thiotepa 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
antineoplastics, thiotepa derivatives 2638 52-24-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • thio-tepa
  • triethylenethiophosphortriamide
  • thiotepa
  • oncotepa
  • phosphorothioic acid triethylenetriamide
  • tespamin
  • tespamine
  • thiophosphamide
  • tepadina
A very toxic alkylating antineoplastic agent also used as an insect sterilant. It causes skin, gastrointestinal, CNS, and bone marrow damage. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), thiotepa may reasonably be anticipated to be a carcinogen (Merck Index, 11th ed).
  • Molecular weight: 189.22
  • Formula: C6H12N3PS
  • CLOGP: 0.52
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 0
  • TPSA: 9.03
  • ALOGS: -1.31
  • ROTB: 3
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Hosey CM, Chan R, Benet LZ
Vd (Volume of distribution) 1.60 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 6.70 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.90 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.70 hours Lombardo F, Berellini G, Obach RS
S (Water solubility) 100 mg/mL Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,AKT2,AKT3,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GSK3B,IGF1R,ITK,JAK2,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPK9,MAPKAPK2,MET,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ZAP70 51
kinase-selectivity-class ACVRL1,AXL,BRAF,CDK1,CDK16,CDK4,CDK6,CDK7,CDK9,CHUK,EPHB4,GRK2,MAP2K6,MAP3K21,PIK3CB,PIK3CD,PRKDC,SIK2,TEK,TGFBR1 20
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
March 26, 2019 PMDA Sumitomo Dainippon Pharma
March 26, 2021 EMA RIEMSER Pharma GmbH
March 9, 1959 FDA

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
Mucosal inflammation 758.88 42.11 271 9614 57354 90561208
Cytomegalovirus infection reactivation 648.63 42.11 154 9731 7646 90610916
Acute graft versus host disease 593.07 42.11 134 9751 5334 90613228
Acute graft versus host disease in skin 539.96 42.11 121 9764 4635 90613927
Human herpesvirus 6 infection 470.87 42.11 102 9783 3330 90615232
Cytomegalovirus infection 356.61 42.11 127 9758 26475 90592087
Febrile neutropenia 354.05 42.11 218 9667 158131 90460431
Chronic graft versus host disease 345.35 42.11 82 9803 4057 90614505
Graft versus host disease in skin 335.41 42.11 79 9806 3774 90614788
Venoocclusive liver disease 320.05 42.11 83 9802 5910 90612652
Thrombotic microangiopathy 316.83 42.11 102 9783 15641 90602921
Adenovirus infection 311.01 42.11 77 9808 4545 90614017
Graft versus host disease 290.29 42.11 82 9803 8062 90610500
Haematotoxicity 255.40 42.11 82 9803 12453 90606109
Encephalitis viral 219.43 42.11 49 9836 1840 90616722
Cytomegalovirus viraemia 215.32 42.11 64 9821 7522 90611040
Acute graft versus host disease in intestine 209.29 42.11 48 9837 2035 90616527
Product use in unapproved indication 208.92 42.11 218 9667 336018 90282544
Pre-engraftment immune reaction 192.03 42.11 32 9853 236 90618326
Posterior reversible encephalopathy syndrome 174.48 42.11 72 9813 22267 90596295
Graft versus host disease in gastrointestinal tract 173.78 42.11 48 9837 4340 90614222
Epstein-Barr virus infection 160.04 42.11 55 9830 10289 90608273
BK virus infection 154.42 42.11 44 9841 4454 90614108
Off label use 149.14 42.11 352 9533 1101900 89516662
Viral haemorrhagic cystitis 147.83 42.11 34 9851 1459 90617103
Inappropriate antidiuretic hormone secretion 142.66 42.11 60 9825 19445 90599117
Transplant dysfunction 138.81 42.11 42 9843 5240 90613322
Viraemia 133.65 42.11 32 9853 1637 90616925
Acute lymphocytic leukaemia recurrent 132.31 42.11 35 9850 2686 90615876
Chronic graft versus host disease in skin 132.24 42.11 30 9855 1210 90617352
Cystitis haemorrhagic 128.58 42.11 40 9845 5473 90613089
Neutropenia 123.82 42.11 137 9748 224767 90393795
Sepsis 121.14 42.11 122 9763 179692 90438870
Venoocclusive disease 111.88 42.11 30 9855 2425 90616137
Bacterial sepsis 111.58 42.11 35 9850 4920 90613642
Thrombocytopenia 111.18 42.11 125 9760 208600 90409962
Transplant failure 94.17 42.11 25 9860 1944 90616618
Toxic erythema of chemotherapy 93.56 42.11 17 9868 217 90618345
JC virus infection 90.64 42.11 26 9859 2693 90615869
Multiple organ dysfunction syndrome 83.39 42.11 65 9820 68271 90550291
Progressive multifocal leukoencephalopathy 81.67 42.11 38 9847 15617 90602945
Fatigue 79.59 42.11 15 9870 1154008 89464554
Pseudomonal sepsis 78.89 42.11 26 9859 4276 90614286
Septic shock 77.53 42.11 68 9817 84092 90534470
Gastroenteritis adenovirus 76.52 42.11 15 9870 294 90618268
Systemic candida 75.26 42.11 26 9859 4933 90613629
Cytomegalovirus urinary tract infection 73.59 42.11 12 9873 76 90618486
Neoplasm recurrence 73.29 42.11 23 9862 3236 90615326
Bacteraemia 71.71 42.11 39 9846 22261 90596301
Skin toxicity 70.91 42.11 27 9858 6752 90611810
Neurotoxicity 70.31 42.11 38 9847 21429 90597133
Polyomavirus viraemia 69.11 42.11 18 9867 1299 90617263
Meningoencephalitis herpetic 67.29 42.11 18 9867 1441 90617121
Anisometropia 66.50 42.11 11 9874 77 90618485
Aplastic anaemia 65.49 42.11 31 9854 13238 90605324
Cytomegalovirus chorioretinitis 62.54 42.11 19 9866 2400 90616162
Pain 62.46 42.11 16 9869 996325 89622237
Acute graft versus host disease in liver 62.19 42.11 15 9870 791 90617771
Human herpesvirus 6 encephalitis 60.70 42.11 13 9872 400 90618162
Post transplant lymphoproliferative disorder 59.71 42.11 24 9861 6925 90611637
Hypogammaglobulinaemia 59.08 42.11 27 9858 10647 90607915
Arthralgia 58.32 42.11 8 9877 778514 89840048
Varicella zoster virus infection 57.57 42.11 20 9865 3857 90614705
Hypogonadism female 56.90 42.11 8 9877 14 90618548
Leukoencephalopathy 56.76 42.11 21 9864 4852 90613710
Staphylococcal infection 56.76 42.11 45 9840 48394 90570168
Human herpesvirus 6 infection reactivation 55.15 42.11 13 9872 621 90617941
Bronchopulmonary aspergillosis 54.33 42.11 26 9859 11372 90607190
Human polyomavirus infection 54.21 42.11 12 9873 432 90618130
Leukaemia recurrent 53.28 42.11 15 9870 1452 90617110
Urinary tract infection viral 52.50 42.11 9 9876 80 90618482
Bone marrow failure 51.33 42.11 36 9849 32185 90586377
Gastroenteritis norovirus 50.24 42.11 16 9869 2360 90616202
Dyspnoea 49.96 42.11 17 9868 880938 89737624
Colitis erosive 49.82 42.11 10 9875 222 90618340
Lymphopenia 49.64 42.11 31 9854 22850 90595712
Citrobacter infection 48.77 42.11 12 9873 688 90617874
Epstein-Barr viraemia 48.74 42.11 14 9871 1456 90617106
Headache 48.31 42.11 17 9868 862729 89755833
Pulmonary arterial hypertension 48.22 42.11 32 9853 26155 90592407
Pyrexia 47.62 42.11 169 9716 660316 89958246
Eustachian tube dysfunction 47.61 42.11 12 9873 760 90617802
Pruritus 47.29 42.11 3 9882 541522 90077040
Haemophagocytic lymphohistiocytosis 46.84 42.11 26 9859 15433 90603129
Respiratory failure 46.73 42.11 61 9824 118357 90500205
Alpha haemolytic streptococcal infection 46.30 42.11 14 9871 1740 90616822
Parotitis 45.02 42.11 14 9871 1911 90616651
Pulmonary vascular disorder 44.96 42.11 10 9875 368 90618194
Infection reactivation 44.91 42.11 14 9871 1926 90616636
Alveolar soft part sarcoma 44.26 42.11 8 9877 99 90618463
Stem cell transplant 43.47 42.11 14 9871 2140 90616422
Engraftment syndrome 43.37 42.11 11 9874 714 90617848
Clostridium difficile colitis 42.91 42.11 30 9855 26676 90591886
Lower respiratory tract infection fungal 42.40 42.11 9 9876 265 90618297
Pseudomonas infection 42.32 42.11 24 9861 14841 90603721

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
Acute graft versus host disease in skin 815.69 36.18 224 12410 7200 42601501
Mucosal inflammation 745.16 36.18 339 12295 49035 42559666
Acute graft versus host disease in intestine 575.09 36.18 149 12485 3802 42604899
Venoocclusive liver disease 545.84 36.18 177 12457 10125 42598576
Cytomegalovirus infection reactivation 539.64 36.18 179 12455 10999 42597702
Acute graft versus host disease 525.67 36.18 163 12471 8052 42600649
Cytomegalovirus infection 443.42 36.18 208 12426 32098 42576603
Graft versus host disease in gastrointestinal tract 392.89 36.18 117 12517 5026 42603675
Adenovirus infection 376.90 36.18 121 12513 6688 42602013
Human herpesvirus 6 infection 351.74 36.18 92 12542 2433 42606268
Graft versus host disease in skin 344.19 36.18 106 12528 5106 42603595
Viral haemorrhagic cystitis 319.25 36.18 80 12554 1774 42606927
Haematotoxicity 270.36 36.18 107 12527 10878 42597823
Chronic graft versus host disease 264.88 36.18 90 12544 5935 42602766
Febrile neutropenia 242.45 36.18 286 12348 185417 42423284
BK virus infection 238.88 36.18 92 12542 8692 42600009
Graft versus host disease 230.40 36.18 100 12534 12825 42595876
Engraftment syndrome 229.48 36.18 58 12576 1332 42607369
Epstein-Barr virus infection 192.37 36.18 81 12553 9637 42599064
Venoocclusive disease 181.99 36.18 61 12573 3854 42604847
Chronic graft versus host disease in skin 169.40 36.18 47 12587 1559 42607142
Thrombotic microangiopathy 156.98 36.18 80 12554 14702 42593999
Off label use 147.24 36.18 467 12167 637868 41970833
Product use in unapproved indication 135.08 36.18 215 12419 184241 42424460
Idiopathic pneumonia syndrome 130.04 36.18 30 12604 461 42608240
Acute graft versus host disease in liver 129.96 36.18 40 12594 1918 42606783
Graft versus host disease in liver 119.53 36.18 36 12598 1603 42607098
Cystitis haemorrhagic 112.22 36.18 51 12583 7278 42601423
Cytomegalovirus viraemia 106.79 36.18 55 12579 10322 42598379
Encephalitis viral 104.74 36.18 32 12602 1496 42607205
Epstein-Barr virus infection reactivation 102.84 36.18 36 12598 2591 42606110
Fatigue 91.60 36.18 11 12623 435630 42173071
Enterocolitis viral 89.20 36.18 22 12612 455 42608246
Chronic graft versus host disease in liver 85.98 36.18 23 12611 663 42608038
Pulmonary vascular disorder 85.91 36.18 23 12611 665 42608036
Posterior reversible encephalopathy syndrome 85.32 36.18 51 12583 12770 42595931
Pulmonary arterial hypertension 85.11 36.18 47 12587 10140 42598561
Parainfluenzae virus infection 84.41 36.18 34 12600 3609 42605092
Autoimmune lymphoproliferative syndrome 83.49 36.18 18 12616 199 42608502
Graft complication 80.03 36.18 22 12612 704 42607997
Dyspnoea 79.98 36.18 17 12617 442604 42166097
Post transplant lymphoproliferative disorder 78.74 36.18 43 12591 9077 42599624
Viraemia 76.03 36.18 26 12608 1744 42606957
Multiple organ dysfunction syndrome 73.43 36.18 115 12519 96920 42511781
Thrombocytopenia 71.16 36.18 167 12467 190112 42418589
Chronic graft versus host disease in intestine 69.92 36.18 18 12616 445 42608256
Death 68.80 36.18 27 12607 471158 42137543
Disseminated toxoplasmosis 68.56 36.18 16 12618 259 42608442
Pulmonary arteriopathy 67.63 36.18 13 12621 76 42608625
Pneumonia cytomegaloviral 67.25 36.18 30 12604 4096 42604605
