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Satralizumab | CAS No: 1535963-91-7 | GMP-certified suppliers
A medication that treats neuromyelitis optica spectrum disorder in anti-aquaporin-4 antibody-positive patients by targeting inflammatory pathways to reduce disease progression and relapse.
Therapeutic categories
Amino Acids, Peptides, and ProteinsAntibodiesAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic and Immunomodulating AgentsBlood Proteins
Generic name
Satralizumab
Molecule type
biotech
CAS number
1535963-91-7
DrugBank ID
DB15762
Approval status
Approved drug
ATC code
L04AC19
Primary indications
- 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
Product Snapshot
- Satralizumab is a subcutaneous injectable monoclonal antibody formulation
- It is primarily used for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 antibody positive
- Satralizumab is approved for use in Canada, the European Union, and the United States
Clinical Overview
Satralizumab (CAS number 1535963-91-7) is a recombinant humanized monoclonal antibody designed to target human interleukin-6 (IL-6) receptors. It is produced in Chinese hamster ovary cells and structured on an IgG2 framework. Satralizumab is primarily indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who test positive for anti-aquaporin-4 (AQP4) antibodies. In Canada, this indication extends to adolescent patients as well. NMOSD is a rare autoimmune condition characterized by inflammatory demyelination within the central nervous system, affecting the optic nerves, spinal cord, brainstem, and cerebrum.
The pathophysiology of NMOSD involves IL-6, a pro-inflammatory cytokine that contributes to disease progression through multiple mechanisms. IL-6 promotes the differentiation of T cells into pro-inflammatory TH17 subsets and drives B-cell maturation into plasmablasts that produce pathogenic AQP4 autoantibodies. Additionally, IL-6 increases blood-brain barrier permeability, facilitating entry of autoantibodies and inflammatory mediators into the CNS. Satralizumab inhibits these processes by binding both soluble and membrane-bound IL-6 receptors, thereby blocking IL-6-mediated signaling cascades.
Satralizumab’s pharmacodynamics are distinguished by a proprietary "recycling antibody technology." This mechanism enables satralizumab to engage IL-6 receptors in a pH-dependent manner, allowing dissociation within acidic endosomal compartments and recycling of the antibody back into systemic circulation. This recycling extends the drug’s duration of action by enabling a single antibody molecule to repeatedly bind multiple IL-6 receptors before elimination.
Clinically approved since 2020 in multiple regions including Canada, Japan, Switzerland, and the United States, satralizumab represents an additional treatment option for NMOSD alongside agents such as eculizumab and inebilizumab. Safety considerations include increased susceptibility to infections, including serious and potentially fatal cases. Satralizumab is contraindicated in patients with active infections such as hepatitis B or tuberculosis and should not be initiated until active infections resolve.
From a pharmaceutical sourcing perspective, satralizumab production involves complex recombinant expression systems requiring stringent quality controls to ensure monoclonal antibody integrity, biological activity, and contaminant exclusion. Procurement of API for satralizumab necessitates robust supplier qualification and compliance with relevant international regulatory standards for biopharmaceutical proteins.
The pathophysiology of NMOSD involves IL-6, a pro-inflammatory cytokine that contributes to disease progression through multiple mechanisms. IL-6 promotes the differentiation of T cells into pro-inflammatory TH17 subsets and drives B-cell maturation into plasmablasts that produce pathogenic AQP4 autoantibodies. Additionally, IL-6 increases blood-brain barrier permeability, facilitating entry of autoantibodies and inflammatory mediators into the CNS. Satralizumab inhibits these processes by binding both soluble and membrane-bound IL-6 receptors, thereby blocking IL-6-mediated signaling cascades.
Satralizumab’s pharmacodynamics are distinguished by a proprietary "recycling antibody technology." This mechanism enables satralizumab to engage IL-6 receptors in a pH-dependent manner, allowing dissociation within acidic endosomal compartments and recycling of the antibody back into systemic circulation. This recycling extends the drug’s duration of action by enabling a single antibody molecule to repeatedly bind multiple IL-6 receptors before elimination.
Clinically approved since 2020 in multiple regions including Canada, Japan, Switzerland, and the United States, satralizumab represents an additional treatment option for NMOSD alongside agents such as eculizumab and inebilizumab. Safety considerations include increased susceptibility to infections, including serious and potentially fatal cases. Satralizumab is contraindicated in patients with active infections such as hepatitis B or tuberculosis and should not be initiated until active infections resolve.
From a pharmaceutical sourcing perspective, satralizumab production involves complex recombinant expression systems requiring stringent quality controls to ensure monoclonal antibody integrity, biological activity, and contaminant exclusion. Procurement of API for satralizumab necessitates robust supplier qualification and compliance with relevant international regulatory standards for biopharmaceutical proteins.
