KOMZIFTI

LaunchSM

ziftomenib

NDAORALCAPSULEPriority Review
Approved
Nov 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
11

Mechanism of Action

Menin Inhibitors

Pharmacologic Class:

Menin Inhibitor

Clinical Trials (5)

NCT07355335Phase 1Not Yet Recruiting

Ziftomenib + Mezigdomide in Adolesc. and Adults w/ R/R AML

Started Jul 2026
24 enrolled
KMT2A-rearrangedNPM1-mutant Refractory or Relapsed AML
NCT06930352Phase 2Not Yet Recruiting

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
NCT07007312Phase 3Recruiting

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)
NCT06655246Phase 1Recruiting

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
NCT06376162Phase 1Recruiting

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

Loss of Exclusivity

LOE Date
Jul 16, 2044
223 months away
Patent Expiry
Jul 16, 2044
Exclusivity Expiry
Nov 13, 2030

Patent Records (5)

Patent #ExpiryTypeUse Code
10077271
Mar 16, 2036
SubstanceProduct
10174041
Mar 16, 2036
U-4354
10869868
Jan 26, 2037
U-4353
11673898
Mar 15, 2037
U-4351
10781218
Mar 15, 2037
SubstanceProduct