venetoclax 🐶 Veterinary Use | 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: 10.21 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: 10.21
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
Dec. 5, 2016	EMA	AbbVie Ltd
April 11, 2016	FDA	ABBVIE INC
Sept. 20, 2019	PMDA	AbbVie GK

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	1330.25	22.42	926	14198	340500	55936443
Febrile neutropenia	853.50	22.42	459	14665	105086	56171857
Acute myeloid leukaemia	693.81	22.42	234	14890	16738	56260205
Off label use	583.90	22.42	727	14397	555453	55721490
Neutropenia	525.55	22.42	392	14732	157775	56119168
Tumour lysis syndrome	503.95	22.42	153	14971	7770	56269173
Chronic lymphocytic leukaemia	467.13	22.42	117	15007	2871	56274072
Hospice care	311.79	22.42	100	15024	6080	56270863
Intentional product use issue	256.51	22.42	213	14911	99520	56177423
Thrombocytopenia	226.90	22.42	228	14896	135996	56140947
Sepsis	218.27	22.42	226	14898	139614	56137329
Acute myeloid leukaemia recurrent	205.11	22.42	53	15071	1475	56275468
Pancytopenia	198.48	22.42	175	14949	88540	56188403
Cytopenia	182.71	22.42	76	15048	9679	56267264
COVID-19	167.71	22.42	148	14976	74910	56202033
Neutrophil count decreased	165.83	22.42	124	15000	49698	56227245
Myelosuppression	160.39	22.42	83	15041	17372	56259571
Platelet count decreased	146.47	22.42	161	14963	106222	56170721
Pneumonia	139.87	22.42	325	14799	406773	55870170
Disease progression	120.84	22.42	145	14979	105028	56171915
White blood cell count decreased	88.74	22.42	137	14987	125853	56151090
Lymphadenopathy	85.77	22.42	73	15051	35135	56241808
Pyrexia	81.47	22.42	272	14852	418501	55858442
Pain	80.57	22.42	39	15085	663145	55613798
Infection	77.56	22.42	168	14956	200038	56076905
Allogenic stem cell transplantation	71.37	22.42	12	15112	31	56276912
Bone marrow transplant	69.41	22.42	19	15105	662	56276281
Joint swelling	65.28	22.42	3	15121	289797	55987146
Acute myeloid leukaemia refractory	64.38	22.42	12	15112	65	56276878
Hyperuricaemia	64.14	22.42	30	15094	5043	56271900
Anaemia	62.21	22.42	185	14939	267326	56009617
Septic shock	61.94	22.42	79	15045	60756	56216187
Mantle cell lymphoma	61.92	22.42	17	15107	599	56276344
Blood lactate dehydrogenase increased	58.98	22.42	47	15077	20628	56256315
Blast cell count increased	58.61	22.42	15	15109	401	56276542
Rhinovirus infection	55.24	22.42	25	15099	3897	56273046
Chronic lymphocytic leukaemia transformation	55.19	22.42	10	15114	45	56276898
Pneumonia fungal	52.93	22.42	26	15098	4867	56272076
Arthralgia	52.92	22.42	35	15089	501634	55775309
Drug ineffective	50.25	22.42	108	15016	918881	55358062
Headache	47.79	22.42	48	15076	558996	55717947
Swelling	46.76	22.42	5	15119	239766	56037177
Myelodysplastic syndrome	46.16	22.42	37	15087	16369	56260574
Hyperphosphataemia	45.45	22.42	18	15106	2017	56274926
Aspergillus infection	45.22	22.42	27	15097	7438	56269505
T-cell prolymphocytic leukaemia	43.95	22.42	7	15117	11	56276932
Rash	43.66	22.42	41	15083	493006	55783937
Chronic lymphocytic leukaemia refractory	42.97	22.42	8	15116	43	56276900
Hospitalisation	42.51	22.42	74	15050	74926	56202017
COVID-19 pneumonia	42.26	22.42	30	15094	11072	56265871
Diffuse large B-cell lymphoma	41.53	22.42	25	15099	6991	56269952
Minimal residual disease	41.43	22.42	9	15115	115	56276828
Bone marrow failure	40.91	22.42	44	15080	28242	56248701
Transformation to acute myeloid leukaemia	40.26	22.42	10	15114	236	56276707
Escherichia sepsis	40.13	22.42	21	15103	4488	56272455
Atrial fibrillation	39.39	22.42	89	15035	108808	56168135
Product dose omission issue	38.10	22.42	5	15119	204748	56072195
Pneumonia adenoviral	35.82	22.42	8	15116	117	56276826
Bronchopulmonary aspergillosis	35.37	22.42	24	15100	8240	56268703
Non-small cell lung cancer	35.33	22.42	18	15106	3640	56273303
Drug hypersensitivity	35.13	22.42	15	15109	275190	56001753
Periorbital cellulitis	34.80	22.42	11	15113	636	56276307
Leukaemia	34.80	22.42	18	15106	3757	56273186
Maternal exposure during pregnancy	34.39	22.42	5	15119	189548	56087395
Escherichia bacteraemia	33.34	22.42	17	15107	3443	56273500
Pleural effusion	33.32	22.42	72	15052	85408	56191535
Abdominal discomfort	32.49	22.42	17	15107	277257	55999686
Synovitis	32.38	22.42	3	15121	161302	56115641
Soft tissue infection	32.27	22.42	14	15110	1973	56274970
Nasopharyngitis	31.64	22.42	10	15114	220949	56055994
Blood phosphorus increased	30.77	22.42	15	15109	2761	56274182
Infusion related reaction	30.73	22.42	9	15115	208922	56068021
Febrile bone marrow aplasia	30.32	22.42	20	15104	6552	56270391
Bacteraemia	29.34	22.42	28	15096	15603	56261340
Plasma cell myeloma	29.03	22.42	48	15076	46598	56230345
Splenomegaly	28.75	22.42	23	15101	10145	56266798
Respiratory failure	28.23	22.42	72	15052	94990	56181953
Neutropenic sepsis	28.12	22.42	27	15097	15158	56261785
Peripheral swelling	28.07	22.42	14	15110	234712	56042231
Dizziness	28.04	22.42	36	15088	376104	55900839
Hepatic enzyme increased	27.87	22.42	6	15118	171378	56105565
Adenoviral hepatitis	27.62	22.42	8	15116	343	56276600
Blood uric acid increased	27.42	22.42	16	15108	4226	56272717
Stem cell transplant	27.39	22.42	12	15112	1732	56275211
Autoimmune haemolytic anaemia	27.30	22.42	16	15108	4260	56272683
Leukaemia recurrent	27.07	22.42	11	15113	1317	56275626
Exposure during pregnancy	26.16	22.42	3	15121	136339	56140604
Pseudomonal skin infection	26.12	22.42	4	15120	4	56276939
Transplant	26.08	22.42	9	15115	685	56276258
Blood pressure increased	25.94	22.42	4	15120	145172	56131771
Splenic abscess	25.49	22.42	6	15118	112	56276831
Hypophosphataemia	25.43	22.42	21	15103	9681	56267262
Portal vein cavernous transformation	25.20	22.42	6	15118	118	56276825
Hypoaesthesia	25.05	22.42	4	15120	141487	56135456
Pruritus	24.96	22.42	29	15095	316594	55960349
Multiple organ dysfunction syndrome	24.75	22.42	48	15076	52722	56224221
Fungal sepsis	24.74	22.42	10	15114	1181	56275762
Cerebral haemorrhage	24.27	22.42	34	15090	28572	56248371
Nonspecific reaction	23.39	22.42	11	15113	1870	56275073
Lymphocyte count decreased	23.39	22.42	33	15091	27906	56249037
Subdural haematoma	23.12	22.42	23	15101	13476	56263467
Terminal ileitis	23.06	22.42	8	15116	619	56276324
Discomfort	22.97	22.42	5	15119	141756	56135187
Pain in extremity	22.64	22.42	28	15096	297403	55979540
Campylobacter gastroenteritis	22.54	22.42	7	15117	382	56276561

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	1535.95	18.84	1675	24820	358894	31311955
Acute myeloid leukaemia	912.64	18.84	399	26096	18273	31652576
Febrile neutropenia	895.95	18.84	769	25726	121080	31549769
Off label use	877.17	18.84	1246	25249	346028	31324821
Tumour lysis syndrome	801.50	18.84	344	26151	15041	31655808
Chronic lymphocytic leukaemia	665.12	18.84	220	26275	4596	31666253
Neutropenia	585.55	18.84	650	25845	139714	31531135
Hospice care	453.82	18.84	172	26323	5404	31665445
Intentional product use issue	396.97	18.84	329	26166	49018	31621831
COVID-19	347.23	18.84	319	26176	54502	31616347
Cytopenia	239.77	18.84	136	26359	10874	31659975
Pneumonia	202.44	18.84	676	25819	334636	31336213
Thrombocytopenia	180.79	18.84	380	26115	142367	31528482
Sepsis	169.15	18.84	384	26111	151545	31519304
Disease progression	166.93	18.84	283	26212	90181	31580668
Pancytopenia	164.89	18.84	276	26219	87040	31583809
Neutrophil count decreased	157.57	18.84	194	26301	46200	31624649
Myelosuppression	150.92	18.84	114	26381	14806	31656043
Infection	149.38	18.84	255	26240	81676	31589173
Acute myeloid leukaemia recurrent	143.08	18.84	56	26439	1918	31668931
Lymphadenopathy	142.24	18.84	140	26355	25981	31644868
Mantle cell lymphoma	127.49	18.84	50	26445	1722	31669127
Platelet count decreased	117.04	18.84	274	26221	110161	31560688
COVID-19 pneumonia	96.61	18.84	82	26413	12573	31658276
Hyperphosphataemia	96.14	18.84	45	26450	2404	31668445
Chronic lymphocytic leukaemia recurrent	86.60	18.84	26	26469	389	31670460
White blood cell count decreased	85.15	18.84	210	26285	87188	31583661
Transplant	84.83	18.84	30	26465	769	31670080
