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

FDA Adverse Event Reporting System (Male)

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

FDA Adverse Event Reporting System (Geriatric)

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

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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

Orange Book exclusivity data (new drug applications)

Formulation 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
C4079830 UMLSCUI
CHEBI:133021 CHEBI
LBM PDB_CHEM_ID
CHEMBL3137309 ChEMBL_ID
49846579 PUBCHEM_CID
DB11581 DRUGBANK_ID
9925 INN_ID
C579720 MESH_SUPPLEMENTAL_RECORD_UI
8318 IUPHAR_LIGAND_ID
1747556 RXNORM
240227 MMSL
31601 MMSL
d08429 MMSL
016803 NDDF
720491001 SNOMEDCT_US
763511000 SNOMEDCT_US
4035629 VANDF

Pharmaceutical products:

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 0074-0566 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