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Venetoclax

Phase 2

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

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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05168930Zanubrutinib and Venetoclax in CLL (ZANU-VEN)PHASE2 RECRUITING 45Feb 18, 2022Oct 28, 2028Dec 5, 20254 United States
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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 — 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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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT05168930studyFirstPostDate: changed