Autoimmune haemolytic anaemia	84.02	18.84	49	26446	4123	31666726
Pneumonia fungal	83.84	18.84	57	26438	6272	31664577
Pyrexia	82.44	18.84	483	26012	303357	31367492
Toxicity to various agents	81.93	18.84	25	26470	181462	31489387
Lymphocyte count increased	74.42	18.84	40	26455	2873	31667976
Splenomegaly	69.85	18.84	71	26424	13678	31657171
Bacteraemia	68.45	18.84	79	26416	17555	31653294
Septic shock	64.43	18.84	159	26336	65999	31604850
Completed suicide	63.88	18.84	3	26492	91511	31579338
Product dose omission issue	58.83	18.84	9	26486	105577	31565272
Blast cell count increased	56.81	18.84	24	26471	1003	31669846
Hyperuricaemia	56.36	18.84	48	26447	7390	31663459
Myelodysplastic syndrome	55.06	18.84	74	26421	19177	31651672
Anaemia	53.62	18.84	333	26162	213189	31457660
Hospitalisation	52.00	18.84	123	26372	49684	31621165
Blood pressure increased	48.69	18.84	5	26490	79628	31591221
Drug interaction	48.46	18.84	62	26433	208481	31462368
Neutropenic sepsis	47.27	18.84	55	26440	12324	31658525
Soft tissue infection	47.27	18.84	26	26469	1955	31668894
Stem cell transplant	46.46	18.84	26	26469	2022	31668827
Leukaemia	45.73	18.84	33	26462	3992	31666857
Headache	44.34	18.84	53	26442	183599	31487250
Hypocalcaemia	43.41	18.84	71	26424	21907	31648942
Condition aggravated	43.25	18.84	44	26451	163965	31506884
Mantle cell lymphoma refractory	42.87	18.84	11	26484	88	31670761
Lymphocytosis	42.85	18.84	25	26470	2104	31668745
Blast cell count decreased	42.62	18.84	7	26488	0	31670849
Blood phosphorus increased	42.56	18.84	33	26462	4449	31666400
Skin infection	41.51	18.84	39	26456	6824	31664025
Overdose	41.27	18.84	10	26485	84654	31586195
Acute myeloid leukaemia refractory	40.14	18.84	9	26486	37	31670812
Weight increased	40.04	18.84	10	26485	82937	31587912
Minimal residual disease	39.91	18.84	14	26481	350	31670499
Pain	38.91	18.84	60	26435	186699	31484150
Depression	38.32	18.84	14	26481	90801	31580048
Somnolence	37.67	18.84	18	26477	99427	31571422
Chemotherapy	37.20	18.84	15	26480	556	31670293
Pain in extremity	36.96	18.84	26	26469	116177	31554672
Tremor	35.39	18.84	10	26485	76410	31594439
Bone marrow transplant	35.09	18.84	17	26478	981	31669868
Squamous cell carcinoma	35.03	18.84	44	26451	10667	31660182
Pruritus	34.82	18.84	32	26463	125135	31545714
Lymphocyte count decreased	34.58	18.84	62	26433	20587	31650262
Bronchopulmonary aspergillosis	33.89	18.84	49	26446	13585	31657264
Blood uric acid abnormal	33.84	18.84	9	26486	84	31670765
Hypogammaglobulinaemia	33.25	18.84	34	26461	6593	31664256
Allogenic stem cell transplantation	32.90	18.84	8	26487	50	31670799
Escherichia bacteraemia	32.72	18.84	24	26471	2977	31667872
Anxiety	32.21	18.84	18	26477	91015	31579834
Blood lactate dehydrogenase increased	31.45	18.84	59	26436	20280	31650569
Chronic lymphocytic leukaemia transformation	31.43	18.84	10	26485	183	31670666
Rash	31.31	18.84	77	26418	201409	31469440
Haemolysis	30.84	18.84	34	26461	7182	31663667
Sinusitis fungal	30.66	18.84	13	26482	548	31670301
Haemoglobin abnormal	29.96	18.84	24	26471	3391	31667458
Dizziness	29.48	18.84	78	26417	199069	31471780
Blood uric acid increased	28.95	18.84	31	26464	6339	31664510
Full blood count abnormal	28.55	18.84	50	26445	16297	31654552
B-cell small lymphocytic lymphoma	28.22	18.84	9	26486	166	31670683
T-cell prolymphocytic leukaemia	28.10	18.84	7	26488	49	31670800
Blastic plasmacytoid dendritic cell neoplasia	27.89	18.84	8	26487	101	31670748
Haematotoxicity	27.73	18.84	32	26463	7105	31663744
Arthralgia	27.54	18.84	53	26442	151371	31519478
Chronic lymphocytic leukaemia refractory	27.40	18.84	8	26487	108	31670741
Agitation	27.18	18.84	6	26489	54163	31616686
Seizure	27.15	18.84	26	26469	99742	31571107
Gait disturbance	26.45	18.84	16	26479	77479	31593370
White blood cell count abnormal	26.10	18.84	21	26474	2986	31667863
Transfusion	25.97	18.84	32	26463	7608	31663241
Chest pain	25.87	18.84	36	26459	116921	31553928
Hallucination	25.73	18.84	4	26491	46406	31624443
Atrial fibrillation	25.73	18.84	173	26322	113610	31557239
