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

Stem definitionDrug idCAS RN
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:

None

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 1185.50 21.70 821 11749 324558 50267996
Febrile neutropenia 683.77 21.70 376 12194 97291 50495263
Off label use 584.08 21.70 647 11923 473779 50118775
Neutropenia 445.65 21.70 335 12235 147630 50444924
Tumour lysis syndrome 413.01 21.70 127 12443 7294 50585260
Intentional product use issue 299.57 21.70 204 12366 76714 50515840
Hospice care 271.92 21.70 87 12483 5685 50586869
Sepsis 181.81 21.70 193 12377 132732 50459822
Thrombocytopenia 172.15 21.70 184 12386 127489 50465065
Pancytopenia 149.81 21.70 141 12429 83889 50508665
Cytopenia 147.90 21.70 62 12508 8713 50583841
COVID-19 147.26 21.70 109 12461 46553 50546001
Neutrophil count decreased 137.40 21.70 104 12466 45922 50546632
Acute myeloid leukaemia recurrent 136.35 21.70 37 12533 1353 50591201
Pneumonia 128.86 21.70 287 12283 378114 50214440
Platelet count decreased 113.01 21.70 132 12438 100594 50491960
Disease progression 104.82 21.70 124 12446 95742 50496812
Lymphadenopathy 75.01 21.70 64 12506 33435 50559119
White blood cell count decreased 74.13 21.70 116 12454 116606 50475948
Infection 72.33 21.70 143 12427 172811 50419743
Pyrexia 65.46 21.70 225 12345 379978 50212576
Acute myeloid leukaemia 63.34 21.70 42 12528 15032 50577522
Hyperuricaemia 62.28 21.70 28 12542 4652 50587902
Bone marrow transplant 62.23 21.70 17 12553 637 50591917
Pain 59.81 21.70 35 12535 578868 50013686
Myelosuppression 57.61 21.70 38 12532 13479 50579075
Blood lactate dehydrogenase increased 53.50 21.70 42 12528 19520 50573034
Allogenic stem cell transplantation 52.87 21.70 8 12562 8 50592546
Pneumonia fungal 51.68 21.70 24 12546 4296 50588258
Rhinovirus infection 49.77 21.70 22 12548 3512 50589042
Joint swelling 49.03 21.70 3 12567 245283 50347271
Drug ineffective 48.50 21.70 81 12489 819252 49773302
Aspergillus infection 46.72 21.70 26 12544 6795 50585759
Blast cell count increased 45.75 21.70 12 12558 384 50592170
Chronic lymphocytic leukaemia transformation 43.92 21.70 8 12562 41 50592513
Chronic lymphocytic leukaemia refractory 43.76 21.70 8 12562 42 50592512
Escherichia sepsis 42.53 21.70 21 12549 4303 50588251
Hospitalisation 42.36 21.70 67 12503 67870 50524684
Minimal residual disease 42.20 21.70 9 12561 114 50592440
Arthralgia 41.84 21.70 29 12541 438673 50153881
Hyperphosphataemia 41.10 21.70 16 12554 1855 50590699
Bone marrow failure 41.00 21.70 42 12528 27582 50564972
Non-small cell lung cancer 40.44 21.70 18 12552 2919 50589635
Anaemia 38.68 21.70 144 12426 252312 50340242
Septic shock 37.89 21.70 58 12512 57117 50535437
Headache 34.81 21.70 45 12525 506490 50086064
COVID-19 pneumonia 34.32 21.70 23 12547 8372 50584182
Pleural effusion 33.55 21.70 67 12503 81387 50511167
Swelling 33.47 21.70 5 12565 200867 50391687
Escherichia bacteraemia 33.24 21.70 16 12554 3100 50589454
Rash 33.11 21.70 36 12534 437435 50155119
Atrial fibrillation 33.05 21.70 76 12494 101669 50490885
Transformation to acute myeloid leukaemia 32.99 21.70 8 12562 185 50592369
Blood phosphorus increased 32.93 21.70 15 12555 2567 50589987
Febrile bone marrow aplasia 32.51 21.70 20 12550 6291 50586263
Myelodysplastic syndrome 32.01 21.70 28 12542 15104 50577450
Soft tissue infection 30.84 21.70 13 12557 1849 50590705
Product dose omission issue 29.67 21.70 5 12565 183833 50408721
Nasopharyngitis 29.53 21.70 6 12564 192921 50399633
Autoimmune haemolytic anaemia 29.47 21.70 16 12554 3983 50588571
Drug hypersensitivity 29.07 21.70 13 12557 250997 50341557
Blood uric acid increased 27.31 21.70 15 12555 3819 50588735
Cerebral haemorrhage 26.27 21.70 33 12537 27019 50565535
Fungal sepsis 25.81 21.70 10 12560 1144 50591410
Stem cell transplant 25.49 21.70 11 12559 1657 50590897
Nonspecific reaction 24.81 21.70 11 12559 1768 50590786
Bronchopulmonary aspergillosis 24.50 21.70 18 12552 7574 50584980
Maternal exposure during pregnancy 24.38 21.70 5 12565 159773 50432781
Colitis 24.00 21.70 38 12532 38491 50554063
Terminal ileitis 23.87 21.70 8 12562 603 50591951
Abdominal discomfort 23.83 21.70 14 12556 231627 50360927
Campylobacter gastroenteritis 23.37 21.70 7 12563 366 50592188
Chronic lymphocytic leukaemia recurrent 23.15 21.70 6 12564 183 50592371
Hypophosphataemia 22.86 21.70 18 12552 8396 50584158
Splenomegaly 22.73 21.70 19 12551 9641 50582913
Lymphocyte count decreased 22.28 21.70 30 12540 26277 50566277
Subacute combined cord degeneration 22.01 21.70 6 12564 223 50592331
Prolymphocytic leukaemia 21.90 21.70 3 12567 0 50592554
Peripheral swelling 21.82 21.70 12 12558 205924 50386630

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 1417.14 18.69 1484 20611 340600 29211832
Off label use 896.00 18.69 1104 20991 299696 29252736
Tumour lysis syndrome 738.59 18.69 305 21790 13579 29538853
Febrile neutropenia 654.79 18.69 592 21503 111648 29440784
Neutropenia 473.64 18.69 535 21560 131176 29421256
Intentional product use issue 434.49 18.69 312 21783 42186 29510246
Hospice care 398.80 18.69 148 21947 4920 29547512
COVID-19 304.37 18.69 236 21859 35778 29516654
Pneumonia 181.95 18.69 587 21508 319585 29232847
Cytopenia 178.92 18.69 104 21991 9755 29542677
Sepsis 154.08 18.69 333 21762 142349 29410083
Disease progression 151.27 18.69 241 21854 81675 29470757
Thrombocytopenia 147.08 18.69 316 21779 134507 29417925
Pancytopenia 139.10 18.69 234 21861 82934 29469498
Infection 131.06 18.69 218 21877 76533 29475899
Lymphadenopathy 129.45 18.69 124 21971 24925 29527507
Neutrophil count decreased 107.48 18.69 147 21948 43420 29509012
Platelet count decreased 100.13 18.69 233 21862 104439 29447993
Autoimmune haemolytic anaemia 81.70 18.69 45 22050 3803 29548629
Hyperphosphataemia 79.29 18.69 37 22058 2201 29550231
Chronic lymphocytic leukaemia recurrent 78.49 18.69 23 22072 355 29552077
Lymphocyte count increased 77.30 18.69 39 22056 2755 29549677
Transplant 76.21 18.69 26 22069 671 29551761
Acute myeloid leukaemia recurrent 74.33 18.69 33 22062 1747 29550685
Pyrexia 72.62 18.69 413 21682 287209 29265223
Myelosuppression 71.76 18.69 65 22030 12162 29540270
COVID-19 pneumonia 70.88 18.69 58 22037 9464 29542968
Pneumonia fungal 69.59 18.69 47 22048 5730 29546702
Splenomegaly 67.17 18.69 65 22030 13214 29539218
Chronic lymphocytic leukaemia 65.03 18.69 38 22057 3595 29548837
Toxicity to various agents 63.82 18.69 25 22070 173636 29378796
White blood cell count decreased 59.26 18.69 166 21929 83196 29469236
Blood phosphorus increased 57.01 18.69 32 22063 2805 29549627
Completed suicide 55.18 18.69 3 22092 90243 29462189
Hospitalisation 53.66 18.69 111 21984 45877 29506555
Acute myeloid leukaemia 52.12 18.69 63 22032 16450 29535982
Bacteraemia 51.07 18.69 62 22033 16261 29536171
Soft tissue infection 49.84 18.69 25 22070 1744 29550688
Product dose omission issue 48.79 18.69 7 22088 96376 29456056
Septic shock 47.84 18.69 128 21967 62432 29490000
Hyperuricaemia 47.20 18.69 40 22055 6849 29545583
Neutropenic sepsis 45.88 18.69 50 22045 11677 29540755
Lymphocytosis 44.83 18.69 24 22071 1916 29550516
Blast cell count increased 43.29 18.69 19 22076 978 29551454
Skin infection 40.87 18.69 36 22059 6491 29545941
Blood pressure increased 40.70 18.69 4 22091 73799 29478633
Drug interaction 40.43 18.69 53 22042 197332 29355100
Mantle cell lymphoma refractory 39.87 18.69 10 22085 82 29552350
Stem cell transplant 38.81 18.69 22 22073 1965 29550467
Headache 37.43 18.69 45 22050 173962 29378470
Blast cell count decreased 37.20 18.69 6 22089 0 29552432
Somnolence 37.07 18.69 12 22083 93943 29458489
Leukaemia 36.60 18.69 27 22068 3783 29548649
Bone marrow transplant 34.72 18.69 16 22079 924 29551508
Blood uric acid increased 34.50 18.69 31 22064 5737 29546695
Minimal residual disease 34.42 18.69 12 22083 331 29552101
Hypogammaglobulinaemia 33.86 18.69 31 22064 5876 29546556
Anaemia 33.75 18.69 261 21834 200690 29351742
Blood lactate dehydrogenase increased 33.28 18.69 55 22040 19154 29533278
Hypocalcaemia 32.93 18.69 57 22038 20608 29531824
Chronic lymphocytic leukaemia transformation 32.69 18.69 10 22085 180 29552252
Condition aggravated 32.34 18.69 37 22058 146258 29406174
Chemotherapy 32.23 18.69 13 22082 541 29551891
Squamous cell carcinoma 32.16 18.69 39 22056 10212 29542220
Overdose 31.83 18.69 10 22085 79809 29472623
Myelodysplastic syndrome 30.90 18.69 51 22044 17743 29534689
Allogenic stem cell transplantation 30.62 18.69 6 22089 12 29552420
Blood uric acid abnormal 30.21 18.69 8 22087 83 29552349
Full blood count abnormal 30.16 18.69 46 22049 14967 29537465
Depression 30.03 18.69 13 22082 85134 29467298
Weight increased 29.88 18.69 10 22085 76657 29475775
Tremor 29.71 18.69 9 22086 73529 29478903
Haemolysis 29.58 18.69 31 22064 6925 29545507
Bronchopulmonary aspergillosis 29.42 18.69 41 22054 12303 29540129
Escherichia bacteraemia 29.15 18.69 21 22074 2837 29549595
Pain in extremity 28.95 18.69 24 22071 110409 29442023
Pruritus 28.70 18.69 27 22068 116822 29435610
Anxiety 28.60 18.69 14 22081 85351 29467081
Acute myeloid leukaemia refractory 28.19 18.69 6 22089 21 29552411
Pain 27.56 18.69 54 22041 171378 29381054
Atrial fibrillation 26.66 18.69 152 21943 105494 29446938
Mantle cell lymphoma recurrent 26.63 18.69 11 22084 487 29551945
Influenza 26.44 18.69 80 22015 41801 29510631
Chronic lymphocytic leukaemia refractory 25.66 18.69 7 22088 82 29552350
Lymphocyte count decreased 25.44 18.69 49 22046 19222 29533210
White blood cell count abnormal 24.81 18.69 19 22076 2816 29549616
Coronavirus infection 24.40 18.69 20 22075 3268 29549164
Rash 23.96 18.69 68 22027 189751 29362681
Dizziness 23.90 18.69 68 22027 189616 29362816
Arthralgia 23.29 18.69 43 22052 139574 29412858
Hallucination 23.20 18.69 3 22092 44709 29507723
Agitation 23.17 18.69 5 22090 51299 29501133
Haemoglobin abnormal 22.99 18.69 19 22076 3142 29549290
General physical health deterioration 22.14 18.69 142 21953 102715 29449717
Gait disturbance 21.73 18.69 14 22081 73335 29479097
Fungal sepsis 21.52 18.69 11 22084 798 29551634
Cellulitis 21.33 18.69 79 22016 45761 29506671
Drug ineffective 21.15 18.69 172 21923 362998 29189434
Transfusion reaction 20.85 18.69 11 22084 852 29551580
International normalised ratio increased 20.71 18.69 4 22091 44368 29508064
Aspergillus infection 20.66 18.69 32 22063 10549 29541883
Joint swelling 20.17 18.69 6 22089 49624 29502808
Transfusion 20.08 18.69 26 22069 7272 29545160
Angiodysplasia 19.76 18.69 9 22086 506 29551926
Respiratory tract infection 19.69 18.69 39 22056 15612 29536820
Seizure 19.03 18.69 25 22070 93098 29459334
Hypercalcaemia 18.78 18.69 34 22061 12725 29539707

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
Death 1404.27 18.50 1364 27128 481341 63988899
Febrile neutropenia 1370.13 18.50 912 27580 186745 64283495
Tumour lysis syndrome 1018.19 18.50 366 28126 19074 64451166
Neutropenia 798.26 18.50 733 27759 238891 64231349
Off label use 694.31 18.50 1097 27395 631709 63838531
Pneumonia 376.78 18.50 787 27705 558789 63911451
Sepsis 373.59 18.50 483 28009 229858 64240382
Thrombocytopenia 325.41 18.50 445 28047 223356 64246884
COVID-19 288.04 18.50 235 28257 64905 64405335
Cytopenia 274.87 18.50 135 28357 15336 64454904
Neutrophil count decreased 257.31 18.50 237 28255 76959 64393281
Intentional product use issue 236.30 18.50 249 28243 95115 64375125
Pancytopenia 206.45 18.50 284 28208 143025 64327215
Platelet count decreased 200.21 18.50 304 28188 167407 64302833
