Overview
Satralizumab is a recombinant humanized monoclonal antibody targeted against human interleukin-6 (IL-6) receptors, similar to tocilizumab, which is produced in Chinese hamster ovary cells and based on an IgG2 framework. Satralizumab is used in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune inflammatory disorder of the central nervous system (CNS) involving demyelinating lesions in the optic nerve, spinal cord, brainstem, and cerebrum. Some of the pro-inflammatory mechanisms involved in NMOSD are thought to be mediated, at least in part, by IL-6, including increased production of anti-aquaporin-4 (AQP4) autoantibodies and increased permeability of the blood-brain barrier, which allows for the passage of pro-inflammatory mediators into the CNS. Satralizumab is thought to exert its therapeutic benefits by blocking IL-6 receptors and, subsequently, these inflammatory responses. Enspryng®, a satralizumab formulation developed by Chugai Pharmaceutical and Roche, is uniquely formulated with "recycling antibody technology" whereby the association of satralizumab to IL-6 receptors occurs in a pH-dependent manner - this allows satralizumab to bind an IL-6 receptor until it reaches an endosome, after which the drug may dissociate from the receptor and move back into the plasma to act again. This novel mechanism effectively increases the duration of action of satralizumab, as it allows for single drug molecules to interact with multiple endogenous IL-6 receptors prior to elimination. Satralizumab was first approved for use in Canada in June 2020 for the treatment of AQP4 antibody-positive patients with NMOSD. It received subsequent approvals in Switzerland and Japan, and was approved for use by the FDA in August 2020, becoming the 3rd treatment to receive FDA approval for NMOSD (after eculizumab in June 2019 and inebilizumab in June 2020).
Indication
Satralizumab is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. In Canada, it is also used in adolescent patients for the same indication.
Associated Conditions
- Neuromyelitis Optica Spectrum Disorders
Research Report
Satralizumab (Enspryng): A Comprehensive Monograph on a Novel IL-6 Receptor Antagonist for Neuromyelitis Optica Spectrum Disorder
Executive Summary
Satralizumab, marketed under the brand name Enspryng, is a first-in-class, subcutaneously self-administered biologic therapy developed by Chugai Pharmaceutical, a subsidiary of Roche, for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD).[1] As a humanized monoclonal antibody, Satralizumab presents a highly targeted therapeutic approach, functioning as an interleukin-6 (IL-6) receptor antagonist. This mechanism directly addresses a key cytokine implicated in the complex pathophysiology of NMOSD.[3] The drug's approval by major global regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the European Commission, was predicated on the robust efficacy demonstrated in two pivotal Phase III clinical trials: SAkuraStar (monotherapy) and SAkuraSky (add-on to immunosuppressive therapy).[5][ These studies showed that Satralizumab significantly reduces the risk of relapse in patients who are seropositive for anti-aquaporin-4 (AQP4) antibodies.]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/06/08 | Phase 4 | Not yet recruiting | |||
2025/02/17 | N/A | Not yet recruiting | |||
2024/06/10 | Phase 2 | Recruiting | |||
2024/01/25 | Phase 2 | Active, not recruiting | |||
2023/10/30 | Phase 3 | Active, not recruiting | |||
2023/08/14 | Phase 3 | Active, not recruiting | |||
2023/02/14 | Early Phase 1 | Withdrawn | |||
2023/01/11 | Phase 2 | Active, not recruiting | |||
2022/08/16 | Phase 3 | Recruiting | |||
2022/03/09 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Genentech Inc. | 50242-007 | SUBCUTANEOUS | 120 mg in 1 mL | 7/12/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 6/24/2021 | ||
Authorised | 6/24/2021 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
ENSPRYNG SOLUTION FOR INJECTION IN PREFILLED SYRINGE 120MG/1ML | SIN16348P | INJECTION, SOLUTION | 120 mg/ml | 10/19/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
ENSPRYNG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 120MG/1ML | N/A | N/A | N/A | 12/16/2020 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
ENSPRYNG satralizumab 120 mg/1 mL solution for injection in pre-filled syringe | 326047 | Medicine | A | 11/17/2020 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
ENSPRYNG | Hoffmann-La Roche Limited | 02499681 | Solution - Subcutaneous | 120 MG / ML | 8/26/2020 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
ENSPRYNG 120 mg SOLUCION INYECTABLE EN JERINGA PRECARGADA | 1211559001 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Diagnóstico Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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