International normalised ratio increased	24.84	18.84	4	26491	45219	31625630
Mantle cell lymphoma recurrent	24.84	18.84	11	26484	516	31670333
Joint swelling	24.72	18.84	7	26488	53424	31617425
Coronavirus infection	24.35	18.84	22	26473	3661	31667188
Bradycardia	24.10	18.84	14	26481	69313	31601536
Confusional state	23.95	18.84	47	26448	133287	31537562
Cellulitis	23.68	18.84	91	26404	47927	31622922
Klebsiella sepsis	22.90	18.84	16	26479	1839	31669010
Influenza	22.68	18.84	85	26410	44240	31626609
Drug ineffective	22.50	18.84	217	26278	395356	31275493
General physical health deterioration	21.88	18.84	166	26329	113269	31557580
Rhabdomyolysis	21.87	18.84	13	26482	63568	31607281
Blood product transfusion dependent	21.53	18.84	9	26486	366	31670483
Diffuse large B-cell lymphoma	21.39	18.84	31	26464	8610	31662239
Plasma cell leukaemia	21.37	18.84	12	26483	939	31669910
Angiodysplasia	21.28	18.84	10	26485	539	31670310
Blood pressure decreased	20.98	18.84	7	26488	48084	31622765
Urticaria	20.88	18.84	11	26484	57506	31613343
Diabetes mellitus	20.78	18.84	5	26490	42551	31628298
Platelet count abnormal	20.38	18.84	17	26478	2542	31668307
Blood creatine phosphokinase increased	20.36	18.84	5	26490	41969	31628880
Fungal sepsis	20.16	18.84	11	26484	814	31670035
Epstein-Barr virus infection reactivation	20.00	18.84	11	26484	827	31670022
Hypersensitivity	19.74	18.84	11	26484	55732	31615117
Transfusion reaction	19.59	18.84	11	26484	861	31669988
Insomnia	19.21	18.84	31	26464	94805	31576044
Palliative care	19.17	18.84	9	26486	484	31670365
Respiratory tract infection	19.00	18.84	44	26451	17517	31653332
Nasopharyngitis	19.00	18.84	15	26480	63230	31607619
Pneumocystis jirovecii pneumonia	18.95	18.84	45	26450	18206	31652643

FDA Adverse Event Reporting System (Geriatric)

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
Febrile neutropenia	1813.39	18.84	1163	33348	203155	70690778
Death	1553.29	18.84	1545	32966	508516	70385417
Acute myeloid leukaemia	1231.39	18.84	489	34022	30451	70863482
Tumour lysis syndrome	1157.61	18.84	423	34088	20937	70872996
Neutropenia	1005.72	18.84	898	33613	256258	70637675
Chronic lymphocytic leukaemia	834.54	18.84	241	34270	5557	70888376
Off label use	656.19	18.84	1236	33275	741824	70152109
Pneumonia	422.59	18.84	907	33604	595325	70298608
Sepsis	419.89	18.84	554	33957	243991	70649942
Thrombocytopenia	412.53	18.84	543	33968	238567	70655366
Cytopenia	358.57	18.84	173	34338	17150	70876783
COVID-19	345.21	18.84	335	34176	105422	70788511
Neutrophil count decreased	339.23	18.84	299	34212	83257	70810676
Myelosuppression	299.01	18.84	185	34326	29960	70863973
Acute myeloid leukaemia recurrent	272.75	18.84	88	34423	2966	70890967
Pancytopenia	269.19	18.84	349	34162	150758	70743175
Platelet count decreased	248.89	18.84	366	34145	177856	70716077
Intentional product use issue	208.42	18.84	274	34237	119868	70774065
Disease progression	190.73	18.84	302	34209	156370	70737563
Lymphadenopathy	186.75	18.84	169	34342	48622	70845311
Pyrexia	185.48	18.84	681	33830	606271	70287662
Infection	184.31	18.84	351	34160	210434	70683499
Hospice care	182.11	18.84	86	34425	8119	70885814
White blood cell count decreased	167.15	18.84	298	34213	169843	70724090
Mantle cell lymphoma	146.83	18.84	48	34463	1687	70892246
Septic shock	138.74	18.84	218	34293	112040	70781893
Anaemia	136.88	18.84	469	34042	402954	70490979
Hyperphosphataemia	133.82	18.84	57	34454	4219	70889714
COVID-19 pneumonia	132.17	18.84	99	34412	21870	70872063
Pain	130.59	18.84	72	34439	628744	70265189
Pneumonia fungal	127.25	18.84	72	34439	9881	70884052
Bacteraemia	123.03	18.84	107	34404	29202	70864731
Hyperuricaemia	120.76	18.84	72	34439	10894	70883039
Blast cell count increased	109.15	18.84	36	34475	1301	70892632
Joint swelling	96.32	18.84	7	34504	253204	70640729
Headache	92.35	18.84	88	34423	580317	70313616
Toxicity to various agents	91.17	18.84	36	34475	382136	70511797
Chronic lymphocytic leukaemia recurrent	90.39	18.84	26	34485	589	70893344
Splenomegaly	89.67	18.84	74	34437	18796	70875137
