Drugs / Siltuximab
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed idiopathic multicentric Castleman disease 2 milestones | |||||
| Filed | US (FDA) | — | idiopathic multicentric Castleman disease | 2013-09-03 | “Simultaneous Applications Submitted to FDA and EMA for Siltuximab for the Treatment of Multicentric Castleman Disease” jnj.com ↗ |
| Filed | EU (EMA) | — | idiopathic multicentric Castleman disease | 2013-09-03 | “Simultaneous Applications Submitted to FDA and EMA for Siltuximab for the Treatment of Multicentric Castleman Disease” jnj.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Sylvant | — | 2014-05-22 | europa.eu ↗ |
| Approved | US (FDA) | SYLVANT | — | 2014-04-23 | fda.gov ↗ |
Trials 36
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT05316116 | Feb 2023 → Oct 2024 | T-cell large granular lymphocyte leukemia | H. Lee Moffitt Cancer Center and Research Institute | Terminated | No outcome recorded |
| Phase 0 | NCT02805868 | Jun 2016 → Feb 2019 | acquired polycythemia vera, myelofibrosis, primary myelofibrosis, thrombocytopenia | Northwestern University | Withdrawn | No outcome recorded Stop: Business |
| Phase 0 | NCT02641522 | Mar 2016 → Mar 2017 | type 1 diabetes mellitus | Carla Greenbaum, MD | Completed | No outcome recorded |
| Phase 19 trials | ||||||
| Phase 1 | NCT06990711 | Nov 2025 → Dec 2027 expected | transplant rejection | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 1 | NCT06447376 | Jan 2025 → Sep 2028 expected | cytokine release syndrome, non-Hodgkin lymphoma | Taylor Brooks | Recruiting | No outcome recorded |
| Phase 1 | NCT05697510 | Mar 2023 → Jun 2025 | acute myeloid leukemia | Nantes University Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT05665725 | Jan → Sep 2023 | non-Hodgkin lymphoma | Timothy Voorhees | Completed | No outcome recorded |
| Phase 1 | NCT01309412 | Jan 2011 → Dec 2012 | plasma cell myeloma | Janssen Pharmaceutical K.K. | Terminated | No outcome recorded |
| Phase 1 | NCT01219010 | Oct 2010 → Jun 2012 | monoclonal gammopathy of uncertain significance, plasma cell myeloma | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02074800 | Jun 2008 → Jun 2009 | — | Centocor, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00401765 | Sep 2005 → Nov 2009 | prostate cancer | Centocor, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00412321 | May 2005 → Apr 2011 | Castleman disease, non-Hodgkin lymphoma, plasma cell myeloma | Centocor, Inc. | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT04191421 | Jan 2020 → Apr 2023 | pancreatic adenocarcinoma | Emory University | Completed | No outcome recorded |
| Phase 1/2 | NCT01531998 | May 2012 → May 2014 | plasma cell myeloma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT00841191 | Mar 2009 → Apr 2011 | colorectal neoplasm, head and neck neoplasm, lung neoplasm, ovarian neoplasm +1 | Centocor, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT00265135 | Aug 2003 → Feb 2006 | renal cell carcinoma | Centocor, Inc. | Completed | No outcome recorded |
| Phase 218 trials · 1 met primary · 3 missed | ||||||
| Phase 2 | NCT07106671 | Aug 2025 → Aug 2026 overdue | cytokine release syndrome, plasma cell myeloma | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase 2 | NCT06352866 | Jan → Apr 2025 | cytokine release syndrome, plasma cell myeloma | Jack Khouri, MD | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT06679829 | Nov 2024 → Nov 2027 expected | plasma cell myeloma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06470971 | Jul 2024 → Dec 2026 expected | cancer, hematopoietic and lymphoid system neoplasm | Yuanquan Yang | Recruiting | No outcome recorded |
| Phase 2 | NCT05684692 | Aug 2023 → Nov 2026 expected | chronic pain syndrome, schwannomatosis | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04975555 | Nov 2021 → Jan 2026 | acute lymphoblastic leukemia, cytokine release syndrome, plasma cell myeloma | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 2 | NCT04329650 | Apr 2020 → Feb 2021 | COVID-19 | Judit Pich Martínez | Completed | No outcome recorded |
| Phase 2 | NCT03315026 | Dec 2017 → Oct 2026 expected | AL amyloidosis, plasma cell myeloma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01484275 | Mar 2012 → May 2015 | smoldering plasma cell myeloma | Janssen Research & Development, LLC | Completed | Missed primary |
| Phase 2 | NCT01513317 | Nov 2011 → Sep 2012 | myelodysplastic syndrome | Janssen Research & Development, LLC | Terminated | Missed primary |
| Phase 2 | NCT01400503 | Apr 2011 → Mar 2017 | multicentric Castleman disease | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01024036 | Mar 2010 → Mar 2013 | multicentric Castleman disease | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 2 | NCT00911859 | Jun 2009 → Apr 2013 | plasma cell myeloma | Janssen Research & Development, LLC | Completed | Missed primary |
| Phase 2 | NCT00433446 | Apr 2007 → May 2009 | prostate cancer | SWOG Cancer Research Network | Completed | No outcome recorded |
| Phase 2 | NCT00401843 | Nov 2006 → Aug 2011 | plasma cell myeloma | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT00385827 | Nov 2006 → Nov 2008 | prostate cancer | Centocor, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT00402181 | Oct 2006 → Jul 2009 | plasma cell myeloma | Centocor, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00311545 | — | renal cell carcinoma | SWOG Cancer Research Network | Withdrawn | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT04616586 | Nov 2020 → Apr 2021 | adult acute respiratory distress syndrome, pneumonia | RECORDATI GROUP | Terminated | No outcome recorded |
