Drug · Small Molecule

Venetoclax

CI-DRUG-00000636Explore in graph →NCIt C103147 CHEMBL3137309 CIViC Approved

Regulatory

Approvals (18)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

emaRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	—	Venclyxto is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL): in combination with acalabrutinib with or without obinutuzumab  in combination with obinutuzumab in combination with ibrutinib   Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.   Venclyxto monotherapy is indicated for the treatment of CLL: in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B cell receptor pathway inhibitor, or in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B cell receptor pathway inhibitor.   Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 14 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	350	195	71	577	18	CA, EU, US	Apr 11, 2016	Jul 11, 2007
Leukemia	Approved	Phase 4	277	168	62	425	1	US	Apr 11, 2016	Jul 11, 2007
Non-Hodgkin Lymphoma	Phase3	Phase 3	87	39	15	166	0	—	—	Jul 11, 2007
Multiple Myeloma	Phase3	Phase 3	10	4	3	25	0	—

Curated evidence

Clinical evidence (37)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–37 of 37 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
BAX mutation1
Venetoclax	Acute Myeloid Leukemia

Clinical trials

Trials with this intervention (590)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 101–150 of 590 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT07059975	UPDATE AML: UPdated Disease Monitoring And Treatment for Enhanced Outcomes for Pediatric AML	recruiting	Early Phase 1	36	Baylor College of MedicineOTHER	1	Aug 24, 2026	clinicaltrials
NCT05263284	8-Chloroadenosine in Combination With Venetoclax for the Treatment of Patients With Relapsed/Refractory Acute Myeloid Leukemia	recruiting

Molecule

Record

Kind: Small Molecule
Mechanism: Apoptosis regulator Bcl-2 inhibitor
Targets: 1 gene
UNII: N54AIC43PW
Aliases: 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, ABBVIE, ABT-0199, ABT 199, ABT-199, ABT199, C45H50CLN7O7S, CHRONIC LYMPHOCYTIC LEUKAEMIA THERAPY, GDC 0199, GDC-0199, GDC0199, RG-7601, RG7601, UNII-N54AIC43PW, Venclexta, Venclyxto, Venetoclax, VENETOCLAX (ABT-199)

Data updated 17 hours agoSource updated unknown

Identifiers

Codes (10)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01XX52	VENETOCLAX
DIN (Health Canada)	02458039

KDM6A Loss2
Olaparib + VenetoclaxCombination	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	submitted	EID11037 Dual targeting of PARP (olipartinib) and BCL2 (venetoclax) was reported to be superior to either PARP or BCL2 inhibition alone in inducing primary AML cell apoptosis, and loss of KDM6A further enhance… (full text at CIViC) Open in CIViC	civic
Venetoclax	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	submitted	EID11036 KDM6A repression was reported to sensitize AML cells to venetoclax. In addition, attenuation of KDM6 was reported to increase mitochondrial activity and intracellular ROS levels and de-reporessed BCL2… (full text at CIViC) Open in CIViC	civic

BCL2 A113G2
Venetoclax	Chronic Lymphocytic Leukemia	Predictive	C	Supports Resistance	3	submitted	EID8308 This study is a follow-up report after the original publication (PMID 30514704). A113G mutation was identified in combination with other BCL2 mutations including G101V in 3 CLL patients with venetocla… (full text at CIViC) PMID 31951646 · Blombery et al., 2020 · Open in CIViC	civic
〃	Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma	Predictive	B	Supports Resistance	3	submitted	EID8189 Associated with venetoclax resistance in high-risk CLL post ibrutinib in "progressive CLL" PMID 32232486 · Lucas et al., 2020 · Open in CIViC	civic

BCL2 D103E2
Venetoclax	Chronic Lymphocytic Leukemia	Predictive	C	Supports Resistance	3	submitted	EID8311 This study is a follow-up report after the original publication (PMID 30514704). D103E mutation was identified in combination with other BCL2 mutations including G101V in 4 CLL patients with venetocla… (full text at CIViC) PMID 31951646 · Blombery et al., 2020 · Open in CIViC	civic
〃	Chronic Lymphocytic Leukemia	Predictive	D	Supports Resistance	3	submitted	EID8335 The authors demonstrated that BCL2 Asp103Glu imparts resistance to venetoclax in vitro by investigating the in vitro binding profile of the Asp103Glu to both venetoclax and proapoptotic proteins in co… (full text at CIViC) PMID 31951646 · Blombery et al., 2020 · Open in CIViC	civic

