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venetoclax

Trade name: venclexta

Small moleculeapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Apr 11, 2016

Venetoclax (trade name Venclexta, also known as ABT-199) is a selective and orally bioavailable small-molecule inhibitor of BCL-2, an antiapoptotic protein. BCL-2 and its related proteins BCL-XL and MCL-1 bind to and sequester pro-apoptotic signals in the cell, causing a down-regulation of apoptosis. As an oncogene and an important regulator of apoptosis, BCL-2 overexpression therefore results in increased tumor cell survival and resistance to chemotherapy. FDA approved Venetoclax in April 2016 for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy. Also this drug in phase 3 clinical trial in combination therapy for the treatment patients with refractory myeloma and Acute Myeloid Leukemia. Common side effects include neutropenia, nausea, anemia, diarrhea, upper respiratory tract infection. Major side effects include tumor lysis syndrome and severe neutropenia. — NCATS

Clinical trial activity

619 trials · 337 clinical orgs · 3 marketing orgs

Phase 1
250
Phase 2
420
Phase 3
64
Phase 4
6

Earliest trial started Jun 14, 2011 (NCT01328626)

Timeline

2010s

  1. Nov 28, 2010

    Abbott — IND Organization

  2. Nov 28, 2010

    Abbott — IND Organization

  3. Jan 1, 2011

    AbbVie — Earliest Phase 1 Sponsor(trial)

  4. Sep 20, 2012

    Orphan Drug Designation

  5. Jan 1, 2013

    AbbVie — Earliest Phase 2 Sponsor(trial)

  6. Jan 1, 2014

    Earliest Phase 3 Sponsor(trial)

  7. Apr 11, 2016

    AbbVie — Earliest FDA Approval

  8. Apr 11, 2016

    AbbVie — NDA Secondary Org

  9. Apr 11, 2016

    AbbVie — NDA Organization

  10. Apr 11, 2016

    AbbVie — Marketing Organization

2020s

  1. May 8, 2025

    Dr. Reddy's Laboratories — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedBreakthroughApr 11, 2016

Chemistry & pharmacology

Loading structure…

SMILES

CC1(C)CCC(CN2CCN(CC2)C3=CC=C(C(=O)NS(=O)(=O)C4=CC=C(NCC5CCOCC5)C(=C4)[N+]([O-])=O)C(OC6=CN=C7NC=CC7=C6)=C3)=C(C1)C8=CC=C(Cl)C=C8
Mol. weight
868.439 g/mol
Lipinski Ro5
3 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

First in class

Sources

Also known as

  • 4-(4-((2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl)methyl)piperazin-1-yl)-n-((3-nitro-4-((tetrahydro-2h-pyran-4-ylmethyl)amino)phenyl)sulfonyl)-2-(1h-pyrrolo(2,3-b)pyridin-5-yloxy)benzamide
  • 4-{4-[(4'-chloro-5,5-dimethyl[3,4,5,6-tetrahydro[1,1'-biphenyl]]-2-yl)methyl]piperazin-1-yl}-n-(3-nitro-4-{[(oxan-4-yl)methyl]amino}benzene-1-sulfonyl)-2-[(1h-pyrrolo[2,3-b]pyridin-5-yl)oxy]benzamide
  • 4-{4-[(4'-chloro-5,5-dimethyl[3,4,5,6-tetrahydro[1,1'-biphenyl]]-2-yl)methyl]piperazin-1-yl}-n-(3-nitro-4-{[(oxan-4-yl)methyl]amino}benzene-1-sulfonyl)-2-[(1h-pyrrolo[2,3-b]pyridin-5-yl)oxy]benzamide
  • abt-0199
  • abt199
  • abt199
  • abt-199
  • abt-199
  • abt-199
  • abt-199
  • abt-199
  • benzamide, 4-(4-((2-(4-chlorophenyl)-4,4-dimethyl-1-cyclohexen-1-yl)methyl)-1-piperazinyl)-n-((3-nitro-4-(((tetrahydro-2h-pyran-4-yl)methyl)amino)phenyl)sulfonyl)-2-(1h-pyrrolo(2,3-b)pyridin-5-yloxy)-
  • gdc-0199
  • gdc-0199
  • gdc-0199
  • gdc-0199
  • rg7601
  • rg7601
  • rg-7601
  • venclexta
  • venclexta
  • venclexta
  • venclexta
  • venclexta
  • venetoclax
  • venetoclax
  • venetoclax
  • venetoclax
  • venetoclax
  • venetoclax
  • venetoclax
  • venetoclax
  • venetoclax
  • venetoclax
  • venetoclax
  • venetoclax

