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

Stem definitionDrug idCAS RN
antivirals 5376 1809249-37-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • veklury
  • captisol-enabled remdesivir
  • captisol-enabled GS 5734
  • remdesivir
  • GS-5734
Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity. Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are also coronaviruses and are structurally similar to COVID-19. The limited preclinical data on remdesivir in MERS and SARS indicate that remdesivir may have potential activity against COVID-19. The only direct-acting antiviral (DAA) currently approved by FDA for the treatment of COVID-19 in certain populations.
  • Molecular weight: 602.59
  • Formula: C27H35N6O8P
  • CLOGP: 1.71
  • LIPINSKI: 2
  • HAC: 14
  • HDO: 4
  • TPSA: 203.55
  • ALOGS: -3.25
  • ROTB: 14
  • Status: ONP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.12 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2D,EIF2AK3,GRK2,ITK,MAP2K6,PDK1,PDK2,PDK4,PIK3CD,PRKDC 13
kinase-selectivity-class AXL,CDK9,ERBB2,GRK2,MAP2K6,TEK 6
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
March 7, 2020 EMA Gilead Sciences Ireland UC
Oct. 22, 2020 FDA GILEAD SCIENCES INC
May 7, 2020 PMDA Gilead Sciences K.K.

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
Off label use 765.96 33.58 786 10111 1101466 89516084
Alanine aminotransferase increased 758.21 33.58 340 10557 117998 90499552
Bradycardia 591.43 33.58 258 10639 83589 90533961
Aspartate aminotransferase increased 522.46 33.58 252 10645 102685 90514865
COVID-19 pneumonia 383.69 33.58 125 10772 18052 90599498
Liver function test increased 297.19 33.58 162 10735 84693 90532857
Premature delivery 252.47 33.58 113 10784 38649 90578901
Respiratory failure 227.82 33.58 154 10743 118264 90499286
Infusion site extravasation 205.65 33.58 68 10829 10260 90607290
Drug ineffective for unapproved indication 205.25 33.58 117 10780 66527 90551023
Acute kidney injury 198.11 33.58 217 10680 320170 90297380
Bronchopulmonary aspergillosis 175.88 33.58 62 10835 11336 90606214
Blood creatinine increased 174.08 33.58 123 10774 101263 90516287
Therapy cessation 168.93 33.58 84 10813 36277 90581273
Sinus bradycardia 155.36 33.58 63 10834 16889 90600661
Death 148.64 33.58 225 10672 456326 90161224
Cardiac arrest 147.82 33.58 113 10784 104822 90512728
Acute respiratory distress syndrome 138.38 33.58 68 10829 28618 90588932
Transaminases increased 132.76 33.58 72 10825 37120 90580430
Hypoxia 119.96 33.58 86 10811 72313 90545237
Septic shock 119.30 33.58 91 10806 84069 90533481
Renal impairment 117.51 33.58 99 10798 105322 90512228
Maternal exposure during pregnancy 113.53 33.58 175 10722 359888 90257662
Glomerular filtration rate decreased 112.20 33.58 50 10847 16882 90600668
Product preparation error 96.99 33.58 39 10858 10222 90607328
Acute respiratory failure 94.97 33.58 61 10836 42857 90574693
Mucormycosis 91.70 33.58 29 10868 3792 90613758
Pulmonary mucormycosis 86.99 33.58 19 10878 581 90616969
Electrocardiogram QT prolonged 86.85 33.58 71 10826 72385 90545165
Exposure during pregnancy 85.22 33.58 123 10774 238287 90379263
Arthralgia 80.67 33.58 3 10894 778519 89839031
Pneumonia bacterial 79.11 33.58 36 10861 12754 90604796
Pain 78.45 33.58 13 10884 996328 89621222
Extravasation 77.42 33.58 24 10873 2940 90614610
COVID-19 76.86 33.58 98 10799 168745 90448805
Fatigue 75.04 33.58 23 10874 1154000 89463550
No adverse event 69.91 33.58 61 10836 67921 90549629
Pneumomediastinum 68.37 33.58 20 10877 2011 90615539
Oxygen saturation decreased 66.48 33.58 73 10824 107410 90510140
Myopathy toxic 64.80 33.58 15 10882 599 90616951
Torsade de pointes 64.39 33.58 33 10864 15149 90602401
Clinical trial participant 59.18 33.58 8 10889 7 90617543
Shock 56.57 33.58 38 10859 28740 90588810
Rhinocerebral mucormycosis 55.63 33.58 14 10883 798 90616752
SARS-CoV-2 test positive 55.49 33.58 27 10870 11101 90606449
Multiple organ dysfunction syndrome 54.11 33.58 53 10844 68283 90549267
Pneumothorax 51.91 33.58 31 10866 19136 90598414
Pulseless electrical activity 51.66 33.58 24 10873 8908 90608642
Herpes simplex reactivation 47.77 33.58 13 10884 1006 90616544
Subcutaneous emphysema 46.64 33.58 13 10884 1099 90616451
Hepatic function abnormal 46.50 33.58 41 10856 46247 90571303
Headache 44.90 33.58 24 10873 862722 89754828
Ischaemic hepatitis 42.33 33.58 15 10882 2778 90614772
Respiratory distress 42.15 33.58 36 10861 38910 90578640
Therapy interrupted 41.80 33.58 40 10857 50068 90567482
Pulmonary trichosporonosis 40.92 33.58 7 10890 55 90617495
Endocarditis 40.79 33.58 19 10878 7094 90610456
Pain in extremity 39.86 33.58 4 10893 450525 90167025
Drug intolerance 39.54 33.58 4 10893 447587 90169963
Drug interaction 39.24 33.58 96 10801 276357 90341193
Enterococcal infection 37.46 33.58 20 10877 9971 90607579
Diarrhoea 37.21 33.58 35 10862 939155 89678395
Drug hypersensitivity 34.33 33.58 7 10890 463602 90153948
Hypotension 34.09 33.58 101 10796 325296 90292254
Swelling 33.93 33.58 5 10892 419053 90198497

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
Alanine aminotransferase increased 1440.48 27.20 694 15849 87712 42517080
Off label use 1032.15 27.20 1238 15305 637097 41967695
Aspartate aminotransferase increased 801.98 27.20 449 16094 76714 42528078
Liver function test increased 694.57 27.20 269 16274 19729 42585063
Bradycardia 554.06 27.20 368 16175 85116 42519676
COVID-19 pneumonia 365.86 27.20 175 16368 21438 42583354
Respiratory failure 360.07 27.20 337 16206 127795 42476997
Drug ineffective for unapproved indication 286.98 27.20 194 16349 45969 42558823
Therapy cessation 247.48 27.20 132 16411 20318 42584474
Hepatic enzyme increased 225.60 27.20 167 16376 45617 42559175
Bronchopulmonary aspergillosis 211.70 27.20 117 16426 19312 42585480
Blood creatinine increased 197.69 27.20 228 16315 109775 42495017
Acute kidney injury 173.24 27.20 415 16128 366922 42237870
Transaminases increased 155.31 27.20 117 16426 32768 42572024
Infusion site extravasation 149.32 27.20 62 16481 5419 42599373
Pneumothorax 129.81 27.20 92 16451 23451 42581341
Hypoxia 129.16 27.20 147 16396 69639 42535153
Acute respiratory distress syndrome 126.60 27.20 100 16443 30008 42574784
Fatigue 120.94 27.20 14 16529 435627 42169165
Pneumomediastinum 115.40 27.20 44 16499 3072 42601720
Septic shock 110.60 27.20 156 16387 91516 42513276
Pneumonia bacterial 109.59 27.20 71 16472 15621 42589171
Death 107.94 27.20 413 16130 470772 42134020
Mucormycosis 106.23 27.20 53 16490 7090 42597702
Cardiac arrest 103.34 27.20 166 16377 109154 42495638
Glomerular filtration rate decreased 99.73 27.20 68 16475 16283 42588509
Sinus bradycardia 95.92 27.20 64 16479 14789 42590003
Clinical trial participant 94.85 27.20 18 16525 70 42604722
Diarrhoea 94.21 27.20 31 16512 460818 42143974
Product preparation error 94.08 27.20 43 16500 4735 42600057
Acute respiratory failure 93.27 27.20 94 16449 38764 42566028
Pulseless electrical activity 92.37 27.20 51 16492 8386 42596406
Oxygen saturation decreased 89.98 27.20 118 16425 64569 42540223
Therapy interrupted 85.23 27.20 70 16473 22180 42582612
Renal impairment 82.57 27.20 151 16392 110077 42494715
Hypertransaminasaemia 80.22 27.20 48 16495 9179 42595613
Rhinocerebral mucormycosis 79.70 27.20 23 16520 667 42604125
No adverse event 73.48 27.20 83 16460 38938 42565854
SARS-CoV-2 test positive 69.30 27.20 42 16501 8218 42596574
Multiple organ dysfunction syndrome 68.97 27.20 130 16413 96905 42507887
COVID-19 68.78 27.20 144 16399 115804 42488988
Weight decreased 68.02 27.20 3 16540 207945 42396847
Nausea 67.59 27.20 35 16508 396764 42208028
Condition aggravated 65.57 27.20 236 16307 260518 42344274
Aspergillus infection 63.12 27.20 51 16492 15786 42589006
Asthenia 62.55 27.20 16 16527 280777 42324015
Cryptococcosis 60.40 27.20 28 16515 3183 42601609
Drug ineffective 59.98 27.20 433 16110 629764 41975028
Toxicity to various agents 57.27 27.20 10 16533 229126 42375666
Headache 56.55 27.20 12 16531 239357 42365435
Fall 54.90 27.20 12 16531 234508 42370284
Pneumonia cryptococcal 54.78 27.20 21 16522 1487 42603305
COVID-19 treatment 54.69 27.20 14 16529 255 42604537
Bronchopleural fistula 53.91 27.20 17 16526 670 42604122
Disseminated cryptococcosis 53.18 27.20 22 16521 1903 42602889
Haemodialysis 51.74 27.20 38 16505 10222 42594570
Product preparation issue 50.19 27.20 18 16525 1057 42603735
Pneumonia staphylococcal 49.35 27.20 25 16518 3451 42601341
Arthralgia 49.06 27.20 10 16533 205228 42399564
Infection reactivation 47.17 27.20 21 16522 2173 42602619
Dizziness 47.00 27.20 19 16524 249235 42355557
Pain 45.62 27.20 19 16524 244829 42359963
Subcutaneous emphysema 45.42 27.20 19 16524 1690 42603102
Shock 44.98 27.20 56 16487 29065 42575727
Vomiting 44.36 27.20 29 16514 289694 42315098
Fibrin D dimer increased 43.50 27.20 26 16517 4959 42599833
Decreased appetite 42.98 27.20 11 16532 193126 42411666
Cutaneous mucormycosis 42.59 27.20 14 16529 631 42604161
Extravasation 42.36 27.20 20 16523 2370 42602422
PaO2/FiO2 ratio decreased 41.21 27.20 8 16535 36 42604756
Abdominal pain 40.23 27.20 12 16531 190459 42414333
Creatinine renal clearance decreased 39.98 27.20 22 16521 3591 42601201
Post-acute COVID-19 syndrome 39.23 27.20 12 16531 427 42604365
Pain in extremity 38.88 27.20 6 16537 150598 42454194
Pruritus 37.90 27.20 13 16530 188758 42416034
Palliative care 37.87 27.20 15 16528 1159 42603633
Constipation 36.57 27.20 9 16534 162282 42442510
Renal replacement therapy 36.25 27.20 8 16535 74 42604718
Oedema peripheral 36.10 27.20 5 16538 136071 42468721
Malaise 35.60 27.20 19 16524 212137 42392655
Blood bilirubin increased 35.59 27.20 61 16482 42191 42562601
Somnolence 35.57 27.20 6 16537 141099 42463693
Diffuse alveolar damage 34.93 27.20 18 16525 2574 42602218
Ischaemic hepatitis 34.88 27.20 17 16526 2160 42602632
Febrile neutropenia 33.63 27.20 15 16528 185688 42419104
Disseminated aspergillosis 32.27 27.20 15 16528 1715 42603077
SARS-CoV-2 RNA increased 32.20 27.20 7 16536 60 42604732
Pulmonary mucormycosis 31.52 27.20 14 16529 1441 42603351
Pneumothorax spontaneous 31.52 27.20 12 16531 834 42603958
Infusion related reaction 30.87 27.20 71 16472 60735 42544057
Insomnia 29.86 27.20 5 16538 118248 42486544
Back pain 29.80 27.20 9 16534 141767 42463025
Retroperitoneal haematoma 29.48 27.20 17 16526 3034 42601758
SARS-CoV-2 viraemia 29.34 27.20 7 16536 94 42604698
Fungaemia 29.05 27.20 17 16526 3119 42601673
Anaemia 28.91 27.20 40 16503 280238 42324554
Cryptococcal meningoencephalitis 28.78 27.20 8 16535 202 42604590
Dialysis 28.74 27.20 29 16514 11957 42592835
Pulse absent 28.71 27.20 22 16521 6305 42598487
Blood alkaline phosphatase increased 27.63 27.20 48 16495 33549 42571243
Gait disturbance 27.46 27.20 3 16540 97997 42506795

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
Alanine aminotransferase increased 2197.67 28.61 1010 25985 182763 110379541
Off label use 1763.74 28.61 1972 25023 1498213 109064091
Aspartate aminotransferase increased 1332.92 28.61 688 26307 159248 110403056
Bradycardia 1122.38 28.61 608 26387 154909 110407395
Liver function test increased 850.66 28.61 420 26575 88128 110474176
COVID-19 pneumonia 687.45 28.61 279 26716 36864 110525440
Respiratory failure 630.95 28.61 477 26518 214855 110347449
Drug ineffective for unapproved indication 495.83 28.61 310 26685 102528 110459776
Therapy cessation 436.85 28.61 215 26780 44642 110517662
Blood creatinine increased 406.79 28.61 345 26650 182544 110379760
Bronchopulmonary aspergillosis 405.02 28.61 180 26815 29683 110532621
Acute kidney injury 403.85 28.61 624 26371 634806 109927498
Death 321.02 28.61 594 26401 698275 109864029
Infusion site extravasation 302.63 28.61 112 26883 11522 110550782
Transaminases increased 285.07 28.61 183 26812 63207 110499097
Hypoxia 258.77 28.61 230 26765 129285 110433019
Cardiac arrest 252.11 28.61 274 26721 196479 110365825
Acute respiratory distress syndrome 250.18 28.61 158 26837 53040 110509264
Sinus bradycardia 236.43 28.61 124 26871 29359 110532945
Septic shock 233.20 28.61 237 26758 157291 110405013
Renal impairment 214.90 28.61 247 26748 188198 110374106
Glomerular filtration rate decreased 213.06 28.61 115 26880 28841 110533463
Pneumothorax 202.31 28.61 119 26876 35166 110527138
Mucormycosis 197.00 28.61 80 26915 10548 110551756
Fatigue 188.28 28.61 35 26960 1215923 109346381
Pneumonia bacterial 184.05 28.61 101 26894 26160 110536144
Acute respiratory failure 181.57 28.61 149 26846 75111 110487193
Pneumomediastinum 178.47 28.61 61 26934 4975 110557329
Premature delivery 177.43 28.61 104 26891 30528 110531776
Product preparation error 161.77 28.61 70 26925 10809 110551495
No adverse event 161.20 28.61 138 26857 73701 110488603
Clinical trial participant 151.20 28.61 26 26969 91 110562213
Oxygen saturation decreased 144.98 28.61 185 26810 156797 110405507
Pulseless electrical activity 144.44 28.61 74 26921 16683 110545621
Arthralgia 143.01 28.61 13 26982 779619 109782685
Pain 140.32 28.61 31 26964 954924 109607380
Therapy interrupted 140.19 28.61 108 26887 49714 110512590
Multiple organ dysfunction syndrome 137.29 28.61 177 26818 151533 110410771
Rhinocerebral mucormycosis 133.76 28.61 37 26958 1480 110560824
COVID-19 133.40 28.61 225 26770 244835 110317469
Diarrhoea 122.46 28.61 63 26932 1139442 109422862
Headache 119.24 28.61 34 26961 882343 109679961
SARS-CoV-2 test positive 112.81 28.61 63 26932 16872 110545432
Nausea 104.85 28.61 89 26906 1235601 109326703
Pulmonary mucormycosis 104.31 28.61 33 26962 2110 110560194
Shock 102.61 28.61 93 26902 53495 110508809
Aspergillus infection 100.60 28.61 68 26927 25548 110536756
Drug ineffective 99.17 28.61 671 26324 1519869 109042435
Hypertransaminasaemia 96.72 28.61 65 26930 24190 110538114
Weight decreased 90.79 28.61 6 26989 468051 110094253
Pain in extremity 89.54 28.61 8 26987 487110 110075194
Haemodialysis 89.23 28.61 55 26940 17664 110544640
Subcutaneous emphysema 86.51 28.61 30 26965 2554 110559750
Abdominal discomfort 82.90 28.61 3 26992 393855 110168449
COVID-19 treatment 78.49 28.61 19 26976 444 110561860
Fall 78.25 28.61 25 26970 603457 109958847
Hepatic enzyme increased 77.74 28.61 212 26783 320680 110241624
Drug hypersensitivity 76.98 28.61 10 26985 454080 110108224
Cryptococcosis 76.13 28.61 32 26963 4599 110557705
Ischaemic hepatitis 76.02 28.61 32 26963 4616 110557688
Pneumonia cryptococcal 75.51 28.61 27 26968 2515 110559789
Fibrin D dimer increased 74.91 28.61 40 26955 9805 110552499
Extravasation 74.74 28.61 32 26963 4813 110557491
Dizziness 74.24 28.61 39 26956 698154 109864150
Pneumonia staphylococcal 73.92 28.61 34 26961 6057 110556247
Malaise 72.20 28.61 37 26958 671782 109890522
Vomiting 71.84 28.61 70 26925 910605 109651699
Drug intolerance 71.24 28.61 8 26987 406504 110155800
Hepatic function abnormal 71.22 28.61 98 26897 89197 110473107
Bronchopleural fistula 70.61 28.61 20 26975 873 110561431
Product preparation issue 69.49 28.61 26 26969 2753 110559551
Insomnia 68.81 28.61 5 26990 360585 110201719
Asthenia 65.47 28.61 44 26951 688955 109873349
Hypoaesthesia 60.99 28.61 4 26991 314219 110248085
Post-acute COVID-19 syndrome 59.43 28.61 20 26975 1555 110560749
Decreased appetite 59.40 28.61 21 26974 475825 110086479
Condition aggravated 58.57 28.61 342 26653 734494 109827810
Palliative care 58.16 28.61 20 26975 1660 110560644
Abdominal pain 56.98 28.61 27 26968 512962 110049342
Infection reactivation 56.57 28.61 25 26970 4056 110558248
Disseminated cryptococcosis 56.19 28.61 22 26973 2635 110559669
Musculoskeletal stiffness 56.01 28.61 3 26992 279819 110282485
Gait disturbance 55.63 28.61 3 26992 278205 110284099
Peripheral swelling 55.51 28.61 15 26980 404019 110158285
Disseminated intravascular coagulation 55.39 28.61 59 26936 41227 110521077
Pulse absent 54.20 28.61 34 26961 11258 110551046
Dialysis 54.01 28.61 42 26953 19577 110542727
Abdominal pain upper 53.90 28.61 10 26985 349101 110213203
Oedema peripheral 53.88 28.61 8 26987 328652 110233652
Toxicity to various agents 53.82 28.61 25 26970 480530 110081774
Stomatitis 53.77 28.61 3 26992 270239 110292065
International normalised ratio increased 52.98 28.61 84 26911 86688 110475616
Hypotension 52.71 28.61 260 26735 523589 110038715
Muscle spasms 52.65 28.61 4 26991 278153 110284151
Paraesthesia 52.27 28.61 4 26991 276517 110285787
Cryptococcal meningoencephalitis 51.02 28.61 13 26982 377 110561927
Blood alkaline phosphatase increased 50.86 28.61 74 26921 70861 110491443
Organising pneumonia 49.32 28.61 35 26960 14208 110548096
Sinusitis 49.15 28.61 7 26988 296681 110265623
Back pain 48.70 28.61 15 26980 370981 110191323
Pruritus 47.79 28.61 43 26952 581517 109980787
Heart rate decreased 47.64 28.61 78 26917 82678 110479626
Cutaneous mucormycosis 47.28 28.61 14 26981 716 110561588
Gastrointestinal disorder 47.18 28.61 3 26992 241949 110320355
Depression 47.07 28.61 10 26985 317325 110244979
Maternal exposure during pregnancy 47.04 28.61 153 26842 254730 110307574
Myopathy toxic 46.75 28.61 16 26979 1309 110560995
Respiratory distress 46.71 28.61 70 26925 68804 110493500
Electrocardiogram QT prolonged 46.38 28.61 90 26905 108870 110453434
Paravenous drug administration 46.38 28.61 7 26988 7 110562297
Constipation 46.01 28.61 15 26980 357771 110204533
Blood bilirubin increased 45.63 28.61 73 26922 75899 110486405
Exposure during pregnancy 44.95 28.61 115 26880 167309 110394995
Swelling 44.64 28.61 15 26980 351026 110211278
Fungaemia 44.27 28.61 24 26971 6062 110556242
