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 133 indications[4].[1]

Venclexta is one of 1237 small molecule programs targeting Acute Myeloid Leukemia. It is currently in Approved.

133

Indications

629

Total Trials

103

Active Trials

1,236

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Acute Myeloid LeukemiaActive, not recruiting

Diffuse Large B-Cell LymphomaCompleted

Chronic Lymphocytic LeukemiaCompleted

AmyloidosisActive, not recruiting

Acute LeukemiaRecruiting

LymphomaCompleted

Chronic Lymphocytic Leukemia (CLL)Recruiting

Myeloproliferative DisorderApproved

Cutaneous T-Cell LymphomaApproved

Acute Myeloid LeukemiaApproved

Active, not recruiting

Diffuse Large B-Cell LymphomaPhase 2

Completed

Chronic Lymphocytic LeukemiaPhase 3

Completed

AmyloidosisPhase 2

Active, not recruiting

Acute LeukemiaPhase 2

Recruiting

LymphomaPhase 2

Completed

Chronic Lymphocytic Leukemia (CLL)Phase 2

Recruiting

Myeloproliferative DisorderApproved

Approved

Cutaneous T-Cell LymphomaApproved

Approved

Showing 10 of 133 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Venclexta

AbbVie

Approved

4 2

Adenocard

Astellas

Preclinical

2 3

Zolymbus

AbbVie

Preclinical

1 4

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 5

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 6

Spravato

WWim Janssens

Preclinical

2 7

Duragesic

CCephalon

Preclinical

1 8

Acupan

YYonsei University

Preclinical

1 9

Chantix

PPrism Pharmaceuticals

Preclinical

1 10

Nubain

AAultman Health Foundation

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

T-Cell Acute Lymphoblastic Leukemia

NCT05268003

Phase 1Recruiting

Acute Myeloid Leukemia

NCT05506332

Phase 2Active, not recruiting

Richter Transformation

NCT04082897

Phase 2Active, not recruiting

Relapsed/refractory

NCT03467867

Phase 1Recruiting

Acute Lymphoblastic Leukemia

NCT04872790

Phase 1Active, not recruiting

B-ALL

NCT05016947

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia43 trials

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

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

Venetoclax Combined With Azacitidine and CAG in Refractory/Relapse Acute Myeloid Leukemia

Unknown status·HHematology department of the 920th hospital·Phase 2·NCT05807347·42 enrolled

A Study of Oral Venetoclax Tablets and Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT04102020·112 enrolled

Show 40 more trials

A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia

Completed· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals·Phase 1·NCT04075747·57 enrolled

Regorafenib in Combination With Venetoclax and Azacitidine for the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia

Suspended·—·Phase 1·NCT06454409·20 enrolled

Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03629171·52 enrolled

A Multi-Site Break Through Cancer Trial: Targeting Measurable Residual Disease in Patients With Acute Myeloid Leukemia: A Phase 1/2 Study of Tagraxofusp, Azacitidine, and Venetoclax

Recruiting·JJacqueline Garcia, MD·Phase 1/2·NCT07148180·31 enrolled

Safety and Efficacy of Venetoclax With Escalating Doses of Omacetaxine in Patients With Acute Myeloid Leukemia Safety and Efficacy of Venetoclax With Escalating Doses of Omacetaxine in Patients With Acute Myeloid Leukemia (AML)

Completed·UUniversity of Illinois at Chicago·Phase 1·NCT04926285·6 enrolled

Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Recruiting·AAptose Biosciences Inc.·Phase 1/2·NCT03850574·240 enrolled

Mitoxantrone Hydrochloride Liposome Combined With Chemotherapy in Untreated de Novo Acute Myeloid Leukemia

Completed·IInstitute of Hematology & Blood Diseases Hospital, China·N/A·NCT05941585·60 enrolled

STAT Inhibitor OPB-111077, Decitabine and Venetoclax in Treating Patients With Acute Myeloid Leukemia That Is Refractory, Relapsed or Newly Diagnosed and Ineligible for Intensive Chemotherapy

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 1·NCT03063944·37 enrolled

Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia

Terminated· Gilead logo

Gilead·Phase 3·NCT05079230·378 enrolled

Study to Assess Adverse Events and Change in Disease State of Oral Venetoclax in Combination With Subcutaneous (SC) Azacitidine in Newly Diagnosed Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy in China

Active, not recruiting· AbbVie logo

AbbVie·Phase 4·NCT05144243·44 enrolled

Decitabine and Cedazuridine in Combination With Venetoclax for the Treatment of Patients Who Have Relapsed Acute Myeloid Leukemia After Donor Stem Cell Transplant

Terminated·SSanjay Mohan·Phase 2·NCT05799079·1 enrolled

A Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Chemotherapy.

