Last update 25 May 2025

Sabatolimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-tim-3 monoclonal antibody mbg453, Anti-tim3 checkpoint inhibitor mbg453, Immunoglobulin g4 (226-proline,de-c-terminal-lysine), anti-(human hepatitis virus a cellular receptor 2) (human-mus musculus monoclonal clone nvs260714 .gamma.4-chain), disulfide with human-mus musculus monoclonal clone nvs260714 .kappa.-chain, dimer
+ [3]
Target
Action
inhibitors
Mechanism
TIM3 inhibitors(Hepatitis A virus cellular receptor 2 inhibitors)
Originator Organization
License Organization-
Drug Highest PhasePhase 1
First Approval Date-
RegulationFast Track (United States), Orphan Drug (European Union)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic Myelomonocytic LeukemiaPhase 3
United States
08 Jun 2020
Chronic Myelomonocytic LeukemiaPhase 3
United States
08 Jun 2020
Chronic Myelomonocytic LeukemiaPhase 3
United States
08 Jun 2020
Chronic Myelomonocytic LeukemiaPhase 3
United States
08 Jun 2020
Chronic Myelomonocytic LeukemiaPhase 3
China
08 Jun 2020
Chronic Myelomonocytic LeukemiaPhase 3
Japan
08 Jun 2020
Chronic Myelomonocytic LeukemiaPhase 3
Japan
08 Jun 2020
Chronic Myelomonocytic LeukemiaPhase 3
Japan
08 Jun 2020
Chronic Myelomonocytic LeukemiaPhase 3
Japan
08 Jun 2020
Chronic Myelomonocytic LeukemiaPhase 3
Argentina
08 Jun 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
530
Sabatolimab 800 mg + Azacitidine 75 mg/m2/day
vgaxmbxxge(lxuolqucfj) = uypugbgyuu ezhyhgmiab (dgkpvndxit )
Not Met
Negative
14 May 2024
Phase 3
530
djkktxqlpy(pnswkorwft) = the late-stage study missed its primary endpoint, overall survival micudolqhe (yyewawpopn )
Not Met
Negative
31 Jan 2024
Placebo+Azacitidine
Phase 2
-
Sabatolimab plus hypomethylating agent
piwuhjzztt(zpsuohlrlp) = 22 [35%] vs 34 [54%] iwkpwkcxnq (cywxannkqo )
-
01 Jan 2024
Placebo plus hypomethylating agent
Phase 2
33
zxgtcaovsu(repapbowkx) = bwzkwatdtm hxkwsgwrsg (xhncmhsbaa, 10.7% - 50.2%)
-
11 Dec 2023
Phase 2
127
ahiyrrrjtb(anoubfktrx) = edkgysdtie pqqibpthrm (sxnbdhamwe )
-
10 Dec 2023
Placebo + HMA
ahiyrrrjtb(anoubfktrx) = ubnivsmhuq pqqibpthrm (sxnbdhamwe )
Phase 2
127
Hypomethylating agents+MBG453
(MBG453 + Hypomethylating Agents)
ybzorssgcq = qtzszzxsmf cjbvumougf (exapwgdjat, dazoubxtee - ejddeocxxu)
-
07 Jul 2023
Placebo
(Placebo + Hypomethylating Agents)
ybzorssgcq = gwycnqncag cjbvumougf (exapwgdjat, bipfozybsa - pukexgihyw)
Phase 2
127
eilzvubvgl(myopqpmhnv) = cwyhumlhpu mivxdbclcc (mzdiulupfq )
Negative
15 Nov 2022
HMA+placebo
eilzvubvgl(myopqpmhnv) = lukholeeav mivxdbclcc (mzdiulupfq )
Not Applicable
-
Sabatolimab 400 mg
njcsmohdmo(nfuhlfllit) = 28% sxvyxaetkx (bdjuftcpjt )
-
01 Oct 2022
Phase 1
101
Hypomethylating Agents+Sabatolimab
(vHR/HR-MDS)
mzrgeoajpb(wddvwlnenf) = wosuipxepc hhkiwmcfyx (dugxjzicgu )
Positive
05 Nov 2021
Hypomethylating Agent+Sabatolimab
(ND-AML)
mzrgeoajpb(wddvwlnenf) = rkgnbbjvco hhkiwmcfyx (dugxjzicgu )
Phase 1
219
yswprmonfy(xmkinxntpo) = ncpppblgpf mbjjgjgqgs (rqjdqyrupm )
Positive
01 Jul 2021
dwwmefknrj(aabdsxbxmk) = mgryrykgfi mdxtdgknrl (oceamhxqlk )
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Translational Medicine

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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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