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VEN+AZA-5

Phase 2

Acute Myeloid Leukemia (AML) | Small molecule | Oncology |AbbVie Inc.|Last Updated: May 1, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05833438Venetoclax in Combination With 5 Days Azacitidine in Untreated AML Patients, Not Eligible for Standard Induction TherapyPHASE2 ACTIVE NOT_RECRUITING 45 — — May 17, 2023May 1, 2026May 1, 202610 Germany
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Study Endpoints
Primary Endpoints
The primary outcome measure is the response rate defined as the rate of CR/CRi after up to 6 cycles of therapy (best response).
best response after up to 6 cycles (each cycle is 28 days)

Bone marrow assessments will be performed at least at screening, at the end of cycle 1, after cycle 4 and after cycle 6 resp. end of treatment (EOT). Criteria for disease status / response assessment follow the ELN-2022 recommendations .

Secondary Endpoints
Rate of CR or CRi by the Initiation of Cycle 2
At the end of Cycle 1 (each cycle is 28 days)
Rate of CR with partial hematologic recovery (CRh) after up to 6 cycles of therapy
after up to 6 cycles (each cycle is 28 days)
Time from initiation of treatment (C1D1) until achievement of CR or CRi
from start of treatment (C1D1) until up to 6 cycles (each cycle is 28 days)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VEN+AZA-5EXPERIMENTALAzacitidine (AZA) 75 mg/m2, d1-5 of each 28 day cycle (SC) in combination with Venetoclax (VEN): 400 mg daily (orally)
Interventions
NameTypeDescription
VEN+AZA-5DRUGUp to 6 cycles: Azacitidine (AZA) 75 mg/m2, d1-5 of each 28 day cycle (SC) in combination with Venetoclax (VEN): 400 mg daily (orally)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Key Inclusion Criteria: * Confirmed diagnosis of AML by World Health Organization (WHO) criteria 2016 * Ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age or comorbidities * Age ≥ 18 years * Life expectancy of at least 12 weeks Key Exclusion Criteria...

Countries:Germany
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT05833438studyFirstPostDate: changed