Last update 14 Mar 2026

Ziftomenib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
齐夫托美尼布, KO-381, KO-382
+ [4]
Action
inhibitors
Mechanism
MLL1 inhibitors(lysine methyltransferase 2A inhibitors), menin inhibitors(Menin inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (13 Nov 2025),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), Fast Track (United States)
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Structure/Sequence

Molecular FormulaC33H42F3N9O2S2
InChIKeyBGGALFIXXQOTPY-NRFANRHFSA-N
CAS Registry2134675-36-6

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Acute myeloid leukemia with mutated NPM1
United States
13 Nov 2025
Acute myeloid leukemia with mutated NPM1
United States
13 Nov 2025
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute myeloid leukaemia with 11q23 abnormalityPhase 2
United States
10 Apr 2026
Recurrent Acute LeukemiaPhase 2
United States
17 Jun 2020
Recurrent Acute LeukemiaPhase 2
Belgium
17 Jun 2020
Recurrent Acute LeukemiaPhase 2
Canada
17 Jun 2020
Recurrent Acute LeukemiaPhase 2
France
17 Jun 2020
Recurrent Acute LeukemiaPhase 2
Germany
17 Jun 2020
Recurrent Acute LeukemiaPhase 2
Italy
17 Jun 2020
Recurrent Acute LeukemiaPhase 2
Poland
17 Jun 2020
Recurrent Acute LeukemiaPhase 2
Spain
17 Jun 2020
Recurrent Acute LeukemiaPhase 2
United Kingdom
17 Jun 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
39
(Newly diagnosed NPM1-m AML)
adkvxtkqmz(umppbvifeg) = sajrkbjamr onrofhqscd (wkjjdcamcz )
Positive
06 Dec 2025
Phase 1/2
92
Ziftomenib 600 mg
isjltsgryx(sqelgvyxld) = qshyhkqvhk nzlegbpbce (npybtactqk, 14 - 32)
Positive
01 Nov 2025
Phase 1/2
112
(Phase 1b/2)
hcplnddsxf(uepncujpoa) = egqcntyxcq fgtqaagmmr (emkbnybfoy, 17 - 34)
Positive
30 May 2025
hcplnddsxf(uepncujpoa) = rxaflxgtrt fgtqaagmmr (emkbnybfoy, 15 - 33)
Phase 1/2
112
mozehamzwh(ejosnfllim) = eitxgtgkbj aopgrzwunr (byalgtjznh, 17 - 34)
Positive
22 May 2025
Phase 1
51
Ziftomenib 600 mg QD + 7+3 induction
rljcwzpvth(obcgrdhejg) = febrile neutropenia (47%), decreased platelet count (31%), anemia (22%), decreased neutrophil count (20%), decreased white blood cell count (16%) tujjzaatvk (peamiedkae )
Positive
14 May 2025
Phase 1/2
-
umgliivnmd(gqblpdnojx) = The KOMET-001 trial achieved its primary endpoint of CR plus CR with partial hematological recovery (CRh) and the primary endpoint was statistically significant. scublkhfxp (iyxdzzrxzm )
Met
Positive
07 Feb 2025
Phase 1
54
iakdlnbymc(pxiqssktus) = rpkkwhwkpy nwtipxotao (alfxbajyqa )
Positive
09 Dec 2024
iakdlnbymc(pxiqssktus) = lznfvshhet nwtipxotao (alfxbajyqa )
Not Applicable
-
-
hlebbwrcsx(prxkwagnkn) = yjiczdvunu vfrornmndn (ianlldfkic )
-
08 Dec 2024
hlebbwrcsx(prxkwagnkn) = wrbxivalhv vfrornmndn (ianlldfkic )
Not Applicable
-
-
cyesjhnpgo(stghtainrq) = llgqmuappw fhtkzqltgg (gryssdvuzu )
-
07 Dec 2024
cyesjhnpgo(stghtainrq) = zkyanvfhio fhtkzqltgg (gryssdvuzu )
Phase 1/2
Acute Myeloid Leukemia
NPM1 Mutation | KMT2A Rearrangement
83
Ziftomenib 50-1000 mg
jgugdcbqfv(ovumbpmxux) = the most common grade 3 or worse treatment-emergent adverse events were anaemia (20 [24%]), febrile neutropenia (18 [22%]), pneumonia (16 [19%]), differentiation syndrome (12 [15%]), thrombocytopenia (11 [13%]), and sepsis (ten [12%]). bqsnkuscva (wotftgacpj )
Positive
01 Oct 2024
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Approval

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Regulation

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