| Phase 3 | NCT01266811 | Jul 2011 → Apr 2014 | plasma cell myeloma | Centocor, Inc. | Withdrawn | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 1/2 | NCT02796859 Comparator | May 2016 → Dec 2023 | schizophrenia | Brian Miller | Unknown | No outcome recorded |
| Phase 2 | NCT07709000 Background | Oct 2026 → Nov 2033 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Merck Sharp & Dohme LLC | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04838860 Comparator | Mar → Apr 2021 | idiopathic multicentric Castleman disease | RECORDATI GROUP | Terminated | No outcome recorded |
| Phase 2/3 | NCT07570173 Background | May 2026 → Oct 2033 expected | B-cell acute lymphoblastic leukemia | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT04330638 Comparator | Apr → Dec 2020 | COVID-19 | University Hospital, Ghent | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2021-12-02 | BeOne Medicines | Regulatory BeiGene and EUSA Pharma Announce NMPA Approval of SYLVANT® (Siltuximab for Injection) in China for Idiopathic Multicentric Castleman Disease beonemedicines.com ↗
“Today’s approval provides a new treatment for patients in China with this rare systemic disorder,” commented Xiaobin Wu, Ph.D., President, Chief Operating Officer, and General Manager of China at BeiGene. |
| 2014-06-05 | Janssen Research & Development, LLC | Regulatory European Commission Approves SYLVANT® (siltuximab) as a Treatment for Patients with Multicentric Castleman's Disease (MCD) jnj.com ↗
European Commission Approves SYLVANT® (siltuximab) as a Treatment for Patients with Multicentric Castleman's Disease (MCD) |
| 2014-04-23 | Janssen Research & Development, LLC | Regulatory SYLVANT® (siltuximab) Receives FDA Approval to Treat Multicentric Castleman's Disease (MCD) jnj.com ↗
Janssen Biotech, Inc. ["Janssen"] today announced the U.S. Food and Drug Administration (FDA) has approved SYLVANT™ (siltuximab) 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. |
| 2014-03-21 | Janssen Research & Development, LLC | Regulatory Siltuximab Receives CHMP Positive Opinion for use in the Treatment of Multicentric Castleman's Disease, a very Rare Blood Disorder jnj.com ↗
Siltuximab Receives CHMP Positive Opinion for use in the Treatment of Multicentric Castleman's Disease, a very Rare Blood Disorder |
| 2013-12-08 | Janssen Research & Development, LLC | Results Siltuximab Pivotal Trial Data Show Efficacy for Treatment of Patients with Multicentric Castleman's Disease jnj.com ↗
Janssen Research & Development, LLC ("Janssen") today announced positive results from a pivotal Phase 2 global registration study (MCD2001) suggesting siltuximab, an investigational compound, along with best supportive care (BSC), exhibited statistically significant efficacy and a tolerable safety profile compared with placebo and BSC in treating patients with the rare disorder Multicentric Castleman's Disease (MCD) who are HIV -negative and human herpes virus-8 (HHV-8)-negative. |
| 2013-09-03 | Janssen Research & Development, LLC | Regulatory Simultaneous Applications Submitted to FDA and EMA for Siltuximab for the Treatment of Multicentric Castleman Disease, a Rare Blood Disorder jnj.com ↗
Simultaneous Applications Submitted to FDA and EMA for Siltuximab for the Treatment of Multicentric Castleman Disease, a Rare Blood Disorder |
All press releases naming this drug 8 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 43 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | siltuximab | “Clinical and correlative results of SWOG S0354: a phase II trial of CNTO328 (siltuximab), a monoclonal antibody against interleukin-6, in chemotherapy-pretreated patients with...” PMID 20484019 ↗ May 201035“Siltuximab is a monoclonal antibody that blocks interleukin-6 (IL-6) from binding to its receptor, preventing it from acting.” NCT06447376 ↗ “A Safety, Efficacy and Pharmacokinetic Study of Siltuximab (CNTO 328) in Participants With Solid Tumors” NCT00841191 ↗ |
| Known as | CLLB8 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743070 ↗ |
| Known as | CNTO328 | “Clinical and correlative results of SWOG S0354: a phase II trial of CNTO328 (siltuximab), a monoclonal antibody against interleukin-6, in chemotherapy-pretreated patients with...” PMID 20484019 ↗ May 201010“A Safety, Efficacy and Pharmacokinetic Study of Siltuximab (CNTO 328) in Participants With Solid Tumors” NCT00841191 ↗ “This is a research study with an experimental drug called siltuximab (also known as CNTO 328).” NCT01219010 ↗ “This is a research study with an experimental drug called siltuximab (also known as CNTO 328).” NCT01266811 ↗ “A Phase 1 Study of CNTO 328 (Siltuximab) in Relapsed or Refractory Multiple Myeloma” NCT01309412 ↗ |
| Known as | Sylvant | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743070 ↗ |
| Action | Inhibit | “anti-IL-6 monoclonal antibody” NCT00265135 ↗ |
| Modality | Monoclonal antibody | “anti-IL-6 monoclonal antibody” NCT00265135 ↗ |
| Route | Intravenous | “4 intravenous infusions (IV)” NCT00265135 ↗ |
| Target | IL6 | “anti-IL-6 monoclonal antibody” NCT00265135 ↗ |