Recent Updates
Recently added Catalysts

VEN+AZA-5

Phase 2

Acute Myeloid Leukemia (AML) | Small molecule | Oncology |AbbVie Inc.|Last Updated: May 1, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

VEN+AZA-5 · 1 trial · 1 indication

Phase 2 1
NCT05833438Venetoclax in Combination With 5 Days Azacitidine in Untreated AML Patients, Not Eligible for Standard Induction TherapyAcute Myeloid Leukemia (AML)
ACTIVE NOT_RECRUITING45 Analytics
PHASE2ACTIVE NOT_RECRUITING
Venetoclax in Combination With 5 Days Azacitidine in Untreated AML Patients, Not Eligible for Standard Induction Therapy
Acute Myeloid Leukemia (AML)Unlock trial analytics

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)
Unlock Study Endpoints

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)
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria

Frequently asked questions about VEN+AZA-5

What is VEN+AZA-5 used for?

VEN+AZA-5 is an investigational combination therapy being studied for the treatment of Acute Myeloid Leukemia (AML). It is specifically being evaluated in untreated AML patients who are not eligible for standard induction therapy. The drug is currently in Phase 2 clinical development.

Who makes VEN+AZA-5?

VEN+AZA-5 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting a Phase 2 clinical trial to evaluate this combination therapy in patients with Acute Myeloid Leukemia.

What phase is VEN+AZA-5 in?

VEN+AZA-5 is currently in Phase 2 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. The ongoing Phase 2 trial is actively recruiting participants, though enrollment is not yet complete.

What clinical trials is VEN+AZA-5 in?

VEN+AZA-5 is being evaluated in a single Phase 2 clinical trial with the identifier NCT05833438. This trial is titled 'Venetoclax in Combination With 5 Days Azacitidine in Untreated AML Patients, Not Eligible for Standard Induction Therapy' and is being conducted in Germany.

How does VEN+AZA-5 work?

VEN+AZA-5 combines venetoclax, a BCL-2 inhibitor, with azacitidine, a hypomethylating agent. This combination is designed to target the mechanisms that allow AML cells to survive and proliferate. The therapy is being studied in patients with Acute Myeloid Leukemia who are not candidates for standard induction therapy.