venetoclax Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	5133	1257044-40-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: venclyxto venetoclax ABT-199 venclexta GDC-0199	Venetoclax is a selective and orally bioavailable small-molecule inhibitor of BCL-2, an anti-apoptotic protein. Overexpression of BCL-2 has been demonstrated in CLL cells where it mediates tumor cell survival and has been associated with resistance to chemotherapeutics. Venetoclax helps restore the process of apoptosis by binding directly to the BCL-2 protein, displacing pro-apoptotic proteins like BIM, triggering mitochondrial outer membrane permeabilization and the activation of caspases. In nonclinical studies, venetoclax has demonstrated cytotoxic activity in tumor cells that overexpress BCL-2. Molecular weight: 868.45 Formula: C45H50ClN7O7S CLOGP: 10.31 LIPINSKI: 3 HAC: 14 HDO: 3 TPSA: 172.03 ALOGS: -5.97 ROTB: 12 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

venclyxto
venetoclax
ABT-199
venclexta
GDC-0199

Venetoclax is a selective and orally bioavailable small-molecule inhibitor of BCL-2, an anti-apoptotic protein. Overexpression of BCL-2 has been demonstrated in CLL cells where it mediates tumor cell survival and has been associated with resistance to chemotherapeutics. Venetoclax helps restore the process of apoptosis by binding directly to the BCL-2 protein, displacing pro-apoptotic proteins like BIM, triggering mitochondrial outer membrane permeabilization and the activation of caspases. In nonclinical studies, venetoclax has demonstrated cytotoxic activity in tumor cells that overexpress BCL-2.

Molecular weight: 868.45
Formula: C45H50ClN7O7S
CLOGP: 10.31
LIPINSKI: 3
HAC: 14
HDO: 3
TPSA: 172.03
ALOGS: -5.97
ROTB: 12

Status: ONP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company
Sept. 20, 2019	PMDA	AbbVie GK
Dec. 5, 2016	EMA	AbbVie Ltd
April 11, 2016	FDA	ABBVIE INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Death	950.83	23.88	671	8821	334877	46341693
Off label use	522.71	23.88	501	8991	379340	46297230
Chronic lymphocytic leukaemia	419.61	23.88	101	9391	2799	46673771
Acute myeloid leukaemia	404.25	23.88	143	9349	15635	46660935
Intentional product use issue	400.62	23.88	201	9291	52579	46623991
Febrile neutropenia	392.62	23.88	242	9250	94385	46582185
Neutropenia	308.44	23.88	245	9247	142959	46533611
Tumour lysis syndrome	302.88	23.88	95	9397	7141	46669429
Hospice care	202.83	23.88	65	9427	5230	46671340
Sepsis	128.69	23.88	148	9344	135866	46540704
Pancytopenia	103.90	23.88	106	9386	84952	46591618
Thrombocytopenia	102.01	23.88	127	9365	126454	46550116
Pneumonia	91.05	23.88	221	9271	376099	46300471
Cytopenia	90.93	23.88	40	9452	7728	46668842
Disease progression	83.95	23.88	98	9394	91202	46585368
Neutrophil count decreased	79.83	23.88	68	9424	43358	46633212
Acute myeloid leukaemia recurrent	74.02	23.88	22	9470	1374	46675196
Platelet count decreased	68.99	23.88	93	9399	99931	46576639
Infection	68.58	23.88	108	9384	133484	46543086
Lymphadenopathy	64.75	23.88	54	9438	33434	46643136
Mantle cell lymphoma	57.54	23.88	15	9477	576	46675994
Bone marrow transplant	55.67	23.88	15	9477	655	46675915
White blood cell count decreased	55.19	23.88	89	9403	112142	46564428
Pyrexia	51.85	23.88	172	9320	348630	46327940
Rhinovirus infection	50.04	23.88	21	9471	3615	46672955
Pneumonia fungal	47.32	23.88	21	9471	4139	46672431
Non-small cell lung cancer	46.10	23.88	19	9473	3125	46673445
Blood lactate dehydrogenase increased	45.84	23.88	36	9456	20464	46656106
Hyperuricaemia	44.79	23.88	21	9471	4696	46671874
COVID-19	42.36	23.88	33	9459	18542	46658028
T-cell prolymphocytic leukaemia	39.13	23.88	6	9486	10	46676560
Chronic lymphocytic leukaemia refractory	38.35	23.88	7	9485	46	46676524
Myelodysplastic syndrome	38.20	23.88	29	9463	15682	46660888
Terminal ileitis	36.75	23.88	8	9484	139	46676431
Hospitalisation	36.35	23.88	54	9438	63331	46613239
Drug ineffective	35.53	23.88	52	9440	677786	45998784
Bone marrow failure	34.39	23.88	36	9456	29633	46646937
Pain	33.21	23.88	29	9463	476919	46199651
Diffuse large B-cell lymphoma	31.86	23.88	18	9474	5920	46670650
Blood phosphorus increased	31.32	23.88	14	9478	2805	46673765
Acute myeloid leukaemia refractory	30.58	23.88	5	9487	15	46676555
Nonspecific reaction	29.94	23.88	12	9480	1838	46674732
Febrile bone marrow aplasia	29.44	23.88	18	9474	6844	46669726
Pleural effusion	28.15	23.88	56	9436	82896	46593674
Allogenic stem cell transplantation	27.77	23.88	4	9488	3	46676567
Transformation to acute myeloid leukaemia	26.53	23.88	6	9486	125	46676445
Arthralgia	25.55	23.88	22	9470	364581	46311989
Headache	24.69	23.88	37	9455	478315	46198255
Aspergillus infection	24.38	23.88	16	9476	6874	46669696
Campylobacter gastroenteritis	24.31	23.88	7	9485	391	46676179
Fungal sepsis	24.12	23.88	9	9483	1138	46675432

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Death	1068.07	20.17	1149	15952	356134	29579243
Off label use	826.33	20.17	850	16251	248440	29686937
Tumour lysis syndrome	570.59	20.17	230	16871	12655	29922722
Chronic lymphocytic leukaemia	566.52	20.17	176	16925	4452	29930925
Intentional product use issue	539.85	20.17	306	16795	36134	29899243
Acute myeloid leukaemia	531.10	20.17	241	16860	17765	29917612
Febrile neutropenia	442.05	20.17	413	16688	106280	29829097
Neutropenia	344.58	20.17	394	16707	128146	29807231
Hospice care	299.79	20.17	108	16993	4344	29931033
Pneumonia	144.89	20.17	468	16633	333838	29601539
Lymphadenopathy	137.86	20.17	113	16988	24263	29911114
Cytopenia	134.62	20.17	74	17027	8182	29927195
Disease progression	131.69	20.17	193	16908	79681	29855696
Sepsis	117.28	20.17	258	16843	146137	29789240
COVID-19	105.53	20.17	85	17016	17793	29917584
Mantle cell lymphoma	102.26	20.17	37	17064	1504	29933873
Thrombocytopenia	92.61	20.17	226	16875	136818	29798559
Infection	90.73	20.17	161	16940	77913	29857464
Pancytopenia	87.01	20.17	166	16935	84886	29850491
Chronic lymphocytic leukaemia recurrent	85.80	20.17	24	17077	414	29934963
Lymphocyte count increased	68.46	20.17	32	17069	2510	29932867
Hyperphosphataemia	65.72	20.17	30	17071	2229	29933148
Autoimmune haemolytic anaemia	65.10	20.17	36	17065	4023	29931354
Platelet count decreased	63.23	20.17	167	16934	105962	29829415
Acute myeloid leukaemia recurrent	56.08	20.17	24	17077	1528	29933849
Splenomegaly	55.10	20.17	52	17049	13428	29921949
Neutrophil count decreased	55.09	20.17	92	17009	42362	29893015
Transplant	48.34	20.17	17	17084	635	29934742
Hospitalisation	47.10	20.17	88	17013	44231	29891146
Blood phosphorus increased	47.00	20.17	25	17076	2586	29932791
Pyrexia	45.94	20.17	306	16795	294183	29641194
Toxicity to various agents	45.78	20.17	22	17079	177161	29758216
Pneumonia fungal	45.28	20.17	32	17069	5501	29929876
Completed suicide	45.07	20.17	3	17098	99489	29835888
Acute myeloid leukaemia refractory	42.97	20.17	8	17093	16	29935361
COVID-19 pneumonia	41.24	20.17	28	17073	4512	29930865
Mantle cell lymphoma refractory	41.23	20.17	10	17091	95	29935282
White blood cell count decreased	40.08	20.17	122	16979	83825	29851552
Influenza	35.17	20.17	77	17024	43321	29892056
Hyperuricaemia	35.05	20.17	31	17070	7363	29928014
