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

Stem definition	Drug id	CAS RN
B-cell lymphoma 2 (Bcl-2) inhibitors, antineoplastics	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:

Property	Value	Reference
S (Water solubility)	0.00 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Bocci G, Oprea TI, Benet LZ

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	1596.39	21.42	1113	17615	373268	63097026
Febrile neutropenia	1050.03	21.42	565	18163	117884	63352410
Off label use	975.93	21.42	1085	17643	673377	62796917
Neutropenia	664.98	21.42	488	18240	174517	63295777
Tumour lysis syndrome	591.14	21.42	182	18546	8808	63461486
Hospice care	347.33	21.42	118	18610	7814	63462480
Myelosuppression	317.42	21.42	150	18578	23553	63446741
Cytopenia	307.10	21.42	119	18609	11482	63458812
Acute myeloid leukaemia recurrent	299.63	21.42	74	18654	1549	63468745
Thrombocytopenia	295.44	21.42	288	18440	150869	63319425
Pancytopenia	264.65	21.42	223	18505	96710	63373584
Neutrophil count decreased	237.71	21.42	168	18560	56238	63414056
Disease progression	236.15	21.42	232	18496	122526	63347768
COVID-19	233.06	21.42	222	18506	112881	63357413
Sepsis	229.25	21.42	253	18475	152870	63317424
Intentional product use issue	217.26	21.42	226	18502	127666	63342628
Platelet count decreased	196.83	21.42	205	18523	115917	63354377
Pneumonia	169.69	21.42	398	18330	456369	63013925
White blood cell count decreased	123.26	21.42	177	18551	138927	63331367
Pyrexia	110.95	21.42	347	18381	470131	63000163
Allogenic stem cell transplantation	107.93	21.42	19	18709	62	63470232
Pain	98.51	21.42	48	18680	740580	62729714
Lymphadenopathy	97.67	21.42	85	18643	38373	63431921
Blast cell count increased	95.91	21.42	23	18705	423	63469871
Anaemia	91.95	21.42	240	18488	293190	63177104
Septic shock	89.12	21.42	104	18624	66525	63403769
Blood lactate dehydrogenase increased	88.47	21.42	65	18663	23051	63447243
Pneumonia fungal	86.97	21.42	39	18689	5416	63464878
Joint swelling	83.47	21.42	3	18725	327663	63142631
Acute myeloid leukaemia	81.37	21.42	55	18673	17092	63453202
Hospitalisation	79.33	21.42	111	18617	84970	63385324
Infection	75.39	21.42	191	18537	228982	63241312
Bone marrow transplant	75.07	21.42	21	18707	721	63469573
Acute myeloid leukaemia refractory	71.23	21.42	14	18714	94	63470200
Arthralgia	66.86	21.42	43	18685	569667	62900627
Hyperuricaemia	62.80	21.42	31	18697	5339	63464955
Headache	62.59	21.42	57	18671	633184	62837110
Rhinovirus infection	61.61	21.42	29	18699	4500	63465794
Swelling	59.75	21.42	6	18722	275372	63194922
Hyperphosphataemia	59.24	21.42	23	18705	2225	63468069
COVID-19 pneumonia	59.03	21.42	42	18686	14167	63456127
Chronic lymphocytic leukaemia recurrent	54.63	21.42	13	18715	231	63470063
Leukaemia	54.35	21.42	26	18702	4182	63466112
Chronic lymphocytic leukaemia transformation	53.06	21.42	10	18718	52	63470242
Bronchopulmonary aspergillosis	51.56	21.42	32	18696	8603	63461691
Rash	51.32	21.42	54	18674	560817	62909477
Atrial fibrillation	48.95	21.42	107	18621	116529	63353765
Transformation to acute myeloid leukaemia	48.58	21.42	12	18716	251	63470043
Chronic lymphocytic leukaemia refractory	48.56	21.42	9	18719	42	63470252
Product dose omission issue	48.56	21.42	6	18722	234307	63235987
Bone marrow failure	46.47	21.42	50	18678	29240	63441054
Febrile bone marrow aplasia	45.91	21.42	28	18700	7297	63462997
Aspergillus infection	45.82	21.42	29	18699	8064	63462230
Minimal residual disease	44.66	21.42	10	18718	134	63470160
Pneumonia adenoviral	44.59	21.42	10	18718	135	63470159
Escherichia sepsis	44.40	21.42	24	18704	4983	63465311
Synovitis	43.48	21.42	3	18725	186915	63283379
Neutropenic sepsis	43.07	21.42	37	18691	16401	63453893
Maternal exposure during pregnancy	42.41	21.42	7	18721	220055	63250239
Lymphoma	41.58	21.42	32	18696	12155	63458139
Nasopharyngitis	41.12	21.42	12	18716	254245	63216049
Abdominal discomfort	40.69	21.42	22	18706	320863	63149431
Agranulocytosis	40.03	21.42	43	18685	25091	63445203
Autoimmune haemolytic anaemia	37.89	21.42	21	18707	4580	63465714
Therapeutic product effect decreased	37.55	21.42	6	18722	193181	63277113
Bacteraemia	37.44	21.42	35	18693	17313	63452981
Myelodysplastic syndrome	36.54	21.42	34	18694	16720	63453574
Dizziness	36.43	21.42	44	18684	429881	63040413
Cerebral haemorrhage	36.20	21.42	45	18683	30684	63439610
Exposure during pregnancy	34.75	21.42	3	18725	155544	63314750
Adenoviral hepatitis	34.49	21.42	10	18718	391	63469903
Peripheral swelling	34.05	21.42	18	18710	265924	63204370
Non-small cell lung cancer	34.04	21.42	18	18710	3577	63466717
Blood pressure increased	33.93	21.42	4	18724	162058	63308236
Hepatic enzyme increased	33.73	21.42	9	18719	202319	63267975
Multiple organ dysfunction syndrome	33.38	21.42	60	18668	56692	63413602
Blood phosphorus increased	33.38	21.42	17	18711	3128	63467166
Pleural effusion	33.01	21.42	80	18648	93130	63377164
Blood disorder	32.79	21.42	22	18706	6749	63463545
Periorbital cellulitis	32.74	21.42	11	18717	702	63469592
Drug ineffective	32.38	21.42	179	18549	1044586	62425708
Stem cell transplant	32.18	21.42	14	18714	1808	63468486
Drug hypersensitivity	31.76	21.42	27	18701	310660	63159634
Transplant	31.53	21.42	11	18717	787	63469507
Respiratory failure	31.46	21.42	83	18645	101775	63368519
Pain in extremity	31.29	21.42	31	18697	331455	63138839
Splenomegaly	31.04	21.42	26	18702	11131	63459163
Infusion related reaction	30.87	21.42	17	18711	245504	63224790
Discomfort	30.78	21.42	6	18722	167368	63302926
Alopecia	30.24	21.42	33	18695	337503	63132791
Soft tissue infection	30.04	21.42	14	18714	2123	63468171
Escherichia bacteraemia	30.01	21.42	17	18711	3866	63466428
Pruritus	29.54	21.42	38	18690	361415	63108879
Neutropenic infection	29.12	21.42	12	18716	1355	63468939
Insomnia	28.39	21.42	14	18714	215238	63255056
Pericarditis	28.17	21.42	3	18725	131576	63338718
Mantle cell lymphoma	28.05	21.42	9	18719	497	63469797
Treatment failure	27.72	21.42	12	18716	199031	63271263
Injection site pain	27.68	21.42	3	18725	129797	63340497
Weight increased	27.47	21.42	22	18706	260770	63209524
Subdural haematoma	27.31	21.42	27	18701	14301	63455993
Hypoaesthesia	27.11	21.42	8	18720	168385	63301909
Somnolence	26.14	21.42	10	18718	178675	63291619
Leukaemia recurrent	26.00	21.42	11	18717	1327	63468967
Lymphocyte count decreased	26.00	21.42	38	18690	30219	63440075
Pseudomonal skin infection	25.75	21.42	4	18724	4	63470290
Pneumonia klebsiella	25.45	21.42	13	18715	2406	63467888
Blister	25.29	21.42	4	18724	129810	63340484
Pseudomonas infection	24.92	21.42	23	18705	11190	63459104
Urticaria	24.72	21.42	9	18719	165793	63304501
Asthma	24.69	21.42	4	18724	127557	63342737
Portal vein cavernous transformation	24.64	21.42	6	18722	118	63470176
Hypophosphataemia	24.55	21.42	23	18705	11403	63458891
Bacterial sepsis	24.47	21.42	15	18713	3943	63466351
Chemotherapy	24.25	21.42	11	18717	1568	63468726
Pneumonia bacterial	24.17	21.42	21	18707	9444	63460850
Leukopenia	23.88	21.42	63	18665	77227	63393067
Fatigue	23.86	21.42	159	18569	887869	62582425
Lymphocytosis	23.81	21.42	13	18715	2754	63467540
Lung infiltration	23.48	21.42	25	18703	14438	63455856
Anxiety	23.35	21.42	18	18710	217523	63252771
Fungal sepsis	23.22	21.42	10	18718	1260	63469034
Graft versus host disease in skin	23.21	21.42	13	18715	2892	63467402
Parainfluenzae virus infection	23.02	21.42	12	18716	2315	63467979
Splenic abscess	22.79	21.42	6	18722	163	63470131
Blood uric acid increased	22.60	21.42	16	18712	5351	63464943
Colitis	22.04	21.42	46	18682	48482	63421812
Drug intolerance	21.73	21.42	36	18692	308625	63161669
Sinusitis	21.60	21.42	21	18707	226632	63243662
Metapneumovirus infection	21.55	21.42	9	18719	1051	63469243

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	1745.55	17.51	1974	30447	396075	34528435
Off label use	1329.15	17.51	1769	30652	417755	34506755
Febrile neutropenia	1116.09	17.51	958	31463	135891	34788619
Tumour lysis syndrome	893.97	17.51	395	32026	16664	34907846
Neutropenia	816.56	17.51	857	31564	155921	34768589
Hospice care	494.28	17.51	200	32221	6740	34917770
COVID-19	425.48	17.51	437	31984	77113	34847397
Intentional product use issue	344.13	17.51	346	32075	59470	34865040
Cytopenia	330.93	17.51	183	32238	12540	34911970
Myelosuppression	306.30	17.51	202	32219	19063	34905447
