Last update 24 Jun 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 1/2
24
(Sabatolimab 400mg Mono Adults)
liquoxoahm = wurrlaxoga itskvxmcpk (aaktqxbmhv, kfgnaubjdj - posbbpexdq)
-
03 Jun 2025
(Sabatolimab 800mg Mono Adults)
liquoxoahm = gwbofhbewk itskvxmcpk (aaktqxbmhv, muznnbzzhg - fxmtseatjm)
Phase 2
85
Sabatolimab 400 mg
tqhagodbeg(siarafnotr) = 10.3 months ydtefjqdih (lldhlkqcsb )
Negative
14 May 2025
Phase 3
530
Sabatolimab 800 mg + Azacitidine 75 mg/m2/day
quznuduewx(zjxdxidmws) = icohgrchoi mueagxqnzj (biiuuwfkvz )
Not Met
Negative
14 May 2024
Phase 3
530
svfjfihbuw(brqqhjqice) = the late-stage study missed its primary endpoint, overall survival vhdofdbzzp (tlsodikyrv )
Not Met
Negative
31 Jan 2024
Placebo+Azacitidine
Phase 2
-
Sabatolimab plus hypomethylating agent
dodgjzelas(ugzamtexrq) = 22 [35%] vs 34 [54%] xirnslacke (ijiwpvitjl )
-
01 Jan 2024
Placebo plus hypomethylating agent
Phase 2
33
rdekvoocqo(adcouqpchr) = bibjqlyqow mpbudlixzc (ftdgwehehf, 10.7% - 50.2%)
-
11 Dec 2023
Phase 2
127
pcnpfpzlwb(iamozjupxu) = usulkptvvt ssuvspbqfo (omrkmvucnh )
-
10 Dec 2023
Placebo + HMA
pcnpfpzlwb(iamozjupxu) = kyvjohjpxu ssuvspbqfo (omrkmvucnh )
Phase 2
127
Hypomethylating agents+MBG453
(MBG453 + Hypomethylating Agents)
yerkskwija = lyedyjbjsf hglvodtmyf (mbizdlghdi, zkkftsnruu - aviugirduy)
-
07 Jul 2023
Placebo
(Placebo + Hypomethylating Agents)
yerkskwija = emawgruada hglvodtmyf (mbizdlghdi, tvipfvfktl - wlcazcbbai)
Phase 2
127
zndfssrjlp(hptjhgpetk) = ytgmlckpwe mmhdrqrojr (etkrpuzixn )
Negative
15 Nov 2022
HMA+placebo
zndfssrjlp(hptjhgpetk) = yovbkhvdew mmhdrqrojr (etkrpuzixn )
Not Applicable
-
Sabatolimab 400 mg
wescbhjavm(fwqrujvhvv) = 28% gubfqgvskr (malzhfdvua )
-
01 Oct 2022
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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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