Last update 24 Jun 2025

Bleximenib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Bleximenib, JNJ 6617, JNJ 75276617
+ [4]
Action
inhibitors
Mechanism
MLL1 inhibitors(lysine methyltransferase 2A inhibitors), menin inhibitors(Menin inhibitors)
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (United States)
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Structure/Sequence

Molecular FormulaC32H50FN7O3
InChIKeyPDUGAXSIWNMIBQ-HHHXNRCGSA-N
CAS Registry2654081-35-1

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute myeloid leukaemia with 11q23 abnormalityPhase 3
United States
23 Jun 2025
Acute myeloid leukaemia with 11q23 abnormalityPhase 3
China
23 Jun 2025
Acute myeloid leukaemia with 11q23 abnormalityPhase 3
Japan
23 Jun 2025
Acute myeloid leukaemia with 11q23 abnormalityPhase 3
Australia
23 Jun 2025
Acute myeloid leukaemia with 11q23 abnormalityPhase 3
Austria
23 Jun 2025
Acute myeloid leukaemia with 11q23 abnormalityPhase 3
Belgium
23 Jun 2025
Acute myeloid leukaemia with 11q23 abnormalityPhase 3
Brazil
23 Jun 2025
Acute myeloid leukaemia with 11q23 abnormalityPhase 3
Canada
23 Jun 2025
Acute myeloid leukaemia with 11q23 abnormalityPhase 3
Czechia
23 Jun 2025
Acute myeloid leukaemia with 11q23 abnormalityPhase 3
Denmark
23 Jun 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
-
qwrbhrkqzc(qeqavwxqkz) = TRAEs (all grades) attributed to bleximenib alone occurred in 18% (4/22) of pts, including thrombocytopenia and neutropenia (2/22; 9% each) and single cases (5% each) of anemia, diarrhea, cerebrovascular accident, dysesthesia and upper abdominal pain. ifpwbkrdem (bryjhgqlev )
-
07 Dec 2024
Phase 1
121
fxmeayaegx(baiyrzdjda) = Seventeen pts experienced DS (bothKMT2AandNPM1), with 8 (7%) DS events ≥G3, including 2 fatal events. One fatal DS AE occurred in a pt with recurrent DS after rapid dose escalation. ctuwiytmjl (lbhvfvjqlm )
Positive
07 Dec 2024
Phase 1
Acute Myeloid Leukemia
KMT2A Mutation | NPM1 Mutation
45
sxskshlkwd(rrnsrpuuor) = 87% (39/45) of pts experienced ≥1 treatment-related AE (TRAE) attributed to any study treatment (allgrades); nausea (38%), vomiting (31%), and thrombocytopenia (31%) were the most common. bhwxzcdzpb (vkqtfwvyet )
Positive
14 May 2024
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Approval

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Regulation

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