MedPath

Satralizumab

Generic Name
Satralizumab
Brand Names
Enspryng
Drug Type
Biotech
CAS Number
1535963-91-7
Unique Ingredient Identifier
YB18NF020M

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

Published: Aug 19, 2025

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.]

Continue reading the full research report

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

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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