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Venetoclax

Phase 2

Chronic Lymphocytic Leukemia (CLL) | Small molecule | Oncology |BeOne Medicines Ltd.|Last Updated: Dec 5, 2025

Target and mechanism

Molecular targetBCL2
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

Venetoclax · 1 trial · 2 indications

Phase 2 1
NCT05168930Zanubrutinib and Venetoclax in CLL (ZANU-VEN)Chronic Lymphocytic Leukemia (CLL)
RECRUITING45 Analytics
PHASE2RECRUITING
Zanubrutinib and Venetoclax in CLL (ZANU-VEN)
Chronic Lymphocytic Leukemia (CLL)Unlock trial analytics

Study Endpoints

Primary Endpoints

Rate of undetectable minimal residual disease (uMRD)
At the end of cycle 15 (each cycle is 28 days)

Assessed by flow cytometry (FC)

Secondary Endpoints

Overall response Rate (ORR)
At the end of cycle 15 (each cycle is 28 days)
Complete Response (CR) Rate
At the end of cycle 15 (each cycle is 28 days)
Percentage of undetectable minimal residual disease (uMRD) in bone marrow with CR
At the end of cycle 15 (each cycle is 28 days)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort A: BTKi and BCL2i naiveEXPERIMENTALParticipants who have never received a BTK inhibitor or a BCL-2 inhibitor
Cohort B: BTKi or BCL2i exposed without disease progressionEXPERIMENTALParticipants who have received prior treatment with a BTK or BCL-2 inhibitor and discontinued treatment for any reason other than disease progression
Cohort C: BTKi exposed and with disease progressionEXPERIMENTALParticipants who experienced disease progression on a prior BTK inhibitor. Participants with BTK C481X mutation at enrollment will be excluded.

Interventions

NameTypeDescription
VenetoclaxDRUGC4-15
ZanubrutinibDRUGC1-15
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria * Confirmed diagnosis of CLL or SLL as per 2018 International Workshop on CLL (IWCLL) criteria. * Participants must have relapsed after at least one prior line of therapy and must currently require therapy by 2019 IWCLL criteria. * For enrollment to Cohort A: Participants must be...

Countries:United States
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Frequently asked questions about Venetoclax

What is Venetoclax used for in Chronic Lymphocytic Leukemia?

Venetoclax is an investigational small molecule being studied for the treatment of Chronic Lymphocytic Leukemia (CLL). It is currently in Phase 2 clinical development. The drug is being evaluated in combination with zanubrutinib in a clinical trial for patients with CLL and Small Lymphocytic Lymphoma.

What does Venetoclax target?

Venetoclax targets the B-cell lymphoma 2 (BCL-2) protein, which is involved in regulating apoptosis. By inhibiting BCL-2, Venetoclax promotes the death of cancer cells. This mechanism is being studied in the context of Chronic Lymphocytic Leukemia, where the drug is evaluated in a Phase 2 clinical trial.

Who makes Venetoclax?

Venetoclax is being developed by BeOne Medicines Ltd., a company listed on the stock exchange under the ticker ONC. The company is conducting a Phase 2 clinical trial of Venetoclax in Chronic Lymphocytic Leukemia. The trial is currently recruiting participants in the United States.

What phase is Venetoclax in?

Venetoclax is in Phase 2 clinical development for Chronic Lymphocytic Leukemia. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 2 trial is actively recruiting patients and is designed to evaluate the drug's safety and efficacy.

What clinical trials is Venetoclax in?

Venetoclax is being studied in a Phase 2 clinical trial with the identifier NCT05168930, titled 'Zanubrutinib and Venetoclax in CLL (ZANU-VEN)'. This trial is recruiting 45 participants with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma in the United States. The study is controlled but not randomized or double-blinded.

Is Venetoclax the same as zanubrutinib?

No, Venetoclax is not the same as zanubrutinib. Venetoclax is a small molecule that targets BCL-2, while zanubrutinib is a separate drug that inhibits Bruton's tyrosine kinase (BTK). In the ongoing Phase 2 clinical trial, Venetoclax is being studied in combination with zanubrutinib for the treatment of Chronic Lymphocytic Leukemia.