Terminated· Novartis logo

Novartis·Phase 1·NCT05155709·14 enrolled

Comparison of VA and D/IA Induction Regimens in Elderly Fit Acute Myeloid Leukemia Patients

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 3·NCT07132684·240 enrolled

Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 Nanoparticles as Monotherapy or in Combination in Acute Myeloid Leukemia Participants.

Terminated· AstraZeneca logo

AstraZeneca·Phase 1·NCT03217838·50 enrolled

A Study of Azacitidine and Venetoclax in People With Acute Myeloid Leukemia (AML)

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06773208·30 enrolled

A Safety, Tolerability and Preliminary Efficacy Study of CC-90011 in Combination With Venetoclax and Azacitidine in R/R Acute Myeloid Leukemia and Treatment-naïve Participants Not Eligible for Intensive Therapy

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04748848·1 enrolled

FHD-286 With Low-Dose Weekly Decitabine/Venetoclax in Patients With Acute Myeloid Leukemia

Recruiting·MMontefiore Medical Center·Phase 1·NCT07283094·33 enrolled

Assessing PI3K Gamma Inhibition With Azacitidine, Venetoclax and Eganelisib in Patients With Acute Myeloid Leukemia

Not yet recruiting·JJacqueline Garcia, MD·Phase 1·NCT07439211·48 enrolled

A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)

Terminated· AbbVie logo

AbbVie·Phase 3·NCT04161885·465 enrolled

A Multicenter Trial Evaluating Efficacy and Safety of A Reduced Venetoclax Exposure To Seven Days Versus Standard Continuous Venetoclax Exposure Combined With Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Intensive Induction

Not yet recruiting·GGustave Roussy, Cancer Campus, Grand Paris·Phase 3·NCT07082452·262 enrolled

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

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

Safety and Efficacy of Venetoclax, Cytarabine and Metformin (VenCM) for Relapsed-Refractory and Induction-Ineligible Acute Myeloid Leukemia

Recruiting·—·Phase 2·NCT06537843·100 enrolled

Tamibarotene Plus Venetoclax/Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Terminated·SSyros Pharmaceuticals·Phase 2·NCT04905407·66 enrolled

Mitoxantrone for Venetoclax Resistant Acute Myeloid Leukemia

Recruiting·UUniversity of Colorado, Denver·Phase 1·NCT06429449·30 enrolled

A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04887857·6 enrolled

A Study of Oral Venetoclax Tablet in Combination With Subcutaneous Low-Dose Cytarabine (LDAC) Injection to Assess Adverse Events in Adult Japanese Participants With Acute Myeloid Leukemia (AML)

Completed· AbbVie logo

AbbVie·Phase 3·NCT04509622·14 enrolled

A Phase I Study Investigating the Combination of the Menin Inhibitor Ziftomenib With Venetoclax and Gemtuzumab in Pediatric Patients With Acute Myeloid Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT06448013·22 enrolled

Salsalate, Venetoclax, and Decitabine or Azacitidine for the Treatment of Acute Myeloid Leukemia or Advanced Myelodysplasia/Myeloproliferative Disease

Completed·RRutgers, The State University of New Jersey·Phase 2·NCT04146038·5 enrolled

Chidamide, Venetoclax, and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·N/A·NCT06386302·184 enrolled

IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia

Active, not recruiting· AbbVie logo

AbbVie·Phase 1/2·NCT04086264·218 enrolled

A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT02993523·443 enrolled

A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

Completed· AbbVie logo

AbbVie·Phase 3·NCT03069352·211 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

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

Completed· AbbVie logo

AbbVie·Phase 1·NCT03441555·36 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

Chronic Lymphocytic Leukemia16 trials

Trabectedin and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Resistant or Intolerant to a BTK Inhibitor

Withdrawn·MM.D. Anderson Cancer Center·Phase 1·NCT03884972

Venetoclax, Rituximab and Ibrutinib in TN Patients With CLL Undetectable Minimal Residual Disease (uMRD) in Treatment-naïve Patients With Chronic Lymphocytic Leukemia (CLL)

Recruiting·PPaolo Ghia·Phase 2·NCT04758975·55 enrolled

Roginolisib (IOA-244) With Venetoclax and Rituximab for Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL)

Recruiting·—·Phase 1/2·NCT06644183·64 enrolled

Show 13 more trials

A Study Evaluating the Impact of Venetoclax on the Quality of Life for Subjects With Relapsed (Your Cancer Has Come Back) or Refractory (no Response to Previous Cancer Treatments) Chronic Lymphocytic Leukemia (CLL) While Receiving Venetoclax Monotherapy (a Single Agent).

