Venclexta

(Venetoclax)

ApprovedSmall molecule

Venetoclax is used to treat certain types of blood cancers, including chronic lymphocytic leukemia and acute myeloid leukemia. It works by helping the body's immune system destroy cancer cells.[2] Venclexta is currently approved and in use across 80 indications[4].[1]

Venclexta is one of 951 small molecule programs targeting Lupus Erythematosus. It is currently in Approved.

Indications

612

Total Trials

115

Active Trials

950

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Lupus ErythematosusApproved

Non-Hodgkins LymphomaApproved

Lymphoplasmacytic LymphomaActive, not recruiting

MacroglobulinemiaActive, not recruiting

T-Cell Acute Lymphoblastic LeukemiaActive, not recruiting

Lymphoblastic LymphomaActive, not recruiting

AL AmyloidosisActive, not recruiting

LymphomaActive, not recruiting

Cutaneous T-Cell LymphomaApproved

Hairy Cell LeukemiaActive, not recruiting

Lupus ErythematosusApproved

Approved

Non-Hodgkins LymphomaApproved

Approved

Lymphoplasmacytic LymphomaPhase 2

Active, not recruiting

MacroglobulinemiaPreclinical

Active, not recruiting

T-Cell Acute Lymphoblastic LeukemiaPhase 2

Active, not recruiting

Lymphoblastic LymphomaPhase 2

Active, not recruiting

AL AmyloidosisPreclinical

Active, not recruiting

LymphomaPhase 2

Active, not recruiting

Cutaneous T-Cell LymphomaApproved

Approved

Hairy Cell LeukemiaPhase 2

Active, not recruiting

Showing 10 of 80 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Venclexta

AbbVie

Approved

4 2

Megace

Bristol-Myers Squibb

Preclinical

4 3

Cymbalta

Alnylam Pharmaceuticals

Preclinical

3 4

Blenoxane

Bristol-Myers Squibb

Preclinical

1 5

Zinecard

CChildren's Oncology Group

Preclinical

2 6

Zoladex

Luye Pharma Group Ltd.

Preclinical

8 7

Apatinib Mesylate

BBukwang Pharmaceutical

Preclinical

3 8

Neoadjuvant Therapy

SSun Yat-sen University

Preclinical

3 9

Metfomin

UUniversity of Texas Southwestern Medical Center

Preclinical

1 10

Naltrexone/bupropion

Novo Nordisk

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Active, not recruiting

Treatment

NCT04501939

Phase 1/2Not yet recruiting

Phase 1

NCT05054465

Phase 2Not yet recruiting

Acute Myeloid Leukemia

NCT05554419

Phase 1Recruiting

Cancer

NCT06514261

Q4 2026

Phase 1/2Active, not recruiting

Follicular Lymphoma

NCT03980171

Phase 1/2Active, not recruiting

Acute Myeloid Leukemia

NCT04817241

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia36 trials

Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms

Recruiting·UUniversity of Washington·Phase 1/2·NCT04797767·62 enrolled

Testing the Use of an IDH1 Inhibitor, Olutasidenib, in Acute Myeloid Leukemia Added to ASTX727 and Venetoclax; in High-Risk MDS Added to ASTX727; and Alone in Low Risk MDS (A MyeloMATCH Treatment Substudy)

Not yet recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT07153497·132 enrolled

A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)

Terminated·AALX Oncology Inc.·Phase 1·NCT04755244·14 enrolled

Show 33 more trials

Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT04774393·84 enrolled

A Study of Venetoclax and Alvocidib in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Completed· AbbVie logo

AbbVie·Phase 1·NCT03441555·36 enrolled

Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06672146·93 enrolled

Navitoclax, Venetoclax, and Decitabine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Previously Treated With Venetoclax

Active, not recruiting·—·Phase 1·NCT05222984·17 enrolled

Hypomethylating Agents and Venetoclax in Newly Diagnosed Acute Myeloid Leukemia Patients Not Eligible for Intensive Chemotherapy

Unknown status·OOspedale Maggiore Di Trieste··NCT04454580·15 enrolled

A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04336982·22 enrolled

Testing Nivolumab in Combination With Decitabine and Venetoclax in Patients With Newly Diagnosed TP53 Gene Mutated Acute Myeloid Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT04277442·1 enrolled

Study of Venetoclax in Combination With Decitabine in Subjects With Acute Myeloid Leukemia

Active, not recruiting·UUniversity of Chicago·Phase 1·NCT03844815·26 enrolled

Venetoclax and Bomedemstat in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Recruiting·—·Phase 1·NCT05597306·18 enrolled

Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia

Recruiting·GGrupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias·Phase 2·NCT06668558·29 enrolled

Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)

Active, not recruiting· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 1/2·NCT04657081·101 enrolled

Combination of Venetoclax, Hypomethylation Agent and Low-dose Cytarabine as a Salvage Therapy for Acute Myeloid Leukemia

Unknown status·—·Phase 2·NCT05362942·52 enrolled

Pegcrisantaspase in Combination With Venetoclax for Treatment of Relapsed or Refractory Acute Myeloid Leukemia (R/R AML)

Completed·UUniversity of Maryland, Baltimore·Phase 1·NCT04666649·27 enrolled

Individualized Induction Therapy for Non-elderly Acute Myeloid Leukemia Patients With Adverse Risk Features

Unknown status·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT04752527·42 enrolled

