SYLVANT (siltuximab)
SYLVANT is indicated for the treatment of Multicentric Castleman's Disease.
How SYLVANT Works
Siltuximab works by binding directly to human IL-6, a protein involved in normal physiologic processes such as immunoglobulin secretion. By binding to this cytokine, the drug prevents IL-6 from interacting with both soluble and membrane-bound IL-6 receptors. This blockade inhibits the signaling pathways that contribute to the clinical symptoms of multicentric Castleman's disease.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-04-23
- Patent Cliff
- 2021
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SYLVANT Approval History
What SYLVANT Treats
1 indicationsSYLVANT is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multicentric Castleman's Disease
SYLVANT Target & Pathway
ProTarget
A cytokine involved in inflammation and immune regulation. Elevated IL-6 drives inflammation in rheumatoid arthritis and is linked to cytokine release syndrome. Blocking IL-6 or its receptor reduces inflammatory responses in autoimmune conditions.
Clinical Trial Registry
23 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07570173 | 1045-005 MK-1045-005, 2025-522267-15-00 | Ph 2, Ph 3 | recruiting | A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005) |
| NCT06679829 | 24-207 | Ph 2 | recruiting | A Study of Melphalan With or Without Siltuximab in People With Multiple Myeloma Having an Autologous Stem Cell Transplant |
| NCT05684692 | 22-512 | Ph 2 | recruiting | Screening Trial for Pain Relief in Schwannomatosis (STARFISH) |
| NCT06470971 | OSU-23393 NCI-2024-04853 | Ph 2 | recruiting | Siltuximab for the Prevention of Severe Immune-Related Adverse Events During Immune Checkpoint Inhibitor Rechallenge in Patients With Advanced Cancer, CIRES Trial |
| NCT06990711 Siltux-AMR | SILTUX_AMR2025 7R61HL169189-02 | Ph 1 | recruiting | A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation |
| NCT03315026 | 17-365 | Ph 2 | active not recruiting | Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL Amyloidosis |
| NCT04975555 | IRB-300007103 | Ph 2 | active not recruiting | Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) and Immune Effector Cell Associated Neurotoxicity (ICANS) Related to CAR-T Cell Therapy |
| NCT04191421 results posted | IRB00105616 NCI-2018-01793, Winship4463-18 | Ph 1, Ph 2 | completed | Siltuximab and Spartalizumab in Patients With Metastatic Pancreatic Cancer |
| NCT07106671 | IIT2025006 | Ph 2 | recruiting | A Phase II Study of Siltuximab for CRS/ICANs After CAR-T in Multiple Myeloma |
| NCT06447376 | CASE1424 | Ph 1 | recruiting | Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab |
| NCT06352866 | CASE3A23 | Ph 2 | withdrawn | Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM |
| NCT05665725 | OSU-22031 NCI-2022-10248 | Ph 1 | completed | Siltuximab for the Prevention of CAR T Cell Related Cytokine Release Syndrome in Patients With CD19 Positive Non-Hodgkin Lymphoma |
| NCT04329650 | SILCOR-COVID-19 | Ph 2 | completed | Efficacy and Safety of Siltuximab vs. Corticosteroids in Hospitalized Patients With COVID-19 Pneumonia |
| NCT04330638 COV-AID results posted | COV-AID | Ph 3 | completed | Treatment of COVID-19 Patients With Anti-interleukin Drugs |
| NCT04838860 SISREMCAD | EUSA SYL 0002 | Ph 2 | terminated | Siltuximab In Siltuximab-RElapsed/REfractory Multicentric CAstleman Disease |
| NCT04616586 SILVAR | EUSA SYL 0004 | Ph 3 | terminated | SILtuximab in Viral ARds (SILVAR) Study |
| NCT01484275 results posted | CR100755 CNTO328SMM2001, 2011-001735-22 | Ph 2 | completed | A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma |
| NCT01400503 results posted | CR018469 CNTO328MCD2002, 2010-022837-27 | Ph 2 | completed | A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease |
| NCT01024036 results posted | CR016705 CNTO328MCD2001, 2009-012380-34 | Ph 2 | completed | A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease |
| NCT01531998 results posted | 2010-0073 NCI-2012-00218 | Ph 1, Ph 2 | completed | Lenalidomide/Bortezomib/Dexamethasone & CNTO 328 in Transplant Eligible Newly Diagnosed Multiple Myeloma (MM) |
| NCT01219010 | CR017452 CNTO328SMM1001 | Ph 1 | completed | A Study Evaluating the Effects of Siltuximab on the Heart in Patients With Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, or Indolent Multiple Myeloma |
| NCT01513317 results posted | CR100752 CNTO328MDS2001, 2011-000261-12 | Ph 2 | terminated | A Study Comparing Siltuximab Plus Best Supportive Care to Placebo Plus Best Supportive Care in Anemic Patients With International Prognostic Scoring System Low- or Intermediate-1-Risk Myelodysplastic Syndrome |
| NCT01309412 | CR017737 JPN-C0328-MM-101 | Ph 1 | terminated | A Phase 1 Study of CNTO 328 (Siltuximab) in Relapsed or Refractory Multiple Myeloma |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SYLVANT FDA Label Details
Indications & Usage
FDA Label (PDF)SYLVANT is indicated for the treatment of Multicentric Castleman's Disease.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment