Venetoclax

Generic Name: Venetoclax

Brand Names: Venclexta, Venclyxto

Drug Type: Small Molecule

Chemical Formula: C_₄₅H_₅₀ClN_₇O_₇S

CAS Number: 1257044-40-8

Unique Ingredient Identifier: N54AIC43PW

Background: Venetoclax is a BCL-2 inhibitor that was initially approved by the FDA in April 2016 . Proteins in the B cell CLL/lymphoma 2 (BCL-2) family are important regulators of the apoptotic (programmed cell death) process , . Venetoclax is used to treat chronic lymphocytic leukemia (CLL) and certain types of small lymphocytic lymphoma . CLL is the most prevalent leukemia diagnosed in Western countries . Venetoclax was developed through reverse engineering of the BCL-2 protein family inhibitor, navitoclax . Venetoclax is approximately 10 times more potent than navitoclax with regard to induction of apoptosis in CLL cells . A new indication was approved in 2018 for the treatment patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy . Previously, this drug was indicated only for patients with 17p gene deletion .

Indication: 本品与阿扎胞苷联合用于治疗因合并症不适合接受强诱导化疗，或者年龄75岁及以上的新诊断的成人急性髓系白血病患者。

Associated Conditions: Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Associated Therapies: -

Clinical Trials

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

Phase 1

Completed

Conditions: Lymphoblastic Lymphoma
Acute Lymphoblastic Leukemia (ALL)

Interventions: Drug: Navitoclax
Drug: Chemotherapy
Drug: Venetoclax

First Posted Date: 2017-06-08

Last Posted Date: 2021-10-14

Lead Sponsor: AbbVie

Target Recruit Count: 69

Registration Number: NCT03181126

Locations: 🇺🇸
City of Hope /ID# 169029, Duarte, California, United States
🇺🇸
LPCH Stanford /ID# 163337, Palo Alto, California, United States
🇺🇸
University of Chicago /ID# 163369, Chicago, Illinois, United States

and more 12 locations

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)

Phase 1

Terminated

Conditions: Follicular Lymphoma
Lymphoma, Large B-Cell, Diffuse

Interventions: Drug: Idasanutlin
Drug: Obinutuzumab
Drug: Venetoclax
Drug: Rituximab

First Posted Date: 2017-05-01

Last Posted Date: 2021-12-07

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 29

Registration Number: NCT03135262

Locations: 🇺🇸
Mount Sinai Medical Center, New York, New York, United States
🇦🇺
Prince of Wales Hospital, Randwick, New South Wales, Australia
🇦🇺
Westmead Hospital, Westmead, New South Wales, Australia

and more 18 locations

Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL

Phase 2

Recruiting

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Ibrutinib
Drug: Venetoclax
Drug: Acalabrutinib

First Posted Date: 2017-04-25

Last Posted Date: 2024-10-29

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 90

Registration Number: NCT03128879

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Expanded Access to Venetoclax

Conditions: Chronic Lymphocytic Leukemia (CLL)
Multiple Myeloma
Acute Myeloid Leukemia (AML)
Non-Hodgkin's Lymphoma
Acute Lymphoblastic Leukemia (ALL)
Amyloidosis
Plasma Cell Leukemia

First Posted Date: 2017-04-21

Last Posted Date: 2024-04-03

Lead Sponsor: AbbVie

Registration Number: NCT03123029

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)

Phase 1

Recruiting

Conditions: Acute Myeloid Leukemia
Blastic Plasmacytoid Dendritic Cell Neoplasm
Myelodysplastic Syndrome

Interventions: Drug: Azacitidine
Drug: SL-401
Drug: Venetoclax

First Posted Date: 2017-04-13

Last Posted Date: 2024-06-11

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 72

Registration Number: NCT03113643

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
City of Hope, Duarte, California, United States
🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States

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

Phase 3

Completed

Conditions: Mantle-Cell Lymphoma

Interventions: Drug: Ibrutinib
Drug: Placebo Oral tablet to match Venetoclax
Drug: Venetoclax

First Posted Date: 2017-04-13

Last Posted Date: 2024-07-01

Lead Sponsor: Pharmacyclics LLC.

Target Recruit Count: 352

Registration Number: NCT03112174

Locations: 🇺🇸
UCLA Department of Medicine-Hematology/Oncology, Los Angeles, California, United States
🇺🇸
The University of Kansas Cancer Center and Medical Pavilion, Westwood, Kansas, United States
🇧🇪
Institut Jules Bordet, Bruxelles, Belgium

and more 117 locations

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

Phase 1

Completed

Conditions: Advanced Solid Tumors
Hematologic Malignancies
Cancer

Interventions: Drug: ABBV-621
Drug: FOLFIRI
Drug: Bevacizumab
Drug: Venetoclax

First Posted Date: 2017-03-17

Last Posted Date: 2022-12-09

Lead Sponsor: AbbVie

Target Recruit Count: 153

Registration Number: NCT03082209

Locations: 🇺🇸
Millennium Oncology /ID# 214981, Houston, Texas, United States
🇺🇸
Yale University /ID# 158029, New Haven, Connecticut, United States
🇺🇸
The University of Chicago Medical Center /ID# 158030, Chicago, Illinois, United States

and more 16 locations

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

Phase 3

Active, not recruiting

Conditions: Acute Myeloid Leukemia (AML)

Interventions: Drug: Placebo
Drug: Venetoclax
Drug: Cytarabine

First Posted Date: 2017-03-03

Last Posted Date: 2024-06-27

Lead Sponsor: AbbVie

Target Recruit Count: 211

Registration Number: NCT03069352

Locations: 🇺🇸
H. Lee Moffit Cancer Center /ID# 164273, Tampa, Florida, United States
🇺🇸
Norton Cancer Institute /ID# 158998, Louisville, Kentucky, United States
🇦🇷
Cemic /Id# 159676, Buenos Aires, Argentina

and more 106 locations

Venetoclax Plus R-ICE Chemotherapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Phase 1

Active, not recruiting

Conditions: Diffuse Large B-cell-lymphoma

Interventions: Drug: Venetoclax
Drug: Rituximab
Drug: Ifosfamide
Drug: Carboplatin
Drug: Etoposide

First Posted Date: 2017-02-27

Last Posted Date: 2022-11-16

Lead Sponsor: Molly Gallogly

Target Recruit Count: 65

Registration Number: NCT03064867

Locations: 🇺🇸
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
🇺🇸
Washington University School of Medicine, Siteman Cancer Center, Saint Louis, Missouri, United States
🇺🇸
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

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

Phase 1

Completed

Conditions: Acute Myeloid Leukemia
Recurrent Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia

Interventions: Drug: STAT Inhibitor OPB-111077
Drug: Decitabine
Drug: Venetoclax
Other: Laboratory Biomarker Analysis

First Posted Date: 2017-02-24

Last Posted Date: 2024-03-12

Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Target Recruit Count: 37

Registration Number: NCT03063944

Locations: 🇺🇸
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy