Komzifti

(Ziftomenib)

Phase 3Small molecule

KKura Oncology, Inc.

Komzifti is one of 208 small molecule programs targeting Acute Myeloid Leukemia (AML). It is currently in Phase 3.

Indications

Total Trials

Active Trials

207

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Acute Myeloid Leukemia (AML)Recruiting

AMLRecruiting

Refractory Acute LeukemiaRecruiting

ARTRecruiting

Gastrointestinal Stromal TumorRecruiting

Acute LeukemiaRecruiting

Acute Myeloid LeukemiaRecruiting

Acute Lymphoblastic LeukemiaRecruiting

AINRecruiting

R/R AMLNot yet recruiting

Acute Myeloid Leukemia (AML)Phase 3

Recruiting

AMLPhase 1

Recruiting

Refractory Acute LeukemiaPhase 1

Recruiting

ARTPhase 1

Recruiting

Gastrointestinal Stromal TumorPhase 1

Recruiting

Acute LeukemiaPhase 1

Recruiting

Acute Myeloid LeukemiaPhase 2

Recruiting

Acute Lymphoblastic LeukemiaPhase 2

Recruiting

AINPhase 1

Recruiting

R/R AMLPhase 1

Not yet recruiting

Competition

Competitive Landscape

255 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Idamycin

Pfizer

Phase 3

59 2

Xospata

Astellas

Phase 3

24 3

Fludara

Sanofi

Phase 3

17 4

Cerubidine

EEastern Cooperative Oncology Group

Phase 3

42 5

Vepesid

AAvyxa

Phase 3

52 6

Mylotarg

WWyeth-Lederle Vaccines

Phase 3

38 7

Neupogen

EEastern Cooperative Oncology Group

Phase 3

31 8

Cerubidine

HHikma Pharmaceuticals LLC

Phase 3

30 9

Nexavar

Cellcept

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

Timeline

Expected Milestones

Q1 2027

Phase 1Recruiting

Acute Leukemia

NCT06376162

Q3 2027

Phase 1Recruiting

AML

NCT06001788

Phase 1Recruiting

AIN

NCT06440135

Q4 2027

Phase 2Recruiting

Acute Myeloid Leukemia

NCT06930352

Q1 2028

Phase 1Not yet recruiting

R/R AML

NCT07355335

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia5 trials

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

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

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

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

Show 2 more trials

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

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 Tumor1 trial

A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)

Recruiting·KKura Oncology, Inc.·Phase 1·NCT06655246·157 enrolled

Acute Leukemia1 trial

Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory Acute Leukemia

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

AIN1 trial

Ziftomenib Maintenance Post Allo-HCT

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

6 more indications

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

R/R AML1 trial

Ziftomenib + Mezigdomide in Adolesc. and Adults w/ R/R AML

Not yet 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

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

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 3[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

Q1 2027

Q3 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Acute Myeloid Leukemia5 trials

Acute Lymphoblastic Leukemia1 trial

Gastrointestinal Stromal Tumor1 trial

Acute Leukemia1 trial

AIN1 trial

ART1 trial

R/R AML1 trial

Refractory Acute Leukemia1 trial

Acute Myeloid Leukemia (AML)1 trial

AML1 trial

Acute Lymphoblastic Leukemia, With KMT2A Rearrangements1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Related News