Infection 175.47 18.50 302 28190 184578 64285662
Lymphadenopathy 174.55 18.50 153 28339 46533 64423707
Hospice care 170.57 18.50 78 28414 7547 64462693
Disease progression 167.86 18.50 256 28236 141424 64328816
Acute myeloid leukaemia recurrent 166.79 18.50 58 28434 2726 64467514
Pyrexia 156.66 18.50 571 27921 558073 63912167
Myelosuppression 129.08 18.50 97 28395 23733 64446507
White blood cell count decreased 121.96 18.50 236 28256 157601 64312639
Hyperphosphataemia 115.84 18.50 49 28443 3932 64466308
Pneumonia fungal 113.14 18.50 62 28430 8815 64461425
Hyperuricaemia 113.11 18.50 65 28427 10126 64460114
COVID-19 pneumonia 102.55 18.50 73 28419 16431 64453809
Septic shock 95.65 18.50 169 28323 105268 64364972
Pain 93.96 18.50 65 28427 553446 63916794
Autoimmune haemolytic anaemia 89.02 18.50 49 28443 7027 64463213
Bacteraemia 88.33 18.50 82 28410 26829 64443411
Anaemia 86.97 18.50 364 28128 378316 64091924
Acute myeloid leukaemia 86.91 18.50 82 28410 27381 64442859
Chronic lymphocytic leukaemia recurrent 85.80 18.50 24 28468 542 64469698
Soft tissue infection 84.98 18.50 37 28455 3186 64467054
Blood lactate dehydrogenase increased 84.71 18.50 88 28404 32990 64437250
Blast cell count increased 81.87 18.50 28 28464 1251 64468989
Toxicity to various agents 78.89 18.50 31 28461 363482 64106758
Blood phosphorus increased 78.50 18.50 40 28452 4906 64465334
Splenomegaly 75.52 18.50 63 28429 17898 64452342
Joint swelling 72.70 18.50 6 28486 215376 64254864
Atrial fibrillation 72.45 18.50 202 28290 170887 64299353
Lymphocytosis 71.34 18.50 34 28458 3610 64466630
Arthralgia 68.49 18.50 57 28435 442203 64028037
Allogenic stem cell transplantation 67.87 18.50 12 28480 23 64470217
Headache 67.41 18.50 81 28411 529386 63940854
Escherichia sepsis 62.13 18.50 39 28453 7126 64463114
Escherichia bacteraemia 61.40 18.50 35 28457 5368 64464872
Blood pressure increased 60.53 18.50 4 28488 172548 64297692
Chronic lymphocytic leukaemia 60.18 18.50 32 28460 4283 64465957
Rhinovirus infection 57.16 18.50 35 28457 6121 64464119
Bronchopulmonary aspergillosis 56.62 18.50 55 28437 19030 64451210
Pruritus 55.17 18.50 35 28457 312365 64157875
Product dose omission issue 54.61 18.50 10 28482 194737 64275503
Rash 52.34 18.50 76 28416 458473 64011767
Myelodysplastic syndrome 51.11 18.50 62 28430 27517 64442723
Nasopharyngitis 50.99 18.50 12 28480 196061 64274179
Lymphocyte count increased 50.63 18.50 30 28462 4945 64465295
Chronic lymphocytic leukaemia transformation 50.01 18.50 13 28479 220 64470020
Drug ineffective 49.28 18.50 198 28294 840049 63630191
Aspergillus infection 48.21 18.50 47 28445 16332 64453908
Skin infection 47.76 18.50 45 28447 14992 64455248
Hypogammaglobulinaemia 47.23 18.50 38 28454 10261 64459979
Chronic lymphocytic leukaemia refractory 47.21 18.50 11 28481 115 64470125
Pain in extremity 46.94 18.50 39 28453 303046 64167194
Squamous cell carcinoma 46.94 18.50 43 28449 13826 64456414
Febrile bone marrow aplasia 46.32 18.50 39 28453 11216 64459024
Hypocalcaemia 45.92 18.50 73 28419 41680 64428560
Blood uric acid increased 45.91 18.50 34 28458 8129 64462111
Swelling 45.40 18.50 8 28484 160210 64310030
Drug interaction 43.30 18.50 58 28434 362025 64108215
Drug hypersensitivity 42.86 18.50 26 28466 237789 64232451
Neutropenic sepsis 42.60 18.50 52 28440 23220 64447020
Minimal residual disease 42.52 18.50 13 28479 404 64469836
Somnolence 41.50 18.50 19 28473 203626 64266614
Condition aggravated 40.27 18.50 64 28428 372362 64097878
Overdose 39.12 18.50 11 28481 159555 64310685
Mantle cell lymphoma refractory 38.13 18.50 9 28483 100 64470140
Weight increased 37.50 18.50 24 28468 213324 64256916
Leukaemia 37.48 18.50 25 28467 5063 64465177
Respiratory failure 36.90 18.50 155 28337 161028 64309212
Dizziness 36.84 18.50 85 28407 430078 64040162
Anxiety 36.72 18.50 22 28470 202627 64267613
