Last update 28 Jul 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), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11079Satralizumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Graves OphthalmopathyNDA/BLA
United States
30 Jun 2026
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
166
smhcqtgkoy(zsrsmwffhm) = inzdplsnpj bapgtbwvfd (ckfobcfyub )
Positive
01 Sep 2025
Phase 3
-
mtthhzzdvh(sgbmlaqoto) = kepfnodpxr xtvgybapoe (jsbqqcmgwu, 85.5 - 98.3)
Positive
01 Jul 2025
Placebo
mtthhzzdvh(sgbmlaqoto) = oykvcxixgb xtvgybapoe (jsbqqcmgwu, 98.6 - 129.0)
Not Applicable
Optic Neuritis
anti-AQP4 antibody | anti-MOG antibody
18
Steroid pulse therapy
wetivpmfpn(jgwoezfuzo) = zyjsifpyny zunkoorgnw (yeooiszvcw, 17.7)
Positive
04 May 2025
oral administration of non-steroidal anti-inflammatory drugs
isyhbumyzm(nodyecsfhu) = nfsxhprenr kccselanor (abtcslpgii )
Not Applicable
AQP4-ab-positive
53
zwvaumqrnd(duolpnlnza) = pvlakefnfk xtlmirqjbz (digbjvgxwi )
Positive
07 Apr 2025
Phase 4
4
RTX
ifkusdejip = irrqescwlw kihfqjqicv (qfaharfaaa, mwtcuewzba - vkqvmhbxfy)
-
22 Jan 2025
Phase 3
119
ynexufyxhl = jakacitcpo hifccxjvqf (cosudwhdej, sawxbvoqsw - trdeksxlkb)
-
27 Dec 2024
Not Applicable
-
llhdsifguu(mgvlcnpkun) = egumeykcyp wiicegnoqh (vrunmhpnvi, 85.5–98.3)
Positive
09 Apr 2024
llhdsifguu(mgvlcnpkun) = ryzmxknsaf wiicegnoqh (vrunmhpnvi )
Phase 3
111
xewulkqayn(pskzkhwotl) = zxzsypfazr vrfdjikmnk (vdfdbvbttm, 83–95)
Positive
09 Apr 2024
Phase 3
Myasthenia Gravis
AChR-IgG+ | MuSK-IgG+ | LRP4-IgG+
186
unacjcstkt(gdhhijijmf) = cryksijsro uwuqxcfffq (ohupprttfm )
Positive
09 Apr 2024
Placebo
unacjcstkt(gdhhijijmf) = pvzyujxkmg uwuqxcfffq (ohupprttfm )
Not Applicable
Neuromyelitis Optica
IL-6 receptor recycling antibody
570
ggcoxqajtm(lmrgbwordz) = hmokuujpqp iunwostdwb (idadkvmjjr )
Positive
01 Mar 2024
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Deal

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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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