BCL2 D103Y2
Venetoclax	Chronic Lymphocytic Leukemia	Predictive	B	Supports Resistance	4	submitted	EID8312 This study is a follow-up report after the original publication (PMID 30514704). D103Y mutation was identified in combination with other BCL2 mutations including G101V in 5 CLL patients with venetocla… (full text at CIViC) PMID 31951646 · Blombery et al., 2020 · Open in CIViC	civic
〃	Chronic Lymphocytic Leukemia	Predictive	C	Supports Resistance	2	submitted	EID8304 This study identified D103Y in one CLL patient with resistance to venetoclax. D103Y was presented in this patient after 39 months of venetoclax treatment in peripheral blood with a VAF of 7% which inc… (full text at CIViC) PMID 31004028 · Tausch et al., 2019 · Open in CIViC	civic

BCL2 G101V7
Venetoclax	Chronic Lymphocytic Leukemia	Predictive	B	Supports Resistance	4	submitted	EID8174 This study identified G101V mutation in BCL2 emerged in 7 out of 15 patients with CLL progression treated with Venetoclax. In addition, this study demonstrated that the G101V mutation impairs binding … (full text at CIViC) PMID 30514704 · Blombery et al., 2019 · Open in CIViC	civic
〃	Chronic Lymphocytic Leukemia	Predictive	C	Supports Resistance	4	submitted	EID7970 Four of six heavily pretreated, high-risk CLL patients with a 17p deletion from the phase 2 trial M13-9824 with continuous venetoclax treatment, who were treated with venetoclax for a period longer th… (full text at CIViC) PMID 31004028 · Tausch et al., 2019 · Open in CIViC	civic
〃	Chronic Lymphocytic Leukemia	Predictive	C	Does Not Support Resistance	3	submitted	EID8303 Previous work by this group used WES and was unable to identify BCL2 G101V mutation in 9 CLL patients with resistance to venetoclax (PMID 29463802). Based on Tausch et al work (PMID 31004028), this gr… (full text at CIViC) PMID 31666345 · Weiss et al., 2019 · Open in CIViC	civic
〃	Chronic Lymphocytic Leukemia	Predictive	C	Supports Resistance	4	submitted	EID8305 This study is a follow-up report after the original publication (PMID 30514704). The authors described multiple acquired resistance mutations including G101V in BCL-2 that occur in different CLL cells… (full text at CIViC) PMID 31951646 · Blombery et al., 2020 · Open in CIViC	civic
〃	Chronic Lymphocytic Leukemia	Predictive	D	Supports Resistance	3	submitted	EID8334 This study demonstrated that the G101V mutation impairs binding of venetoclax to BCL2, confers resistance to venetoclax in both patient leukemia cells and engineered cell lines, thus provides a select… (full text at CIViC) PMID 30514704 · Blombery et al., 2019 · Open in CIViC	civic
〃	Chronic Lymphocytic Leukemia	Predictive	D	Supports Resistance	3	accepted	EID8841 This study described the similar crystal structures of BCL-2 wild-type and G101V when bound to venetoclax. Steady state competition surface plasmon resonance experiments demonstrated a ~177 fold decre… (full text at CIViC) PMID 31160589 · Birkinshaw et al., 2019 · Open in CIViC	civic
〃	Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma	Predictive	C	Supports Resistance	2	accepted	EID8185 The effective cohort in this study was 11 CLL patients who were first treated with ibrutinib and then on progression treated with venetoclax until progression. Patient samples were sequenced before an… (full text at CIViC) PMID 32232486 · Lucas et al., 2020 · Open in CIViC	civic

BCL2 F104I2
Venetoclax	Follicular Lymphoma	Predictive	C	Supports Resistance	2	accepted	EID8375 This study identified BCL2 F104I mutation in one Follicular Lymphoma patient who developed resistance to venetoclax. Codon 104 is located at the venetoclax binding site of BCL2. PMID 31234236 · Blombery et al., 2019 · Open in CIViC	civic
〃	Follicular Lymphoma	Predictive	D	Supports Resistance	3	accepted	EID8376 Rs4;11 cells overexpressing BCL2 F104I exhibited >40-fold greater resistance to venetoclax after 24-hour treatment (IC50 not reached) than Rs4;11 overexpressing BCL2 WT cells as determined by cell tit… (full text at CIViC) PMID 31234236 · Blombery et al., 2019 · Open in CIViC	civic