Transplant failure 64.62 36.18 29 12605 4015 42604686
Pre-engraftment immune reaction 64.27 36.18 14 12620 163 42608538
Aplastic anaemia 61.66 36.18 41 12593 12343 42596358
Serratia sepsis 60.03 36.18 13 12621 147 42608554
Inappropriate antidiuretic hormone secretion 59.72 36.18 45 12589 16496 42592205
Asthenia 59.14 36.18 7 12627 280786 42327915
Retinopathy haemorrhagic 56.70 36.18 11 12623 68 42608633
Juvenile melanoma benign 56.29 36.18 11 12623 71 42608630
Osteosarcoma 56.11 36.18 14 12620 304 42608397
Bone marrow failure 54.97 36.18 58 12576 33035 42575666
Cytomegalovirus chorioretinitis 54.94 36.18 27 12607 4584 42604117
Central nervous system viral infection 53.87 36.18 12 12622 156 42608545
Hypogammaglobulinaemia 53.56 36.18 37 12597 11854 42596847
Autoimmune haemolytic anaemia 52.47 36.18 28 12606 5643 42603058
Epstein-Barr viraemia 51.78 36.18 21 12613 2268 42606433
Infection 51.59 36.18 107 12527 111961 42496740
Bacterial sepsis 48.96 36.18 28 12606 6454 42602247
Serratia infection 48.17 36.18 17 12617 1252 42607449
Human polyomavirus infection 47.73 36.18 17 12617 1286 42607415
Herpes simplex pneumonia 47.69 36.18 12 12622 270 42608431
Hyperfibrinogenaemia 46.51 36.18 10 12624 109 42608592
Enterococcal infection 46.25 36.18 34 12600 12005 42596696
Cystitis viral 44.73 36.18 16 12618 1226 42607475
Klebsiella infection 43.52 36.18 32 12602 11300 42597401
Malaise 42.92 36.18 6 12628 212150 42396551
Hepatic failure 41.86 36.18 54 12580 38046 42570655
Herpes simplex 41.51 36.18 26 12608 7069 42601632
Pyrexia 41.12 36.18 227 12407 393815 42214886
Neutropenia 40.95 36.18 141 12493 199290 42409411
Gastrointestinal inflammation 40.60 36.18 22 12612 4570 42604131
NPM1 gene mutation 40.40 36.18 9 12625 117 42608584
Clostridium difficile colitis 40.28 36.18 40 12594 21212 42587489
Myelitis transverse 39.80 36.18 15 12619 1332 42607369
Sepsis 39.25 36.18 139 12495 199195 42409506
CNS ventriculitis 39.18 36.18 11 12623 381 42608320
Chimerism 38.81 36.18 10 12624 248 42608453
Acute respiratory distress syndrome 38.41 36.18 46 12588 30062 42578639
Respiratory tract inflammation 37.80 36.18 11 12623 434 42608267
Weight decreased 37.42 36.18 8 12626 207940 42400761
Bronchiolitis obliterans syndrome 36.96 36.18 10 12624 301 42608400
Constipation 36.86 36.18 3 12631 162288 42446413
Aplasia 36.79 36.18 21 12613 4822 42603879
Respiratory syncytial virus infection 36.38 36.18 24 12610 7128 42601573

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
Mucosal inflammation 1237.02 36.84 517 20434 95624 110472724
Acute graft versus host disease in skin 1167.23 36.84 293 20658 10447 110557901
Cytomegalovirus infection reactivation 1070.10 36.84 306 20645 18027 110550321
Acute graft versus host disease 939.17 36.84 256 20695 12625 110555723
Cytomegalovirus infection 910.81 36.84 354 20597 54090 110514258
Human herpesvirus 6 infection 817.75 36.84 200 20751 6381 110561967
Venoocclusive liver disease 794.70 36.84 233 20718 14974 110553374
Acute graft versus host disease in intestine 791.12 36.84 189 20762 5450 110562898
Adenovirus infection 761.93 36.84 210 20741 10784 110557564
Graft versus host disease in skin 676.59 36.84 180 20771 8074 110560274
Graft versus host disease 546.11 36.84 184 20767 18622 110549726
Graft versus host disease in gastrointestinal tract 542.32 36.84 154 20797 8814 110559534
Febrile neutropenia 486.06 36.84 433 20518 316334 110252014
Chronic graft versus host disease 481.19 36.84 142 20809 9315 110559033
Haematotoxicity 438.74 36.84 161 20790 20921 110547427
Thrombotic microangiopathy 429.09 36.84 173 20778 28976 110539372
Viral haemorrhagic cystitis 425.69 36.84 104 20847 3295 110565053
Epstein-Barr virus infection 404.40 36.84 147 20804 18591 110549757
Product use in unapproved indication 389.24 36.84 450 20501 446927 110121421
BK virus infection 379.51 36.84 128 20823 12978 110555370
Venoocclusive disease 321.47 36.84 95 20856 6255 110562093
Encephalitis viral 316.30 36.84 80 20871 2927 110565421
Off label use 309.13 36.84 791 20160 1499394 109068954
Cytomegalovirus viraemia 294.77 36.84 115 20836 17649 110550699
Pre-engraftment immune reaction 242.60 36.84 46 20905 413 110567935
Engraftment syndrome 241.32 36.84 59 20892 1873 110566475
Cystitis haemorrhagic 234.70 36.84 88 20863 12121 110556227
Viraemia 223.60 36.84 65 20886 4037 110564311
Chronic graft versus host disease in skin 223.50 36.84 59 20892 2560 110565788
Posterior reversible encephalopathy syndrome 197.96 36.84 106 20845 33755 110534593
Transplant failure 174.86 36.84 58 20893 5577 110562771
Acute graft versus host disease in liver 172.31 36.84 47 20904 2312 110566036
Bacterial sepsis 167.67 36.84 66 20885 10360 110557988
Fatigue 162.55 36.84 20 20931 1215938 109352410
Multiple organ dysfunction syndrome 147.31 36.84 162 20789 151548 110416800
Thrombocytopenia 144.17 36.84 246 20705 348639 110219709
Autoimmune haemolytic anaemia 139.33 36.84 58 20893 10509 110557839
Idiopathic pneumonia syndrome 136.17 36.84 32 20919 855 110567493
Post transplant lymphoproliferative disorder 135.81 36.84 64 20887 15549 110552799
Pulmonary vascular disorder 135.25 36.84 33 20918 1038 110567310
Sepsis 131.52 36.84 228 20723 327118 110241230
Transplant dysfunction 131.39 36.84 52 20899 8276 110560072
Acute lymphocytic leukaemia recurrent 127.03 36.84 46 20905 5741 110562607
Pulmonary arterial hypertension 126.18 36.84 78 20873 32490 110535858
Aplastic anaemia 125.20 36.84 70 20881 24238 110544110
Dyspnoea 118.30 36.84 32 20919 1106840 109461508
Arthralgia 116.84 36.84 8 20943 779624 109788724
Neutropenia 114.39 36.84 232 20719 374388 110193960
Pneumonia cytomegaloviral 108.24 36.84 43 20908 6911 110561437
Dizziness 108.10 36.84 6 20945 698187 109870161
Graft versus host disease in liver 108.01 36.84 33 20918 2432 110565916
Toxic erythema of chemotherapy 107.87 36.84 23 20928 389 110567959
Adenovirus reactivation 104.75 36.84 25 20926 715 110567633
Chronic graft versus host disease in intestine 101.25 36.84 24 20927 666 110567682
Human polyomavirus infection 100.18 36.84 29 20922 1773 110566575
Pain 99.38 36.84 29 20922 954926 109613422
Disseminated toxoplasmosis 98.99 36.84 22 20929 455 110567893
Bone marrow failure 98.16 36.84 84 20867 57764 110510584
Osteosarcoma 95.74 36.84 21 20930 408 110567940
Parainfluenzae virus infection 94.37 36.84 39 20912 6935 110561413
Epstein-Barr viraemia 92.04 36.84 32 20919 3547 110564801
Herpes simplex 91.13 36.84 49 20902 15715 110552633
Pulmonary arteriopathy 90.18 36.84 16 20935 95 110568253
Pruritus 89.98 36.84 5 20946 581555 109986793
Autoimmune lymphoproliferative syndrome 89.94 36.84 18 20933 219 110568129
Gastroenteritis adenovirus 89.75 36.84 20 20931 419 110567929
Cytomegalovirus chorioretinitis 86.87 36.84 37 20914 7091 110561257
Enterocolitis viral 85.57 36.84 22 20929 859 110567489
Chronic graft versus host disease in liver 84.58 36.84 22 20929 900 110567448
Epstein-Barr virus infection reactivation 84.20 36.84 31 20920 4053 110564295
Pyrexia 83.84 36.84 364 20587 897901 109670447
Neoplasm recurrence 83.69 36.84 33 20918 5199 110563149
Malaise 82.68 36.84 14 20937 671805 109896543
Skin toxicity 77.70 36.84 40 20911 11743 110556605