Identification & chemistry
| Generic name | Satralizumab |
|---|---|
| Molecule type | Biotech |
| CAS | 1535963-91-7 |
| UNII | YB18NF020M |
| DrugBank ID | DB15762 |
Pharmacology
| Summary | Satralizumab is a humanized monoclonal antibody that selectively binds to soluble and membrane-bound interleukin-6 receptor alpha (IL-6Rα), inhibiting IL-6 mediated pro-inflammatory signaling. This blockade reduces the differentiation of pro-inflammatory TH17 cells and plasmablasts producing pathogenic AQP4 autoantibodies implicated in neuromyelitis optica spectrum disorder (NMOSD). The drug employs a pH-dependent recycling mechanism to extend target receptor engagement and sustain its immunomodulatory effects. |
|---|---|
| Mechanism of action | Interleukin-6 (IL-6) is a pro-inflammatory cytokine which has been implicated in the pathogenesis of NMOSD. The inflammatory cascade triggered by IL-6 signaling is thought to result in the differentiation of T-cells into pro-inflammatory TH17 cells and the differentiation of B-cells into plasmablasts producing AQP4 autoantibodies. IL-6 may also play a role in increasing the permeability of the blood-brain barrier, thereby allowing penetration of autoantibodies and pro-inflammatory mediators into the central nervous system. Satralizumab is a humanized monoclonal antibody targeted against human IL-6 receptors. It binds to soluble and membrane-bound IL-6 receptors and prevents the signaling cascade, and subsequent pro-inflammatory effects, associated with its binding to endogenous IL-6. |
| Pharmacodynamics | Enspryng®, a satralizumab formulation developed by Chugai Pharmaceutical and Roche, utilizes a novel "recycling antibody technology" whereby the association of satralizumab to IL-6 receptors occurs in a pH-dependent manner. Satralizumab-bound IL-6 receptors are taken up into cells and transported into endosomes, a relatively acidic environment in comparison to plasma (pH 5.5-6.0 vs. pH 7.4) - this decrease in pH allows satralizumab to dissociate from the IL-6 receptor and be recycled back into the plasma, where it can bind to another IL-6 receptor and repeat the process. Satralizumab has been associated with an increased risk of infection, including serious and potentially fatal infections. It should not be administered to patients with active infections, including localized infections, until the infection resolves, and is contraindicated for use in patients with active hepatitis B or tuberculosis. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Interleukin-6 receptor subunit alpha | Humans | binder, antibody |
ADME / PK
| Absorption | The C<sub>max</sub> and AUC at steady-state, achieved after an 8-week loading period, were approximately 31.5 mcg/mL and 737 mcg.mL/day, respectively. Average C<sub>trough</sub> concentrations were approximately 19 mcg/mL. The bioavailability of satralizumab following subcutaneous injection has been reported to be between 78.5% and 85%. |
|---|---|
| Half-life | The terminal half-life of satralizumab is approximately 30 days (range 22-37 days). |
| Metabolism | While the metabolism of satralizumab has not been studied directly, monoclonal antibodies as a class are principally cleared by catabolism. |
| Route of elimination | Monoclonal antibodies are typically eliminated via uptake into cells and subsequent catabolism via lysosomal degradation. Due to their large size, they are only eliminated renally under pathologic conditions. |
| Volume of distribution | Satralizumab is subject to biphasic distribution - the estimated volume of distribution for the central and peripheral compartments are 3.46 L and 2.07 L, respectively. |
| Clearance | The total clearance of satralizumab is concentration-dependent and is estimated to be 0.0601-0.0679 L/day. The inter-compartmental clearance was 0.336 L/day. |
Formulation & handling
- Satralizumab is a biotechnology-derived peptide administered exclusively via subcutaneous injection.
- The API is supplied as a liquid solution, necessitating appropriate cold chain storage to maintain stability.
- Due to its biologic nature, handling should minimize agitation and exposure to extreme temperatures to preserve efficacy.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient's primary patents have expired across Canada, the EU, and the US, allowing for generic market entry and indicating a mature market phase in these regions. Ongoing regulatory approvals continue to support product availability. |
|---|
| Markets | Canada, EU, US |
|---|
Supply Chain
| Supply chain summary | Satralizumab is marketed under the brand name Enspryng and is available in Canada, the EU, and the US, indicating a global presence across major pharmaceutical markets. The product is originated by a limited number of originator companies specializing in biologic therapies. Given that satralizumab is a relatively recent biologic treatment, patent protections are likely still in place, suggesting limited or no generic competition at this time. |
|---|
Safety
| Toxicity | There is no data regarding overdose of satralizumab. No serious adverse effects were noted in healthy adults receiving a single dose of 240mg subcutaneously in clinical trials. Patients experiencing a suspected overdose should be treated with symptomatic and supportive measures as clinically indicated. |
|---|
High Level Warnings:
- No specific overdose data available
- Handle with standard laboratory safety protocols to avoid unintended exposure
- Clinical administration at single doses up to 240 mg subcutaneously showed no serious adverse effects in healthy adults
Satralizumab is a type of Anticancer drugs
Anticancer drugs belong to the pharmaceutical API (Active Pharmaceutical Ingredient) category designed specifically to combat cancer cells. These powerful medications play a crucial role in cancer treatment and are developed to target and destroy cancerous cells, preventing their growth and spread.
Anticancer drugs are classified based on their mode of action and can include various types such as chemotherapy drugs, targeted therapy drugs, immunotherapy drugs, and hormonal therapy drugs. Chemotherapy drugs work by interfering with the cell division process, thereby inhibiting the growth of cancer cells. Targeted therapy drugs, on the other hand, are designed to attack specific molecules or genes involved in cancer growth, minimizing damage to healthy cells. Immunotherapy drugs stimulate the body's immune system to recognize and destroy cancer cells. Hormonal therapy drugs are used in cancers that are hormone-dependent, such as breast or prostate cancer, to block the hormones that fuel cancer cell growth.
These APIs are typically synthesized through complex chemical processes in state-of-the-art manufacturing facilities. Stringent quality control measures ensure the purity, potency, and safety of these drugs. Anticancer APIs undergo rigorous testing and adhere to stringent regulatory guidelines before being approved for clinical use.
Due to their critical role in cancer treatment, anticancer drugs are in high demand worldwide. Researchers and pharmaceutical companies continually strive to develop new and more effective APIs in this category to enhance treatment outcomes and minimize side effects. The ongoing advancements in the field of anticancer drug development offer hope for improved cancer therapies and better patient outcomes.
