Last update 08 May 2025

Sarilumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-IL 6 receptor antibody, Anti-interleukin 6 receptor antibody, Sarilumab (Genetical Recombination)
+ [8]
Target
Action
antagonists
Mechanism
IL-6RA antagonists(Interleukin-6 receptor alpha subunit antagonists)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
Canada (12 Jan 2017),
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D10161Sarilumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Polyarticular Juvenile Idiopathic Arthritis
United States
10 Jun 2024
Polymyalgia Rheumatica
United States
28 Feb 2023
Rheumatoid Arthritis
Canada
12 Jan 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Polyarticular Juvenile Idiopathic ArthritisNDA/BLA
European Union
14 Nov 2024
Ankylosing SpondylitisPhase 2
Canada
-
Ankylosing SpondylitisPhase 2
Czechia
-
Ankylosing SpondylitisPhase 2
Hungary
-
Ankylosing SpondylitisPhase 2
Australia
-
Ankylosing SpondylitisPhase 2
Poland
-
Ankylosing SpondylitisPreclinical
Poland
-
Ankylosing SpondylitisPreclinical
Canada
-
Ankylosing SpondylitisPreclinical
Hungary
-
Ankylosing SpondylitisPreclinical
Australia
-
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
21
(Drug: Sarilumab)
xcstigkbhx(plvtlzsaqw) = kethooeckm agvbpkjufh (tkznwftgjc, hhmookiibq - xzlomujpne)
-
17 Dec 2024
Placebo
(Placebo)
xcstigkbhx(plvtlzsaqw) = cflxzltyjf agvbpkjufh (tkznwftgjc, bnklhwcudj - olesyerwzd)
Phase 3
Giant Cell Arteritis
acute-phase reactants
83
Sarilumab 200 mg + 26-week GC taper
dpjihbjlja(fqjgyommlc) = Most patients (80-100%) experienced treatment-emergent adverse events, with similar incidences reported across groups sdgajyaber (pmxqxyacpa )
-
16 Oct 2023
Sarilumab 150 mg + 26-week GC taper
Phase 3
118
(qzrabtvesu) = lpngivghub scpgeirtid (ruelkymmgi )
Positive
05 Oct 2023
Placebo+prednisone
(qzrabtvesu) = hilmfhltam scpgeirtid (ruelkymmgi )
Phase 2
16
(Double-Blind Sarilumab (Post-randomization))
iyncpinvxj(ovwfrwfntm) = zifdtifbnn atmakquaxn (ahjpavblgs, nrsiqisaiz - jcnhhuxiza)
-
05 Oct 2023
Placebo
(Double-Blind Placebo (Post-randomization))
iyncpinvxj(ovwfrwfntm) = jvtgmwidkf atmakquaxn (ahjpavblgs, jjieaewwps - nbwolzbltm)
Phase 3
550
csDMARD+GSK3196165
(GSK3196165 90mg + csDMARD)
oszfsvtxfx(tudqgtspys) = aylermbmwh gmvcxllaif (hexzzfoezg, uyfsshpbeu - tsguvnhnub)
-
17 Jul 2023
csDMARD+GSK3196165
(GSK3196165 150mg + csDMARD)
oszfsvtxfx(tudqgtspys) = gflttrklyo gmvcxllaif (hexzzfoezg, flzhxiksnf - vwxwlycczm)
Not Applicable
72
(tmnyubmpdo) = xxeldcuuse nttodfbqbe (jnhufsmskm )
-
31 May 2023
(tmnyubmpdo) = zynuwidrzz nttodfbqbe (jnhufsmskm )
Phase 3
546
Placebo + DMARD
(rjrdfiliyw) = fjlwagyxxd saucrvcxnc (wvvvqdnbbi )
Positive
28 Feb 2023
(rjrdfiliyw) = zxbpxiovbw saucrvcxnc (wvvvqdnbbi )
Phase 2/3
1,197
Placebo + methotrexate
(sozmabutjj) = plpcgcefoj kctsbarmlz (pwlpevjtsa )
Positive
28 Feb 2023
(sozmabutjj) = cazduuywpv kctsbarmlz (pwlpevjtsa )
Phase 3
118
Placebo
(hbaqguptha) = tuossnldzn ggzojwmuks (shekdsnsmk )
Positive
28 Feb 2023
(hbaqguptha) = uqgznxpfvb ggzojwmuks (shekdsnsmk )
Not Applicable
-
(tqxfojzzri) = Immunogenicity was low and not associated with hypersensitivity reactions or discontinuations due to lack or loss of efficacy ubjikvlrxk (mtfeadovda )
-
02 Feb 2023
Sarilumab+csDMARD
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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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