Completed· AbbVie logo

AbbVie·Phase 3·NCT02980731·210 enrolled

Standard Chemoimmunotherapy (FCR/BR) Versus Rituximab + Venetoclax (RVe) Versus Obinutuzumab (GA101) + Venetoclax (GVe) Versus Obinutuzumab + Ibrutinib + Venetoclax (GIVe) in Fit Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without Del(17p) or TP53 Mutation

Completed·GGerman CLL Study Group·Phase 3·NCT02950051·926 enrolled

Ibrutinib and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia After Ibrutinib Resistance

Withdrawn·KKerry Rogers·Phase 2·NCT03943342

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

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

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

Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Richter Transformation (RT)

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05536349·60 enrolled

Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax in Combination With Intravenous (IV) Obinutuzumab or Oral Ibrutinib in Adult Participants With Untreated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Completed· AbbVie logo

AbbVie·Phase 2·NCT05105841·20 enrolled

Pharmacokinetics of Venetoclax in Patients With Chronic Lymphocytic Leukemia

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

A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia (CLL) Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy

Completed· AbbVie logo

AbbVie·Phase 2·NCT02141282·127 enrolled

Observational Study Relapsed or Refractory Chronic Lymphocytic Leukemia Venetoclax-based Regimens Outside Clinical Trials in Italy

Recruiting·GGruppo Italiano Malattie EMatologiche dell'Adulto··NCT04282811·321 enrolled

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

Lymphoma12 trials

Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04739813·55 enrolled

A Study to Evaluate Safety, Pharmacokinetics, and Clinical Activity of Combination of RO6870810 and Venetoclax, With or Without Rituximab, in Participants With Relapsed/Refractory DLBCL and/or High-Grade B-Cell Lymphoma and/or High Grade B-Cell Lymphoma With MYC and/or BCL2 and/or BCL6

Completed· Roche logo

Roche·Phase 1·NCT03255096·39 enrolled

Venetoclax, Carmustine, Etoposide, Cytarabine, and Melphalan Before Stem Cell Transplant in Treating Participants With Relapsed or Refractory Non-Hodgkin Lymphoma

Completed·OOhio State University Comprehensive Cancer Center·Phase 1/2·NCT03583424·19 enrolled

Show 9 more trials

A Study Evaluating the Safety and Efficacy of Venetoclax (GDC-0199) Plus Bendamustine + Rituximab (BR) in Comparison With BR or Venetoclax Plus Rituximab in Participants With Relapsed and Refractory Follicular Non-Hodgkin's Lymphoma (fNHL)

Completed· Roche logo

Roche·Phase 2·NCT02187861·163 enrolled

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

A Prospective Clinical Study of Bridging alloHSCT After Treatment With Obinutuzumab in Combination With Chidamide and Venetoclax in RR Ph-ALL and B-cell Lymphoma Patients

Unknown status·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 1/2·NCT06087419·42 enrolled

Study to Assess the Safety, Tolerability and Pharmacokinetics of Fimepinostat (CUDC-907) in Patients With Lymphoma

Completed·CCuris, Inc.·Phase 1·NCT01742988·106 enrolled

An Early Phase Study of Venetoclax, Lenalidomide, and Rituximab/Hyaluronidase in Slow-Growing Lymphomas That Have Come Back After Treatment or Have Not Responded to Treatment

Active, not recruiting·TThomas Jefferson University·Phase 1·NCT04447716·4 enrolled

Rituximab Plus Venetoclax in Front Line Marginal Zone Lymphoma

Recruiting·GGottfried von Keudell, MD PhD·Phase 2·NCT06510309·33 enrolled

A Study of TAK-659 in Combination With Venetoclax for Adult Participants With Previously Treated Non-Hodgkin Lymphoma

Completed·CCalithera Biosciences, Inc·Phase 1·NCT03357627·43 enrolled

Tazemetostat and Venetoclax in Relapsed/Refractory Non-Hodgkin Lymphoma

Recruiting·WWeill Medical College of Cornell University·Phase 1·NCT05618366·38 enrolled

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

Mantle Cell Lymphoma9 trials

Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

Recruiting·—·Phase 1/2·NCT03523975·28 enrolled

Polatuzumab Vedotin, Venetoclax, and Rituximab and Hyaluronidase Human for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Terminated·—·Phase 2·NCT04659044·3 enrolled

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05529069·30 enrolled

Show 6 more trials

Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL)

Completed·PPharmacyclics LLC.·Phase 3·NCT03112174·366 enrolled

Phase II Trial of Venetoclax and Rituximab as Initial Therapy in Older Patients With Mantle Cell Lymphoma

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT05025423·7 enrolled

Genetically Risk-Stratified Venetoclax, Ibrutinib, Rituximab (± Navitoclax) in Relapsed/Refractory Mantle Cell Lymphoma

Active, not recruiting·PPeter MacCallum Cancer Centre, Australia·Phase 2·NCT05864742·40 enrolled

Venetoclax and Eprenetapopt for the Treatment of Relapsed of Refractory Mantle Cell Lymphoma

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT04990778

Tafasitamab, Lenalidomide and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Recruiting·—·Phase 2·NCT05910801·100 enrolled

Ibrutinib, Rituximab, Venetoclax, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03710772·51 enrolled

Newly Diagnosed9 trials

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

Low-dose Venetoclax and Azacitidine as Front-line Therapy in Newly Diagnosed AML

Completed·HHospital Universitario Dr. Jose E. Gonzalez·Phase 2·NCT05048615·15 enrolled

Venetoclax-containing Therapy Combined With Microtransplant for Newly Diagnosed AML

Recruiting·—·Phase 2·NCT07078591·50 enrolled

Show 6 more trials

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

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

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 Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy

Recruiting·OOncoVerity, Inc.·Phase 2·NCT06384261·120 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

63 more indications

Myelodysplastic Syndrome8 trials

Navitoclax in Relapsed or Refractory High-Risk Myelodysplastic Syndrome

Active, not recruiting·TThomas Jefferson University·Phase 1·NCT05564650·6 enrolled

Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome

Terminated· AbbVie logo

AbbVie·Phase 1·NCT04912063·40 enrolled

Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT02115295·508 enrolled

Show 5 more trials

Dose Escalation/ Expansion Study of CA-4948 as Monotherapy in Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Suspended·CCuris, Inc.·Phase 1/2·NCT04278768·366 enrolled

HDM201 in Combination With MBG453 or Venetoclax in Patients With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS)

Terminated· Novartis logo

Novartis·Phase 1·NCT03940352·52 enrolled

Venetoclax and Azacitidine for Treatment of Therapy Related or Secondary Myelodysplastic Syndrome

Active, not recruiting·UUma Borate·Phase 2·NCT05379166·33 enrolled

Venetoclax and Decitabine in Treating Participants With Relapsed/Refractory Acute Myeloid Leukemia or Relapsed High-Risk Myelodysplastic Syndrome

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT03404193·235 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

Multiple Myeloma7 trials

A Study Evaluating Venetoclax (ABT-199) in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy

Completed· AbbVie logo

AbbVie·Phase 3·NCT02755597·291 enrolled

A Study of Cobimetinib Administered as Single Agent and in Combination With Venetoclax, With or Without Atezolizumab, in Participants With Relapsed and Refractory Multiple Myeloma

Completed· Roche logo

Roche·Phase 1/2·NCT03312530·49 enrolled

A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractory Multiple Myeloma

Active, not recruiting· AbbVie logo

AbbVie·Phase 2·NCT03314181·156 enrolled

Show 4 more trials

A Study of Venetoclax in Combination With Isatuximab and Dexamethasone for Relapsed/Refractory Multiple Myeloma

Recruiting·OOncotherapeutics·Phase 2·NCT06115135·39 enrolled

A Study Designed to Evaluate the Safety and Efficacy of Venetoclax Plus Dexamethasone (VenDex) Compared With Pomalidomide Plus Dexamethasone (PomDex) in Participants With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma.

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT03539744·265 enrolled

Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (MM)

Active, not recruiting· AbbVie logo

AbbVie·Phase 2·NCT02899052·120 enrolled

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

Relapsed/Refractory6 trials

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

Venetoclax and Irinotecan in Relapsed/Refractory SCLC

Withdrawn·VVirginia Commonwealth University·Phase 1/2·NCT04543916

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

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

Show 3 more trials

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

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

Efficacy and Safety6 trials

A Study Comparing the Efficacy and Safety of Pola-RCHP-X Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With DLBCL

Not yet recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT06516978·528 enrolled

Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V)

Terminated·TTG Therapeutics, Inc.·Phase 2/3·NCT03801525·277 enrolled

Efficacy and Safety of Venetoclax Combined With Dexamethasone and Etoposide in HLH

Unknown status·—·Phase 1·NCT05546060·20 enrolled

Show 3 more trials

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

The Efficacy and Safety of Third-generation TKIs Combined With Azacitidine and Bcl-2 Inhibitor in Patients With CML-MBP

Recruiting·PPeking University People's Hospital··NCT06390306·30 enrolled

Efficacy and Safety of HMAs Combined With Venetoclax Versus HMAs Alone in ND Int-and H-risk MDS or CMML

Active, not recruiting·GGuangdong Provincial People's Hospital··NCT07318662·224 enrolled

Acute Lymphoblastic Leukemia5 trials

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, Dasatinib, Prednisone, Rituximab and Blinatumomab for the Treatment of Newly Diagnosed or Relapsed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia

Recruiting·OOHSU Knight Cancer Institute·Phase 1·NCT04872790·20 enrolled

A Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma

Completed· AbbVie logo

AbbVie·Phase 1·NCT03181126·69 enrolled

Show 2 more trials

A Study of Venetoclax in Combination With Chemotherapy to Treat Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT05386576·12 enrolled

Venetoclax and a Pediatric-Inspired Regimen for the Treatment of Newly Diagnosed B Cell Acute Lymphoblastic Leukemia

Recruiting·—·Phase 1·NCT05157971·24 enrolled

Treatment5 trials

Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment

Recruiting·RRuijin Hospital·Phase 3·NCT06496308·78 enrolled

Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment

Recruiting·TTechnische Universität Dresden·Phase 2·NCT06696183·60 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

Show 2 more trials

Mitoxantrone Hydrochloride Liposome Injection, Cytarabine Combined With Venetoclax in the Treatment of R/R AML

Recruiting·FFirst Affiliated Hospital of Zhejiang University·Phase 2·NCT06434662·34 enrolled

A Trial of CPX-351 Lower Intensity Therapy (LIT) Plus Venetoclax as First Line Treatment for Subjects With AML

Completed· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals·Phase 1·NCT04038437·35 enrolled

Hematologic Malignancies4 trials

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

A Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies

Terminated· AbbVie logo

AbbVie·Phase 1·NCT03797261·9 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

Show 1 more trial

Venetoclax Basket Trial for High Risk Hematologic Malignancies

Recruiting·—·Phase 1·NCT05292664·30 enrolled

CLL3 trials

Venetoclax-Obinutuzumab +/- Acalabrutinib in R/R CLL

Recruiting·MMassachusetts General Hospital·Phase 2·NCT04560322·40 enrolled

Safe Accelerated Venetoclax Escalation in CLL

Active, not recruiting·—·Phase 1·NCT04843904·40 enrolled

Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL

Withdrawn·MMEI Pharma, Inc.·Phase 2·NCT05209308

Relapsed or Refractory3 trials

Combination of Obinutuzumab and Venetoclax in Relapsed or Refractory DLBCL

Completed·AArbeitsgemeinschaft medikamentoese Tumortherapie·Phase 2·NCT02987400·22 enrolled

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

Duvelisib and Venetoclax in Relapsed or Refractory CLL or SLL or RS

Active, not recruiting·—·Phase 1/2·NCT03534323·55 enrolled

Elderly Patients2 trials

Rituximab, Bendamustine and Cytarabine Followed by Venetoclax in High Risk Elderly Patients With MCL

Completed·FFondazione Italiana Linfomi - ETS·Phase 2·NCT03567876·141 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

Safety and Efficacy2 trials

Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With Higher-risk MDS

Unknown status·—·Phase 2·NCT06109064·14 enrolled

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

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

Trial2 trials

Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage

Terminated·DDelta-Fly Pharma, Inc.·Phase 3·NCT03926624·167 enrolled

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

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

Breast Cancer2 trials

A Study to Evaluate the Safety and Tolerability of Venetoclax Tablets in Combination With Capecitabine Tablets in Adult Participants With Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Had Disease Progression During or After CDK4/6 Inhibitor Therapy

Terminated· AbbVie logo

AbbVie·Phase 1·NCT04274933·4 enrolled

A Phase II Study Comparing The Efficacy Of Venetoclax + Fulvestrant Vs. Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy

Terminated· Roche logo

Roche·Phase 2·NCT03584009·103 enrolled

Leukemia2 trials

Trial of Novel Anti-leukemia Agents in Flu/Mel RIC Transplant for Myeloid Malignancies

Recruiting·UUniversity of Alabama at Birmingham·Phase 1·NCT07044544·20 enrolled

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

Relapsed/Refractory AML2 trials

CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory AML or MDS

Completed·CCyclacel Pharmaceuticals, Inc.·Phase 1·NCT04017546·14 enrolled

CLAG+VEN vs CLAG in the Treatment of Relapsed/Refractory AML

Not yet recruiting·NNanfang Hospital, Southern Medical University·Phase 4·NCT06763666·172 enrolled

Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma2 trials

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

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

Acute Promyelocytic Leukemia2 trials

Venetoclax Combined With ATRA and ATO in Hyperleukocytic Acute Promyelocytic Leukemia

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

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

Acute Leukemia2 trials

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

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

Chronic Myelomonocytic Leukemia2 trials

A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05365035·60 enrolled

Venetoclax and Azacitidine for the Treatment of Relapsed or Refractory High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT04550442·34 enrolled

T-cell acute lymphoblastic leukemia1 trial

A Phase II Study of the Combination of Ponatinib With Mini-hyper CVD Chemotherapy and Venetoclax in Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05268003·26 enrolled

Blastic Plasmacytoid Dendritic Cell Neoplasm1 trial

Study of Venetoclax, a BCL2 Antagonist, for Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Completed·—·Phase 1·NCT03485547·5 enrolled

TED1 trial

Ibrutinib + Venetoclax in Untreated WM

Active, not recruiting·—·Phase 2·NCT04273139·45 enrolled

Follicular Lymphoma1 trial

Ibrutinib and Venetoclax in Relapsed and Refractory Follicular Lymphoma

Completed·GGeorgetown University·Phase 1/2·NCT02956382·24 enrolled

Olverembatinib1 trial

Olverembatinib Combined With Venetoclax and Azacitidine in Blast Phase Ph Chromosome-positive CML

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 1/2·NCT06757855·29 enrolled

MDS1 trial

Venetoclax-containing Therapy Combined With Microtransplant for Intermediate-risk and Higher MDS

Recruiting·—·Phase 2·NCT07238686·40 enrolled

Impaired Renal Function1 trial

Study to Assess Adverse Events and the Movement of Oral Venetoclax Tablet Through the Body of Female Participants Aged 18-75 Years With Impaired Renal Function

Completed· AbbVie logo

AbbVie·Phase 1·NCT04810598·12 enrolled

Transplantation1 trial

Microtransplantation Combined With Azacytidine to Improve the Efficacy of EAML

Unknown status·Gguomei·N/A·NCT05262465·300 enrolled

MDS/AML1 trial

A Study to Evaluate S227928 as a Single Agent and in Combination With Venetoclax in Patients With R/R AML, MDS/AML, or CMML

Terminated·SServier Bio-Innovation LLC·Phase 1/2·NCT06563804·13 enrolled

Chronic Lymphocytic Leukaemia (CLL)1 trial

Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL)

Active, not recruiting·GGerman CLL Study Group·Phase 3·NCT04608318·897 enrolled

Elderly1 trial

RIC Allo-HSCT vs. Venetoclax-Based Consolidation in Elderly AML Patients After First CR

Recruiting·HHe Huang·Phase 4·NCT06571825·118 enrolled

Richter Transformation1 trial

ObinutuzuMab AtezOlizumab and VenetocLax in RichTer transfOrmation

Active, not recruiting·NNiguarda Hospital·Phase 2·NCT04082897·28 enrolled

Prospective1 trial

Sorafenib Combined With Venetoclax as Pre-emptive Therapy Strategy for MRD+ AML: a Prospective, Single-arm, Multicenter Clinical Study

Not yet recruiting·NNanfang Hospital, Southern Medical University·Phase 2/3·NCT07264010·87 enrolled

Myeloid Malignancies1 trial

VEN+DAC+Bu2Flu4 vs Bu2Flu5 Conditioning Regimen for Elderly Myeloid Malignancies Undergoing Allo-HSCT

