT06829524

Q1 2028

Recruiting

Neuromyelitis Optica Spectrum Disorders (NMOSD)

NCT07762872

Q2 2028

Phase 3Active, not recruiting

Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

NCT05271409

Clinical

Trials by Indication[1]

Neuromyelitis Optica4 trials

Efficacy and Safety Study of Satralizumab (SA237) as Monotherapy to Treat Participants With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)

Completed· Roche logo

Roche·Phase 3·NCT02073279·95 enrolled

A Study In Neuromyelitis Optica Spectrum Disorder (NMOSD) With Satralizumab As An Intervention

Terminated· Roche logo

Roche·Phase 4·NCT05269667·4 enrolled

A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)

Completed· Roche logo

Roche·Phase 3·NCT04660539·119 enrolled

Show 1 more trial

Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)

Completed· Roche logo

Roche·Phase 3·NCT02028884·85 enrolled

Neuromyelitis Optica Spectrum Disorders (NMOSD)2 trials

A Real-World Practical Model of Integrated Management for Chinese Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD) on Satralizumab

Recruiting·HHuashan Hospital··NCT06829524·100 enrolled

Real-World Effectiveness and Safety of Satralizumab in the Early Treatment of Attacks in Neuromyelitis Optica Spectrum Disorder: A Multicenter Prospective Cohort Study

Recruiting·JJunwei Hao, MD··NCT07762872·50 enrolled

Thyroid Eye Disease2 trials

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

Completed· Roche logo

Roche·Phase 3·NCT06106828·127 enrolled

Completed· Roche logo

Roche·Phase 3·NCT05987423·131 enrolled

Myasthenia Gravis1 trial

A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis

Terminated· Roche logo

Roche·Phase 3·NCT04963270·188 enrolled

Subarachnoid Hemorrhage1 trial

Satralizumab in Aneurysmal Subarachnoid Hemorrhage

Withdrawn·UUniversity of Florida·Phase 1·NCT05727657

6 more indications

Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD)1 trial

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 recruiting· Roche logo

Roche·Phase 3·NCT05271409·139 enrolled

Autoimmune Encephalitis1 trial

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 recruiting· Roche logo

Roche·Phase 3·NCT05503264·122 enrolled

Neuromyelitis Optica Spectrum Disorder1 trial

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)

Recruiting· Roche logo

Roche·Phase 3·NCT05199688·8 enrolled

NMOSD1 trial

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

Recruiting·MMassachusetts General Hospital·Approved·NCT07010302·540 enrolled

Duchenne Muscular Dystrophy1 trial

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)

Active, not recruiting· Roche logo

Roche·Phase 2·NCT06450639·30 enrolled

Pulmonary Arterial Hypertension1 trial

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

Completed·IInternational University of Health and Welfare·Phase 2·NCT05679570·20 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 14, 2020

ENSPRYNG

BLA BLA761149

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for Satralizumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Satralizumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Satralizumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761149). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Approved[1]
Company: Roche

ENSPRYNG

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q1 2028

Q2 2028

Trials by Indication[1]

Neuromyelitis Optica4 trials

Neuromyelitis Optica Spectrum Disorders (NMOSD)2 trials

Thyroid Eye Disease2 trials

Myasthenia Gravis1 trial

Subarachnoid Hemorrhage1 trial

Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD)1 trial

Autoimmune Encephalitis1 trial

Neuromyelitis Optica Spectrum Disorder1 trial

NMOSD1 trial

Duchenne Muscular Dystrophy1 trial

Pulmonary Arterial Hypertension1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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