Leukaemia recurrent 76.70 36.84 27 20924 3104 110565244
Graft complication 75.49 36.84 21 20930 1111 110567237
Systemic candida 74.98 36.84 37 20914 9937 110558411
Bacteraemia 74.87 36.84 63 20888 42327 110526021
Leukoencephalopathy 74.80 36.84 36 20915 9159 110559189
Respiratory syncytial virus infection 72.65 36.84 41 20910 14443 110553905
Headache 71.80 36.84 39 20912 882338 109686010
Drug hypersensitivity 69.91 36.84 4 20947 454086 110114262
Infection reactivation 69.72 36.84 27 20924 4054 110564294
Pericardial effusion 69.63 36.84 69 20882 57148 110511200
Acute respiratory distress syndrome 68.19 36.84 66 20885 53132 110515216
Meningoencephalitis herpetic 67.69 36.84 23 20928 2379 110565969
Polyomavirus viraemia 66.60 36.84 25 20926 3449 110564899
Cytomegalovirus urinary tract infection 63.66 36.84 12 20939 104 110568244
Metaplasia 62.57 36.84 16 20935 611 110567737
Pulmonary veno-occlusive disease 62.23 36.84 21 20930 2127 110566221
Septic shock 62.19 36.84 109 20842 157419 110410929
Cytopenia 62.12 36.84 49 20902 30067 110538281
Abdominal discomfort 62.10 36.84 3 20948 393855 110174493
Condition aggravated 61.93 36.84 31 20920 734805 109833543
Nausea 61.51 36.84 87 20864 1235603 109332745
Clostridium difficile colitis 61.22 36.84 57 20894 43721 110524627
Neurotoxicity 61.05 36.84 56 20895 42151 110526197
Pain in extremity 60.22 36.84 10 20941 487108 110081240
JC virus infection 59.67 36.84 26 20925 5264 110563084
Herpes simplex pneumonia 59.39 36.84 14 20937 379 110567969
Respiratory failure 59.34 36.84 128 20823 215204 110353144
Serratia sepsis 58.62 36.84 13 20938 266 110568082
Asthenia 58.15 36.84 29 20922 688970 109879378
Retinopathy haemorrhagic 57.88 36.84 11 20940 100 110568248
Cystitis viral 57.29 36.84 18 20933 1455 110566893
Focal nodular hyperplasia 56.62 36.84 16 20935 897 110567451
Nasopharyngitis 56.31 36.84 5 20946 394356 110173992
Bronchopulmonary aspergillosis 56.10 36.84 46 20905 29817 110538531
Pancytopenia 54.81 36.84 122 20829 209491 110358857
Cerebral toxoplasmosis 54.43 36.84 21 20930 3121 110565227
Gastrointestinal toxicity 54.41 36.84 31 20920 11117 110557231
Stem cell transplant 54.01 36.84 23 20928 4404 110563944
Toxoplasmosis 53.81 36.84 21 20930 3218 110565130
Lip ulceration 53.29 36.84 20 20931 2758 110565590
Anisometropia 53.01 36.84 10 20941 87 110568261
Weight decreased 52.81 36.84 12 20939 468045 110100303
Aplasia 52.70 36.84 27 20924 7846 110560502
Parvovirus B19 infection 52.58 36.84 20 20931 2861 110565487
Constipation 52.56 36.84 4 20947 357782 110210566
Hypogonadism female 52.48 36.84 8 20943 14 110568334
Myelitis transverse 52.38 36.84 19 20932 2382 110565966
Staphylococcal infection 51.69 36.84 65 20886 69879 110498469
Central nervous system viral infection 51.01 36.84 12 20939 322 110568026
Infection 50.39 36.84 167 20784 362033 110206315
Rhinovirus infection 50.18 36.84 30 20921 11759 110556589
Human herpesvirus 6 encephalitis 49.71 36.84 15 20936 1059 110567289
NPM1 gene mutation 49.35 36.84 10 20941 130 110568218
Varicella zoster virus infection 48.99 36.84 24 20927 6344 110562004
Alpha haemolytic streptococcal infection 48.30 36.84 20 20931 3573 110564775
Gastrointestinal inflammation 48.02 36.84 27 20924 9442 110558906
Disease recurrence 47.34 36.84 58 20893 60726 110507622
Hyperfibrinogenaemia 47.01 36.84 10 20941 167 110568181
Bronchiolitis obliterans syndrome 46.93 36.84 13 20938 677 110567671
Bone sarcoma 46.86 36.84 9 20942 87 110568261
Mucosal toxicity 46.64 36.84 13 20938 693 110567655
Klebsiella infection 46.61 36.84 35 20916 19974 110548374