Not yet recruiting·NNanfang Hospital, Southern Medical University·Phase 2/3·NCT07052422·160 enrolled

Chemotherapy1 trial

Venetoclax Plus Intensive Chemotherapy in AML and Advanced MDS

Recruiting·MMontefiore Medical Center·Phase 1·NCT05342584·99 enrolled

Hematological Malignancies1 trial

A Study of Dual-SIgnaling Protein 107 (DSP107) for Patients With Hematological Malignancies

Terminated·KKahr Medical·Phase 1·NCT04937166·25 enrolled

Female1 trial

A Study to Evaluate the Bioavailability and Food Effects of Oral Venetoclax New Tablet Formulation 2.0 in Healthy Adult Female Participants

Completed· AbbVie logo

AbbVie·Phase 1·NCT06742086·72 enrolled

Induction Chemotherapy1 trial

Venetoclax + Decitabine vs. "7+3" Induction Chemotherapy in Young AML

Active, not recruiting·CChen Suning·Phase 3·NCT05177731·188 enrolled

Clinical Trial1 trial

An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT03844048·165 enrolled

Lymphoplasmacytic Lymphoma1 trial

A Study of Pirtobrutinib, Venetoclax, and Rituximab in People With Waldenström's Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT07231952·40 enrolled

Chronic Lymphocytic Leukaemia1 trial

This Study in Patients With Chronic Lymphocytic Leukaemia is Done to Determine a Safe and Effective Dose of BI 836826 in Combination With Venetoclax

Withdrawn· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT03343678

Kidney Transplant1 trial

Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation

Not yet recruiting·MMassachusetts General Hospital·Phase 1·NCT07358195·3 enrolled

Ptosis1 trial

Inhibiting the Anti-apoptotic Factor, BCL-2, at the Time of ART Initiation to Promote Apoptosis of HIV-infected Cells and Restrict the Seeding of the HIV Reservoir: An Investigator-initiated Randomised, Controlled, Open-label Clinical Trial (The INITIATE Study)

Not yet recruiting·TThomas Aagaard Rasmussen·Phase 1·NCT07481175·38 enrolled

ART1 trial

A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML

Recruiting·KKura Oncology, Inc.·Phase 1·NCT05735184·420 enrolled

Prostate Cancer1 trial

Enzalutamide With Venetoclax in Treating Patients With Metastatic Castration Resistant Prostate Cancer

Completed·RRoswell Park Cancer Institute·Phase 1·NCT03751436·10 enrolled

AML1 trial

Azacitidine in Combination With Low Dose Intensity Venetoclax in Patients With AML Incl. Explorative AML Profiling

Recruiting·RRigshospitalet, Denmark·Phase 2·NCT05431257·117 enrolled

TIA1 trial

Acalabrutinib, Venetoclax, and Obinutuzumab for Initial Therapy of CLL

Active, not recruiting·—·Phase 2·NCT03580928·72 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

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

Induction Therapy1 trial

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

Recruiting·—·Phase 2·NCT06221683·500 enrolled

Efficacy1 trial

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

CLL/SLL1 trial

Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL

Recruiting·ZZulfa Omer·Phase 2·NCT07014917·62 enrolled

Idiopathic Pulmonary Fibrosis1 trial

Safety and Efficacy of Venetoclax in Idiopathic Pulmonary Fibrosis

Completed·UUniversity of Alabama at Birmingham·Phase 1·NCT05976217·3 enrolled

Advanced Solid Tumors1 trial

A Study of Budigalimab (ABBV-181) in Participants With Advanced Solid Tumors

Completed· AbbVie logo

AbbVie·Phase 1·NCT03000257·182 enrolled

B-ALL1 trial

Venetoclax Plus Inotuzumab for B-ALL

Active, not recruiting·—·Phase 1·NCT05016947·23 enrolled

AL amyloidosis1 trial

Trial of Venetoclax (ABT-199) and Dexamethasone for Relapsed or Refractory Systemic AL Amyloidosis

Terminated·TTufts Medical Center·Phase 1·NCT03000660·3 enrolled

Outcome1 trial

Real World Outcomes Using Novel Agents for AML in the UK

Unknown status·GGuy's and St Thomas' NHS Foundation Trust··NCT05312112·1,000 enrolled

Myelodysplastic Syndromes1 trial

A Study Evaluating Venetoclax Alone and in Combination With Azacitidine in Participants With Relapsed/Refractory Myelodysplastic Syndromes (MDS)

