Overview
Siltuximab is a chimeric (human-mouse) monoclonal immunoglobulin G1-kappa antibody produced in a Chinese hamster ovary (CHO) cell line by recombinant DNA technology. Siltuximab prevents the binding of IL-6 to soluble and membrane-bound IL-6 receptors by forming high affinity complexes with human interleukin-6 (IL-6). Its use is indicated for the treatment of adult patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. MCD is a rare blood disorder caused by dysregulated IL-6 production, proliferation of lymphocytes, and subsequent enlargement of the lymph nodes. It is administered as a 1 hour intravenous infusion every 3 weeks.
Indication
Siltuximab is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Siltuximab did not bind to virally produced IL-6 in a nonclinical study and was therefore not studied in patients with MCD who are HIV or HHV-8 positive.
Associated Conditions
- Castleman Disease
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/05/25 | Phase 1 | Not yet recruiting | |||
2024/11/08 | Phase 2 | Recruiting | |||
2024/06/24 | Phase 2 | Recruiting | Yuanquan Yang | ||
2024/06/07 | Phase 1 | Recruiting | Taylor Brooks | ||
2024/04/08 | Phase 2 | Withdrawn | Jack Khouri, MD | ||
2023/01/26 | Phase 1 | Recruiting | |||
2023/01/13 | Phase 2 | Recruiting | |||
2022/12/27 | Phase 1 | Completed | Timothy Voorhees | ||
2022/04/07 | Early Phase 1 | Active, not recruiting | |||
2021/07/23 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
EUSA Pharma (UK) Ltd | 73090-420 | INTRAVENOUS | 100 mg in 1 1 | 2/21/2024 | |
EUSA Pharma (UK) Ltd | 73090-421 | INTRAVENOUS | 400 mg in 1 1 | 2/21/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 5/22/2014 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
SYLVANT POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL | SIN14762P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100mg/vial | 3/23/2015 | |
SYLVANT POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 400MG/VIAL | SIN14763P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 400mg/vial | 3/23/2015 |
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 |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
SYLVANT siltuximab (rmc) 400mg powder for injection vial | 229997 | Medicine | A | 8/31/2015 | |
SYLVANT siltuximab (rmc) 100mg powder for injection vial | 229996 | Medicine | A | 8/31/2015 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
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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