Thrombocytopenia	273.65	17.51	506	31915	155741	34768769
Neutrophil count decreased	244.44	17.51	268	32153	50836	34873674
Disease progression	230.54	17.51	382	32039	107695	34816815
Pneumonia	217.27	17.51	782	31639	361845	34562665
Pancytopenia	213.25	17.51	344	32077	94813	34829697
Acute myeloid leukaemia recurrent	198.45	17.51	75	32346	2095	34922415
Infection	172.21	17.51	305	32116	90610	34833900
Sepsis	172.10	17.51	436	31985	166125	34758385
Platelet count decreased	151.22	17.51	339	32082	119378	34805132
Lymphadenopathy	144.25	17.51	154	32267	28309	34896201
COVID-19 pneumonia	123.68	17.51	112	32309	16855	34907655
Pyrexia	114.74	17.51	609	31812	332404	34592106
Pneumonia fungal	111.68	17.51	74	32347	7026	34917484
Toxicity to various agents	99.68	17.51	31	32390	200331	34724179
Acute myeloid leukaemia	94.57	17.51	100	32321	18170	34906340
White blood cell count decreased	93.32	17.51	245	32176	95200	34829310
Hyperphosphataemia	91.75	17.51	55	32366	4382	34920128
Transplant	88.21	17.51	32	32389	794	34923716
Hospitalisation	86.59	17.51	174	32247	56728	34867782
Chronic lymphocytic leukaemia	86.32	17.51	52	32369	4180	34920330
Bacteraemia	84.91	17.51	98	32323	19619	34904891
Autoimmune haemolytic anaemia	83.42	17.51	52	32369	4444	34920066
Chronic lymphocytic leukaemia recurrent	80.03	17.51	25	32396	385	34924125
Product dose omission issue	79.58	17.51	9	32412	119702	34804808
Completed suicide	77.93	17.51	3	32418	98165	34826345
Blast cell count increased	76.47	17.51	31	32390	1047	34923463
Septic shock	73.88	17.51	188	32233	71646	34852864
Splenomegaly	73.41	17.51	80	32341	15037	34909473
Anaemia	72.89	17.51	416	32005	232919	34691591
Hyperuricaemia	70.52	17.51	59	32362	7984	34916526
Lymphocyte count increased	70.33	17.51	42	32379	3323	34921187
Blood pressure increased	62.83	17.51	5	32416	88097	34836413
Allogenic stem cell transplantation	60.71	17.51	14	32407	59	34924451
Bronchopulmonary aspergillosis	58.36	17.51	70	32351	14589	34909921
Neutropenic sepsis	56.88	17.51	67	32354	13700	34910810
Stem cell transplant	56.22	17.51	31	32390	2108	34922402
Blood lactate dehydrogenase increased	55.32	17.51	86	32335	22904	34901606
Mantle cell lymphoma recurrent	54.33	17.51	22	32399	741	34923769
Somnolence	52.04	17.51	19	32402	111097	34813413
Hypocalcaemia	49.14	17.51	84	32337	24205	34900305
Overdose	49.12	17.51	12	32409	91047	34833463
Headache	48.84	17.51	69	32352	200566	34723944
Weight increased	48.76	17.51	13	32408	93020	34831490
Drug interaction	48.10	17.51	85	32336	225861	34698649
Soft tissue infection	46.92	17.51	28	32393	2212	34922298
Condition aggravated	46.87	17.51	66	32355	192130	34732380
Skin infection	46.66	17.51	46	32375	7691	34916819
Inappropriate schedule of product administration	45.95	17.51	3	32418	62293	34862217
Lymphocytosis	45.78	17.51	29	32392	2548	34921962
Blast cell count decreased	45.33	17.51	8	32413	3	34924507
Hypogammaglobulinaemia	44.80	17.51	45	32376	7695	34916815
Chemotherapy	44.32	17.51	18	32403	611	34923899
Pruritus	44.15	17.51	40	32381	141941	34782569
Pain in extremity	43.87	17.51	32	32389	126481	34798029
Acute myeloid leukaemia refractory	43.78	17.51	10	32411	40	34924470
Myelodysplastic syndrome	43.65	17.51	70	32351	19138	34905372
Anxiety	43.28	17.51	19	32402	99409	34825101
Minimal residual disease	43.22	17.51	16	32405	421	34924089
Anal inflammation	43.10	17.51	22	32399	1278	34923232
Leukaemia	42.92	17.51	35	32386	4568	34919942
Chronic lymphocytic leukaemia transformation	42.31	17.51	13	32408	189	34924321
Haematotoxicity	40.89	17.51	44	32377	8150	34916360
Tremor	40.60	17.51	13	32408	82574	34841936
Depression	40.04	17.51	20	32401	97078	34827432
Escherichia bacteraemia	39.44	17.51	29	32392	3251	34921259
SARS-CoV-2 test negative	38.95	17.51	19	32402	1001	34923509
Bone marrow transplant	38.12	17.51	19	32402	1049	34923461
Rash	37.98	17.51	95	32326	222657	34701853
Mantle cell lymphoma refractory	37.20	17.51	10	32411	87	34924423
Arthralgia	37.04	17.51	63	32358	169978	34754532
Rhinovirus infection	36.58	17.51	31	32390	4268	34920242
Squamous cell carcinoma	36.49	17.51	49	32372	11426	34913084