Completed· AbbVie logo

AbbVie·Phase 1·NCT02966782·70 enrolled

T-ALL1 trial

VHAG in Treating R/R T-ALL/LBL

Recruiting·FFirst Affiliated Hospital of Zhejiang University·Phase 2·NCT06742463·50 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

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

Regulatory

FDA Approval Timeline[5]

Apr 11, 2016

VENCLEXTA

NDA NDA208573

Apr 11, 2016

VENCLEXTA

NDA NDA208573

Dec 20, 2017

VENCLEXTA

NDA NDA208573

Jun 8, 2018

VENCLEXTA

NDA NDA208573

Jun 8, 2018

VENCLEXTA

NDA NDA208573

Sep 7, 2018

VENCLEXTA

NDA NDA208573

Sep 7, 2018

VENCLEXTA

NDA NDA208573

Nov 21, 2018

VENCLEXTA

NDA NDA208573

May 15, 2019

VENCLEXTA

NDA NDA208573

Jul 25, 2019

VENCLEXTA

NDA NDA208573

Jul 25, 2019

VENCLEXTA

NDA NDA208573

Jul 25, 2019

VENCLEXTA

NDA NDA208573

May 29, 2020

VENCLEXTA

NDA NDA208573

Jun 12, 2020

VENCLEXTA

NDA NDA208573

Oct 16, 2020

VENCLEXTA

NDA NDA208573

Oct 16, 2020

VENCLEXTA

NDA NDA208573

Nov 19, 2020

VENCLEXTA

NDA NDA208573

Oct 4, 2021

VENCLEXTA

NDA NDA208573

Oct 22, 2021

VENCLEXTA

NDA NDA208573

Jun 15, 2022

VENCLEXTA

NDA NDA208573

Feb 19, 2026

VENCLEXTA

NDA NDA208573

May 20, 2026

VENCLEXTA

NDA NDA208573

Sources

References

[1]
ClinicalTrials.gov — 629 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

Q4 2026

Trials by Indication[1]

Acute Myeloid Leukemia43 trials

Chronic Lymphocytic Leukemia16 trials

Lymphoma12 trials

Mantle Cell Lymphoma9 trials

Newly Diagnosed9 trials

Myelodysplastic Syndrome8 trials

Multiple Myeloma7 trials

Relapsed/Refractory6 trials

Efficacy and Safety6 trials

Acute Lymphoblastic Leukemia5 trials

Treatment5 trials

Hematologic Malignancies4 trials

CLL3 trials

Relapsed or Refractory3 trials

Elderly Patients2 trials

Safety and Efficacy2 trials

Trial2 trials

Breast Cancer2 trials

Leukemia2 trials

Relapsed/Refractory AML2 trials

Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma2 trials

Acute Promyelocytic Leukemia2 trials

Acute Leukemia2 trials

Chronic Myelomonocytic Leukemia2 trials

T-cell acute lymphoblastic leukemia1 trial

Blastic Plasmacytoid Dendritic Cell Neoplasm1 trial

TED1 trial

Follicular Lymphoma1 trial

Olverembatinib1 trial

MDS1 trial

Impaired Renal Function1 trial

Transplantation1 trial

MDS/AML1 trial

Chronic Lymphocytic Leukaemia (CLL)1 trial

Elderly1 trial

Richter Transformation1 trial

Prospective1 trial

Myeloid Malignancies1 trial

Chemotherapy1 trial

Hematological Malignancies1 trial

Female1 trial

Induction Chemotherapy1 trial

Clinical Trial1 trial

Lymphoplasmacytic Lymphoma1 trial

Chronic Lymphocytic Leukaemia1 trial

Kidney Transplant1 trial

Ptosis1 trial

ART1 trial

Prostate Cancer1 trial

AML1 trial

TIA1 trial

Azacytidine1 trial

B-cell Malignancies1 trial

Acute Leukemia of Ambiguous Lineage1 trial

Induction Therapy1 trial

Efficacy1 trial

CLL/SLL1 trial

Idiopathic Pulmonary Fibrosis1 trial

Advanced Solid Tumors1 trial

B-ALL1 trial

AL amyloidosis1 trial

Outcome1 trial

Myelodysplastic Syndromes1 trial

T-ALL1 trial

Metastatic Colorectal Cancer1 trial

Diffuse Large B-Cell Lymphoma1 trial

Targeted Therapy1 trial

Myeloid Neoplasm1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Related News