Venetoclax and Azacitidine for the Management of Molecular Relapse/Progression in Adult NPM1-mutated Acute Myeloid Leukemia

Unknown status·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT04867928·35 enrolled

Venetoclax-Navitoclax With Cladribine-based Salvage Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Withdrawn·MMedical College of Wisconsin·Phase 1·NCT06007911

Nivolumab and Azacitidine With or Without Ipilimumab in Treating Patients With Refractory/Relapsed or Newly Diagnosed Acute Myeloid Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT02397720·150 enrolled

Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results

Recruiting·SShanghai Tong Ren Hospital·Phase 2·NCT05736978·58 enrolled

Testing the Use of Combination Therapy in Patients With Persistent Low Level Acute Myeloid Leukemia Following Initial Treatment, The ERASE Study (A MyeloMATCH Treatment Trial)

Not yet recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05554419·184 enrolled

A Phase Ib Trial of Azacitidine, Venetoclax and Allogeneic NK Cells for Acute Myeloid Leukemia (ADVENT-AML)

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT05834244·32 enrolled

A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia

Recruiting·SShanghai Tong Ren Hospital·Phase 2·NCT05736965·58 enrolled

Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Patients With Previously Untreated Acute Myeloid Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03586609·145 enrolled

BCL2i CLAG-M in R/R Acute Myeloid Leukemia

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT06660368·52 enrolled

OX40, Venetoclax, Avelumab, Glasdegib, Gemtuzumab Ozogamicin, and Azacitidine in Relapsed or Refractory Acute Myeloid Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT03390296·50 enrolled

A Phase I-II Study Investigating the All-Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine/Cedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE)

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT05360160·43 enrolled

Treatment With ABT-199 (Venetoclax) and Purine Analogues in Relapsed/Refractory Acute Myeloid Leukemia

Recruiting·UUniversity Hospital, Antwerp·Phase 1·NCT05506332·10 enrolled

Testing Oral Decitabine and Cedazuridine (ASTX727) in Combination With Venetoclax for Higher-Risk Acute Myeloid Leukemia Patients

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1/2·NCT04817241·5 enrolled

A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Terminated· AbbVie logo

AbbVie·Phase 1·NCT03484520·48 enrolled

Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia

Recruiting·SSt. Jude Children's Research Hospital·Phase 1·NCT06177067·24 enrolled

Testing a New Chemotherapy Drug, KRT-232 (AMG-232) in Combination With Decitabine and Venetoclax in Patients With Acute Myeloid Leukemia

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT03041688·58 enrolled

Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated

Terminated· Gilead logo

Gilead·Phase 3·NCT04778397·258 enrolled

Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure

Recruiting·BBrian Jonas·Phase 2·NCT04905810·20 enrolled

BLAST MRD AML-2: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Azacitidine and Venetoclax as Frontline Therapy in Unfit Patients With Acute Myeloid Leukemia

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04284787·60 enrolled

Chronic Lymphocytic Leukemia18 trials

Ibrutinib, Obinutuzumab and Venetoclax for Patients With Chronic Lymphocytic Leukemia

Completed·GGrupo Cooperativo de Hemopatías Malignas·Phase 2·NCT03755947·3 enrolled

Acalabrutinib, Venetoclax and Durvalumab for the Treatment of Richter Transformation From Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Recruiting·MMayo Clinic·Phase 2·NCT05388006·27 enrolled

Pharmacokinetics of Venetoclax in Patients With Chronic Lymphocytic Leukemia

Unknown status·NNational Taiwan University Hospital··NCT04616274·500 enrolled

Show 15 more trials

A Randomized Phase II Study Of Bruton Tyrosine Kinase Inhibitor With Or Without Venetoclax In Veterans With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Recruiting·VVA Office of Research and Development·Phase 2·NCT06520098·100 enrolled

Zanubrutinib and Venetoclax as Initial Therapy for Chronic Lymphocytic Leukemia (CLL) With Response-based Obinutuzumab

Active, not recruiting·WWeill Medical College of Cornell University·Phase 2·NCT05650723·50 enrolled

Evaluation of Risk-Adapted and MRD-Driven Strategy for Untreated Fit Patients With Intermediate Risk Chronic Lymphocytic Leukemia

Completed·FFrench Innovative Leukemia Organisation·Phase 2·NCT04010968·120 enrolled

Venetoclax and Obinutuzumab Followed by Epcoritamab for the Treatment of Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, LonGEVity Trial

Recruiting·—·Phase 2·NCT07218510·33 enrolled

Acalabrutinib in Combination With Venetoclax for the Treatment of Refractory or Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, The AVENUE-2 Trial

Recruiting·FFred Hutchinson Cancer Center·Phase 2·NCT04941716·20 enrolled

A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Completed· Roche logo

Roche·Phase 3·NCT02005471·389 enrolled

A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy

Completed· AbbVie logo

AbbVie·Phase 3·NCT03406156·120 enrolled

A Study of Venetoclax in Combination With Bendamustine + Rituximab or Bendamustine + Obinutuzumab in Participants With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Completed· Roche logo

Roche·Phase 1·NCT01671904·84 enrolled

Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax

Terminated·TTG Therapeutics, Inc.·Phase 2·NCT04016805·41 enrolled

Pirtobrutinib and Venetoclax With MRD Detection for Previously Untreated Chronic Lymphocytic Leukemia

Active, not recruiting·MMayo Clinic·Phase 2·NCT05677919·72 enrolled

Activity and Safety of Front-line Venetoclax and Rituximab in Young and Fit Patients With Chronic Lymphocytic Leukemia

