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Ziftomenib - Kura Oncology

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Drug Profile

Ziftomenib - Kura Oncology

Alternative Names: KO-539

Latest Information Update: 25 Jun 2025

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At a glance

  • Originator University of Michigan
  • Developer Kura Oncology; Kyowa Kirin; University of Michigan
  • Class 2 ring heterocyclic compounds; Amines; Antihyperglycaemics; Antineoplastics; Fluorocarbons; Indoles; Nitriles; Pyrimidines; Small molecules; Sulfonamides; Thiophenes
  • Mechanism of Action KMT2A protein inhibitors; Menin inhibitors; Protein-protein interaction inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Acute myeloid leukaemia
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Acute myeloid leukaemia
  • Phase I/II Precursor cell lymphoblastic leukaemia-lymphoma
  • Phase I Gastrointestinal stromal tumours; Leukaemia
  • Preclinical Type 2 diabetes mellitus

Most Recent Events

  • 12 Jun 2025 Efficacy and adverse events data from the phase Ia/Ib KOMET-007 trial in Acute myeloid leukemia released by Kura Oncology
  • 12 Jun 2025 Kura Oncology plans phase-III (KOMET-017-IC) and (KOMET-017-NIC) trial in Acute myeloid leukemia (Combination therapy, First-line therapy) in September 2025 (PO) (NCT07007312)
  • 02 Jun 2025 FDA assigns PDUFA action date of 30/11/2025 for Ziftomenib for Acute myeloid leukemia (Second-line therapy or greater)

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