Urticaria 36.40 18.50 10 28482 147307 64322933
Bone marrow transplant 34.66 18.50 15 28477 1272 64468968
Blood uric acid abnormal 34.64 18.50 9 28483 152 64470088
Depression 34.49 18.50 19 28473 183272 64286968
Hypoaesthesia 33.34 18.50 10 28482 139098 64331142
Synovitis 32.76 18.50 3 28489 99087 64371153
Abdominal discomfort 32.74 18.50 20 28472 182302 64287938
Hyperkalaemia 32.08 18.50 108 28384 101021 64369219
Multiple organ dysfunction syndrome 31.90 18.50 108 28384 101305 64368935
Tremor 31.51 18.50 13 28479 148217 64322023
Maternal exposure during pregnancy 31.44 18.50 3 28489 95881 64374359
Asthma 31.17 18.50 3 28489 95222 64375018
Fungal sepsis 31.03 18.50 15 28477 1643 64468597
Bacterial sepsis 31.02 18.50 26 28466 7431 64462809
Hospitalisation 31.00 18.50 88 28404 75119 64395121
Inappropriate schedule of product administration 29.96 18.50 3 28489 92283 64377957
Klebsiella sepsis 29.77 18.50 17 28475 2615 64467625
Rhabdomyolysis 29.74 18.50 3 28489 91723 64378517
Cellulitis 29.69 18.50 100 28392 93557 64376683
Transplant 29.58 18.50 12 28480 866 64469374
Gait disturbance 29.39 18.50 20 28472 172135 64298105
General physical health deterioration 29.24 18.50 172 28320 204253 64265987
Contraindicated product administered 29.23 18.50 6 28486 107823 64362417
Pleural effusion 29.19 18.50 122 28370 126437 64343803
Lymphocyte count decreased 29.12 18.50 59 28433 40640 64429600
Systemic toxicity 29.08 18.50 7 28485 85 64470155
Respiratory tract infection 28.90 18.50 56 28436 37351 64432889
Hypophosphataemia 28.76 18.50 34 28458 14686 64455554
Peripheral swelling 28.72 18.50 30 28462 209123 64261117
Bone marrow failure 27.98 18.50 64 28428 47888 64422352
Infusion related reaction 26.90 18.50 20 28472 164447 64305793
Blast cells 26.90 18.50 4 28488 0 64470240
Campylobacter gastroenteritis 26.80 18.50 12 28480 1104 64469136
Feeling abnormal 26.39 18.50 13 28479 133589 64336651
Pneumocystis jirovecii pneumonia 25.94 18.50 45 28447 27589 64442651
Transfusion reaction 25.25 18.50 13 28479 1628 64468612
Full blood count abnormal 24.78 18.50 46 28446 29711 64440529
Therapeutic product effect decreased 24.70 18.50 10 28482 115341 64354899
White blood cell count abnormal 24.60 18.50 19 28473 4835 64465405
Non-small cell lung cancer 24.48 18.50 19 28473 4871 64465369
Flushing 24.41 18.50 3 28489 78645 64391595
Malaise 23.99 18.50 92 28400 396155 64074085
Chest discomfort 23.38 18.50 11 28481 116095 64354145
Erythema 23.32 18.50 29 28463 187041 64283199
Transformation to acute myeloid leukaemia 23.08 18.50 10 28482 851 64469389
Hypersensitivity 22.91 18.50 32 28460 196420 64273820
Wheezing 22.87 18.50 4 28488 80575 64389665
Vascular device infection 22.56 18.50 20 28472 6160 64464080
Insomnia 22.31 18.50 33 28459 197803 64272437
Leukaemia recurrent 22.19 18.50 14 28478 2580 64467660
Sinusitis fungal 21.97 18.50 12 28480 1694 64468546
Hypercalcaemia 21.83 18.50 45 28447 31371 64438869
Pseudomonal sepsis 21.44 18.50 18 28474 5154 64465086
Acute myeloid leukaemia refractory 21.31 18.50 5 28487 54 64470186
Colitis 20.71 18.50 65 28427 58609 64411631
General physical condition abnormal 20.53 18.50 18 28474 5464 64464776
Chemotherapy 20.52 18.50 11 28481 1496 64468744
Coronavirus infection 20.40 18.50 18 28474 5512 64464728
Alopecia 20.32 18.50 26 28466 165664 64304576
Angiodysplasia 20.18 18.50 9 28483 820 64469420
Clostridium colitis 20.04 18.50 13 28479 2512 64467728
Herpes simplex 20.03 18.50 24 28468 10512 64459728
Agitation 20.02 18.50 7 28485 88360 64381880
Blood product transfusion dependent 19.77 18.50 7 28485 347 64469893
Chondrocalcinosis pyrophosphate 19.50 18.50 11 28481 1653 64468587
Wound 19.25 18.50 5 28487 76472 64393768
Terminal ileitis 19.03 18.50 8 28484 632 64469608
Wrong technique in product usage process 18.94 18.50 3 28489 64971 64405269
Paraesthesia 18.79 18.50 19 28473 134503 64335737