Completed·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT03455517·77 enrolled

A Study to Evaluate the Effect of Venetoclax on Participants Receiving a Covalent Bruton's Tyrosine Kinase Inhibitor (cBTKi) for First-line Chronic Lymphocytic Leukemia (1L CLL) to Achieve Deep Durable Remissions to Allow Off-treatment Period

Active, not recruiting· Roche logo

Roche·Phase 2·NCT06524375·118 enrolled

Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04169737·168 enrolled

A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation

Completed· Roche logo

Roche·Phase 3·NCT04285567·166 enrolled

Atezolizumab, Obinutuzumab, and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Relapsed or Refractory Richter Syndrome

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT02846623·50 enrolled

Newly Diagnosed16 trials

Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants with Relapsed, Refractory, or Newly Diagnosed Cancers

Terminated·IIGM Biosciences, Inc.·Phase 1·NCT04553692·272 enrolled

A Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine in Adult Patients With Newly Diagnosed AML

Recruiting·SStichting Hemato-Oncologie voor Volwassenen Nederland·Phase 2·NCT06014489·142 enrolled

VAH vs VA in Newly Diagnosed Elderly AML

Not yet recruiting·SShanghai General Hospital, Shanghai Jiao Tong University School of Medicine·Phase 3·NCT07469046·308 enrolled

Show 13 more trials

Venetoclax Plus Azacitidine Versus Intensive Chemotherapy for Fit Patients With Newly Diagnosed NPM1 Mutated AML

Recruiting·TTechnische Universität Dresden·Phase 2·NCT05904106·146 enrolled

Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients

Recruiting·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT05376111·28 enrolled

Study of VA Combined With HAAG Regimen in Newly Diagnosed Intermediate and High-risk AML Patients

Recruiting·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT06394011·60 enrolled

Ivosidenib and Azacitidine With or Without Venetoclax in Adult Patients With Newly Diagnosed IDH1-Mutated AML or MDS/AML Considered Ineligible for Intensive Chemotherapy

Recruiting·SStichting Hemato-Oncologie voor Volwassenen Nederland·Phase 3·NCT07075016·227 enrolled

A Phase I/II Dose Escalation and Expansion Study of BST-236 Plus Venetoclax in Patients With Unfit Newly Diagnosed AML

Unknown status·BBioSight Ltd.·Phase 1/2·NCT05503355·80 enrolled

Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML

Recruiting·FFirst Affiliated Hospital of Zhejiang University·Phase 2·NCT06621199·42 enrolled

Clinical Trial to Assess the Safety and Tolerability of the Combination of Low-dose Cytarabine or Azacitidine Plus Venetoclax and Quizartinib in Newly Diagnosed AML Patients Aged Equal or More Than 60 Years Old

Unknown status·PPETHEMA Foundation·Phase 1/2·NCT04687761·84 enrolled

Venetoclax, Azacitidine, and Mitoxantrone Hydrochloride Liposome Versus Idarubicin and Cytarabine in Newly Diagnosed AML

Not yet recruiting·TThe First Affiliated Hospital of Soochow University·Phase 3·NCT07486479·204 enrolled

Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in Newly Diagnosed ETP-ALL

Recruiting·FFirst Affiliated Hospital of Zhejiang University·Phase 3·NCT06361329·81 enrolled

Chemotherapy-free Regimen of Venetoclax, Azacitidine Plus Orebatinib (VAO Regimen) for Newly Diagnosed ph+ALL

Recruiting·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT06578546·30 enrolled

APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML

Recruiting·AAptevo Therapeutics·Phase 1·NCT06634394·39 enrolled

Venetoclax + Azacytidine for Newly Diagnosed ETP-like ALL and T-ALL With Myeloid Mutations

Recruiting·Yyuejun Liu·Phase 2·NCT07012447·32 enrolled

Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·N/A·NCT07490288·30 enrolled

Relapsed/Refractory6 trials

Phase II Study to Evaluate Safety and Efficacy of CB-103 With Venetoclax in Adolescent and Young Adult Patients With Relapsed/Refractory T-ALL or T-LBL

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT05464836·2 enrolled

Venetoclax and Ibrutinib in Patients With Relapsed/Refractory CLL or SLL

Completed·SSteven E. Coutre·Phase 2·NCT03045328·22 enrolled

Acalabrutinib in Combination With Anti-CD20 and Venetoclax in Relapsed/Refractory or Untreated CLL/SLL/PLL

Completed·AAcerta Pharma BV·Phase 1·NCT02296918·69 enrolled

Show 3 more trials

A Study of Venetoclax and Rituximab/Hyaluronidase Human in Relapsed/Refractory CLL

Active, not recruiting·GGeorgetown University·Phase 2·NCT03467867·25 enrolled

CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory CLL

Completed·CCyclacel Pharmaceuticals, Inc.·Phase 1·NCT03739554·5 enrolled

Sequential Regimen of Bendamustin-Debulking Followed by Obinutuzumab, Acalabrutinib and Venetoclax in Patients with Relapsed/refractory CLL

Completed·GGerman CLL Study Group·Phase 2·NCT03787264·46 enrolled

Multiple Myeloma6 trials

A Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma

Terminated· AbbVie logo

AbbVie·Phase 2·NCT03567616·8 enrolled

A Study of Venetoclax Plus Lenalidomide and Dexamethasone for the Treatment of Newly Diagnosed t(11;14)-Positive Multiple Myeloma in Subjects Who Are Ineligible for High-Dose Therapy

