ENSPRYNG

(Satralizumab)

ApprovedMonoclonal antibody

Roche

ENSPRYNG is one of 248 small molecule programs targeting Autoimmune Encephalitis. It is currently in Approved.

Indications

Total Trials

Active Trials

247

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Autoimmune EncephalitisRecruiting

Neuromyelitis OpticaActive, not recruiting

EncephalitisActive, not recruiting

Myasthenia GravisActive, not recruiting

Pulmonary Arterial HypertensionActive, not recruiting

Duchenne Muscular DystrophyActive, not recruiting

Thyroid Eye DiseaseActive, not recruiting

Neuromyelitis Optica Spectrum DisorderRecruiting

NMOSDNot yet recruiting

Subarachnoid HemorrhageActive, not recruiting

Autoimmune EncephalitisPhase 3

Recruiting

Neuromyelitis OpticaPhase 3

Active, not recruiting

EncephalitisPhase 3

Active, not recruiting

Myasthenia GravisPhase 3

Active, not recruiting

Pulmonary Arterial HypertensionPhase 2

Active, not recruiting

Duchenne Muscular DystrophyPhase 2

Active, not recruiting

Thyroid Eye DiseasePhase 3

Active, not recruiting

Neuromyelitis Optica Spectrum DisorderPhase 3

Recruiting

NMOSDApproved

Not yet recruiting

Subarachnoid HemorrhagePhase 1

Active, not recruiting

Competition

Competitive Landscape

179 competitors in Pulmonary Arterial Hypertension

#DrugCompanyPhaseTrials

ENSPRYNG

Roche

Approved

1 2

Gleevec

Novartis

Phase 3

6 3

Reata

Biogen

Phase 3

1 4

Levitra

Bayer

Phase 3

1 5

Aurlumyn

BBTG International Inc.

Phase 3

8 6

Flolan

Johnson & Johnson

Phase 3

1 7

Zesly

MMezzion Pharma Co. Ltd

Phase 3

1 8

Atrovent

Inhaled Iloprost

1 10

Bayer Aspirin

Bayer

Phase 2

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

Timeline

Expected Milestones

Q2 2027

Not yet recruiting

NMOSD

NCT06829524

Q2 2028

Phase 2Recruiting

Duchenne Muscular Dystrophy

NCT06450639

Q4 2028

Phase 3Active, not recruiting

Autoimmune Encephalitis

NCT05503264

Phase 3Recruiting

Efficacy

NCT05271409

Q3 2029

Phase 3Recruiting

Neuromyelitis Optica Spectrum Disorder

NCT05199688

Clinical

Trials by Indication[1]

Neuromyelitis Optica4 trials

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

Terminated· Roche logo

Roche·Phase 4·NCT05269667·4 enrolled

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

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

Show 1 more trial

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

Thyroid Eye Disease2 trials

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease

Active, not recruiting· Roche logo

Roche·Phase 3·NCT06106828·127 enrolled

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease

Active, not recruiting· Roche logo

Roche·Phase 3·NCT05987423·131 enrolled

NMOSD2 trials

HANDLE-a Real World Study on Satralizumab in NMOSD

Not yet recruiting·HHuashan Hospital··NCT06829524·100 enrolled

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

Not yet recruiting·MMassachusetts General Hospital·Approved·NCT07010302·540 enrolled

Pulmonary Arterial Hypertension1 trial

Satralizumab in the Treatment of Pulmonary Arterial Hypertension (SATISFY-JP Trial)

Active, not recruiting·IInternational University of Health and Welfare·Phase 2·NCT05679570·20 enrolled

Duchenne Muscular Dystrophy1 trial

A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD)

Recruiting· Roche logo

Roche·Phase 2·NCT06450639·50 enrolled

5 more indications

Subarachnoid Hemorrhage1 trial

Satralizumab in Aneurysmal Subarachnoid Hemorrhage

Withdrawn·UUniversity of Florida·Phase 1·NCT05727657

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

Efficacy1 trial

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease

Recruiting· Roche logo

Roche·Phase 3·NCT05271409·152 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

Regulatory

FDA Approval Timeline[4]

Aug 14, 2020

ENSPRYNG

BLA BLA761149

Sources

References

[1]
ClinicalTrials.gov — 15 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

Q2 2027

Q2 2028

Q4 2028

Q3 2029

Trials by Indication[1]

Neuromyelitis Optica4 trials

Thyroid Eye Disease2 trials

NMOSD2 trials

Pulmonary Arterial Hypertension1 trial

Duchenne Muscular Dystrophy1 trial

Subarachnoid Hemorrhage1 trial

Myasthenia Gravis1 trial

Efficacy1 trial

Autoimmune Encephalitis1 trial

Neuromyelitis Optica Spectrum Disorder1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Related News