Myelodysplastic syndrome	88.93	18.84	90	34421	29695	70864238
Blood lactate dehydrogenase increased	86.86	18.84	96	34415	35031	70858902
Arthralgia	86.45	18.84	71	34440	503319	70390614
Autoimmune haemolytic anaemia	85.66	18.84	51	34460	7695	70886238
Allogenic stem cell transplantation	84.94	18.84	16	34495	44	70893889
Soft tissue infection	84.24	18.84	39	34472	3518	70890415
Atrial fibrillation	78.46	18.84	232	34279	184116	70709817
Bronchopulmonary aspergillosis	76.90	18.84	71	34440	20931	70873002
Rash	71.58	18.84	86	34425	510476	70383457
Neutropenic sepsis	70.45	18.84	73	34438	24757	70869176
Lymphocytosis	69.02	18.84	35	34476	3855	70890078
Pruritus	68.11	18.84	42	34469	345518	70548415
Product dose omission issue	67.82	18.84	12	34499	217456	70676477
Blood pressure increased	66.82	18.84	7	34504	188510	70705423
Escherichia bacteraemia	65.83	18.84	39	34472	5830	70888103
Swelling	64.32	18.84	8	34503	188531	70705402
Rhinovirus infection	63.39	18.84	40	34471	6693	70887240
Blood phosphorus increased	63.18	18.84	40	34471	6730	70887203
Escherichia sepsis	61.64	18.84	41	34470	7502	70886431
Pain in extremity	60.43	18.84	43	34468	328039	70565894
Hypocalcaemia	59.40	18.84	90	34421	44769	70849164
Nasopharyngitis	57.96	18.84	18	34493	222188	70671745
Acute myeloid leukaemia refractory	57.33	18.84	13	34498	107	70893826
T-cell prolymphocytic leukaemia	56.09	18.84	12	34499	73	70893860
Weight increased	55.83	18.84	24	34487	242307	70651626
Condition aggravated	54.78	18.84	77	34434	427558	70466375
Diffuse large B-cell lymphoma	54.67	18.84	48	34463	13254	70880679
Drug hypersensitivity	54.39	18.84	30	34481	262429	70631504
Chronic lymphocytic leukaemia transformation	53.07	18.84	14	34497	227	70893706
Skin infection	52.37	18.84	51	34460	16061	70877872
Hypogammaglobulinaemia	52.23	18.84	44	34467	11494	70882439
Febrile bone marrow aplasia	50.75	18.84	44	34467	11947	70881986
Aspergillus infection	49.73	18.84	52	34459	17816	70876117
Dizziness	49.70	18.84	94	34417	464047	70429886
Drug interaction	49.52	18.84	68	34443	381373	70512560
Overdose	49.49	18.84	11	34500	169734	70724199
Squamous cell carcinoma	48.92	18.84	47	34464	14557	70879376
Lymphocyte count increased	48.70	18.84	31	34480	5265	70888668
Transplant	48.53	18.84	18	34493	924	70893009
Respiratory failure	48.37	18.84	186	34325	168549	70725384
Synovitis	47.91	18.84	4	34507	129224	70764709
Abdominal discomfort	46.74	18.84	23	34488	214635	70679298
Drug ineffective	46.60	18.84	268	34243	939484	69954449
Anxiety	45.91	18.84	25	34486	220305	70673628
Leukaemia	45.82	18.84	30	34481	5345	70888588
Minimal residual disease	45.38	18.84	14	34497	406	70893527
Chronic lymphocytic leukaemia refractory	44.39	18.84	11	34500	137	70893796
Maternal exposure during pregnancy	44.38	18.84	3	34508	115342	70778591
Somnolence	44.14	18.84	25	34486	215581	70678352
Asthma	44.07	18.84	4	34507	120789	70773144
Urticaria	42.88	18.84	13	34498	163036	70730897
Bone marrow transplant	42.33	18.84	18	34493	1326	70892607
Depression	42.30	18.84	22	34489	198952	70694981
Mantle cell lymphoma refractory	41.92	18.84	10	34501	105	70893828
Blood uric acid increased	41.71	18.84	35	34476	9094	70884839
Lymphocyte count decreased	41.04	18.84	75	34436	43464	70850469
Hypoaesthesia	40.90	18.84	12	34499	153727	70740206
Leukaemia recurrent	40.75	18.84	22	34489	2753	70891180
Contraindicated product administered	40.72	18.84	8	34503	134604	70759329
Therapeutic product effect decreased	40.24	18.84	10	34501	143008	70750925
Tremor	39.87	18.84	13	34498	155611	70738322
Inappropriate schedule of product administration	38.08	18.84	4	34507	107551	70786382
Sinusitis fungal	37.69	18.84	19	34492	2066	70891867
Klebsiella sepsis	37.59	18.84	21	34490	2810	70891123
Infusion related reaction	37.52	18.84	25	34486	197509	70696424
Peripheral swelling	37.35	18.84	36	34475	236527	70657406
Gait disturbance	37.12	18.84	22	34489	185084	70708849
Blood uric acid abnormal	36.67	18.84	10	34501	185	70893748
Multiple organ dysfunction syndrome	36.47	18.84	126	34385	108389	70785544