Platelet disorder 18.71 18.50 12 28480 2275 64467965
Bradycardia 18.54 18.50 15 28477 118204 64352036

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 INC N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT IN COMBINATION WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
100MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
100MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
100MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
10MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT IN COMBINATION WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
10MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
10MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
10MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
50MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT IN COMBINATION WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
50MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
50MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
50MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
100MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL 10993942 Sept. 6, 2033 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP THAT INCLUDES A DOSE OF 50 MG PER DAY FOR 1 WEEK FOLLOWED BY 100 MG PER DAY FOR 1 WEEK
100MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL 11110087 Sept. 6, 2033 TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) BY ORALLY ADMINISTERING VENETOCLAX WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE IN ADULTS 75 YEARS OR OLDER OR HAVING CERTAIN COMORBIDITIES ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE
100MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL 11110087 Sept. 6, 2033 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE
100MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL 9539251 Sept. 6, 2033 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LEUKEMIA (SLL) IN COMBINATION WITH A GA101 ANTIBODY SUCH AS OBINUTUZUMAB FOR ONE OR MORE DOSING PERIODS, WHEREIN THE CLL OR SLL IS A CD20-EXPRESSING CANCER
10MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL 10993942 Sept. 6, 2033 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP THAT INCLUDES A DOSE OF 50 MG PER DAY FOR 1 WEEK FOLLOWED BY 100 MG PER DAY FOR 1 WEEK
10MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL 11110087 Sept. 6, 2033 TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) BY ORALLY ADMINISTERING VENETOCLAX WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE IN ADULTS 75 YEARS OR OLDER OR HAVING CERTAIN COMORBIDITIES ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE
10MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL 11110087 Sept. 6, 2033 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE
10MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL 9539251 Sept. 6, 2033 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LEUKEMIA (SLL) IN COMBINATION WITH A GA101 ANTIBODY SUCH AS OBINUTUZUMAB FOR ONE OR MORE DOSING PERIODS, WHEREIN THE CLL OR SLL IS A CD20-EXPRESSING CANCER
50MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL 10993942 Sept. 6, 2033 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP THAT INCLUDES A DOSE OF 50 MG PER DAY FOR 1 WEEK FOLLOWED BY 100 MG PER DAY FOR 1 WEEK
50MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL 11110087 Sept. 6, 2033 TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) BY ORALLY ADMINISTERING VENETOCLAX WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE IN ADULTS 75 YEARS OR OLDER OR HAVING CERTAIN COMORBIDITIES ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE
50MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL 11110087 Sept. 6, 2033 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE
50MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL 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 INC N208573 April 11, 2016 RX TABLET ORAL May 15, 2022 VENETOCLAX IN COMBINATION WITH OBINUTUZUMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA
10MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL May 15, 2022 VENETOCLAX IN COMBINATION WITH OBINUTUZUMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA
50MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL May 15, 2022 VENETOCLAX IN COMBINATION WITH OBINUTUZUMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA
100MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL April 11, 2023 TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION, AS DETECTED BY AN FDA APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
10MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL April 11, 2023 TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION, AS DETECTED BY AN FDA APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
50MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL April 11, 2023 TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION, AS DETECTED BY AN FDA APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
100MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL Oct. 16, 2023 REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY M15-656 (VIALE-A) AND M16-043 (VIALE-C) TO SUPPORT PMR 3545-1 AND PMR 3545-2
10MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL Oct. 16, 2023 REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY M15-656 (VIALE-A) AND M16-043 (VIALE-C) TO SUPPORT PMR 3545-1 AND PMR 3545-2
50MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL Oct. 16, 2023 REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY M15-656 (VIALE-A) AND M16-043 (VIALE-C) TO SUPPORT PMR 3545-1 AND PMR 3545-2
100MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL June 8, 2025 INDICATED FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
10MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL June 8, 2025 INDICATED FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
50MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL June 8, 2025 INDICATED FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
100MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL Nov. 21, 2025 INDICATED IN COMBO WITH AZACITIDINE, OR DECITABINE, OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
10MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL Nov. 21, 2025 INDICATED IN COMBO WITH AZACITIDINE, OR DECITABINE, OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
50MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL Nov. 21, 2025 INDICATED IN COMBO WITH AZACITIDINE, OR DECITABINE, OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
100MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL May 15, 2026 TREATMENT OF PREVIOUSLY UNTREATED ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
10MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL May 15, 2026 TREATMENT OF PREVIOUSLY UNTREATED ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
50MG VENCLEXTA ABBVIE INC N208573 April 11, 2016 RX TABLET ORAL May 15, 2026 TREATMENT OF PREVIOUSLY UNTREATED ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)

Bioactivity Summary:

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
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
8318 IUPHAR_LIGAND_ID
1747556 RXNORM
240227 MMSL
31601 MMSL
d08429 MMSL
720491001 SNOMEDCT_US
763511000 SNOMEDCT_US
016803 NDDF
C579720 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Venclexta HUMAN PRESCRIPTION DRUG LABEL 1 0074-0561 TABLET, FILM COATED 10 mg ORAL NDA 31 sections
Venclexta HUMAN PRESCRIPTION DRUG LABEL 1 0074-0566 TABLET, FILM COATED 50 mg ORAL NDA 31 sections
Venclexta HUMAN PRESCRIPTION DRUG LABEL 1 0074-0576 TABLET, FILM COATED 100 mg ORAL NDA 31 sections