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07175415Phase 1/Phase 2 (Phase 2)Oct 1, 2026AbbVie, AstraZeneca, Humboldt University, Princess Maxima Center for Pediatric Oncology
NCT07311746Phase 1/Phase 2 (Phase 2)Jun 1, 2026University of Texas at Houston
NCT07294677Phase 1/Phase 2 (Phase 2)Mar 17, 2026University of Chicago
NCT07148180Phase 1/Phase 2 (Phase 2)Feb 28, 2026Harvard University, Pipeline Therapeutics, Inc.
NCT07153497Phase 2Feb 26, 2026National Cancer Institute (NCI)
NCT07277231Phase 3Jan 31, 2026BeOne Medicines
NCT07283094Phase 1Jan 31, 2026Foghorn Therapeutics Inc., Yeshiva University
NCT07243483N/AJan 1, 2026Centre Leon Berard, Fédération Leucémie Espoir
NCT07177079Phase 1Dec 31, 2025University of Iowa
NCT07255872Phase 2/Phase 3 (Phase 3)Dec 31, 2025Baili Pharmaceutical Group
NCT07228273Phase 2Dec 24, 2025OHSU Knight Cancer Institute, Oregon Health and Science University
NCT06954987Phase 2Dec 18, 2025National Cancer Institute (NCI)
NCT06770257Phase 2Dec 10, 2025China Academy of Chinese Medical Sciences, CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
NCT07218510Phase 2Dec 9, 2025City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07007052Phase 2Dec 1, 2025AbbVie, French Innovative Leukemia Organisation, Pipeline Therapeutics, Inc.
NCT07264010Phase 2/Phase 3 (Phase 3)Dec 1, 2025Southern Medical University
NCT06958705Phase 2Dec 1, 2025AbbVie, Nanjing Medical University
NCT06522386Phase 2Dec 1, 2025University of Texas at Houston
NCT07133997Phase 1Nov 26, 2025City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07236931N/ANov 20, 2025Huazhong University of Science and Technology
Showing 20 of 619 trials
Page 1 / 31

Organizations

Research & Development (337)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AbbVieFor profit1276052011
National Cancer Institute (NCI)Government763332017
University of Texas at HoustonAcademic/Hospital646022016
GenentechFor profit53342011
Soochow UniversityAcademic/Hospital292932021
RocheFor profit271532013
Harvard UniversityAcademic/Hospital262322016
China Academy of Chinese Medical SciencesAcademic/Hospital181832023
People's Liberation Army of ChinaGovernment171152020
Jiao Tong UniversityAcademic/Hospital161532021
Nanjing Medical UniversityAcademic/Hospital14632021
Zhejiang UniversityAcademic/Hospital141452021
City of Hope National Medical CenterAcademic/Hospital121122018
AstraZenecaFor profit10532017
German CLL Study GroupAcademic/Hospital10622014
HOVON - Dutch Haemato-Oncology AssociationAcademic/Hospital10622016
Ohio State UniversityAcademic/Hospital10922015
BeOne MedicinesFor profit9522017
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital9922017
Bengbu Medical CollegeAcademic/Hospital8022021
337 organizations
Page 1 / 17

Marketing (6)

OrganizationOrg typeRelationshipDate
AbbVieFor profitNDA2Apr 11, 2016
AbbVieFor profitNDAApr 11, 2016
AbbVieFor profitMKTGApr 11, 2016
AbbottFor profitINDNov 28, 2010
Dr. Reddy's LaboratoriesFor profitMKTGMay 8, 2025
Dr. Reddy's LaboratoriesFor profitSYNMay 15, 2026