Escherichia sepsis	36.14	17.51	32	32389	4672	34919838
Gait disturbance	35.92	17.51	17	32404	85123	34839387
Haemoglobin abnormal	35.13	17.51	29	32392	3851	34920659
Dizziness	35.11	17.51	96	32325	218425	34706085
Full blood count abnormal	34.43	17.51	62	32359	18606	34905904
Transfusion	34.17	17.51	41	32380	8544	34915966
Agitation	34.17	17.51	6	32415	57393	34867117
Joint swelling	34.08	17.51	7	32414	59883	34864627
Lymphocyte count decreased	32.98	17.51	68	32353	22554	34901956
Proctalgia	32.62	17.51	33	32388	5690	34918820
Blood uric acid abnormal	32.36	17.51	9	32412	90	34924420
Pain	32.07	17.51	91	32330	204584	34719926
Seizure	32.04	17.51	30	32391	104827	34819683
Blood phosphorus increased	30.94	17.51	37	32384	7684	34916826
Lymphoma	30.38	17.51	47	32374	12460	34912050
International normalised ratio increased	30.34	17.51	4	32417	47323	34877187
Rhabdomyolysis	29.70	17.51	13	32408	68150	34856360
Cellulitis	29.51	17.51	112	32309	52839	34871671
Sinusitis fungal	28.99	17.51	13	32408	565	34923945
Bradycardia	28.94	17.51	17	32404	75401	34849109
Asthma	28.84	17.51	3	32418	42653	34881857
Accident	28.58	17.51	29	32392	5018	34919492
Chronic lymphocytic leukaemia refractory	28.33	17.51	8	32413	85	34924425
Insomnia	27.01	17.51	34	32387	103873	34820637
Atrial fibrillation	26.91	17.51	200	32221	122193	34802317
Chest pain	26.64	17.51	48	32373	126714	34797796
Haemolysis	26.40	17.51	35	32386	8059	34916451
Respiratory tract infection	26.12	17.51	57	32364	19655	34904855
Confusional state	25.71	17.51	60	32361	144100	34780410
Hallucination	25.49	17.51	8	32413	51490	34873020
Dyspnoea	24.75	17.51	227	32194	376555	34547955
White blood cell count abnormal	24.73	17.51	22	32399	3231	34921279
Blood uric acid increased	24.55	17.51	37	32384	9587	34914923
Hypersensitivity	24.51	17.51	13	32408	61022	34863488
B-cell small lymphocytic lymphoma recurrent	24.12	17.51	5	32416	11	34924499
Fungal sepsis	24.03	17.51	13	32408	851	34923659
Blood creatine phosphokinase increased	24.00	17.51	6	32415	44851	34879659
Neutrophil count abnormal	23.28	17.51	17	32404	1885	34922625
Coronavirus infection	23.04	17.51	24	32397	4283	34920227
Hypoglycaemia	22.90	17.51	11	32410	54629	34869881
Emphysematous cholecystitis	22.77	17.51	6	32415	48	34924462
Platelet count abnormal	22.69	17.51	20	32401	2902	34921608
Nasopharyngitis	22.59	17.51	19	32402	69949	34854561
Klebsiella sepsis	22.24	17.51	17	32404	2020	34922490
Hypoaesthesia	21.99	17.51	15	32406	61429	34863081
Diabetes mellitus	21.95	17.51	8	32413	46865	34877645
Myocardial infarction	21.90	17.51	50	32371	121035	34803475
Myeloblast count increased	21.70	17.51	4	32417	3	34924507
Haematochezia	21.69	17.51	8	32413	46526	34877984
SARS-CoV-2 test positive	21.46	17.51	27	32394	5906	34918604
Paraesthesia	21.24	17.51	17	32404	64155	34860355
Epstein-Barr virus infection reactivation	21.06	17.51	13	32408	1091	34923419
Transfusion reaction	20.68	17.51	12	32409	900	34923610
Pneumocystis jirovecii pneumonia	20.66	17.51	52	32369	19658	34904852
Blood pressure decreased	20.64	17.51	11	32410	51504	34873006
Pneumonia respiratory syncytial viral	20.54	17.51	12	32409	911	34923599
Urticaria	20.06	17.51	17	32404	62360	34862150
Muscle spasms	20.05	17.51	24	32397	74977	34849533
Blood product transfusion dependent	20.01	17.51	9	32412	394	34924116
Hypercalcaemia	19.67	17.51	44	32377	15424	34909086
Wheezing	19.50	17.51	7	32414	41395	34883115
Blood glucose increased	19.32	17.51	20	32401	66698	34857812
Erythema	19.20	17.51	33	32388	88747	34835763
Bacterial sepsis	19.16	17.51	24	32397	5226	34919284
Liver function test abnormal	19.04	17.51	3	32418	31071	34893439
Abdominal lymphadenopathy	18.74	17.51	11	32410	843	34923667
Drug ineffective	18.64	17.51	305	32116	456446	34468064
Loss of personal independence in daily activities	18.62	17.51	4	32417	33175	34891335
Swelling	18.58	17.51	8	32413	42358	34882152
Hypotension	18.49	17.51	125	32296	221524	34702986
Influenza	18.44	17.51	93	32328	49573	34874937
Hyperhidrosis	18.41	17.51	26	32395	75666	34848844
Abdominal discomfort	18.41	17.51	17	32404	59818	34864692
B-cell small lymphocytic lymphoma	18.37	17.51	7	32414	200	34924310