Withdrawn· AbbVie logo

AbbVie·Phase 2·NCT03785184

Daratumumab, Bortezomib, and Dexamethasone With or Without Venetoclax in Treating Patients With Relapsed or Refractory Multiple Myeloma

Withdrawn·NNational Cancer Institute (NCI)·Phase 1/2·NCT03701321

Show 3 more trials

Ixazomib and Dexamethasone With or Without Venetoclax in Treating Patients With Non-t(11;14) Relapsed or Refractory Multiple Myeloma

Withdrawn·NNational Cancer Institute (NCI)·Phase 1/2·NCT03856112

Selinexor, Venetoclax, and Dexamethasone (XVenD) in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma

Recruiting·UUniversity of Miami·Phase 2·NCT05530421·33 enrolled

MC210808 Venetoclax in Combination With Lenalidomide and Dexamethasone (Ven-Rd), Daratumumab and Dexamethasone (Ven-Dd), or Daratumumab-Lenalidomide-Dexamethasone (Ven-DRd) for the Treatment of Multiple Myeloma

Recruiting·MMayo Clinic·Phase 1·NCT06042725·100 enrolled

69 more indications

Lymphoma6 trials

A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax Combined With Chemotherapy in Participants With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL

Completed· Roche logo

Roche·Phase 1/2·NCT02055820·267 enrolled

Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Recruiting·JJonsson Comprehensive Cancer Center·Phase 1/2·NCT06810778·12 enrolled

Loncastuximab Tesirine and Venetoclax for Relapsed/ Refractory Non-Hodgkin Lymphoma

Active, not recruiting·PPaolo Caimi, MD·Phase 1·NCT05053659·23 enrolled

Show 3 more trials

Study of Venetoclax Plus DA-EPOCH-R for the Treatment of Aggressive B-Cell Lymphomas

Completed·WWeill Medical College of Cornell University·Phase 1·NCT03036904·31 enrolled

Venetoclax and Romidepsin in Treating Patients With Recurrent or Refractory Mature T-Cell Lymphoma

Completed·—·Phase 2·NCT03534180·12 enrolled

Venetoclax in Combination With BEAM Conditioning Regimen for ASCT in Non-Hodgkin Lymphoma

Active, not recruiting·—·Phase 1·NCT03713580·25 enrolled

Treatment6 trials

Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of R/R AML

Recruiting·TThe First Affiliated Hospital of Xiamen University·Phase 2·NCT05305859·30 enrolled

Clinical Study Protocol for the Treatment of ND-AML and RR-AML With KMT2A Gene Abnormalities Using VHEA.

Recruiting·HHuai'an First People's Hospital·N/A·NCT06328179·34 enrolled

Clinical Study Protocol of Venetoclax Combined With Azacitidine and Harringtonine in the Treatment of sAML

Unknown status·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT05513131·30 enrolled

Show 3 more trials

REtreatment With VEnetoclax and Acalabrutinib After Venetoclax Limited Duration (REVEAL)

Recruiting·SStichting Hemato-Oncologie voor Volwassenen Nederland·Phase 2·NCT04523428·60 enrolled

Cirmtuzumab Consolidation for Treatment of Patients With Detectable CLL on Venetoclax

Active, not recruiting·UUniversity of California, San Diego·Phase 2·NCT04501939·5 enrolled

UPDATE AML: UPdated Disease Monitoring And Treatment for Enhanced Outcomes for Pediatric AML

Recruiting·JJoanna Yi·Phase 1·NCT07059975·36 enrolled

Myeloid Malignancies4 trials

Hypomethylating Agent and Venetoclax After Allo-HSCT in Patients With High-risk Myeloid Malignancies.

Recruiting·SShanghai General Hospital, Shanghai Jiao Tong University School of Medicine·Phase 2·NCT05841771·78 enrolled

APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies

Completed·AAprea Therapeutics·Phase 1·NCT04214860·51 enrolled

Venetoclax Plus RIC Regimen Allo-HSCT for Elderly Patients With High-risk Myeloid Malignancies

Unknown status·XXianmin Song, MD·Phase 2·NCT05583175·50 enrolled

Show 1 more trial

Study of Magrolimab Combinations in Participants With Myeloid Malignancies

Terminated· Gilead logo

Gilead·Phase 2·NCT04778410·54 enrolled

Hematologic Malignancies4 trials

Venetoclax Basket Trial for High Risk Hematologic Malignancies

Recruiting·—·Phase 1·NCT05292664·30 enrolled

A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies

Completed· AbbVie logo

AbbVie·Phase 1·NCT03082209·153 enrolled

Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT03471260·96 enrolled

Show 1 more trial

A Study of PRT2527 as Monotherapy and in Combination With Zanubrutinib or Venetoclax in Participants With R/R Hematologic Malignancies

Completed·PPrelude Therapeutics·Phase 1·NCT05665530·86 enrolled

Myelodysplastic Syndrome4 trials

Pembrolizumab and Decitabine With or Without Venetoclax in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome That Is Newly-Diagnosed, Recurrent, or Refractory

Recruiting·—·Phase 1·NCT03969446·54 enrolled

Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double and Triple Combination With Azacitidine and Venetoclax in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT06419634·105 enrolled

Venetoclax and Sequential Busulfan, Cladribine, and Fludarabine Phosphate Before Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT02250937·116 enrolled

