KOMZIFTI
LaunchSMziftomenib
NDAORALCAPSULEPriority Review
Approved
Nov 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
11
Data completeness
6/8 — Strong
Priority Review
KOMZIFTI (ziftomenib) is menin inhibitors [moa]. Approved for acute myeloid leukemia. First approved in 2025.
Drug data last refreshed Yesterday · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KOMZIFTI (ziftomenib) is an oral menin inhibitor approved for acute myeloid leukemia (AML) in November 2025. It works by inhibiting the menin protein, which plays a critical role in leukemic cell survival and proliferation. This represents a novel mechanism of action in the AML treatment landscape.
Launch18.2 years to LOE
Early-stage launch product with significant market penetration opportunity against established competitors; small team building phase with growth potential.
Mechanism of Action
Menin Inhibitors
Pharmacologic Class:
Menin Inhibitor
Indications (1)
Clinical Trials (11)
Ziftomenib + Mezigdomide in Adolesc. and Adults w/ R/R AML
Started Jul 2026
24 enrolled
KMT2A-rearrangedNPM1-mutant Refractory or Relapsed AML
Ziftomenib for the Treatment of Patients With NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia Not Eligible for Standard Therapy
Started Apr 2026
70 enrolled
Acute Myeloid Leukemia
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
157 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.