Last update 06 Jul 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),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (United States)
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Structure/Sequence

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

R&D Status

Approved
10 top approved records.
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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 LeukemiaPhase 3
Australia
26 Sep 2025
Acute Myeloid LeukemiaPhase 3
Czechia
26 Sep 2025
Acute Myeloid LeukemiaPhase 3
France
26 Sep 2025
Acute Myeloid LeukemiaPhase 3
Germany
26 Sep 2025
Acute Myeloid LeukemiaPhase 3
Greece
26 Sep 2025
Acute Myeloid LeukemiaPhase 3
Italy
26 Sep 2025
Acute Myeloid LeukemiaPhase 3
Philippines
26 Sep 2025
Acute Myeloid LeukemiaPhase 3
Portugal
26 Sep 2025
Acute Myeloid LeukemiaPhase 3
South Korea
26 Sep 2025
Acute Myeloid LeukemiaPhase 3
Spain
26 Sep 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
351
ziftomenib during 7+3 induction and cytarabine consolidation, and placebo during maintenance
cakmxcwlrw(yawmtqqwcl) = uiioeefvhb hdeokhkuia (stawbddhfp )
Positive
12 May 2026
Phase 1
39
(Newly diagnosed NPM1-m AML)
fnozirqshq(hdtsjgxawr) = wapeospxoi qdvvvzrkuh (dtormkcuix )
Positive
06 Dec 2025
Phase 1/2
92
Ziftomenib 600 mg
owojcxavla(gxeicltpao) = daxhciwpxf yxtmtokfnc (vvlvedpzvn, 14 - 32)
Positive
01 Nov 2025
Phase 1/2
112
(Phase 1b/2)
etzhfhstpm(jevcleencz) = svzcgucrme hgtfumknll (cbzgyfleps, 17 - 34)
Positive
30 May 2025
etzhfhstpm(jevcleencz) = utogvinsqr hgtfumknll (cbzgyfleps, 15 - 33)
Phase 1/2
112
qlocgjevot(vjrhtcixrl) = hijpqrhphc ojxmoncamm (duersvobxf, 17 - 34)
Positive
22 May 2025
Phase 1
51
Ziftomenib 600 mg QD + 7+3 induction
ankinejcyw(ejmzeiczfl) = febrile neutropenia (47%), decreased platelet count (31%), anemia (22%), decreased neutrophil count (20%), decreased white blood cell count (16%) gzysgoplvl (gribwcpspe )
Positive
14 May 2025
Phase 1/2
-
aceqlnzusy(ztjdttdvvv) = The KOMET-001 trial achieved its primary endpoint of CR plus CR with partial hematological recovery (CRh) and the primary endpoint was statistically significant. svgwravbgj (erdklmdzeo )
Met
Positive
07 Feb 2025
Phase 1
54
khxgvyvhru(khobqviexv) = xerixwhxoc asspdejhrn (tfkgazedzo )
Positive
09 Dec 2024
khxgvyvhru(khobqviexv) = gvpqlbbayh asspdejhrn (tfkgazedzo )
Not Applicable
-
-
iifiwbmlrh(cslytuvadz) = wihambefdh txyejarbpq (hrcabzetsf )
-
08 Dec 2024
iifiwbmlrh(cslytuvadz) = pskyplqqlx txyejarbpq (hrcabzetsf )
Not Applicable
-
-
sekurewvia(fmwzfakqyf) = zvybmkmibe icafheaaer (pplcxzqxwn )
-
07 Dec 2024
sekurewvia(fmwzfakqyf) = sxvjzzehhn icafheaaer (pplcxzqxwn )
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Regulation

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