Show 1 more trial

Azacitidine, Venetoclax, and Trametinib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndrome

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT04487106·21 enrolled

Diffuse Large B-Cell Lymphoma3 trials

A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL)

Completed· Roche logo

Roche·Phase 1/2·NCT02611323·133 enrolled

Rituximab, Venetoclax, and Bortezomib for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Withdrawn·RRutgers, The State University of New Jersey·Phase 2·NCT04285268

A Study of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Participants With Relapsed or Refractory (R/R) Follicular Lymphoma (FL) or Rituximab in Combination With Idasanutlin and Venetoclax in Participants With R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Terminated· Roche logo

Roche·Phase 1/2·NCT03135262·29 enrolled

T-cell acute lymphoblastic leukemia3 trials

Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)

Recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT06390319·100 enrolled

A Phase 2 Study to Evaluate Efficacy of Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and T- Cell Lymphoblastic Lymphoma (T-LLy)

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06561074·22 enrolled

Low-Intensity Chemotherapy and Venetoclax in Treating Patients With Relapsed or Refractory B- or T-Cell Acute Lymphoblastic Leukemia

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT03808610·50 enrolled

Efficacy and Safety3 trials

Efficacy and Safety of Venetoclax Combined With BEAM Pretreatment in Autologous Transplantation for DLBCL

Unknown status·RRuijin Hospital·N/A·NCT05863845·52 enrolled

Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Ph- B-ALL

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·N/A·NCT06481241·77 enrolled

Efficacy and Safety of TKI Combined With Chemotherapy and Sequential CAR-T Cells in ND Adult Patients With Ph+ ALL

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·N/A·NCT06481228·82 enrolled

Hematological Malignancies3 trials

Study Evaluating Venetoclax in Subjects With Hematological Malignancies

Completed· AbbVie logo

AbbVie·Phase 1/2·NCT02265731·38 enrolled

HEM-iSMART-A: Decitabine / Venetoclax and Navitoclax in Pediatric Patients With Relapsed or Refractory Hematological Malignancies

Withdrawn·PPrincess Maxima Center for Pediatric Oncology·Phase 1/2·NCT05740449

HEM-iSMART-B: Dasatinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relapsed or Refractory Hematological Malignancies

Recruiting·PPrincess Maxima Center for Pediatric Oncology·Phase 1/2·NCT05751044·26 enrolled

Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma3 trials

A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT04965493·600 enrolled

Venetoclax, Rituximab and Nivolumab in Combination for the Treatment of Richter's Transformation Arising From Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Withdrawn·NNorthwestern University·Phase 2·NCT06247540

Pirtobrutinib (LOXO-305) Consolidation for MRD Eradication in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL) Treated With Venetoclax

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT05317936·3 enrolled

Induction Therapy3 trials

A Clinical Study of VA-CAG as Induction Therapy in Newly Diagnosed AML Patients

Completed·HHematology department of the 920th hospital·Phase 2·NCT05662956·114 enrolled

Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML

Recruiting·—·Phase 2·NCT06221683·500 enrolled

Randomized Study of ABC-14 Regimen Compared With "3+7" Standard Induction Therapy or AB-14 for ND AML

Recruiting·GGuangdong Provincial People's Hospital·Phase 2·NCT06451861·240 enrolled

Acute Lymphoblastic Leukemia3 trials

Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax

Active, not recruiting·SSt. Jude Children's Research Hospital·Phase 1/2·NCT05192889·35 enrolled

CD19CD22 CAR-T Therapy in Patients With High-Risk B Acute Lymphoblastic Leukemia (B-ALL).

Unknown status·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT06078306·20 enrolled

Venetoclax, Ponatinib, and Dexamethasone in Participants With Philadelphia Chromosome or BCR-ABL Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT03576547·9 enrolled

Relapsed or Refractory2 trials

Alvocidib in Combination With Decitabine and Venetoclax in Patients With Relapsed or Refractory AML or as Frontline Therapy in Unfit Patients With AML

Withdrawn·MM.D. Anderson Cancer Center·Phase 1/2·NCT04493099

Venetoclax Treatment (26 Cycles) With 6 Cycles or 12 Cycles of Epcoritamab in Patients With Relapsed or Refractory CLL or SLL

Recruiting·SStichting Hemato-Oncologie voor Volwassenen Nederland·Phase 1/2·NCT05791409·112 enrolled

Myeloid Neoplasm2 trials

A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)

Recruiting· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 2/3·NCT04256317·316 enrolled

Combination Navitoclax, Venetoclax and Decitabine for Advanced Myeloid Neoplasms

Active, not recruiting·JJacqueline Garcia, MD·Phase 1·NCT05455294·16 enrolled

Mantle Cell Lymphoma2 trials

Venetoclax and Acalabrutinib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03946878·32 enrolled

Copanlisib and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Active, not recruiting·—·Phase 1/2·NCT04939272·8 enrolled

Acute Promyelocytic Leukemia2 trials

Venetoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients

Enrolling by invitation·TThe First Affiliated Hospital of Soochow University·Phase 2/3·NCT06544109·98 enrolled

Venetoclax Combined With ATRA and ATO in Hyperleukocytic Acute Promyelocytic Leukemia

Active, not recruiting·—·N/A·NCT07187505·28 enrolled

AML2 trials

Use of Venetoclax , AML , Sohag , Egypt

Completed·SSohag University··NCT06993883·43 enrolled

Venetoclax and Lintuzumab-Ac225 in AML Patients

Unknown status·AActinium Pharmaceuticals·Phase 1/2·NCT03867682·38 enrolled

Acute Leukemia2 trials

A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1)