Dry mouth	18.29	17.51	3	32418	30162	34894348
Dehydration	18.05	17.51	61	32360	129908	34794602
General physical health deterioration	18.00	17.51	190	32231	128079	34796431
Platelet disorder	18.00	17.51	14	32407	1707	34922803
Angiodysplasia	17.94	17.51	10	32411	694	34923816
Palliative care	17.73	17.51	10	32411	710	34923800
Electrocardiogram QT prolonged	17.53	17.51	8	32413	40944	34883566
Myalgia	17.53	17.51	32	32389	84078	34840432

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	2260.94	18.05	1438	40410	229561	79472979
Death	1827.24	18.05	1833	40015	564681	79137859
Neutropenia	1337.69	18.05	1145	40703	286565	79415975
Tumour lysis syndrome	1327.85	18.05	492	41356	23447	79679093
Off label use	855.87	18.05	1620	40228	905595	78796945
Myelosuppression	623.92	18.05	339	41509	39957	79662583
Thrombocytopenia	581.76	18.05	705	41143	264554	79437986
Cytopenia	517.90	18.05	240	41608	20143	79682397
Neutrophil count decreased	513.54	18.05	412	41436	93547	79608993
COVID-19	495.16	18.05	506	41342	157168	79545372
Pneumonia	490.49	18.05	1071	40777	659175	79043365
Sepsis	454.10	18.05	629	41219	268799	79433741
Acute myeloid leukaemia recurrent	425.84	18.05	129	41719	3254	79699286
Pancytopenia	379.83	18.05	451	41397	165294	79537246
Platelet count decreased	348.05	18.05	468	41380	194196	79508344
Disease progression	311	18.05	431	41417	183931	79518609
Pyrexia	255.57	18.05	858	40990	677851	79024689
White blood cell count decreased	207.68	18.05	362	41486	187926	79514614
Infection	201.18	18.05	412	41436	241300	79461240
Pneumonia fungal	197.85	18.05	103	41745	11107	79691433
Anaemia	194.69	18.05	593	41255	444422	79258118
Lymphadenopathy	192.92	18.05	185	41663	53062	79649478
COVID-19 pneumonia	186.74	18.05	140	41708	28709	79673831
Septic shock	178.89	18.05	268	41580	122533	79580007
Hospice care	174.06	18.05	92	41756	10232	79692308
Intentional product use issue	172.30	18.05	296	41552	151816	79550724
Blast cell count increased	157.23	18.05	49	41799	1361	79701179
Bacteraemia	150.13	18.05	130	41718	32694	79669846
Hyperphosphataemia	146.25	18.05	70	41778	6306	79696234
Acute myeloid leukaemia	138.59	18.05	121	41727	30764	79671776
Hyperuricaemia	136.11	18.05	82	41766	11717	79690823
Pain	133.12	18.05	105	41743	703697	78998843
Bronchopulmonary aspergillosis	130.67	18.05	102	41746	22192	79680348
Allogenic stem cell transplantation	128.24	18.05	25	41823	79	79702461
Blood lactate dehydrogenase increased	126.79	18.05	128	41720	39042	79663498
Joint swelling	123.20	18.05	7	41841	288639	79413901
Arthralgia	112.26	18.05	82	41766	571721	79130819
Headache	107.47	18.05	111	41737	653661	79048879
Chronic lymphocytic leukaemia recurrent	100.28	18.05	29	41819	619	79701921
Atrial fibrillation	92.17	18.05	270	41578	197616	79504924
Autoimmune haemolytic anaemia	90.91	18.05	56	41792	8324	79694216
Escherichia sepsis	90.13	18.05	56	41792	8452	79694088
Splenomegaly	88.48	18.05	79	41769	20675	79681865
Product dose omission issue	87.14	18.05	13	41835	247524	79455016
Blood pressure increased	84.71	18.05	7	41841	211353	79491187
Pruritus	83.53	18.05	52	41796	394596	79307944
Swelling	82.03	18.05	9	41839	216702	79485838
Rash	81.30	18.05	111	41737	578247	79124293
Soft tissue infection	80.86	18.05	40	41808	3872	79698668
Arthropathy	79.74	18.05	3	41845	177108	79525432
Neutropenic sepsis	79.56	18.05	84	41764	26980	79675560
Pain in extremity	78.58	18.05	47	41801	364491	79338049
Rhinovirus infection	78.36	18.05	50	41798	7903	79694637
Toxicity to various agents	75.68	18.05	66	41782	421474	79281066
Hypocalcaemia	75.55	18.05	111	41737	49813	79652727
Lymphocytosis	73.98	18.05	40	41808	4653	79697887
Escherichia bacteraemia	71.56	18.05	44	41804	6518	79696022
Myelodysplastic syndrome	68.46	18.05	82	41766	30219	79672321
Acute myeloid leukaemia refractory	68.39	18.05	16	41832	141	79702399
Nasopharyngitis	68.24	18.05	24	41824	253857	79448683
Chronic lymphocytic leukaemia	67.17	18.05	38	41810	4828	79697712
Weight increased	66.78	18.05	31	41817	277355	79425185
Febrile bone marrow aplasia	66.57	18.05	55	41793	12965	79689575
Chronic lymphocytic leukaemia transformation	64.78	18.05	17	41831	249	79702291