Hypersensitivity	35.10	18.84	36	34475	229776	70664157
Transformation to acute myeloid leukaemia	34.23	18.84	14	34497	935	70892998
Bone marrow failure	33.68	18.84	74	34437	48936	70844997
Hyperkalaemia	33.44	18.84	121	34390	106470	70787463
Hypophosphataemia	32.62	18.84	40	34471	16286	70877647
Periorbital cellulitis	32.55	18.84	13	34498	816	70893117
Cellulitis	32.49	18.84	114	34397	98814	70795119
Pneumocystis jirovecii pneumonia	32.47	18.84	55	34456	30027	70863906
Bacterial sepsis	32.24	18.84	28	34483	7619	70886314
Blast cells	30.80	18.84	5	34506	3	70893930
Insomnia	30.11	18.84	37	34474	217769	70676164
Malaise	29.99	18.84	109	34402	432823	70461110
Feeling abnormal	29.85	18.84	16	34495	142303	70751630
Fungal sepsis	29.27	18.84	15	34496	1688	70892245
Flushing	29.23	18.84	3	34508	82169	70811764
Chest discomfort	29.14	18.84	12	34499	124369	70769564
General physical health deterioration	28.75	18.84	205	34306	235826	70658107
B-cell small lymphocytic lymphoma	28.47	18.84	8	34503	166	70893767
Hospitalisation	27.85	18.84	96	34415	82472	70811461
Wheezing	27.65	18.84	6	34505	94164	70799769
Wound	27.58	18.84	7	34504	98725	70795208
Erythema	27.48	18.84	34	34477	199529	70694404
Systemic toxicity	27.30	18.84	7	34504	101	70893832
Pleural effusion	26.94	18.84	132	34379	132732	70761201
Respiratory tract infection	26.88	18.84	62	34449	42336	70851597
Coronavirus infection	26.58	18.84	23	34488	6229	70887704
Dyspnoea	25.85	18.84	245	34266	769815	70124118
Hepatic enzyme increased	25.82	18.84	23	34488	156967	70736966
White blood cell count abnormal	25.52	18.84	21	34490	5309	70888624
Blood product transfusion dependent	25.51	18.84	9	34502	400	70893533
Full blood count abnormal	25.40	18.84	53	34458	33825	70860108
Cytomegalovirus colitis	25.31	18.84	19	34492	4207	70889726
Epstein-Barr virus infection reactivation	25.04	18.84	13	34498	1503	70892430
Cytomegalovirus infection reactivation	24.97	18.84	23	34488	6758	70887175
Pseudomonal sepsis	24.82	18.84	21	34490	5516	70888417
Muscle spasms	24.82	18.84	23	34488	154023	70739910
Campylobacter gastroenteritis	24.80	18.84	12	34499	1195	70892738
Treatment failure	23.85	18.84	21	34490	144121	70749812
Seizure	23.79	18.84	31	34480	177931	70716002
Anaphylactic reaction	23.65	18.84	4	34507	74970	70818963
Pseudomonas infection	23.58	18.84	37	34474	18957	70874976
Agitation	23.56	18.84	8	34503	93367	70800566
Transfusion reaction	23.55	18.84	13	34498	1700	70892233
Impaired healing	23.39	18.84	4	34507	74370	70819563
Discomfort	23.39	18.84	11	34500	105425	70788508
Wrong technique in product usage process	23.21	18.84	3	34508	68695	70825238
Paraesthesia	23.13	18.84	22	34489	145515	70748418
Phlebitis	23.07	18.84	24	34487	8170	70885763
Stress	22.88	18.84	3	34508	67963	70825970
Chest pain	22.60	18.84	56	34455	251204	70642729
Plasma cell leukaemia	22.48	18.84	13	34498	1858	70892075
Alopecia	22.26	18.84	39	34472	198451	70695482
Bradycardia	22.04	18.84	17	34494	124598	70769335
Angiodysplasia	21.92	18.84	10	34501	872	70893061
Atypical pneumonia	21.77	18.84	20	34491	5855	70888078
Refractory cancer	21.66	18.84	7	34504	237	70893696
Herpes simplex	21.60	18.84	27	34484	11205	70882728
Blister	21.52	18.84	11	34500	100515	70793418
Chemotherapy	21.49	18.84	12	34499	1604	70892329
Portal vein cavernous transformation	21.38	18.84	6	34505	124	70893809
Drug intolerance	21.32	18.84	49	34462	225638	70668295
Stem cell transplant	21.21	18.84	16	34495	3569	70890364
Clostridium colitis	21.09	18.84	14	34497	2552	70891381
Blood glucose increased	20.98	18.84	12	34499	102970	70790963
Platelet disorder	20.97	18.84	14	34497	2577	70891356
Terminal ileitis	20.92	18.84	9	34502	682	70893251
Blastic plasmacytoid dendritic cell neoplasia	20.81	18.84	6	34505	137	70893796
Pseudomonal skin infection	20.73	18.84	4	34507	13	70893920
Pneumonia adenoviral	20.64	18.84	8	34503	464	70893469
Balance disorder	20.62	18.84	9	34502	90119	70803814
Colitis	20.48	18.84	73	34438	63741	70830192
Migraine	20.41	18.84	5	34506	72233	70821700
