CDEK
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siltuximab

Trade name: sylvant

mAbapprovedCOVID-19Orphan Drug FDA

Approved

Apr 23, 2014

Siltuximab (INN), sold under the brand name Sylvant, is used for the treatment of people with multicentric Castleman's disease. It is a chimeric monoclonal antibody that binds to interleukin-6. It is an interleukin-6 (IL-6) antagonist. — Wikipedia

Clinical trial activity

39 trials · 37 clinical orgs · 2 marketing orgs

Phase 1
17
Phase 2
27
Phase 3
3
Phase 4
0

Earliest trial started Aug 1, 2003 (NCT00265135)

Timeline

2000s

  1. Jan 1, 2003

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

  3. May 26, 2006

    Orphan Drug Designation

2010s

  1. Jan 1, 2011

    Earliest Phase 3 Sponsor(trial)

  2. Apr 23, 2014

    Johnson and Johnson — Earliest FDA Approval

  3. Apr 23, 2014

    Johnson and Johnson — Marketing Organization

  4. Apr 23, 2014

    Johnson and Johnson — NDA Organization

  5. Apr 23, 2014

    Jazz Pharmaceuticals — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedApr 23, 2014

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

First in class

Sources

Also known as

  • cclb8 monoclonal antibody
  • cllb8
  • cnto 328
  • cnto 328
  • cnto-328
  • cnto-328
  • cnto 328 monoclonal antibody
  • monoclonal antibody cnto328
  • monoclonal antibody cnto 328
  • monoclonal antibody cnto-328
  • siltuximab
  • siltuximab
  • siltuximab
  • siltuximab
  • siltuximab
  • siltuximab
  • siltuximab
  • siltuximab
  • siltuximab
  • siltuximab
  • sylvant
  • sylvant
  • sylvant
  • sylvant

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06990711Phase 1Sep 1, 2025National Heart, Lung, and Blood Institute (NHLBI), University of Utah, Washington University in St. Louis
NCT07106671Phase 2Aug 10, 2025China Academy of Chinese Medical Sciences
NCT06352866Phase 2Jan 1, 2025Case Western Reserve University
NCT06447376Phase 1Dec 1, 2024AbbVie, Case Western Reserve University, Genmab, Recordati, University of Rochester
NCT06679829Phase 2Nov 6, 2024Memorial Sloan-Kettering Cancer Center, Recordati
NCT06470971Phase 2Jul 31, 2024Ohio State University
NCT05684692Phase 2Aug 31, 2023Department of Defense, Harvard University, Recordati
NCT05697510Phase 1Mar 16, 2023University of Nantes
NCT05665725Phase 1Jan 1, 2023Ohio State University
NCT05316116Early Phase 1 (Phase 1)Mar 29, 2022EUSA, University of South Florida
NCT04975555Phase 2Nov 15, 2021University of Alabama, Birmingham
NCT04838860Phase 2Mar 31, 2021EUSA, Syneos Health
NCT04191421Phase 1/Phase 2 (Phase 2)Dec 1, 2020Emory University, EUSA, National Cancer Institute (NCI), National Institutes of Health (NIH), Novartis
NCT04616586Phase 3Nov 2, 2020EUSA, Syneos Health
NCT04330638Phase 3Apr 30, 2020Ghent University, Katholieke Universiteit Leuven
NCT04329650Phase 2Apr 15, 2020University of Barcelona
NCT03315026Phase 2Dec 14, 2017Janssen Pharmaceutica NV, Memorial Sloan-Kettering Cancer Center
NCT02805868Early Phase 1 (Phase 1)Jun 1, 2016National Cancer Institute (NCI), Northwestern University
NCT02796859Phase 1/Phase 2 (Phase 2)May 1, 2016Augusta University, Stanley Medical Research Institute
NCT02641522Early Phase 1 (Phase 1)Mar 1, 2016Benaroya Research Institute, Johnson and Johnson, Virginia Mason Medical Center
Showing 20 of 39 trials
Page 1 / 2

Organizations

Research & Development (37)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Johnson and JohnsonFor profit9822006
CentocorFor profit8832003
EUSAFor profit4232020
Janssen Pharmaceutica NVFor profit4022009
National Cancer Institute (NCI)Government4022006
RecordatiFor profit3022023
Case Western Reserve UniversityAcademic/Hospital2222024
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital2212017
Ohio State UniversityAcademic/Hospital2222023
Southwest Oncology GroupAcademic/Hospital2212006
Syneos HealthFor profit2022020
University of Southern CaliforniaAcademic/Hospital2012006
AbbVieFor profit1012024
Augusta UniversityAcademic/Hospital1112016
Benaroya Research InstituteAcademic/Hospital1112016
China Academy of Chinese Medical SciencesAcademic/Hospital1112025
Department of DefenseGovernment1012023
Emory UniversityAcademic/Hospital1112020
GenmabFor profit1012024
Ghent UniversityAcademic/Hospital1112020
37 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
Jazz PharmaceuticalsFor profitNDA2Apr 23, 2014
Johnson and JohnsonFor profitMKTGApr 23, 2014
Johnson and JohnsonFor profitNDAApr 23, 2014