ENSPRYNG (satralizumab)
ENSPRYNG is indicated for the treatment of Neuromyelitis Optica Spectrum Disorder.
How ENSPRYNG Works
Satralizumab-mwge functions by binding to both soluble and membrane-bound interleukin-6 (IL-6) receptors. This action is presumed to inhibit IL-6-mediated signaling, which is the biological pathway through which the drug exerts its therapeutic effects. While the precise mechanism in NMOSD is unknown, the drug acts as an antagonist to block these specific receptors.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-08-14
- Patent Cliff
- 2027
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ENSPRYNG Approval History
What ENSPRYNG Treats
1 indicationsENSPRYNG is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Neuromyelitis Optica Spectrum Disorder
ENSPRYNG Target & Pathway
ProTarget
A cytokine involved in inflammation and immune regulation. Elevated IL-6 drives inflammation in rheumatoid arthritis and is linked to cytokine release syndrome. Blocking IL-6 or its receptor reduces inflammatory responses in autoimmune conditions.
ENSPRYNG Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05199688 SAkuraSun | WN41733 2019-004092-39, 2023-507817-85-00 | Ph 3 | recruiting | 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) |
| NCT05271409 Meteoroid | WN43194 2021-003192-34, 2023-507196-22-00 | Ph 3 | recruiting | A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease |
| NCT05987423 SatraGO-1 | GP44467 2023-503309-13-00 | Ph 3 | active not recruiting | Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease |
| NCT05503264 Cielo | WN43174 2021-002395-39, 2023-504226-18-00 | Ph 3 | recruiting | 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 |
| NCT06450639 SHIELD DMD | BN45398 2024-512383-65-00 | Ph 2 | active not recruiting | A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD) |
| NCT07010302 BEST-NMOSD | 40200 | Ph 4 | not yet recruiting | Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD |
| NCT06106828 SatraGO-2 | GP44729 2023-503669-50-00 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease |
| NCT04963270 results posted | WN42636 | Ph 3 | terminated | A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis |
| NCT04660539 results posted | WN42349 2020-003413-35 | Ph 3 | completed | A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD) |
| NCT02028884 results posted | BN40898 2013-003752-21, SA-307JG | Ph 3 | completed | Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) |
| NCT02073279 results posted | BN40900 SA-309JG, 2015-005431-41 | Ph 3 | completed | Efficacy and Safety Study of Satralizumab (SA237) as Monotherapy to Treat Participants With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ENSPRYNG FDA Label Details
Indications & Usage
FDA Label (PDF)ENSPRYNG is indicated for the treatment of Neuromyelitis Optica Spectrum Disorder.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment