KOMZIFTI
LaunchSMziftomenib
NDAORALCAPSULEPriority Review
Approved
Nov 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
11
Data completeness
5/8 — Partial
Priority Review
KOMZIFTI (ziftomenib) is menin inhibitors [moa]. First approved in 2025.
Drug data last refreshed 19h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KOMZIFTI (ziftomenib) is an oral menin inhibitor approved November 2025 for the treatment of acute myeloid leukemia and other hematologic malignancies. It works by inhibiting the menin protein, which plays a critical role in leukemic cell proliferation in patients with specific genetic alterations. This small-molecule approach represents a novel targeted mechanism in the oncology space.
Growth17.7 years to LOE
Early-stage launch with no current competitive pressure creates opportunity for rapid market penetration and commercial team expansion.
Mechanism of Action
Menin Inhibitors
Pharmacologic Class:
Menin Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (11)
Ziftomenib for the Treatment of Patients With NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia Not Eligible for Standard Therapy
Started Oct 2026
70 enrolled
Acute Myeloid Leukemia
Ziftomenib + Mezigdomide in Adolesc. and Adults w/ R/R AML
Started Sep 2026
24 enrolled
KMT2A-rearrangedNPM1-mutant Refractory or Relapsed AML
Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML
Started Sep 2025
1,300 enrolled
Acute Myeloid Leukemia (AML)
A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Started Mar 2025
135 enrolled
Gastrointestinal Stromal Tumor (GIST)Gastrointestinal Stromal CancerGastrointestinal Stromal Neoplasm+2 more
Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory Acute Leukemia
Started Mar 2025
20 enrolled
Relapsed/Refractory KMT2A-r Acute LeukemiaRelapsed/Refractory NUP98-r Acute LeukemiaRelapsed/Refractory NPM1-m Acute Leukemia
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.