Chimerism 46.24 36.84 11 20940 310 110568038
Serratia infection 46.03 36.84 17 20934 2242 110566106
Urticaria 45.62 36.84 4 20947 318853 110249495
Mucormycosis 45.12 36.84 27 20924 10601 110557747
Back pain 44.99 36.84 8 20943 370988 110197360
Hepatic failure 44.74 36.84 60 20891 68679 110499669
Infusion related reaction 44.57 36.84 9 20942 381153 110187195
Multisystem inflammatory syndrome in children 44.20 36.84 8 20943 54 110568294
Haemophagocytic lymphohistiocytosis 43.95 36.84 41 20910 31518 110536830
Progressive multifocal leukoencephalopathy 43.88 36.84 37 20914 24919 110543429
Hepatotoxicity 43.82 36.84 57 20894 63343 110505005
Abdominal pain upper 43.50 36.84 7 20944 349104 110219244
Hyperbilirubinaemia 43.01 36.84 40 20911 30631 110537717
Death 42.37 36.84 42 20909 698827 109869521
Colitis erosive 42.24 36.84 10 20941 276 110568072
Urethral polyp 41.87 36.84 8 20943 75 110568273
Rash 41.55 36.84 57 20894 820907 109747441
Musculoskeletal stiffness 41.46 36.84 3 20948 279819 110288529
Herpes simplex reactivation 41.15 36.84 14 20937 1454 110566894
Drug intolerance 40.98 36.84 13 20938 406499 110161849
Second primary malignancy 40.75 36.84 31 20920 18037 110550311
Cytokine release syndrome 40.70 36.84 58 20893 70248 110498100
Depression 40.36 36.84 6 20945 317329 110251019
Ascites 40.27 36.84 67 20884 92741 110475607
Chest pain 39.83 36.84 11 20940 376364 110191984
Myelosuppression 38.15 36.84 66 20885 94274 110474074
Synovitis 37.73 36.84 4 20947 274088 110294260
Eustachian tube dysfunction 37.64 36.84 11 20940 695 110567653
Respiratory tract inflammation 37.48 36.84 12 20939 1031 110567317
Parotitis 37.21 36.84 16 20935 3137 110565211
Myelopathy 36.97 36.84 19 20932 5557 110562791
Chronic graft versus host disease oral 36.87 36.84 10 20941 481 110567867

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01AC01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
ALKYLATING AGENTS
Ethylene imines
FDA MoA N0000000236 Alkylating Activity
FDA EPC N0000175558 Alkylating Drug
MeSH PA D000477 Alkylating Agents
MeSH PA D000970 Antineoplastic Agents
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
MeSH PA D018906 Antineoplastic Agents, Alkylating
MeSH PA D019653 Myeloablative Agonists
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:233423 antifibrotic agent

Related Drugs by ATC class:

L01AC Ethylene imines 2 drugs
carboquonetriaziquone

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

DiseaseRelationSNOMED_IDDOID
Allogeneic bone marrow transplantation indication 58390007
Hodgkin's disease indication 118599009
Malignant lymphoma indication 118600007 DOID:0060058
Non-Hodgkin's lymphoma indication 118601006
Malignant tumor of ovary indication 363443007 DOID:2394
Malignant tumor of urinary bladder indication 399326009 DOID:11054
Carcinoma of female breast indication 447782002
Pleural Malignant Effusions indication
Peritoneal Malignant Effusions indication
Pericardial Malignant Effusions indication
Acute infectious disease contraindication 63171007
Blood coagulation disorder contraindication 64779008 DOID:1247
Leukopenia contraindication 84828003 DOID:615
Kidney disease contraindication 90708001 DOID:557
Disease of liver contraindication 235856003 DOID:409
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Bone marrow depression contraindication 307762000
Breastfeeding (mother) contraindication 413712001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG/10ML (10MG/ML) TEPYLUTE SHORLA N216984 Feb. 26, 2025 RX SOLUTION INTRAVENOUS 12622921 Aug. 16, 2041 TREATMENT OF ADENOCARCINOMA OF THE BREAST OR OVARY