Diffuse alveolar damage 44.19 28.61 21 26974 4026 110558278
Retroperitoneal haematoma 44.10 28.61 24 26971 6107 110556197
Rash 43.61 28.61 84 26911 820880 109741424
Renal replacement therapy 43.37 28.61 10 26985 188 110562116
Confusional state 43.06 28.61 31 26964 468649 110093655
Contusion 42.39 28.61 4 26991 233357 110328947
Tachypnoea 42.07 28.61 50 26945 39345 110522959
Lower respiratory tract infection 42.03 28.61 5 26990 243101 110319203
Pericarditis 41.89 28.61 3 26992 219111 110343193
Cardio-respiratory arrest 41.39 28.61 89 26906 115747 110446557
Herpes simplex reactivation 41.38 28.61 15 26980 1453 110560851
SARS-CoV-2 viraemia 40.40 28.61 9 26986 144 110562160
Disseminated aspergillosis 40.31 28.61 17 26978 2463 110559841
Pneumonia pseudomonal 39.46 28.61 24 26971 7522 110554782
Immunosuppression 38.33 28.61 33 26962 17726 110544578
Humoral immune defect 38.33 28.61 12 26983 741 110561563
SARS-CoV-2 RNA increased 38.09 28.61 9 26986 189 110562115
PaO2/FiO2 ratio decreased 37.91 28.61 7 26988 40 110562264
Opportunistic infection 37.51 28.61 18 26977 3525 110558779
Sleep disorder 37.18 28.61 3 26992 198641 110363663
Torsade de pointes 37.06 28.61 36 26959 22564 110539740
Memory impairment 36.79 28.61 3 26992 196941 110365363
Shock haemorrhagic 36.65 28.61 39 26956 27208 110535096
Retroperitoneal haemorrhage 36.18 28.61 21 26974 6044 110556260
Candida infection 35.75 28.61 51 26944 47958 110514346
Discomfort 35.70 28.61 5 26990 214702 110347602
Endocarditis 35.46 28.61 28 26967 13343 110548961
Klebsiella infection 34.95 28.61 33 26962 19976 110542328
Pulmonary trichosporonosis 34.93 28.61 7 26988 65 110562239
Blood urea increased 34.65 28.61 54 26941 54903 110507401
Enterococcal infection 34.45 28.61 33 26962 20333 110541971
Creatinine renal clearance decreased 34.37 28.61 34 26961 21781 110540523
Haemodynamic instability 33.00 28.61 34 26961 22854 110539450
Dyspepsia 32.83 28.61 4 26991 190961 110371343
Anaemia 32.62 28.61 52 26943 547034 110015270
Mechanical ventilation 32.60 28.61 16 26979 3291 110559013
Staphylococcal infection 32.52 28.61 60 26935 69884 110492420
Impaired healing 31.74 28.61 5 26990 196712 110365592
Malignant neoplasm progression 31.68 28.61 3 26992 174564 110387740
Renal tubular necrosis 31.43 28.61 38 26957 30437 110531867
Pneumothorax spontaneous 31.36 28.61 13 26982 1804 110560500
Leukocytosis 31.33 28.61 51 26944 53777 110508527
Migraine 31.02 28.61 3 26992 171649 110390655
Tuberculosis 30.44 28.61 29 26966 17745 110544559
Influenza 30.44 28.61 3 26992 169098 110393206
Pulmonary nocardiosis 29.80 28.61 14 26981 2615 110559689
Type 2 diabetes mellitus 29.77 28.61 4 26991 177228 110385076
Infusion site swelling 29.06 28.61 22 26973 9855 110552449
Pulmonary cavitation 29.00 28.61 13 26982 2181 110560123
Diverticulitis intestinal perforated 28.87 28.61 9 26986 548 110561756

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J05AB16 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Nucleosides and nucleotides excl. reverse transcriptase inhibitors
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000963 Antimetabolites
MeSH PA D000998 Antiviral Agents
MeSH PA D009676 Noxae
FDA EPC N0000193948 SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:33281 antimicrobial agent
CHEBI has role CHEBI:36044 antiviral drug
CHEBI has role CHEBI:50266 prodrug
CHEBI has role CHEBI:149553 anticoronaviral agent

Related Drugs by ATC class:

J05AB Nucleosides and nucleotides excl. reverse transcriptase inhibitors 11 drugs
