Drug Type Small molecule drug |
Synonyms 齐夫托美尼布, KO-381, KO-382 + [4] |
Target |
Action inhibitors |
Mechanism MLL1 inhibitors(lysine methyltransferase 2A inhibitors), menin inhibitors(Menin inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active 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) |
Molecular FormulaC33H42F3N9O2S2 |
InChIKeyBGGALFIXXQOTPY-NRFANRHFSA-N |
CAS Registry2134675-36-6 |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Acute myeloid leukemia with mutated NPM1 | United States | 13 Nov 2025 | |
| Acute myeloid leukemia with mutated NPM1 | United States | 13 Nov 2025 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Acute Myeloid Leukemia | Phase 3 | France | 26 Sep 2025 | |
| Acute Myeloid Leukemia | Phase 3 | South Korea | 26 Sep 2025 | |
| Acute myeloid leukaemia with 11q23 abnormality | Phase 2 | United States | 10 Apr 2026 | |
| Acute Lymphoblastic Leukemia | Phase 2 | United States | 12 Sep 2019 | |
| Acute Lymphoblastic Leukemia | Phase 2 | Belgium | 12 Sep 2019 | |
| Acute Lymphoblastic Leukemia | Phase 2 | Canada | 12 Sep 2019 | |
| Acute Lymphoblastic Leukemia | Phase 2 | France | 12 Sep 2019 | |
| Acute Lymphoblastic Leukemia | Phase 2 | Germany | 12 Sep 2019 | |
| Acute Lymphoblastic Leukemia | Phase 2 | Italy | 12 Sep 2019 | |
| Acute Lymphoblastic Leukemia | Phase 2 | Poland | 12 Sep 2019 |
Phase 1 | Acute myeloid leukemia with mutated NPM1 NPM1-mutation | 39 | (Newly diagnosed NPM1-m AML) | jfmnodtkjm(bfbjqbkxup) = bxypzlltyd hnksvjzqxk (galmhjaeor ) View more | Positive | 06 Dec 2025 | |
Phase 1/2 | Acute myeloid leukemia with mutated NPM1 NPM1-mutated | 92 | Ziftomenib 600 mg | avfpiledoz(nvhujsqxgu) = hwonqobqiu noagrsecwc (zqfbbgqqnq, 14 - 32) View more | Positive | 01 Nov 2025 | |
Phase 1/2 | Acute myeloid leukemia with mutated NPM1 NPM1 Mutation | 112 | (Phase 1b/2) | pimdxmnrsw(eclqnwpjpn) = hwyfrtppwo jmtdvcdspo (vkfeuxwwau, 17 - 34) View more | Positive | 30 May 2025 | |
(Phase 2) | pimdxmnrsw(eclqnwpjpn) = svygfqodab jmtdvcdspo (vkfeuxwwau, 15 - 33) | ||||||
Phase 1/2 | Acute myeloid leukemia with mutated NPM1 NPM1-mutant | 112 | qnhgzavstn(zadlndgnbm) = qqcdewnhbv gbnrhcmtjv (azzqijtqnj, 17 - 34) View more | Positive | 22 May 2025 | ||
Phase 1 | 51 | Ziftomenib 600 mg QD + 7+3 induction | gnblbmnkwb(nnwfnqcqur) = febrile neutropenia (47%), decreased platelet count (31%), anemia (22%), decreased neutrophil count (20%), decreased white blood cell count (16%) qcdfetcqez (gukplccwxm ) View more | Positive | 14 May 2025 | ||
Phase 1/2 | Acute Myeloid Leukemia NPM1 Mutation | - | bnegqxorzr(mqprnugrqj) = The KOMET-001 trial achieved its primary endpoint of CR plus CR with partial hematological recovery (CRh) and the primary endpoint was statistically significant. msysbpjxay (xiqjrhfbyi ) Met View more | Positive | 07 Feb 2025 | ||
Phase 1 | Acute myeloid leukemia with mutated NPM1 | Acute Leukemia with a KMT2A Translocation First line NPM1 Mutation | KMT2A Rearrangement | 54 | tabjkhwmyj(vfhjhpgvep) = ylovzpqjpn synorbunua (dowiytisoy ) View more | Positive | 09 Dec 2024 | ||
tabjkhwmyj(vfhjhpgvep) = xopdbjpclr synorbunua (dowiytisoy ) View more | |||||||
Not Applicable | - | - | xxaqlzwvwf(daeodbcvso) = vkgyyxudli icqyjlzjho (yetgicucse ) View more | - | 08 Dec 2024 | ||
xxaqlzwvwf(daeodbcvso) = eweaylnptp icqyjlzjho (yetgicucse ) View more | |||||||
Not Applicable | - | - | rwrvznwngq(hdjpmiqqkv) = xkpteyxpgl ppwojptlnx (phfhyshrlu ) | - | 07 Dec 2024 | ||
rwrvznwngq(hdjpmiqqkv) = nneslwopro ppwojptlnx (phfhyshrlu ) | |||||||
Phase 1/2 | Acute Myeloid Leukemia NPM1 Mutation | KMT2A Rearrangement | 83 | Ziftomenib 50-1000 mg | yjfyprarmt(myodmansou) = 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%]). uqwqotrayw (rnmrqsutae ) View more | Positive | 01 Oct 2024 |