Dizziness	63.47	18.05	112	41736	526329	79176211
Synovitis	63.23	18.05	4	41844	150730	79551810
Condition aggravated	60.96	18.05	106	41742	501018	79201522
Hypogammaglobulinaemia	60.63	18.05	52	41796	12899	79689641
Abdominal discomfort	60.38	18.05	28	41820	250699	79451841
Drug hypersensitivity	59.68	18.05	42	41806	298874	79403666
Maternal exposure during pregnancy	59.19	18.05	3	41845	136535	79566005
Somnolence	58.62	18.05	26	41822	238955	79463585
Drug interaction	57.95	18.05	80	41768	415103	79287437
Skin infection	57.89	18.05	59	41789	18186	79684354
Overdose	57.67	18.05	13	41835	184193	79518347
Anxiety	56.45	18.05	30	41818	248482	79454058
Blood phosphorus increased	55.61	18.05	45	41803	10302	79692238
Squamous cell carcinoma	54.14	18.05	53	41795	15569	79686971
Minimal residual disease	53.94	18.05	17	41831	490	79702050
Transplant	53.18	18.05	20	41828	988	79701552
Peripheral swelling	52.36	18.05	39	41809	269578	79432962
Respiratory failure	51.81	18.05	210	41638	180701	79521839
Contraindicated product administered	51.61	18.05	10	41838	157528	79545012
Agranulocytosis	51.38	18.05	88	41760	44942	79657598
Aspergillus infection	50.25	18.05	56	41792	19105	79683435
Asthma	50.13	18.05	6	41842	135089	79567451
Hypoaesthesia	49.84	18.05	16	41832	179336	79523204
Anal inflammation	49.72	18.05	21	41827	1409	79701131
Inappropriate schedule of product administration	49.42	18.05	6	41842	133622	79568918
Urticaria	48.91	18.05	18	41830	185183	79517357
Haematotoxicity	48.90	18.05	50	41798	15469	79687071
Hypersensitivity	48.31	18.05	40	41808	262199	79440341
Leukaemia	48.07	18.05	33	41815	5892	79696648
Depression	48.02	18.05	27	41821	216763	79485777
Gait disturbance	47.19	18.05	25	41823	207481	79495059
Therapeutic product effect decreased	46.64	18.05	14	41834	163849	79538691
Transformation to acute myeloid leukaemia	46.21	18.05	18	41830	979	79701561
Bone marrow transplant	46.17	18.05	20	41828	1428	79701112
Tremor	45.82	18.05	16	41832	170067	79532473
Chronic lymphocytic leukaemia refractory	45.32	18.05	11	41837	115	79702425
Proctalgia	44.48	18.05	39	41809	9962	79692578
Lymphocyte count increased	43.37	18.05	31	41817	5901	79696639
Glossodynia	42.58	18.05	3	41845	103334	79599206
Blood disorder	42.40	18.05	35	41813	8238	79694302
Insomnia	42.02	18.05	40	41808	245130	79457410
Infusion related reaction	41.32	18.05	36	41812	230201	79472339
Lymphocyte count decreased	40.86	18.05	82	41766	47207	79655333
Cellulitis	40.77	18.05	138	41710	108922	79593618
SARS-CoV-2 test negative	40.68	18.05	18	41830	1353	79701187
Bacterial sepsis	40.60	18.05	34	41814	8164	79694376
Multiple organ dysfunction syndrome	40.50	18.05	147	41701	120099	79582441
Blood uric acid abnormal	40.01	18.05	11	41837	194	79702346
Hyperkalaemia	39.51	18.05	141	41707	114257	79588283
Leukaemia recurrent	39.20	18.05	22	41826	2752	79699788
Pneumocystis jirovecii pneumonia	39.04	18.05	65	41783	32443	79670097
Chest discomfort	38.91	18.05	12	41836	138032	79564508
Klebsiella sepsis	38.54	18.05	23	41825	3229	79699311
Sinusitis fungal	36.77	18.05	20	41828	2354	79700186
Pneumonia bacterial	36.77	18.05	48	41800	19283	79683257
Wound	36.75	18.05	8	41840	116171	79586369
Blood uric acid increased	36.68	18.05	40	41808	13320	79689220
Bone marrow failure	36.50	18.05	82	41766	51025	79651515
Alopecia	35.98	18.05	41	41807	231314	79471226
Mantle cell lymphoma refractory	35.43	18.05	9	41839	115	79702425
Treatment failure	35.28	18.05	23	41825	170463	79532077
Respiratory tract infection	33.52	18.05	77	41771	48612	79653928
Discomfort	33.51	18.05	12	41836	125605	79576935
Hospitalisation	33.26	18.05	117	41731	94119	79608421
Blood cholesterol increased	32.90	18.05	3	41845	83717	79618823
Fungal sepsis	32.82	18.05	17	41831	1813	79700727
Blister	32.59	18.05	11	41837	119465	79583075
Paraesthesia	32.33	18.05	27	41821	176296	79526244
Impaired healing	32.25	18.05	4	41844	87651	79614889
Feeling abnormal	32.23	18.05	22	41826	159177	79543363
Hepatic enzyme increased	32.22	18.05	29	41819	182581	79519959
Erythema	32.15	18.05	42	41806	223248	79479292
Autologous haematopoietic stem cell transplant	31.73	18.05	7	41841	46	79702494
