Last update 30 Mar 2025

Siltuximab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-interleukin-6 monoclonal antibody, Chimeric anti-interleukin-6 monoclonal antibody, Siltuximab (USAN/INN)
+ [6]
Target
Action
inhibitors
Mechanism
IL-6 inhibitors(Interleukin-6 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (23 Apr 2014),
RegulationOrphan Drug (United States), Orphan Drug (South Korea), Overseas New Drugs Urgently Needed in Clinical Settings (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D09669Siltuximab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multi-Centric Castleman's Disease
United States
23 Apr 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Castleman DiseaseNDA/BLA
China
-20 Jan 2021
PneumoniaPhase 3
United States
13 Nov 2020
Respiratory Distress Syndrome, AcutePhase 3
United States
13 Nov 2020
Refractory Multiple MyelomaPhase 3
United States
01 Jul 2011
Refractory Multiple MyelomaPhase 3
Australia
01 Jul 2011
Refractory Multiple MyelomaPhase 3
Belgium
01 Jul 2011
Refractory Multiple MyelomaPhase 3
Bulgaria
01 Jul 2011
Refractory Multiple MyelomaPhase 3
Canada
01 Jul 2011
Refractory Multiple MyelomaPhase 3
Czechia
01 Jul 2011
Refractory Multiple MyelomaPhase 3
India
01 Jul 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
-
pkkwlaeluy(ahfqgvdgsh) = yxxxgpiaqt qltwknyiir (duufioejzo )
Positive
05 Apr 2024
pkkwlaeluy(ahfqgvdgsh) = kdapniikoh qltwknyiir (duufioejzo )
Phase 1
11
cjtufvhmvx(apcymkicra) = gndqdrvktz zwvtacyqwc (oyyivtrehi )
Positive
01 Feb 2024
Not Applicable
-
qyvpbvywjv(gpetgckybb) = tklflmhlnd wqlsgijtbj (molqoccymw )
Positive
01 Feb 2024
Not Applicable
-
52
vmzbzfhdyd(bewhsbxwme) = fuliubqcrm nzvmeesypf (bmswawwobb )
-
11 Dec 2023
Not Applicable
40
meguqekcsf(yxjzqnnxje) = lvwnaqceur oyatovtqpa (cjtsnierdw, 59.7)
Positive
31 May 2023
Not Applicable
Cytokine Release Syndrome
Interleukin-6 (IL6) receptor | interleukin-1 (IL1)
-
uuujrviexj(kszejbkrvh) = aplczlweeb jmwvvyxmms (ydkvpeptmg )
-
23 Apr 2023
Phase 2
6
Siltuximab 11mg/kg
fithxdtrcs(krtrttitzq) = 1 pt who did not respond to siltuximab and received rescue tocilizumab for persistent CRS grade 2 required ICU transfer for ICANS grade 3 rahogneihq (gqhlwssgjd )
Positive
01 Feb 2023
Phase 2
79
ybidlhksge(zwchjmlslb) = evhrhwskst dvhqsympwj (rdzordskev )
-
12 May 2022
Placebo
ybidlhksge(zwchjmlslb) = rkxedzyyfc dvhqsympwj (rdzordskev, 13.6 - upper bound not reached)
Not Applicable
8
ngktiljwxy(gfxvqezojd) = mpticjdwqw tvzurtlqiz (tflvuekknm )
-
01 Jun 2021
Phase 2
60
ztwphffysa(elkzlbcofh) = wnmrjfwpbk sdrafdfavc (ouexaaooqa )
Positive
01 Mar 2020
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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