acyclovirbrivudinecidofovirfamciclovirgancicloviridoxuridinemolnupiravirpenciclovirvalaciclovirvalganciclovirvidarabine

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

DiseaseRelationSNOMED_IDDOID
Disease caused by Severe acute respiratory syndrome coronavirus 2 indication 840539006
Coronavirus infection off-label use 186747009




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.68 acidic
pKa2 12.82 acidic
pKa3 4.2 Basic
pKa4 1.68 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 DISCN SOLUTION INTRAVENOUS 10695361 Sept. 16, 2036 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (WEIGHING AT LEAST 40 KG) REQUIRING HOSPITALIZATION
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 DISCN SOLUTION INTRAVENOUS 10695361 Sept. 16, 2036 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (WEIGHING AT LEAST 40 KG)
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 DISCN SOLUTION INTRAVENOUS 11007208 Sept. 16, 2036 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (WEIGHING AT LEAST 40 KG) REQUIRING HOSPITALIZATION
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 DISCN SOLUTION INTRAVENOUS 11007208 Sept. 16, 2036 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (WEIGHING AT LEAST 40 KG)
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 DISCN SOLUTION INTRAVENOUS 11382926 Sept. 16, 2036 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (WEIGHING AT LEAST 40 KG) REQUIRING HOSPITALIZATION
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 DISCN SOLUTION INTRAVENOUS 11382926 Sept. 16, 2036 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (WEIGHING AT LEAST 40 KG)
100MG/VIAL VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX POWDER INTRAVENOUS 10695361 Sept. 16, 2036 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (BIRTH TO < 18 YEARS OF AGE WEIGHING > 1.5 KG) REQUIRING HOSPITALIZATION
100MG/VIAL VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX POWDER INTRAVENOUS 10695361 Sept. 16, 2036 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (BIRTH TO < 18 YEARS OF AGE WEIGHING > 1.5 KG)
100MG/VIAL VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX POWDER INTRAVENOUS 11007208 Sept. 16, 2036 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (BIRTH TO < 18 YEARS OF AGE WEIGHING > 1.5 KG) REQUIRING HOSPITALIZATION
100MG/VIAL VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX POWDER INTRAVENOUS 11007208 Sept. 16, 2036 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (BIRTH TO < 18 YEARS OF AGE WEIGHING > 1.5 KG)
100MG/VIAL VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX POWDER INTRAVENOUS 11382926 Sept. 16, 2036 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (BIRTH TO < 18 YEARS OF AGE WEIGHING > 1.5 KG) REQUIRING HOSPITALIZATION
100MG/VIAL VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX POWDER INTRAVENOUS 11382926 Sept. 16, 2036 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (BIRTH TO < 18 YEARS OF AGE WEIGHING > 1.5 KG)
100MG/VIAL VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX POWDER INTRAVENOUS 11266681 July 10, 2038 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (BIRTH TO < 18 YEARS OF AGE WEIGHING > 1.5 KG) REQUIRING HOSPITALIZATION
100MG/VIAL VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX POWDER INTRAVENOUS 11266681 July 10, 2038 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (BIRTH TO < 18 YEARS OF AGE WEIGHING > 1.5 KG)