Chronic lymphocytic leukaemia transformation	34.50	20.17	10	17091	197	29935180
Blood count abnormal	33.17	20.17	37	17064	11615	29923762
Bone marrow transplant	31.81	20.17	14	17087	954	29934423
Stem cell transplant	31.72	20.17	18	17083	2113	29933264
Leukaemia	31.55	20.17	21	17080	3276	29932101
Neutropenic sepsis	30.39	20.17	35	17066	11374	29924003
Myelodysplastic syndrome	30.31	20.17	45	17056	18733	29916644
Blood pressure increased	30.26	20.17	3	17098	71925	29863452
Drug interaction	30.18	20.17	42	17059	199526	29735851
Headache	30.00	20.17	36	17065	182270	29753107
Skin infection	29.60	20.17	26	17075	6118	29929259
Product dose omission issue	29.35	20.17	8	17093	91623	29843754
Hypogammaglobulinaemia	28.93	20.17	24	17077	5228	29930149
Depression	28.77	20.17	8	17093	90429	29844948
Somnolence	28.21	20.17	10	17091	96753	29838624
Overdose	27.70	20.17	7	17094	84330	29851047
Blood uric acid abnormal	27.69	20.17	7	17094	80	29935297
Lymphocytosis	27.61	20.17	16	17085	1954	29933423
Bacteraemia	27.60	20.17	39	17062	15521	29919856
Blood uric acid increased	26.08	20.17	24	17077	5999	29929378
Chronic lymphocytic leukaemia refractory	26.06	20.17	7	17094	103	29935274
Diffuse large B-cell lymphoma	26.01	20.17	27	17074	7814	29927563
Blast cell count decreased	25.88	20.17	4	17097	0	29935377
Pruritus	25.77	20.17	18	17083	118186	29817191
Blood lactate dehydrogenase increased	24.53	20.17	43	17058	20558	29914819
Escherichia bacteraemia	24.25	20.17	17	17084	2885	29932492
Septic shock	22.82	20.17	84	17017	63523	29871854
Soft tissue infection	22.40	20.17	13	17088	1592	29933785
Blastic plasmacytoid dendritic cell neoplasia	22.29	20.17	6	17095	89	29935288
Ureteric compression	22.22	20.17	5	17096	33	29935344
Anxiety	21.92	20.17	12	17089	89859	29845518
Condition aggravated	21.85	20.17	28	17073	137838	29797539
Chemotherapy	21.68	20.17	9	17092	531	29934846
Coronavirus infection	21.41	20.17	17	17084	3481	29931896
Haemoglobin abnormal	20.87	20.17	16	17085	3113	29932264
Respiratory tract infection	20.62	20.17	34	17067	15472	29919905
T-cell prolymphocytic leukaemia	20.57	20.17	5	17096	48	29935329
Lymphocyte count decreased	20.43	20.17	38	17063	19017	29916360
Mantle cell lymphoma recurrent	20.25	20.17	8	17093	415	29934962
Aspergillus infection	20.22	20.17	27	17074	10187	29925190