15MG/1.5ML (10MG/ML) TEPYLUTE SHORLA N216984 June 25, 2024 RX SOLUTION INTRAVENOUS 12622921 Aug. 16, 2041 TREATMENT OF ADENOCARCINOMA OF THE BREAST OR OVARY

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Cytochrome P450 2B6 Enzyme INHIBITOR Ki 5.32 IUPHAR

External reference:

IDSource
4017910 VUID
N0000146261 NUI
D00583 KEGG_DRUG
4017910 VANDF
C0039871 UMLSCUI
CHEBI:9570 CHEBI
CHEMBL671 ChEMBL_ID
D013852 MESH_DESCRIPTOR_UI
DB04572 DRUGBANK_ID
7622 IUPHAR_LIGAND_ID
881 INN_ID
905Z5W3GKH UNII
5453 PUBCHEM_CID
10473 RXNORM
184712 MMSL
2134 MMSL
5573 MMSL
d00390 MMSL
002637 NDDF
387508004 SNOMEDCT_US
88997008 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Thiotepa HUMAN PRESCRIPTION DRUG LABEL 1 0143-9292 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRACAVITARY ANDA 27 sections
Thiotepa HUMAN PRESCRIPTION DRUG LABEL 1 0143-9309 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 15 mg INTRACAVITARY ANDA 22 sections
Thiotepa HUMAN PRESCRIPTION DRUG LABEL 1 0143-9565 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 15 mg INTRACAVITARY ANDA 22 sections
Thiotepa HUMAN PRESCRIPTION DRUG LABEL 1 25021-246 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 15 mg INTRAVENOUS ANDA 23 sections
Thiotepa HUMAN PRESCRIPTION DRUG LABEL 1 25021-246 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 15 mg INTRAVENOUS ANDA 23 sections
Thiotepa HUMAN PRESCRIPTION DRUG LABEL 1 43598-171 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVESICAL ANDA 27 sections
Thiotepa HUMAN PRESCRIPTION DRUG LABEL 1 43598-650 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 15 mg INTRAVENOUS ANDA 20 sections
Thiotepa HUMAN PRESCRIPTION DRUG LABEL 1 65219-029 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 27 sections
Thiotepa Human Prescription Drug Label 1 68083-446 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 15 mg INTRAVENOUS ANDA 27 sections
Thiotepa Human Prescription Drug Label 1 68083-503 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 27 sections
TEPADINA HUMAN PRESCRIPTION DRUG LABEL 1 70121-1630 INJECTION, POWDER, FOR SOLUTION 15 mg INTRACAVITARY NDA 20 sections
TEPADINA HUMAN PRESCRIPTION DRUG LABEL 1 70121-1630 INJECTION, POWDER, FOR SOLUTION 15 mg INTRACAVITARY NDA 20 sections
TEPADINA HUMAN PRESCRIPTION DRUG LABEL 1 70121-1631 INJECTION, POWDER, FOR SOLUTION 100 mg INTRACAVITARY NDA 20 sections
TEPADINA HUMAN PRESCRIPTION DRUG LABEL 1 70121-1631 INJECTION, POWDER, FOR SOLUTION 100 mg INTRACAVITARY NDA 20 sections
TEPADINA HUMAN PRESCRIPTION DRUG LABEL 1 70121-1687 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 400 mg INTRACAVITARY NDA 20 sections
TEPADINA HUMAN PRESCRIPTION DRUG LABEL 1 70121-2749 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 mg INTRACAVITARY NDA 20 sections
TEPADINA HUMAN PRESCRIPTION DRUG LABEL 1 70121-2749 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 mg INTRACAVITARY NDA 20 sections
Thiotepa HUMAN PRESCRIPTION DRUG LABEL 1 71288-156 INJECTION, POWDER, FOR SOLUTION 15 mg INTRAVENOUS ANDA 30 sections
Thiotepa HUMAN PRESCRIPTION DRUG LABEL 1 71288-157 INJECTION, POWDER, FOR SOLUTION 100 mg INTRAVENOUS ANDA 30 sections
Thiotepa Human Prescription Drug Label 1 72205-045 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 15 mg INTRAVENOUS ANDA 25 sections
Thiotepa Human Prescription Drug Label 1 72205-046 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 25 sections
TEPYLUTE HUMAN PRESCRIPTION DRUG LABEL 1 81927-105 INJECTION 10 mg INTRAVENOUS NDA 32 sections
TEPYLUTE HUMAN PRESCRIPTION DRUG LABEL 1 81927-106 INJECTION 10 mg INTRAVENOUS NDA 32 sections