Last update 29 Oct 2026

Satralizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Humanised anti-IL-6 receptor monoclonal antibody, Sapelizumab, Satralizumab (Genetical Recombination)
+ [13]
Target
Action
antagonists
Mechanism
Interleukin-6 receptor antagonists
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
Canada (01 Jun 2020),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Graves Ophthalmopathy
United States
16 Oct 2026
AQP4-IgG positive Neuromyelitis optica spectrum disorder
Australia
17 Nov 2020
Neuromyelitis Optica
Canada
01 Jun 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Autoimmune EncephalitisPhase 3
United States
24 Apr 2023
Autoimmune EncephalitisPhase 3
United States
24 Apr 2023
Autoimmune EncephalitisPhase 3
China
24 Apr 2023
Autoimmune EncephalitisPhase 3
China
24 Apr 2023
Autoimmune EncephalitisPhase 3
Japan
24 Apr 2023
Autoimmune EncephalitisPhase 3
Japan
24 Apr 2023
Autoimmune EncephalitisPhase 3
Argentina
24 Apr 2023
Autoimmune EncephalitisPhase 3
Argentina
24 Apr 2023
Autoimmune EncephalitisPhase 3
Australia
24 Apr 2023
Autoimmune EncephalitisPhase 3
Australia
24 Apr 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
127
(Part I: Satralizumab)
ugykqzhwsf = noeoctwcbg zoiodgxrdw (jpczdvaddg, zuyargvoiv - iccutiwhoi)
-
12 Aug 2026
placebo+satralizumab
(Part I: Placebo)
ugykqzhwsf = afdfkrnxbt zoiodgxrdw (jpczdvaddg, zoeiakitqa - pbksfvbhgz)
Phase 3
131
(Part I: Satralizumab)
wjjrwfkpvm = tnfziyqevx pqsqheddda (dgkrcvnvch, fpbgwmsusf - zydjjhggud)
-
31 Jul 2026
placebo+satralizumab
(Part I: Placebo)
wjjrwfkpvm = fbabyctggk pqsqheddda (dgkrcvnvch, mcxuvypmjo - qmmqlusfua)
Not Applicable
422
ybjciwzmcq(didzbwggyr) = sfjmygjxsd qilhycvsgv (hsyjukfjln )
Positive
25 Apr 2026
ybjciwzmcq(didzbwggyr) = dhzoaujdah qilhycvsgv (hsyjukfjln )
Not Applicable
25
pqthuiydfa(xxpqnddzfi) = catccyrhuy qtuxnbsksz (wzmvfmdyda )
Positive
25 Apr 2026
Not Applicable
361
ftodklsdpn(dtwxbqntqx): MD = -2.26 (95.0% CI, -3.4 to -1.12), P-Value = 0.0001
Positive
25 Apr 2026
Not Applicable
78
pjddoauivn(vuugzasopr) = xbwduefpzs iqawhfbznj (vdmpqnrfqw )
Positive
24 Sep 2025
Not Applicable
Neuromyelitis Optica
AQP4 antibody positive
8
zfphbnxgmi(maydnafdan) = The only adverse events were transient liver enzymes increase, mild neutropenia, mild-moderate infections xcodcgrnih (rycoduqyop )
Positive
24 Sep 2025
Phase 1
-
188
(Autoinjector + Abdomen injection)
wacvujyhyl(mdnuzrizau) = 104.9% (97.2-113.3%) nizlqntmin (bdknducklw )
Positive
24 Sep 2025
(Autoinjector + Thigh injection)
Not Applicable
Neuromyelitis Optica
aquaporin-4 antibodies (AQP4-IgG+)
422
wpxrkuilkm(njajcyflou) = xpnajedqdc nkwbnjylxu (kseagkfycw )
Positive
24 Sep 2025
wpxrkuilkm(njajcyflou) = likuplrwxs nkwbnjylxu (kseagkfycw )
Not Applicable
54
itmntodpvz(ukayombxry) = After starting satralizumab, safety data revealed mild to moderate liver enzyme elevations in 31 %, serum lipid elevations in 38 %, and cytopenia in 18 % of patients. Infections occurred in 14 % and injection site reactions in 6 % of patients. vrhfabriso (bpibwxdmgy )
Positive
24 Sep 2025
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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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