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 Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia

Phase 1

Recruiting

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Mosunetuzumab
Drug: Tocilizumab
Drug: Venetoclax

First Posted Date: 2021-10-25

Last Posted Date: 2024-12-03

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 137

Registration Number: NCT05091424

Locations: 🇰🇷
Seoul St Mary's Hospital, Seoul, Korea, Republic of
🇰🇷
Yeouido St. Mary's Hospital, Seoul, Korea, Republic of
🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of

and more 18 locations

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

Phase 3

Terminated

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Venetoclax
Drug: Magrolimab
Drug: Magrolimab Placebo
Drug: Azacitidine

First Posted Date: 2021-10-15

Last Posted Date: 2024-04-16

Lead Sponsor: Gilead Sciences

Target Recruit Count: 378

Registration Number: NCT05079230

Locations: 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸
UC Irvine Health- Chao Family Comprehensive Cancer Center, Orange, California, United States
🇺🇸
The University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

and more 161 locations

Study of Venetoclax and Azacitidine in Advanced BCR-ABL Negative Myeloproliferative Neoplasms

Phase 2

Recruiting

Conditions: Myeloproliferative Neoplasm

Interventions: Drug: Azacitidine
Drug: Venetoclax

First Posted Date: 2021-10-12

Last Posted Date: 2024-02-05

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 40

Registration Number: NCT05074355

Locations: 🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada

A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Phase 3

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Interventions: Drug: Acalabrutinib
Drug: Venetoclax
Drug: Obinutuzumab

First Posted Date: 2021-09-27

Last Posted Date: 2024-12-06

Lead Sponsor: AstraZeneca

Target Recruit Count: 607

Registration Number: NCT05057494

Locations: 🇪🇸
Research Site, Palma de Mallorca, Spain

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

Phase 1

Not yet recruiting

Conditions: Acute Lymphoblastic Leukemia

Interventions: Drug: Navitoclax
Drug: Venetoclax

First Posted Date: 2021-09-23

Last Posted Date: 2021-09-23

Lead Sponsor: Israeli Medical Association

Target Recruit Count: 48

Registration Number: NCT05054465

Locations: 🇮🇱
Shaare Zedek Medical Center, Jerusalem, Israel
🇮🇱
Soroka Medical Center, Be'er Sheva, Israel
🇮🇱
Rabin Medical Center, Petah Tikva, Israel

and more 3 locations

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

Phase 1

Recruiting

Conditions: Relapsed Non Hodgkin Lymphoma
Refractory Non-Hodgkin Lymphoma

Interventions: Drug: Loncastuximab tesirine
Drug: Venetoclax

First Posted Date: 2021-09-22

Last Posted Date: 2024-07-23

Lead Sponsor: Brian Hill

Target Recruit Count: 36

Registration Number: NCT05053659

Locations: 🇺🇸
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

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

Not Applicable

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Venetoclax
Drug: Azacitidine
Drug: Cladribine
Drug: Cytarabine
Drug: Idarubicin

First Posted Date: 2021-09-22

Last Posted Date: 2022-04-26

Lead Sponsor: LanZhou University

Target Recruit Count: 30

Registration Number: NCT05053425

Locations: 🇨🇳
Long Zhao, Lanzhou, Gansu, China

Venetoclax Plus Inotuzumab for B-ALL

Phase 1

Recruiting

Conditions: B-cell Acute Lymphoblastic Leukemia
B-Cell Lymphoma
ALL

Interventions: Drug: Venetoclax
Drug: Dexamethasone
Drug: Inotuzumab Ozogamicin

First Posted Date: 2021-08-23

Last Posted Date: 2024-08-14

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 26

Registration Number: NCT05016947

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States