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Venetoclax

Phase 1

Acute Myeloid Leukemia | Small molecule | Oncology |Syndax Pharmaceuticals, Inc.|Last Updated: Apr 13, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06284486A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and RevumenibPHASE1 RECRUITING 8Sep 23, 2024Dec 30, 2028Apr 13, 20264 United States
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Study Endpoints
Primary Endpoints
Safety and adverse events (AEs)
Through study completion; an average of 1 year.

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Venetoclax + RevumenibEXPERIMENTALParticipants may receive the combination of venetoclax and revumenib for up to 1 year, and then 1 more year of venetoclax alone. You will no longer be able to take the study drug(s) if the disease gets worse or if intolerable side effects occur. Participants will take venetoclax by mouth on 1 time a day at about the same time each day, on Days 1-14 of each cycle. Take each dose with about 1 cup of water within 30 minutes after a meal, preferably breakfast.
Interventions
NameTypeDescription
VenetoclaxDRUGGiven by PO
RevumenibDRUGGiven by PO
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Age ≥ 12 years with weight ≥ 45Kg. 2. ECOG performance status of ≤ 2. (if aged ≥18 years); Karnofsky Performance Scale of ≥50 (if aged ≥16 years and \<18 years); Lansky Performance Score of ≥50 (if aged \<16 years). 3. Leukemia status: * Known history of NPM1mt, or KMT2Ar...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06284486studyFirstPostDate: changed