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Ziftomenib is a **selective, oral, once-daily small-molecule menin inhibitor** developed by Kura Oncology and Kyowa Kirin for genetically defined acute leukemias. It disrupts the menin-KMT2A interaction and downstream leukemogenic transcriptional programs that are particularly important in **NPM1-mutated** and **KMT2A-rearranged** acute myeloid leukemia. Ziftomenib received FDA approval in November 2025 as **Komzifti** for adults with relapsed or refractory acute myeloid leukemia with a susceptible **NPM1 mutation** and no satisfactory alternative treatment options, based on the pivotal KOMET-001 study. The drug is also being studied in broader AML settings, including frontline combinations and KMT2A-rearranged disease, with Kura leading key U.S. activities and Kyowa Kirin supporting global development and ex-U.S. commercialization.
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