MedPath

Siltuximab

Generic Name
Siltuximab
Brand Names
Sylvant
Drug Type
Biotech
CAS Number
541502-14-1
Unique Ingredient Identifier
T4H8FMA7IM

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Withdrawn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

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
SYLVANT
recordati rare diseases canada inc
02435128
Powder For Solution - Intravenous
100 MG / VIAL
3/3/2015
SYLVANT
recordati rare diseases canada inc
02435136
Powder For Solution - Intravenous
400 MG / VIAL
3/3/2015

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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