Komzifti

(Ziftomenib)

Phase 2Small molecule

KKura Oncology, Inc.

Komzifti is one of 134 small molecule programs targeting Acute Lymphoblastic Leukemia. It is currently in Phase 2.

Indications

Total Trials

Active Trials

133

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Acute Lymphoblastic LeukemiaRecruiting

Acute Myeloid LeukemiaRecruiting

Refractory Acute LeukemiaRecruiting

ARTRecruiting

AMLRecruiting

Acute Lymphoblastic LeukemiaPhase 2

Recruiting

Acute Myeloid LeukemiaPhase 2

Recruiting

Refractory Acute LeukemiaPhase 1

Recruiting

ARTPhase 1

Recruiting

AMLPhase 1

Recruiting

Competition

Competitive Landscape

235 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Idamycin

Pfizer

Phase 3

60 2

Novantrone

Pfizer

Phase 3

34 3

Xospata

Astellas

Phase 3

24 4

Fludara

Sanofi

Phase 3

18 5

Vepesid

AAvyxa

Phase 3

52 6

Cerubidine

HHikma Pharmaceuticals LLC

Phase 3

42 7

Vanflyta

Daiichi Sankyo

Phase 3

16 8

Mylotarg

WWyeth-Lederle Vaccines

Phase 3

38 9

Cerubidine

HHikma Pharmaceuticals LLC

Phase 3

32 10

Neupogen

EEastern Cooperative Oncology Group

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Phase 1Recruiting

AML

NCT06001788

Q4 2027

Phase 2Recruiting

Acute Myeloid Leukemia

NCT06930352

Q1 2028

Phase 1Recruiting

KMT2A-Rearranged

NCT07355335

Q4 2028

Phase 1/2Recruiting

Acute Myeloid Leukemia

NCT04067336

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia6 trials

A Phase I Study Investigating the Combination of the Menin Inhibitor Ziftomenib With Venetoclax and Gemtuzumab in Pediatric Patients With Acute Myeloid Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT06448013·22 enrolled

First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia

Recruiting·KKura Oncology, Inc.·Phase 1/2·NCT04067336·263 enrolled

An Open Label Phase I Study of Ziftomenib as Maintenance Therapy Following Allogeneic Hematopoietic Cell Transplantation

Recruiting·MMassachusetts General Hospital·Phase 1·NCT06440135·22 enrolled

Show 3 more trials

Phase 1 Dose Escalation and Expansion of Ziftomenib in Combination With Quizartinib in Acute Myeloid Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT06769490·44 enrolled

Frontline Ziftomenib in NPM1-Mutated or KMT2A-Rearranged Acute Myeloid Leukemia in Patients Not Eligible for Intensive Induction or Other Therapy

Recruiting·UUma Borate·Phase 2·NCT06930352·70 enrolled

Phase 1/1b Trial Of Olutasidenib And Ziftomenib For NPM1 And IDH1 Co-Mutated Acute Myeloid Leukemia

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT07411586·32 enrolled

ART1 trial

A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML

Recruiting·KKura Oncology, Inc.·Phase 1·NCT05735184·420 enrolled

Acute Lymphoblastic Leukemia1 trial

TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II

Recruiting·TTanja Andrea Gruber·Phase 1/2·NCT05848687·90 enrolled

Gastrointestinal Stromal Tumor (GIST)1 trial

A Phase 1a/1b Study of the Safety, Pharmacokinetics, and Antitumor Activity of the Oral Menin Inhibitor Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) After Imatinib Failure

Recruiting·KKura Oncology, Inc.·Phase 1·NCT06655246·135 enrolled

Acute Myeloid Leukemia (AML)1 trial

Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination With Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients With Untreated NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia

Recruiting·KKura Oncology, Inc.·Phase 3·NCT07007312·1,300 enrolled

5 more indications

Acute Leukemia1 trial

A Phase 1 Trial of Menin-inhibitor Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory KMT2A-r/NUP98-r/NPM1-m Acute Leukemia

Recruiting·PPedAL BCU, LLC·Phase 1·NCT06376162·20 enrolled

KMT2A-rearranged1 trial

A Phase 1 Study of Menin-KMT2A Inhibitor Ziftomenib (KO-539) in Combination With Cereblon E3 Ligase Modulator Mezigdomide (CC-92480) in Adolescents and Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Recruiting·MMassachusetts General Hospital·Phase 1·NCT07355335·24 enrolled

Refractory Acute Leukemia1 trial

A Phase I Study Investigating the Combination of the Ziftomenib, Venetoclax and Azacitidine in Pediatric Relapsed and Refractory Acute Leukemias

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT06397027·22 enrolled

AML1 trial

Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia

Recruiting·KKura Oncology, Inc.·Phase 1·NCT06001788·171 enrolled

Acute Lymphoblastic Leukemia, With KMT2A Rearrangements1 trial

Expanded Access to Ziftomenib

Available·KKura Oncology, Inc.··NCT05738538

Regulatory

FDA Approval Timeline[4]

Nov 13, 2025

KOMZIFTI

NDA NDA220305

Sources

References

[1]
ClinicalTrials.gov — 15 trial records for Ziftomenib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ziftomenib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ziftomenib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA220305). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Komzifti. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Kura Oncology, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: KKura Oncology, Inc.

Patent Landscape[5]

Patent Cliff

Mar 16, 2036

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10077271Mar 16, 2036

10174041Mar 16, 2036

10869868Jan 26, 2037

11673898Mar 15, 2037

10781218Mar 15, 2037

3 more patents

11944627Sep 6, 2038

12410184Jul 16, 2044

12521396Jul 16, 2044

Komzifti

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2027

Q1 2028

Q4 2028

Trials by Indication[1]

Acute Myeloid Leukemia6 trials

ART1 trial

Acute Lymphoblastic Leukemia1 trial

Gastrointestinal Stromal Tumor (GIST)1 trial

Acute Myeloid Leukemia (AML)1 trial

Acute Leukemia1 trial

KMT2A-rearranged1 trial

Refractory Acute Leukemia1 trial

AML1 trial

Acute Lymphoblastic Leukemia, With KMT2A Rearrangements1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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