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Ziftomenib

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

Also known as Komzifti

Kura Oncology, Inc. KURA · Acute Myeloid Leukemia (AML)

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Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Approved

    Not recorded

  • Linked trials

    1

    From ClinicalTrials.gov

  • Latest FDA action

    Approved

    NDA220305,

Recalls, shortages, patents and EU status at a glance

Key information

Sponsor
Kura Oncology, Inc. KURA Source: Company record for Kura Oncology, Inc. (opens in a new tab)
Indication
Acute Myeloid Leukemia (AML) Source: Conditions from ClinicalTrials.gov (opens in a new tab)
Application
NDA 220305 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 220305 (opens in a new tab)
Designations
None recorded
Next catalyst
None scheduled

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 Completed
  4. Phase 3 CompletedFirst trial start 26 Sep 20251 linked trial
  5. Filed Completed
  6. Approved Current stageFirst approval 13 Nov 2025

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

  1. ZiftomenibPDUFAOccurred

    · PDUFA date · Kura Oncology, Inc. KURA

    Kura Oncology, Inc.: PDUFA date in EX-99.1 (8-K) filed 7 August 2025

    “As a menin inhibitor, ziftomenib targets a fundamental disease driver in certain genetically defined subsets of AML, and along with our partners at Kyowa Kirin, we are committed to advancing ziftomenib as a potential therapy for patients throughout the continuum of care. With preparations underway for commercialization, upcoming initiation of two registrational trials of ziftomenib in the frontline setting and a strong pipeline to support future growth, we believe Kura is well-positioned to deliver meaningful benefit to patients and long-term value to stakeholders.” Recent Highlights • FDA Priority Review of New Drug Application for ziftomenib with PDUFA target action date of November 30, 2025 – In June 2025, Kura and Kyowa Kirin Co., Ltd.

    Source: 0000950170-25-105024 (opens in a new tab)

    337days ago

FDA designations

No FDA designations are on record for Ziftomenib. Editors add each one with its source.

Filed application

No filed application is on record for Ziftomenib. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for Ziftomenib.

Clinical trials

Trials linked to Ziftomenib
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT07007312ClinicalTrials.gov record for NCT07007312 (opens in a new tab)Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AMLPhase 3Recruiting1,300 (estimated)Nov 2031 (estimated) No

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.

Trial quality

About CT-VCA

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FDA actions

Original approvals and new-indication supplements for Ziftomenib, newest first
ApplicationActionDateOutcomeReviewSource
NDA220305Action letter for NDA220305 (opens in a new tab) Original 1 Type 1 - New Molecular EntityApprovedpriorityDrugs@FDA via openFDA (opens in a new tab)

Data provided by the U.S. Food and Drug Administration.

FDA recalls load here.

FDA drug shortages load here.

Orange Book patents load here.

FAERS adverse event counts load here.

Papers and preprints load here.

Community discussion loads here.

EU status (EMA)

EMA's medicines data lists no human medicine with the same active substance as Ziftomenib.

Source: European Medicines Agency (EMA), medicines data download.

Related news

No recent headlines mention this drug.

Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.