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

Stem definitionDrug idCAS RN
B-cell lymphoma 2 (Bcl-2) inhibitors, antineoplastics 5133 1257044-40-8

Description:

MoleculeDescription

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:

PropertyValueReference
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:

DateAgencyCompanyOrphan
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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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|

DiseaseRelationSNOMED_IDDOID
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 levelDissociation constantType (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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Apoptosis regulator Bcl-2 Cytosolic other INHIBITOR Ki 11 SCIENTIFIC LITERATURE DRUG LABEL
Aspartyl/asparaginyl beta-hydroxylase Enzyme IC50 5.89 CHEMBL
Bcl2-associated agonist of cell death Unclassified Ki 4.80 CHEMBL
Bcl-2-like protein 1 Cytosolic other INHIBITOR Ki 7.32 SCIENTIFIC LITERATURE
Apoptosis regulator Bcl-W Cytosolic other INHIBITOR Ki 6.61 SCIENTIFIC LITERATURE

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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