Recruiting· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 1/2·NCT04988555·606 enrolled

Study of Azacitidine，Venetoclax，and Flumatinib in Newly Diagnosed Ph-positive Acute Leukemia and CML-AP/BP Patients

Completed·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT05433532·20 enrolled

Age2 trials

Venetoclax With High-dose Ibrutinib for CLL Progressing on Single Agent Ibrutinib

Active, not recruiting·MMichael Choi·Phase 1·NCT03422393·24 enrolled

Plasma Dosage of Venetoclax in the Fup of AML Patients Treated With Aza + Ven

Completed·—·N/A·NCT06030089·20 enrolled

Phase 12 trials

A Phase 1b-2 Trial to Assess Venetoclax and Navitoclax Consolidation and Post-transplant Maintenance in High-risk Patients With T-ALL

Not yet recruiting·IIsraeli Medical Association·Phase 1/2·NCT05054465·48 enrolled

Phase 1 Study of Shattuck Labs (SL)-172154 in Subjects With MDS or AML

Terminated·SShattuck Labs, Inc.·Phase 1·NCT05275439·106 enrolled

Chemotherapy2 trials

Trial in AML Secondary to MPNs Patients, Unfit for Intensive Chemotherapy, Investigating a Treatment Combination Including Decitabine and Venetoclax

Active, not recruiting·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT04763928·101 enrolled

CApivasertib, Venetoclax And Low-intensity chemotheRapY for Adults With ALL/LBL

Recruiting·UUniversity of Chicago·Phase 1/2·NCT07294677·104 enrolled

Allogeneic Hematopoietic Stem Cell Transplantation2 trials

Molecular Genetics Guide the Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation

Recruiting·RRuijin Hospital·Phase 2/3·NCT06972641·126 enrolled

Fludarabine Plus Melphalan Versus Addition of Venetoclax to Fludarabine/Melphalan Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation in AML/MDS Patients Aged > 50 Years: a Multicenter, Randomized, Phase 3 Trial

Recruiting·FFirst Affiliated Hospital of Zhejiang University·Phase 3·NCT07396480·186 enrolled

Elderly Patients2 trials

Venetoclax+HMA+Aclarubicin Versus Venetoclax+HMA in Treatment-Naive Elderly Patients With AML

Unknown status·TThe First Affiliated Hospital with Nanjing Medical University·Phase 3·NCT05264883·170 enrolled

Bcl-2 Inhibitors Combined With Azacytidine and Chemotherapy in Elderly Patients With Previously Untreated AML

Unknown status·LLanZhou University·N/A·NCT05053425·30 enrolled

Conditioning2 trials

VA Conditioning Regimen Allo-HSCT for Elderly Higher-risk MDS

Recruiting·NNavy General Hospital, Beijing·Phase 1/2·NCT06471946·54 enrolled

Venetoclax-Enhanced BUCY vs. Standard BUCY Conditioning in High-Risk AML and MDS Patients Undergoing Allo-HSCT (Ven-BUCY Study)

Recruiting·FFirst Affiliated Hospital of Zhejiang University·N/A·NCT07183878·138 enrolled

Efficacy2 trials

Efficacy of Low-dose Venetoclax With Itraconazole + TACL for R/R ALL Patients

Recruiting·HHospital Universitario Dr. Jose E. Gonzalez·Phase 2·NCT07039877·12 enrolled

Study to Evaluate Safety and Preliminary Efficacy of Tafasitamab With Idelalisib or Venetoclax in R/R CLL/SLL Patients Pretreated With BTKi

Completed·MMorphoSys AG·Phase 2·NCT02639910·24 enrolled

ESS2 trials

Expanded Access to Navitoclax

No longer available· AbbVie logo

AbbVie··NCT03592576

Expanded Access to Venetoclax

Available· AbbVie logo

AbbVie··NCT03123029

Leukemia2 trials

Pevonedistat, Azacitidine (or Decitabine), and Venetoclax for the Treatment of Patients With Acute Myelogenous Leukemia

Terminated·MMedical College of Wisconsin·Phase 1·NCT04172844·16 enrolled

A Study Evaluating Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Participants With Acute Myelogenous Leukemia

Completed· AbbVie logo

AbbVie·Phase 1/2·NCT02287233·94 enrolled

Blastic Plasmacytoid Dendritic Cell Neoplasm2 trials

Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04216524·40 enrolled

SL-401 in Combination With Azacitidine or Azacitidine/Venetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Recruiting·—·Phase 1·NCT03113643·72 enrolled

Frontline1 trial

Trial of Cladribine and Low-Dose Cytarabine (LoDAC) Alternating With Decitabine vs. Hypomethylating Agents (HMA) Plus Venetoclax as Frontline Therapy for AML or High-Grade MDS in Patients Unfit for Intensive Induction

Withdrawn·UUniversity of Florida·Phase 2·NCT05766514

CLL1 trial

Ibrutinib lead-in Followed by Venetoclax Plus Ibrutinib in Patients With RR CLL

Terminated·SSwiss Cancer Institute·Phase 2·NCT03708003·30 enrolled

Metastatic Colorectal Cancer1 trial

Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer

Recruiting·OOslo University Hospital·Phase 2·NCT05725200·40 enrolled

Targeted Therapy1 trial

FLT3-ITD Targeted Therapy in Fit AML Patients

Not yet recruiting·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2/3·NCT07425808·230 enrolled