Pharmacologic Action:

Source	Code	Description
ATC	L01XX52	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Other antineoplastic agents
FDA PE	N0000009176	Increased Cellular Death
MeSH PA	D000970	Antineoplastic Agents
FDA MoA	N0000185503	P-Glycoprotein Inhibitors
FDA EPC	N0000192515	BCL-2 Inhibitor
CHEBI has role	CHEBI:35610	cytostatic
CHEBI has role	CHEBI:68495	type i programmed cell-death inducer
CHEBI has role	CHEBI:133022	bcl-2 inhibitor

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Chronic lymphoid leukemia, disease	indication	92814006

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	2.0	acidic
pKa2	13.01	acidic
pKa3	7.73	Basic
pKa4	4.24	Basic
pKa5	3.47	Basic
pKa6	0.56	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
100MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	April 11, 2021	NEW CHEMICAL ENTITY
10MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	April 11, 2021	NEW CHEMICAL ENTITY
50MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	April 11, 2021	NEW CHEMICAL ENTITY
100MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	June 8, 2021	INFORMATION ADDED TO THE PACKAGE INSERT REGARDING THE REVISION OF THE MONOTHERAPY INDICATION OF VENETOCLAX
100MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	June 8, 2021	REVISIONS TO INDICATION FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
10MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	June 8, 2021	INFORMATION ADDED TO THE PACKAGE INSERT REGARDING THE REVISION OF THE MONOTHERAPY INDICATION OF VENETOCLAX
10MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	June 8, 2021	REVISIONS TO INDICATION FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
50MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	June 8, 2021	INFORMATION ADDED TO THE PACKAGE INSERT REGARDING THE REVISION OF THE MONOTHERAPY INDICATION OF VENETOCLAX
50MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	June 8, 2021	REVISIONS TO INDICATION FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
100MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	Nov. 21, 2021	VENETOCLAX IN COMBO WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
10MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	Nov. 21, 2021	VENETOCLAX IN COMBO WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
50MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	Nov. 21, 2021	VENETOCLAX IN COMBO WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
100MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	May 15, 2022	VENETOCLAX IN COMBINULLTION WITH OBINUTUZUMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA
10MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	May 15, 2022	VENETOCLAX IN COMBINULLTION WITH OBINUTUZUMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA
50MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	May 15, 2022	VENETOCLAX IN COMBINULLTION WITH OBINUTUZUMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA
100MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	April 11, 2023	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
10MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	April 11, 2023	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
50MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	April 11, 2023	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
100MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	Oct. 16, 2023	REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY M15-656 (VIALE-A) AND M16-043 (VIALE-C) TO SUPPORT PMR 3545-1 AND PMR 3545-2
10MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	Oct. 16, 2023	REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY M15-656 (VIALE-A) AND M16-043 (VIALE-C) TO SUPPORT PMR 3545-1 AND PMR 3545-2
50MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	Oct. 16, 2023	REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY M15-656 (VIALE-A) AND M16-043 (VIALE-C) TO SUPPORT PMR 3545-1 AND PMR 3545-2
100MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	June 8, 2025	INDICATED FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
10MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	June 8, 2025	INDICATED FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
50MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	June 8, 2025	INDICATED FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
100MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	Nov. 21, 2025	INDICATED IN COMBO WITH AZACITIDINE, OR DECITABINE, OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
10MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	Nov. 21, 2025	INDICATED IN COMBO WITH AZACITIDINE, OR DECITABINE, OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
50MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	Nov. 21, 2025	INDICATED IN COMBO WITH AZACITIDINE, OR DECITABINE, OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
100MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	May 15, 2026	TREATMENT OF PREVIOUSLY UNTREATED ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
10MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	May 15, 2026	TREATMENT OF PREVIOUSLY UNTREATED ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
50MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	May 15, 2026	TREATMENT OF PREVIOUSLY UNTREATED ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Apoptosis regulator Bcl-2	Cytosolic other	P10415	BCL2_HUMAN	INHIBITOR	Ki	11	SCIENTIFIC LITERATURE	DRUG LABEL
Bcl-2-like protein 1	Cytosolic other	Q07817	B2CL1_HUMAN	INHIBITOR	Ki	7.32	SCIENTIFIC LITERATURE
Apoptosis regulator Bcl-W	Cytosolic other	Q92843	B2CL2_HUMAN	INHIBITOR	Ki	6.61	SCIENTIFIC LITERATURE

External reference:

ID	Source
D10679	KEGG_DRUG
4035629	VANDF
C3641087	UMLSCUI
CHEBI:133021	CHEBI
LBM	PDB_CHEM_ID
CHEMBL3137309	ChEMBL_ID
49846579	PUBCHEM_CID
C579720	MESH_SUPPLEMENTAL_RECORD_UI
9925	INN_ID
DB11581	DRUGBANK_ID
N54AIC43PW	UNII
8318	IUPHAR_LIGAND_ID
1747556	RXNORM
240227	MMSL
31601	MMSL
d08429	MMSL
016803	NDDF
720491001	SNOMEDCT_US
763511000	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Venclexta	HUMAN PRESCRIPTION DRUG LABEL	1	0074-0561	TABLET, FILM COATED	10 mg	ORAL	NDA	28 sections
Venclexta	HUMAN PRESCRIPTION DRUG LABEL	1	0074-0566	TABLET, FILM COATED	50 mg	ORAL	NDA	28 sections
Venclexta	HUMAN PRESCRIPTION DRUG LABEL	1	0074-0576	TABLET, FILM COATED	100 mg	ORAL	NDA	28 sections