Hypophosphataemia	31.17	18.05	45	41803	19868	79682672
Pseudomonas infection	30.93	18.05	46	41802	20857	79681683
Stress	30.90	18.05	3	41845	79609	79622931
Blast cells	30.42	18.05	5	41843	3	79702537
Febrile infection	30.42	18.05	20	41828	3326	79699214
Drug intolerance	30.15	18.05	58	41790	264061	79438479
Periorbital cellulitis	30.09	18.05	13	41835	922	79701618
Leukopenia	30.02	18.05	131	41717	116382	79586158
Dyspnoea	29.79	18.05	297	41551	856728	78845812
Wheezing	29.70	18.05	12	41836	116652	79585888
Drug ineffective	29.65	18.05	395	41453	1080518	78622022
Epstein-Barr virus infection reactivation	29.47	18.05	16	41832	1876	79700664
Muscle spasms	29.36	18.05	29	41819	174701	79527839
Full blood count abnormal	28.97	18.05	65	41783	40409	79662131
Malaise	28.62	18.05	146	41702	489723	79212817
Campylobacter gastroenteritis	28.34	18.05	14	41834	1351	79701189
Blood product transfusion dependent	28.12	18.05	10	41838	421	79702119
Flushing	28.08	18.05	6	41842	88262	79614278
Cerebral haemorrhage	28.06	18.05	80	41768	57593	79644947
Dry mouth	27.96	18.05	6	41842	88013	79614527
Acute febrile neutrophilic dermatosis	27.77	18.05	20	41828	3852	79698688
Lymphopenia	27.62	18.05	54	41794	30503	79672037
Colitis	27.60	18.05	93	41755	73214	79629326
Balance disorder	27.14	18.05	9	41839	98848	79603692
Coronavirus infection	27.04	18.05	26	41822	7471	79695069
Pleural effusion	26.48	18.05	148	41700	145114	79557426
Pneumonia adenoviral	26.44	18.05	10	41838	502	79702038
Stem cell transplant	26.26	18.05	19	41829	3685	79698855
Blood glucose increased	25.91	18.05	14	41834	114961	79587579
Haematochezia	25.83	18.05	7	41841	87638	79614902
Agitation	25.80	18.05	10	41838	99705	79602835
Contusion	25.80	18.05	24	41824	148752	79553788
Bradycardia	25.79	18.05	20	41828	135537	79567003
Migraine	25.77	18.05	7	41841	87486	79615054
Chest pain	25.74	18.05	70	41778	282234	79420306
Seizure	25.69	18.05	37	41811	188797	79513743
Myeloblast count increased	25.60	18.05	5	41843	16	79702524
Medication error	25.58	18.05	3	41845	68639	79633901
Hyperbilirubinaemia	25.48	18.05	46	41802	24472	79678068
Loss of personal independence in daily activities	25.39	18.05	11	41837	102569	79599971
Fatigue	25.37	18.05	340	41508	929387	78773153
Pseudomonal sepsis	25.32	18.05	23	41825	6151	79696389
Lymphoma	25.23	18.05	38	41810	17422	79685118
Accident	25.22	18.05	27	41821	8804	79693736
Blast cell count decreased	25.15	18.05	5	41843	18	79702522
Emphysematous cholecystitis	24.96	18.05	6	41842	60	79702480
Parainfluenzae virus infection	24.95	18.05	22	41826	5660	79696880
White blood cell count abnormal	24.74	18.05	22	41826	5723	79696817
Transfusion reaction	24.65	18.05	14	41834	1792	79700748
Hyperhidrosis	24.48	18.05	26	41822	151466	79551074
Systemic toxicity	24.40	18.05	7	41841	145	79702395
Lung infiltration	23.83	18.05	43	41805	22869	79679671
Blast cells present	23.68	18.05	11	41837	926	79701614
Wrong technique in product usage process	23.54	18.05	5	41843	73870	79628670
Subdural haematoma	23.08	18.05	51	41797	31383	79671157
Pneumonia klebsiella	23.06	18.05	20	41828	5034	79697506
Platelet disorder	23.02	18.05	16	41832	2913	79699627
Escherichia infection	22.95	18.05	37	41811	17980	79684560
Nasal congestion	22.78	18.05	6	41842	76546	79625994
Irritable bowel syndrome	22.51	18.05	3	41845	62238	79640302
Cytomegalovirus colitis	22.31	18.05	19	41829	4666	79697874
Cytomegalovirus infection reactivation	22.04	18.05	25	41823	8691	79693849
Electrocardiogram QT prolonged	21.88	18.05	10	41838	90376	79612164
Diverticulitis	21.65	18.05	63	41785	45873	79656667
Rhabdomyolysis	21.21	18.05	14	41834	103117	79599423
Clostridium colitis	21.13	18.05	15	41833	2824	79699716
General physical health deterioration	21.06	18.05	229	41619	275009	79427531
Portal vein cavernous transformation	20.93	18.05	6	41842	124	79702416
Musculoskeletal pain	20.91	18.05	14	41834	102340	79600200
Neutropenic infection	20.84	18.05	14	41834	2413	79700127
Streptococcal sepsis	20.81	18.05	15	41833	2892	79699648
Aplasia	20.75	18.05	23	41825	7797	79694743
Anorectal infection	20.74	18.05	8	41840	424	79702116
