Ziftomenib FDA Approval Status
Last updated by Judith Stewart, BPharm on May 28, 2025.
FDA Approved: No
Generic name: ziftomenib
Company: Kura Oncology, Inc. and Kyowa Kirin Co., Ltd.
Treatment for: Acute Myeloid Leukemia
Ziftomenib is an oral menin inhibitor in development for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) mutation.
- AML is the most common acute leukemia in adults and begins when the bone marrow makes abnormal myeloblasts (white blood cells), red blood cells, or platelets. The menin pathway is considered a driver for multiple genetic alterations of the disease, of which NPM1 mutations are among the most common, representing approximately 30% of AML cases.
- Ziftomenib is a menin inhibitor that works to stop the growth and spread of leukemia cells by inhibiting the interaction between two proteins: menin and MLL (also known as KMT2A).
- Ziftomenib has been granted Breakthrough Therapy, Fast Track, and Orphan Drug Designations by the U.S. Food and Drug Administration (FDA).
Development timeline for ziftomenib
Further information
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