Allogeneic Haematopoietic Stem Cell Transplantation1 trial

Venetoclax in Combination With Non-myeloablative Conditioning Allogeneic Haematopoietic Stem Cell Transplantation

Recruiting·MMelbourne Health·Phase 1·NCT05005299·18 enrolled

Outcome1 trial

Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS

Recruiting·MM.D. Anderson Cancer Center·Phase 2/3·NCT04708054·324 enrolled

Lymphoid Leukemia1 trial

Preemptive Therapy for High Risk Chronic Lymphoid Leukemia Stage A

Active, not recruiting·FFrench Innovative Leukemia Organisation·Phase 2·NCT03766763·82 enrolled

Chronic Myelogenous Leukemia1 trial

Decitabine, Venetoclax, and Ponatinib for the Treatment of Philadelphia Chromosome-Positive Acute Myeloid Leukemia or Myeloid Blast Phase or Accelerated Phase Chronic Myelogenous Leukemia

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04188405·20 enrolled

Follicular Lymphoma1 trial

Study of Lenalidomide, Venetoclax and Obinutuzumab in Patients With Treatment-Naïve Follicular Lymphoma

Active, not recruiting·PPeter MacCallum Cancer Centre, Australia·Phase 1/2·NCT03980171·50 enrolled

T-ALL1 trial

Venetoclax Based Regimen for R/R T-ALL

Completed·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT05149378·25 enrolled

Relapse1 trial

Venetoclax in Patients With MDS or AML in Relapse After AHSCT

Active, not recruiting·GGroupe Francophone des Myelodysplasies·Phase 1/2·NCT05226455·55 enrolled

Myelodysplastic/Myeloproliferative Neoplasm1 trial

Clinical Study of Venetoclax Combined With Azacytiside in the Treatment of Myelodysplastic/Myeloproliferative Neoplasms in Adults

Unknown status·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT05282719·33 enrolled

Recruiting·YYang Xiaotian·N/A·NCT06536010·50 enrolled

Macroglobulinemia1 trial

Efficacy of Venetoclax in Combination With Rituximab in Waldenström's Macroglobulinemia

Recruiting·CChristian Buske·Phase 2·NCT05099471·80 enrolled

Maintenance Therapy1 trial

VA as Maintenance Therapy Post Allo-HSCT in MDS and AML

Not yet recruiting·NNavy General Hospital, Beijing·Phase 2·NCT06598384·40 enrolled

HSCT1 trial

Venetoclax and Azacitidine Combined With Homoharringtonine, Followed by Allo-HSCT for Intermediate and High-risk AML.

Recruiting·SShanghai General Hospital, Shanghai Jiao Tong University School of Medicine·Phase 2·NCT06483906·56 enrolled

Prevention1 trial

Efficacy of Venetoclax Based Regimen in Prevention Relapse of Consecutive MRD Positive AML Patients

Terminated·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT05361057·20 enrolled

Myeloma1 trial

Myeloma-Developing Regimens Using Genomics (MyDRUG)

Completed·MMultiple Myeloma Research Consortium·Phase 1/2·NCT03732703·103 enrolled

Consolidation Therapy1 trial

Clinical Study Protocol of IAV-induced Remission Followed by Consolidation Therapy With MDCyta+Ven in ND-AML

Recruiting·TThe First Affiliated Hospital with Nanjing Medical University·N/A·NCT06232694·54 enrolled

Elective1 trial

A Study Of The Selective PKC-β Inhibitor MS- 553

Terminated·MMingSight Pharmaceuticals, Inc·Phase 1/2·NCT03492125·60 enrolled

Azacytidine1 trial

Study of Venetoclax in Combination With Azacytidine in AML Patients Selected Using Ex Vivo Drug Sensitivity Screening

Completed·HHelsinki University Central Hospital·Phase 2·NCT04267081·104 enrolled

Lymphoid Malignancies1 trial

Study of VIP152, Venetoclax, and Prednisone (VVIP) in Relapsed/Refractory Lymphoid Malignancies

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT05371054·8 enrolled

Chronic Myelomonocytic Leukemia1 trial

Azacitidine Combined With Venetoclax in Patients With Higher-risk Chronic Myelomonocytic Leukemia (AVENHIR)

Active, not recruiting·GGroupe Francophone des Myelodysplasies·Phase 2·NCT05768711·44 enrolled

Elderly1 trial

Shortened Venetoclax Duration Based on Day 14 BM Blasts Versus Standard Therapy in Elderly or Frail Patients With AML Patients Treated With Azacitidine Plus Venetoclax

Not yet recruiting·PPeking University People's Hospital·Phase 3·NCT07407660·250 enrolled

Myelodysplastic Syndromes1 trial

A Study Evaluating Venetoclax in Combination With Azacitidine in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

Active, not recruiting· AbbVie logo

AbbVie·Phase 1·NCT02942290·129 enrolled

Relapsed AML1 trial

Imetelstat Combinations in Relapsed AML

Recruiting·UUnknown Sponsor·Phase 1·NCT07320235·36 enrolled

B-cell Malignancies1 trial

Venetoclax With Obinutuzumab and Magrolimab (VENOM) in Relapsed and Refractory Indolent B-cell Malignancies