Splenic abscess	20.10	18.84	8	34503	498	70893435
Vascular device infection	19.93	18.84	22	34489	8008	70885925
Blast cell count decreased	19.89	18.84	4	34507	17	70893916
Subdural haematoma	19.86	18.84	44	34467	29254	70864679
Systemic candida	19.69	18.84	19	34492	5915	70888018
Electrocardiogram QT prolonged	19.65	18.84	8	34503	83509	70810424
Hyperhidrosis	19.64	18.84	21	34490	131565	70762368
Haemolysis	19.45	18.84	26	34485	11525	70882408
Hypercalcaemia	19.34	18.84	48	34463	34337	70859596
Acute febrile neutrophilic dermatosis	19.27	18.84	15	34496	3504	70890429
Escherichia infection	19.16	18.84	31	34480	16300	70877633
Haematotoxicity	18.90	18.84	28	34483	13646	70880287
Haematochezia	18.90	18.84	6	34505	73075	70820858

FDA Adverse Event Reporting System (Pediatric)

None

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	antineoplastic agents
CHEBI has role	CHEBI:68495	Type I cell-death inducers
CHEBI has role	CHEBI:133022	B-cell lymphoma 2 inhibitors

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID
Acute myeloid leukemia, disease	indication	91861009
Chronic lymphoid leukemia, disease	indication	92814006
Malignant lymphoma - small lymphocytic	indication	302841002

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
100MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	9174982	May 26, 2030	TREATMENT IN COMBINATION WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) 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	9174982	May 26, 2030	TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
100MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	9174982	May 26, 2030	TREATMENT OF ADULT 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	9174982	May 26, 2030	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	9174982	May 26, 2030	TREATMENT IN COMBINATION WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) 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	9174982	May 26, 2030	TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
10MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	9174982	May 26, 2030	TREATMENT OF ADULT 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	9174982	May 26, 2030	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	9174982	May 26, 2030	TREATMENT IN COMBINATION WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) 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	9174982	May 26, 2030	TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
50MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	9174982	May 26, 2030	TREATMENT OF ADULT 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	9174982	May 26, 2030	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	10993942	Sept. 6, 2033	TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP THAT INCLUDES A DOSE OF 50 MG PER DAY FOR 1 WEEK FOLLOWED BY 100 MG PER DAY FOR 1 WEEK
100MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	11110087	Sept. 6, 2033	TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) BY ORALLY ADMINISTERING VENETOCLAX WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE IN ADULTS 75 YEARS OR OLDER OR HAVING CERTAIN COMORBIDITIES ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE
100MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	11110087	Sept. 6, 2033	TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE
100MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	11413282	Sept. 6, 2033	TREATMENT OF ADULTS WITH RELAPSED, REFRACTORY OR PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA INCLUDING A DOSE RAMP-UP AND IN COMBINATION WITH OBINUTUZUMAB IN MULTIPLE 28-DAY DOSING CYCLES FOLLOWED BY ADMINISTRATION IN ABSENCE OF OBINUTUZUMAB
100MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	9539251	Sept. 6, 2033	TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LEUKEMIA (SLL) IN COMBINATION WITH A GA101 ANTIBODY SUCH AS OBINUTUZUMAB FOR ONE OR MORE DOSING PERIODS, WHEREIN THE CLL OR SLL IS A CD20-EXPRESSING CANCER
10MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	10993942	Sept. 6, 2033	TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP THAT INCLUDES A DOSE OF 50 MG PER DAY FOR 1 WEEK FOLLOWED BY 100 MG PER DAY FOR 1 WEEK
10MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	11110087	Sept. 6, 2033	TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) BY ORALLY ADMINISTERING VENETOCLAX WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE IN ADULTS 75 YEARS OR OLDER OR HAVING CERTAIN COMORBIDITIES ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE
10MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	11110087	Sept. 6, 2033	TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE
10MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	11413282	Sept. 6, 2033	TREATMENT OF ADULTS WITH RELAPSED, REFRACTORY OR PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA INCLUDING A DOSE RAMP-UP AND IN COMBINATION WITH OBINUTUZUMAB IN MULTIPLE 28-DAY DOSING CYCLES FOLLOWED BY ADMINISTRATION IN ABSENCE OF OBINUTUZUMAB
10MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	9539251	Sept. 6, 2033	TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LEUKEMIA (SLL) IN COMBINATION WITH A GA101 ANTIBODY SUCH AS OBINUTUZUMAB FOR ONE OR MORE DOSING PERIODS, WHEREIN THE CLL OR SLL IS A CD20-EXPRESSING CANCER
50MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	10993942	Sept. 6, 2033	TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP THAT INCLUDES A DOSE OF 50 MG PER DAY FOR 1 WEEK FOLLOWED BY 100 MG PER DAY FOR 1 WEEK
50MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	11110087	Sept. 6, 2033	TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) BY ORALLY ADMINISTERING VENETOCLAX WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE IN ADULTS 75 YEARS OR OLDER OR HAVING CERTAIN COMORBIDITIES ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE
50MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	11110087	Sept. 6, 2033	TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE
50MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	11413282	Sept. 6, 2033	TREATMENT OF ADULTS WITH RELAPSED, REFRACTORY OR PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA INCLUDING A DOSE RAMP-UP AND IN COMBINATION WITH OBINUTUZUMAB IN MULTIPLE 28-DAY DOSING CYCLES FOLLOWED BY ADMINISTRATION IN ABSENCE OF OBINUTUZUMAB
50MG	VENCLEXTA	ABBVIE INC	N208573	April 11, 2016	RX	TABLET	ORAL	9539251	Sept. 6, 2033	TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LEUKEMIA (SLL) IN COMBINATION WITH A GA101 ANTIBODY SUCH AS OBINUTUZUMAB FOR ONE OR MORE DOSING PERIODS, WHEREIN THE CLL OR SLL IS A CD20-EXPRESSING CANCER

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	May 15, 2022	VENETOCLAX IN COMBINATION 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 COMBINATION 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 COMBINATION 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
Aspartyl/asparaginyl beta-hydroxylase	Enzyme	Q12797	ASPH_HUMAN		IC50	5.89	CHEMBL
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
N54AIC43PW	UNII
D10679	KEGG_DRUG
C4079830	UMLSCUI
CHEBI:133021	CHEBI
LBM	PDB_CHEM_ID
CHEMBL3137309	ChEMBL_ID
49846579	PUBCHEM_CID
DB11581	DRUGBANK_ID
9925	INN_ID
C579720	MESH_SUPPLEMENTAL_RECORD_UI
8318	IUPHAR_LIGAND_ID
1747556	RXNORM
240227	MMSL
31601	MMSL
d08429	MMSL
016803	NDDF
720491001	SNOMEDCT_US
763511000	SNOMEDCT_US
4035629	VANDF

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	32 sections
Venclexta	HUMAN PRESCRIPTION DRUG LABEL	1	0074-0561	TABLET, FILM COATED	10 mg	ORAL	NDA	32 sections
Venclexta	HUMAN PRESCRIPTION DRUG LABEL	1	0074-0566	TABLET, FILM COATED	50 mg	ORAL	NDA	32 sections
Venclexta	HUMAN PRESCRIPTION DRUG LABEL	1	0074-0566	TABLET, FILM COATED	50 mg	ORAL	NDA	32 sections
Venclexta	HUMAN PRESCRIPTION DRUG LABEL	1	0074-0576	TABLET, FILM COATED	100 mg	ORAL	NDA	32 sections
Venclexta	HUMAN PRESCRIPTION DRUG LABEL	1	0074-0576	TABLET, FILM COATED	100 mg	ORAL	NDA	32 sections