Adenoviral hepatitis	20.72	18.05	10	41838	917	79701623
Hypoglycaemia	20.61	18.05	14	41834	101580	79600960
Osteoarthritis	20.61	18.05	10	41838	87299	79615241
Memory impairment	20.61	18.05	17	41831	111717	79590823
Pseudomonal skin infection	20.43	18.05	4	41844	13	79702527
General physical condition abnormal	20.41	18.05	21	41827	6542	79695998
Atypical pneumonia	20.22	18.05	21	41827	6615	79695925
B-cell small lymphocytic lymphoma recurrent	20.20	18.05	4	41844	14	79702526
Phlebitis	20.11	18.05	24	41824	8806	79693734
Systemic candida	20.04	18.05	21	41827	6685	79695855
Pseudomonal bacteraemia	20.03	18.05	15	41833	3067	79699473
Abdominal lymphadenopathy	20.00	18.05	11	41837	1323	79701217
Clostridium difficile colitis	20.00	18.05	49	41799	32234	79670306
Ill-defined disorder	19.91	18.05	5	41843	65870	79636670
Diffuse large B-cell lymphoma	19.81	18.05	28	41820	12121	79690419
Sinusitis	19.73	18.05	46	41802	195455	79507085
Platelet count abnormal	19.72	18.05	18	41830	4844	79697696
Chemotherapy	19.72	18.05	12	41836	1745	79700795
Cardiac failure	19.70	18.05	144	41704	154698	79547842
Unrelated donor bone marrow transplantation therapy	19.66	18.05	3	41845	0	79702540
Klebsiella infection	19.64	18.05	32	41816	15688	79686852
Myalgia	19.29	18.05	43	41805	185598	79516942
Aspiration bone marrow abnormal	19.24	18.05	6	41842	167	79702373
Haemoglobin abnormal	19.16	18.05	21	41827	7033	79695507
Angiodysplasia	19.08	18.05	10	41838	1092	79701448
Anal abscess	19	18.05	24	41824	9331	79693209
Confusional state	18.99	18.05	94	41754	317903	79384637
Burning sensation	18.62	18.05	4	41844	58628	79643912
Pneumonia influenzal	18.57	18.05	14	41834	2890	79699650
Therapy partial responder	18.54	18.05	33	41815	17364	79685176
Sleep disorder	18.49	18.05	11	41837	85666	79616874
Diabetes mellitus	18.47	18.05	9	41839	78381	79624159
Staphylococcal sepsis	18.43	18.05	30	41818	14696	79687844
Herpes simplex	18.29	18.05	27	41821	12160	79690380
Splenic abscess	18.25	18.05	8	41840	588	79701952
Neutrophil count abnormal	18.24	18.05	15	41833	3511	79699029
International normalised ratio increased	18.11	18.05	11	41837	84710	79617830

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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	N208573	April 11, 2016	RX	TABLET	ORAL	11590128	Sept. 6, 2033	TREATMENT OF AML BY ORALLY ADMINISTERING VENETOCLAX WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE TO ADULTS 75 YEARS OR OLDER OR HAVING CERTAIN COMORBIDITIES PER A DOSE RAMP-UP INCLUDING AN INITIAL 100 MG OR A FINAL 400 MG PER DAY DOSE
100MG	VENCLEXTA	ABBVIE	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	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	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	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	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	N208573	April 11, 2016	RX	TABLET	ORAL	11590128	Sept. 6, 2033	TREATMENT OF AML BY ORALLY ADMINISTERING VENETOCLAX WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE TO ADULTS 75 YEARS OR OLDER OR HAVING CERTAIN COMORBIDITIES PER A DOSE RAMP-UP INCLUDING AN INITIAL 100 MG OR A FINAL 400 MG PER DAY DOSE
10MG	VENCLEXTA	ABBVIE	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	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	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	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	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	N208573	April 11, 2016	RX	TABLET	ORAL	11590128	Sept. 6, 2033	TREATMENT OF AML BY ORALLY ADMINISTERING VENETOCLAX WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE TO ADULTS 75 YEARS OR OLDER OR HAVING CERTAIN COMORBIDITIES PER A DOSE RAMP-UP INCLUDING AN INITIAL 100 MG OR A FINAL 400 MG PER DAY DOSE
50MG	VENCLEXTA	ABBVIE	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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
Bcl2-associated agonist of cell death	Unclassified	Q92934	BAD_HUMAN		Ki	4.80	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
4035629	VANDF
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

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