Asset profile

Ziftomenib

Small molecule

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Approvedregulatory verdict

Evidence outlook

Approved: relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (... (FDA)

This approval is for an indication outside this terminal's covered markets; the covered program shown here is investigational. Regulatory approval supersedes design-level evidence grading for the approved use.

Source for the program status

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Competitive landscape

62 competitors in this universe: 1 direct rival (same mechanism and indication), 1 same-class, 60 same-indication; 11 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Ziftomenib: this drugPhase 3Small moleculeMenin
RevumenibApprovedSmall moleculeMenin
BMF-219Phase 2Small moleculeMenin
ASTX727ApprovedSmall moleculeDecitabine/cedazuridine fixed combination (DNMT + CDA inhibition)
EnasidenibApprovedSmall moleculeIDH2
Gemtuzumab OzogamicinApprovedAntibody–drug conjugateCD33
GilteritinibApprovedSmall moleculeFLT3
MidostaurinApprovedSmall moleculeFLT3;KIT;PKC;PDGFR
OlutasidenibApprovedSmall moleculeMutant IDH1
QuizartinibApprovedSmall moleculeFLT3
Tretinoin (Vesanoid)ApprovedSmall moleculeRARA (retinoic acid receptor alpha); degrades the PML-RARA fusion oncoprotein in APL
VenetoclaxApprovedSmall moleculeBCL-2
VyxeosApprovedSmall moleculeDNA synthesis (cytarabine, antimetabolite) / Topoisomerase II
131I-ApamistamabPhase 3Monoclonal antibodyCD45
AK117Phase 3Monoclonal antibodyCD47
APG-2575(Lisaftoclax )Phase 3Small moleculeBCL-2

…and 47 more. Research shows the complete landscape.

Research

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(14 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (1)
December 2026 (1)
Phase 1Acute Myeloid LeukemiaRecruiting
Est. primary completion 2026-12 · NCT06001788 · CT.gov ↗
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2027 (6)
January 2027 (2)
Phase 1Relapsed/Refractory KMT2A-r Acute Leukemia, Relapsed/Refractory NUP98-r Acute Leukemia, Relapsed/Refractory NPM1-m Acute LeukemiaRecruiting
Est. primary completion 2027-01 · NCT06376162 · CT.gov ↗
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Phase 1Acute Myeloid LeukemiaActive not recruiting
Est. primary completion 2027-01-14 · NCT07411586 · CT.gov ↗
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March 2027 (1)
Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2027-03 · NCT07623616 · CT.gov ↗
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July 2027 (1)
Phase 1Acute Myeloid LeukemiaNot yet recruiting
Est. primary completion 2027-07-01 · NCT07355335 · CT.gov ↗
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December 2027 (2)
Phase 1Gastrointestinal Stromal Tumor (GIST), Gastrointestinal Stromal Cancer, Gastrointestinal Stromal Neoplasm, Gastrointestinal Stromal Tumor …Recruiting
Est. primary completion 2027-12 · NCT06655246 · CT.gov ↗
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Phase 2Acute Myeloid LeukemiaRecruiting
Est. primary completion 2027-12-31 · NCT06930352 · CT.gov ↗
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2028 (5)
September 2028 (1)
Phase 1Acute Myeloid LeukemiaRecruiting
Est. primary completion 2028-09-15 · NCT06769490 · CT.gov ↗
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October 2028 (1)
Phase 1/2Acute Myeloid LeukemiaActive not recruiting
Est. primary completion 2028-10-16 · NCT04067336 · CT.gov ↗
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December 2028 (3)
Phase 1/2Lymphoblastic LeukemiaRecruiting
Est. primary completion 2028-12 · NCT05848687 · CT.gov ↗
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Phase 1Acute Myeloid LeukemiaRecruiting
Est. primary completion 2028-12-31 · NCT06448013 · CT.gov ↗
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Phase 1Refractory Acute Leukemia, Pediatric RelapsedRecruiting
Est. primary completion 2028-12-31 · NCT06397027 · CT.gov ↗
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2030 (1)
April 2030 (1)
Phase 1Acute Myeloid LeukemiaRecruiting
Est. primary completion 2030-04 · NCT05735184 · CT.gov ↗
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2031 (1)
November 2031 (1)
Phase 3Acute Myeloid LeukemiaRecruiting
Est. primary completion 2031-11 · NCT07007312 · CT.gov ↗
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See the full readout calendar ↗

All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (1)
Phase 2 (2)
Phase 1/2 (2)
Phase 1 (10)