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT04599634·11 enrolled

Acute Leukemia of Ambiguous Lineage1 trial

Immune-targeted Combination With Chemotherapy for Acute Leukemia of Ambiguous Lineage

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·N/A·NCT06991920·50 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With AML

Unknown status·—·Phase 2·NCT06105658·20 enrolled

Trial1 trial

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03878524·2 enrolled

Cancer1 trial

Testing the Combination of an Anti-Cancer Drug, Iadademstat, With Other Anti-Cancer Drugs (Venetoclax and Azacitidine) for Treating AML

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT06514261·45 enrolled

Pilot Study1 trial

Pilot Study of Reduced Venetoclax Exposure

Recruiting·NNorthwell Health·Phase 2·NCT07163793·41 enrolled

High Risk CLL1 trial

A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL

Recruiting·GGerman CLL Study Group·Phase 3·NCT05197192·202 enrolled

Blinatumomab1 trial

Blinatumomab Plus Venetoclax Sequenced With Inotuzumab Ozogamicin in Treating B-ALL

Recruiting·FFirst Affiliated Hospital of Zhejiang University·Phase 2·NCT06554626·20 enrolled

Small Cell Lung Cancer1 trial

A Study Evaluating The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Venetoclax In Combination With Atezolizumab, Carboplatin, And Etoposide In Participants With Untreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC).

Terminated· Roche logo

Roche·Phase 1·NCT04422210·2 enrolled

Breast Cancer1 trial

Palbociclib, Letrozole & Venetoclax in ER and BCL-2 Positive Breast Cancer

Active, not recruiting·PPeter MacCallum Cancer Centre, Australia·Phase 1·NCT03900884·17 enrolled

Female1 trial

A Study to Assess Food Effect of Venetoclax New Tablet Formulation in Healthy Female Participants

Withdrawn· AbbVie logo

AbbVie·Phase 1·NCT06070948

Pediatric1 trial

Newly-diagnosed Pediatric T-cell ALL Protocol

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2/3·NCT06855810·610 enrolled

T-Cell Prolymphocytic Leukemia1 trial

A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia

Completed· AbbVie logo

AbbVie·Phase 2·NCT03873493·14 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 11, 2016

VENCLEXTA

NDA NDA208573

Sources

References

[1]
ClinicalTrials.gov — 612 trial records for Venetoclax. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Venclexta drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Venetoclax compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Venetoclax. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA208573). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Venclexta. U.S. Food & Drug Administration.
[7]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Apoptosis Regulator Bcl-2 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AbbVie

Patent Landscape[6]

Patent Cliff

May 26, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9174982May 26, 2030

8546399Jun 27, 2031

10730873Nov 21, 2031

8722657Jan 29, 2032

11369599May 23, 2032

5 more patents

11110087Sep 6, 2033

11413282Sep 6, 2033

11590128Sep 6, 2033

10993942Sep 6, 2033

9539251Sep 6, 2033

Venclexta

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Trials by Indication[1]

Acute Myeloid Leukemia36 trials

Chronic Lymphocytic Leukemia18 trials

Newly Diagnosed16 trials

Relapsed/Refractory6 trials

Multiple Myeloma6 trials

Lymphoma6 trials

Treatment6 trials

Myeloid Malignancies4 trials

Hematologic Malignancies4 trials

Myelodysplastic Syndrome4 trials

Diffuse Large B-Cell Lymphoma3 trials

T-cell acute lymphoblastic leukemia3 trials

Efficacy and Safety3 trials

Hematological Malignancies3 trials

Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma3 trials

Induction Therapy3 trials

Acute Lymphoblastic Leukemia3 trials

Relapsed or Refractory2 trials

Myeloid Neoplasm2 trials

Mantle Cell Lymphoma2 trials

Acute Promyelocytic Leukemia2 trials

AML2 trials

Acute Leukemia2 trials

Age2 trials

Phase 12 trials

Chemotherapy2 trials

Allogeneic Hematopoietic Stem Cell Transplantation2 trials

Elderly Patients2 trials

Conditioning2 trials

Efficacy2 trials

ESS2 trials

Leukemia2 trials

Blastic Plasmacytoid Dendritic Cell Neoplasm2 trials

Frontline1 trial

CLL1 trial

Metastatic Colorectal Cancer1 trial

Targeted Therapy1 trial

Allogeneic Haematopoietic Stem Cell Transplantation1 trial

Outcome1 trial

Lymphoid Leukemia1 trial

Chronic Myelogenous Leukemia1 trial

Follicular Lymphoma1 trial

T-ALL1 trial

Relapse1 trial

Myelodysplastic/Myeloproliferative Neoplasm1 trial

Prospective1 trial

Monotherapy1 trial

Clinical Trial1 trial

Macroglobulinemia1 trial

Maintenance Therapy1 trial

HSCT1 trial

Prevention1 trial

Myeloma1 trial

Consolidation Therapy1 trial

Elective1 trial

Azacytidine1 trial

Lymphoid Malignancies1 trial

Chronic Myelomonocytic Leukemia1 trial

Elderly1 trial

Myelodysplastic Syndromes1 trial

Relapsed AML1 trial

B-cell Malignancies1 trial

Acute Leukemia of Ambiguous Lineage1 trial

Safety and Efficacy1 trial

Trial1 trial

Cancer1 trial

Pilot Study1 trial

High Risk CLL1 trial

Blinatumomab1 trial

Small Cell Lung Cancer1 trial

Breast Cancer1 trial

Female1 trial

Pediatric1 trial