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Drug

Siltuximab

Established medicine
ClassInterleukin-6 antagonistResearchOngoing clinical research

Also known as Sylvant.

RxNorm1535218ChEMBLCHEMBL1743070UNIIT4H8FMA7IM
8
Active clinical trials
Interleukin-6
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 2/3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Clinical trial2026-08-07Results expected Q4 2033 · ClinicalTrials.gov

A Prospective, Single-Arm, Single-Center, Phase II Clinical Trial of Siltuximab for Cytokine Release Syndrome and Immune Effector Cell-Associated Neurotoxicity After CAR-T Treatment in Multiple Myeloma

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

Pilot Safety-feasibility Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab

Clinical trial2026-06-25Results expected Q3 2028 · ClinicalTrials.gov

A Phase II Pilot Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) and Immune Effector Cell Associated Neurotoxicity (ICANS) Related to Chimeric Antigen Receptor T-Cell Therapy (CAR-T) in Hematological Malignancies

Clinical trial2026-06-03Results posted · ClinicalTrials.gov

Phase II Randomized Trial of Population PK Dosed Melphalan With Interleukin-6 Blockade With Siltuximab Vesrus BSA Based Melphalan in Patients With Multiple Myeloma Over Age 60 Undergoing Autologous Stem Cell Transplantation

Clinical trial2026-04-24Results expected Q4 2027 · ClinicalTrials.gov

Screening Trial for Pain Relief in Schwannomatosis (STARFISH)

Clinical trial2026-04-23Results expected Q4 2026 · ClinicalTrials.gov

Immune Checkpoint Inhibitor Rechallenge in Combination With Siltuximab Prophylaxis for Patients Who Had Prior Immune-Related Adverse Event (CIRES Trial)

Clinical trial2026-01-20Results expected Q4 2026 · ClinicalTrials.gov

A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation (Siltux-AMR)

Clinical trial2025-12-31Results expected Q4 2027 · ClinicalTrials.gov

Phase II Trial of Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to Treatment With Teclistamab in Relapsed or Refractory Multiple Myeloma (RRMM)

Clinical trial2025-12-01Withdrawn · ClinicalTrials.gov

Phase II Study of Interleukin 6 Blockade With Siltuximab to Decrease Symptom Burden in Patients Age 60-75 Undergoing Autologous Stem Cell Transplantation for Multiple Myeloma and AL Amyloidosis

Clinical trial2025-11-04Results expected Q4 2026 · ClinicalTrials.gov

A Phase Ib/II Trial of Siltuximab and Spartalizumab in Metastatic Pancreatic Cancer

Clinical trial2025-08-22Results posted · ClinicalTrials.gov

Accelerated approval: Sylvant (EMA)

Regulatory2014-05-22EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Siltuximab
Aliases & brands
Sylvant
RxNorm CUI
1535218
ChEMBL ID
CHEMBL1743070
UNII
T4H8FMA7IM
Primary mechanism
Interleukin-6 antagonist
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Interleukin-6
IL6 · P05231
ANTAGONISTInterleukin-6 antagonist

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2014-05-22
Latest approval
2014-05-22
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2014-05-22Accelerated approval
Accelerated approval: Sylvant (EMA)
Indication: Sylvant 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… Show full indication

Sylvant 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.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

31 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
31
registered trials across all phases
LATEST COMPLETION 2026
8
Active studies
7
Recruiting
3
Late-stage (III+)
13
Completed
10
Discontinued
PHASE DISTRIBUTIONn = 31
Early Phase 13Phase 16Phase 1 / 23Phase 216Phase 2 / 31Phase 32

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Phase 2/3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)

RecruitingPH II/IIIMerck Sharp & Dohme LLCn=3402033

A Prospective, Randomized, Factorial Design, Interventional Study to Compare the Safety and Efficacy of Combinations of Blockade of Interleukin-6 Pathway and Interleukin-1 Pathway to Best Standard of Care in Improving Oxygenation and Short- and Long-term Outcome of COVID-19 Patients With Acute Hypoxic Respiratory Failure and Systemic Cytokine Release Syndrome

CompletedPH IIIUniversity Hospital, Ghentn=3422021

A Study Comparing the Efficacy and Safety of Standard of Care With or Without Siltuximab in Selected Hospitalized Patients With Viral Acute Respiratory Distress Syndrome (SILVAR)

TerminatedPH IIIRECORDATI GROUPn=5552021

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase II Pilot Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) and Immune Effector Cell Associated Neurotoxicity (ICANS) Related to Chimeric Antigen Receptor T-Cell Therapy (CAR-T) in Hematological Malignancies

CompletedPH IIUniversity of Alabama at Birminghamn=242026

Phase I Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab

CompletedPH ITimothy Voorheesn=112024

A Phase Ib/II Trial of Siltuximab and Spartalizumab in Metastatic Pancreatic Cancer

CompletedPH I/IIEmory Universityn=352023

A Prospective, Randomized, Factorial Design, Interventional Study to Compare the Safety and Efficacy of Combinations of Blockade of Interleukin-6 Pathway and Interleukin-1 Pathway to Best Standard of Care in Improving Oxygenation and Short- and Long-term Outcome of COVID-19 Patients With Acute Hypoxic Respiratory Failure and Systemic Cytokine Release Syndrome

CompletedPH IIIUniversity Hospital, Ghentn=3422021

Phase 2, Randomized, Open-label Study to Compare Efficacy and Safety of Siltuximab vs. Corticosteroids in Hospitalized Patients With COVID19 Pneumonia

CompletedPH IIJudit Pich Martínezn=1632021

A Phase 2, Randomized, Double-blind, Placebo-controlled Study Comparing the Combination of CNTO 328 (Anti-IL-6 Monoclonal Antibody) and Velcade Versus Velcade Alone in Subjects With Relapsed or Refractory Multiple Myeloma

CompletedPH IIJanssen Research & Development, LLCn=3072019
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.