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

Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations

Phase 1

Active, not recruiting

Conditions: Myelodysplastic Syndrome (MDS)
Myeloproliferative Neoplasms (MPNs)
Acute Myeloid Leukemia (AML)
Chronic Myelomonocytic Leukemia (CMML)

Interventions: Drug: LY3410738
Drug: Venetoclax
Drug: Azacitidine

First Posted Date: 2020-10-26

Last Posted Date: 2024-10-18

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 260

Registration Number: NCT04603001

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States
🇺🇸
University of Chicago Hospital, Chicago, Illinois, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

and more 34 locations

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

Phase 1

Completed

Conditions: Mantle Cell Lymphoma
B-Cell Lymphoma
Marginal Zone Lymphoma
Chronic Lymphocytic Lymphoma
Follicular Lymphoma

Interventions: Drug: Obinutuzumab
Drug: Venetoclax
Drug: Magrolimab

First Posted Date: 2020-10-23

Last Posted Date: 2024-07-29

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 1

Registration Number: NCT04599634

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies

Phase 1

Recruiting

Conditions: Hematologic Malignancies

Interventions: Drug: SLS009
Drug: venetoclax
Drug: azacitidine

First Posted Date: 2020-10-19

Last Posted Date: 2024-06-14

Lead Sponsor: Sellas Life Sciences Group

Target Recruit Count: 160

Registration Number: NCT04588922

Locations: 🇺🇸
MD Anderson, Houston, Texas, United States
🇨🇳
Linyi Cancer Hospital, Linyi, Shandong, China
🇨🇳
The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China

and more 18 locations

Copanlisib Plus Venetoclax in R/R DLBCL

Phase 1

Active, not recruiting

Conditions: Relapsed Diffuse Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
Diffuse Large B Cell Lymphoma

Interventions: Drug: Copanlisib
Drug: Venetoclax

First Posted Date: 2020-10-01

Last Posted Date: 2024-12-20

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 48

Registration Number: NCT04572763

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
City of Hope Cancer Center, Duarte, California, United States
🇺🇸
Siteman Cancer Center at Washington University, Saint Louis, Missouri, United States

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

Phase 2

Recruiting

Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Interventions: Drug: Venetoclax
Drug: Obinutuzumab
Drug: Acalabrutinib

First Posted Date: 2020-09-23

Last Posted Date: 2024-05-08

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 40

Registration Number: NCT04560322

Locations: 🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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

Phase 1

Active, not recruiting

Conditions: Acute Myeloid Leukemia
Sarcoma
Chondrosarcoma
Chronic Lymphocytic Leukemia
Colorectal Cancer
Solid Tumor
Non Hodgkin Lymphoma
Small Lymphocytic Lymphoma

Interventions: Drug: Aplitabart (IGM-8444)
Drug: FOLFIRI
Drug: Birinapant
Drug: Gemcitabine
Drug: Venetoclax
Drug: Azacitidine
Drug: Bevacizumab (and approved biosimilars)
Drug: Docetaxel

First Posted Date: 2020-09-17

Last Posted Date: 2024-08-22

Lead Sponsor: IGM Biosciences, Inc.

Target Recruit Count: 272

Registration Number: NCT04553692

Locations: 🇺🇸
Mayo Clinic, Minneapolis, Minnesota, United States
🇺🇸
Minnesota Oncology - Minneapolis Clinic, Minneapolis, Minnesota, United States
🇺🇸
UCSF, San Francisco, California, United States

and more 53 locations

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

Phase 1

Active, not recruiting

Conditions: Recurrent Chronic Myelomonocytic Leukemia
Recurrent Myelodysplastic Syndrome
Refractory Chronic Myelomonocytic Leukemia
Refractory Myelodysplastic Syndrome
Therapy-Related Myelodysplastic Syndrome

Interventions: Drug: Azacitidine
Drug: Venetoclax

First Posted Date: 2020-09-16

Last Posted Date: 2024-11-18

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 34

Registration Number: NCT04550442

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

Pitavastatin in Combination With Venetoclax for Chronic Lymphocytic Leukemia or Acute Myeloid Leukemia

Phase 1

Active, not recruiting

Conditions: Acute Myeloid Leukemia
Chronic Lymphocytic Leukemia
AML, Adult
CLL
CLL, Relapsed
CLL, Refractory

Interventions: Drug: Pitavastatin
Drug: Venetoclax

First Posted Date: 2020-08-13

Last Posted Date: 2024-10-21

Lead Sponsor: University of California, Irvine

Target Recruit Count: 6

Registration Number: NCT04512105

Locations: 🇺🇸
Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, California, United States

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)

Phase 3

Completed

Conditions: Acute Myeloid Leukemia (AML)

Interventions: Drug: Venetoclax
Drug: Cytarabine

First Posted Date: 2020-08-12

Last Posted Date: 2022-05-05

Lead Sponsor: AbbVie

Target Recruit Count: 14

Registration Number: NCT04509622

Locations: 🇯🇵
NTT Medical Center Tokyo /ID# 223574, Shinagawa-ku, Tokyo, Japan
🇯🇵
Okayama University Hospital /ID# 222990, Okayama-shi, Okayama, Japan
🇯🇵
NHO Nagoya Medical Center /ID# 223671, Nagoya-shi, Aichi, Japan

and more 13 locations

Cirmtuzumab Consolidation for Treatment of Patients With Detectable CLL on Venetoclax

Phase 2

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Cirmtuzumab
Drug: Venetoclax

First Posted Date: 2020-08-06

Last Posted Date: 2023-11-28

Lead Sponsor: University of California, San Diego

Target Recruit Count: 5

Registration Number: NCT04501939

Locations: 🇺🇸
UCSD Koman Family Outpatient Pavilion, San Diego, California, United States

Drug Development Updates

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