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Ziftomenib FDA Approval Status

Last updated by Judith Stewart, BPharm on June 3, 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.

Development timeline for ziftomenib

DateArticle
Jun  1, 2025Kura Oncology and Kyowa Kirin Announce FDA Acceptance and Priority Review of New Drug Application for Ziftomenib in Adults with Relapsed or Refractory NPM1-Mutant AML
Apr  8, 2025Kura Oncology and Kyowa Kirin Announce Submission of New Drug Application for Ziftomenib to FDA
Feb  5, 2025Kura Oncology and Kyowa Kirin Announce Positive Ziftomenib Monotherapy Registrational Trial and Positive FDA Feedback for Upcoming Frontline Combination Trial Designs

Further information

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