Drugs / Ziftomenib

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) KOMZIFTI 2025-11-13 fda.gov

Trials 16 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 110 trials
Phase 1 NCT07411586 Aug 2026 → Jan 2027 expected acute myeloid leukemia M.D. Anderson Cancer Center Not yet recruiting No outcome recorded
Phase 1 NCT07355335 Jul 2026 → Jul 2027 expected B-lymphoblastic leukemia/lymphoma MLL rearranged, acute myeloid leukemia with mutated NPM1 Massachusetts General Hospital Not yet recruiting No outcome recorded
Phase 1 NCT06769490 Jul 2025 → Sep 2028 expected acute myeloid leukemia M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 1 NCT06655246 Mar 2025 → Dec 2027 expected gastrointestinal stromal tumor Kura Oncology, Inc. Recruiting No outcome recorded
Phase 1 NCT06376162 Mar 2025 → Jan 2027 expected B-lymphoblastic leukemia/lymphoma MLL rearranged, acute myeloid leukemia with mutated NPM1, acute myeloid leukemia, t(5;11)(q35;p15) PedAL BCU, LLC Recruiting No outcome recorded
Phase 1 NCT06448013 Mar 2025 → Dec 2028 expected acute myeloid leukemia M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 1 NCT06397027 Dec 2024 → Dec 2028 expected refractory hematologic cancer M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 1 NCT06440135 Jun 2024 → Sep 2026 expected acute myeloid leukemia with NPM1 somatic mutations, acute myeloid leukemia, MLL gene rearrangement Massachusetts General Hospital Recruiting No outcome recorded
Phase 1 NCT06001788 Feb 2024 → Aug 2026 overdue acute myeloid leukemia with mutated NPM1, acute myeloid leukemia, MLL gene rearrangement Kura Oncology, Inc. Recruiting No outcome recorded
Phase 1 NCT05735184 Jul 2023 → Apr 2030 expected acute myeloid leukemia with mutated NPM1, acute myeloid leukemia, MLL gene rearrangement, myeloid sarcoma Kura Oncology, Inc. Recruiting No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT05848687 Nov 2023 → Dec 2028 expected acute lymphoblastic leukemia Tanja Andrea Gruber Recruiting No outcome recorded
Phase 1/2 NCT04067336 Sep 2019 → Oct 2028 expected mixed phenotype acute leukemia with MLL rearranged Kura Oncology, Inc. Active not recruiting No outcome recorded
Phase 22 trials
Phase 2 NCT06930352 Sep 2026 → Dec 2027 expected acute myeloid leukemia Uma Borate Not yet recruiting No outcome recorded
Phase 2 NCT07623616 Apr 2026 → Mar 2027 expected acute myeloid leukemia Kyowa Kirin, Inc. Recruiting No outcome recorded
Phase 31 trial
Phase 3 NCT07007312 Sep 2025 → Nov 2031 expected acute myeloid leukemia Kura Oncology, Inc. Recruiting No outcome recorded
Phase not stated1 trial
NCT05738538 B-lymphoblastic leukemia/lymphoma MLL rearranged, acute myeloid leukemia with NPM1 somatic mutations, acute myeloid leukemia, MLL gene rearrangement Kura Oncology, Inc. Available No outcome recorded

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 18 sources stand behind the page.

FieldValueCited text
Known as Ziftomenib ClinicalTrials.gov intervention name — accepted as the source's own label NCT06440135
15

NCT05848687

NCT07623616

NCT06397027

NCT07007312

NCT06001788

NCT06655246

NCT06376162

NCT06448013

NCT05738538

NCT07411586

NCT04067336

NCT07355335

NCT06769490

NCT06930352

NCT05735184

Known as KO-539 ChEMBL registry synonym — accepted as the source's own label CHEMBL5095038
Action Inhibit “Ziftomenib - a potent, selective, oral menin inhibitor - is approved as monotherapy for adults with relapsed/refractory (R/R) NPM1-mutated acute myeloid leukemia (NPM1-m AML).” PMID 42227701 Jun 2026
Modality Small molecule CHEMBL5095038
Route Oral Oral administration” NCT06001788
Target KMT2A “Menin-KMT2A Inhibitor Ziftomenib” NCT07355335