Last update 04 Jan 2026

Venetoclax

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
VENCLYXTO, Venetoclax (JAN/USAN/INN), 维奈妥拉
+ [15]
Target
Action
inhibitors
Mechanism
Bcl-2 inhibitors(Apoptosis regulator Bcl-2 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (11 Apr 2016),
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Special Review Project (China), Orphan Drug (Japan), Orphan Drug (Australia), Conditional marketing approval (China)
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Structure/Sequence

Molecular FormulaC45H50ClN7O7S
InChIKeyLQBVNQSMGBZMKD-UHFFFAOYSA-N
CAS Registry1257044-40-8

External Link

KEGGWikiATCDrug Bank
D10679Venetoclax

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Mantle cell lymphoma recurrent
Japan
27 Mar 2025
Mantle cell lymphoma refractory
Japan
27 Mar 2025
Chronic lymphocytic leukaemia refractory
Japan
20 Sep 2019
Recurrent Chronic Lymphoid Leukemia
Japan
20 Sep 2019
Small Lymphocytic Lymphoma
United States
08 Jun 2018
Adult Acute Myeloblastic Leukemia
European Union
04 Dec 2016
Adult Acute Myeloblastic Leukemia
Iceland
04 Dec 2016
Adult Acute Myeloblastic Leukemia
Liechtenstein
04 Dec 2016
Adult Acute Myeloblastic Leukemia
Norway
04 Dec 2016
Acute Myeloid Leukemia
Canada
31 Oct 2016
Chronic Lymphocytic Leukemia
United States
11 Apr 2016
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Tumor Lysis SyndromePhase 3
United States
05 Aug 2024
Tumor Lysis SyndromePhase 3
Australia
05 Aug 2024
Tumor Lysis SyndromePhase 3
France
05 Aug 2024
Tumor Lysis SyndromePhase 3
Greece
05 Aug 2024
Tumor Lysis SyndromePhase 3
Serbia
05 Aug 2024
Tumor Lysis SyndromePhase 3
Spain
05 Aug 2024
Tumor Lysis SyndromePhase 3
Taiwan Province
05 Aug 2024
Tumor Lysis SyndromePhase 3
United Kingdom
05 Aug 2024
Relapsing acute myeloid leukemiaPhase 3
United States
01 Oct 2022
Relapsing acute myeloid leukemiaPhase 3
United States
01 Oct 2022
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
12
otfjpjtbjb(fzxkyrrhhb) = Only 2 patients experienced infusion reactions related to Dara with no serious treatment-related adverse events. moujghpcym (rovccaypab )
Positive
06 Dec 2025
Not Applicable
ANKRD26 pathogenic variants
27
iwvzmnyuyg(jaghznzlgt) = xtolhaiuok xqdrymdgdv (xhgymddsbs )
Positive
06 Dec 2025
Not Applicable
72
skykcftdlm(ckshhvuedx) = kncphpbwcj usyvmzafix (ktilerxitx )
Positive
06 Dec 2025
(VEN altered per physician discretion in subsequent cycles)
skykcftdlm(oiwyibhrwr) = ydapmgobcw yekotbewcl (cmvaeihmyt )
Not Applicable
600
iwrxlbzcgd(hlccvxmeii) = wtnitssitn knuusiliap (khfqbtsptv )
Positive
06 Dec 2025
Venetoclax +Hypomethylating Agents
iwrxlbzcgd(hlccvxmeii) = dmqmdhdmrl knuusiliap (khfqbtsptv )
Phase 1
15
joamibbxqf(ltekzfzfyy) = ublsuixydr agqwxsppuq (ykuiclipci )
Positive
06 Dec 2025
(prior VEN exposure)
snnpxowhfe(kkprqpluvm) = fdkoxygrmd usitxklzet (firyikxvqq )
Not Applicable
1,393
xxzgeqrcqf(vysfaabnlq) = caxjwqgxes keozdigumg (vmklsupsmj, 39 - 51)
Positive
06 Dec 2025
BTK inhibitors (BTKis)
xxzgeqrcqf(vysfaabnlq) = bidumtakns keozdigumg (vmklsupsmj, 62 - 80)
Phase 2
77
sjqolkrsfx(fkwgtluidn) = jznpokokbl undthrmlor (jftdkgaipx )
Positive
06 Dec 2025
-
sjqolkrsfx(fkwgtluidn) = dcsbhzqrzf undthrmlor (jftdkgaipx )
Phase 1/2
Acute Myeloid Leukemia
First line
FLT3mut+
44
ohawcvqcfh(nxoeznujeq) = vagyjetrld wvgfddiscx (xvvfwbbhfm, 46 - 88)
Positive
06 Dec 2025
ohawcvqcfh(nxoeznujeq) = hargaroilr wvgfddiscx (xvvfwbbhfm, 43 - 84)
Not Applicable
6
FLAG-IDA-Ven
(high-risk AML + underwent stem cell transplantation)
vthnryotwc(xfynwwvmgc) = mgjkzzyjkb swnxkibjbx (wjmcwfjmmq )
Positive
06 Dec 2025
Not Applicable
65
Discontinuation of HMA and/or VEN
seahzomsuj(tvgrbubksl) = yveolnbcbc ovqssmctda (pjqwkrpyuj )
Positive
06 Dec 2025
No discontinuation of HMA-VEN
favvyvjbqc(usftmbgpbt) = leklphzjxl qzhnfohgle (jvwojosjxj )
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Regulation

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