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 DISCN SOLUTION INTRAVENOUS 11491169 May 28, 2041 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (WEIGHING AT LEAST 40 KG) REQUIRING HOSPITALIZATION AND FOR WHOM CONCOMITANT USE OF CHLOROQUINE, OR AN ANALOG OR SALT THEREOF, IS NOT RECOMMENDED
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 DISCN SOLUTION INTRAVENOUS 11491169 May 28, 2041 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (WEIGHING AT LEAST 40 KG) AND FOR WHOM CONCOMITANT USE OF CHLOROQUINE, OR AN ANALOG OR SALT THEREOF, IS NOT RECOMMENDED
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 DISCN SOLUTION INTRAVENOUS 11903953 May 28, 2041 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (WEIGHING AT LEAST 40 KG) REQUIRING HOSPITALIZATION AND FOR WHOM CONCOMITANT USE OF CHLOROQUINE, OR AN ANALOG OR SALT THEREOF, IS NOT RECOMMENDED
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 DISCN SOLUTION INTRAVENOUS 11903953 May 28, 2041 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (WEIGHING AT LEAST 40 KG) AND FOR WHOM CONCOMITANT USE OF CHLOROQUINE, OR AN ANALOG OR SALT THEREOF, IS NOT RECOMMENDED
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 DISCN SOLUTION INTRAVENOUS 11975012 May 28, 2041 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (WEIGHING AT LEAST 40 KG) REQUIRING HOSPITALIZATION AND FOR WHOM CONCOMITANT USE OF CHLOROQUINE, OR AN ANALOG OR SALT THEREOF, IS NOT RECOMMENDED
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 DISCN SOLUTION INTRAVENOUS 11975012 May 28, 2041 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (WEIGHING AT LEAST 40 KG) AND FOR WHOM CONCOMITANT USE OF CHLOROQUINE, OR AN ANALOG OR SALT THEREOF, IS NOT RECOMMENDED
100MG/VIAL VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX POWDER INTRAVENOUS 11491169 May 28, 2041 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (BIRTH TO < 18 YEARS OF AGE WEIGHING > 1.5 KG) REQUIRING HOSPITALIZATION AND FOR WHOM CONCOMITANT USE OF CHLOROQUINE, OR AN ANALOG OR SALT THEREOF, IS NOT RECOMMENDED
100MG/VIAL VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX POWDER INTRAVENOUS 11491169 May 28, 2041 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (BIRTH TO < 18 YEARS OF AGE WEIGHING > 1.5 KG) AND FOR WHOM CONCOMITANT USE OF CHLOROQUINE, OR AN ANALOG OR SALT THEREOF, IS NOT RECOMMENDED
100MG/VIAL VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX POWDER INTRAVENOUS 11903953 May 28, 2041 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (BIRTH TO < 18 YEARS OF AGE WEIGHING > 1.5 KG) REQUIRING HOSPITALIZATION AND FOR WHOM CONCOMITANT USE OF CHLOROQUINE, OR AN ANALOG OR SALT THEREOF, IS NOT RECOMMENDED
100MG/VIAL VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX POWDER INTRAVENOUS 11903953 May 28, 2041 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (BIRTH TO < 18 YEARS OF AGE WEIGHING > 1.5 KG) AND FOR WHOM CONCOMITANT USE OF CHLOROQUINE, OR AN ANALOG OR SALT THEREOF, IS NOT RECOMMENDED
100MG/VIAL VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX POWDER INTRAVENOUS 11975012 May 28, 2041 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (BIRTH TO < 18 YEARS OF AGE WEIGHING > 1.5 KG) REQUIRING HOSPITALIZATION AND FOR WHOM CONCOMITANT USE OF CHLOROQUINE, OR AN ANALOG OR SALT THEREOF, IS NOT RECOMMENDED
100MG/VIAL VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX POWDER INTRAVENOUS 11975012 May 28, 2041 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (BIRTH TO < 18 YEARS OF AGE WEIGHING > 1.5 KG) AND FOR WHOM CONCOMITANT USE OF CHLOROQUINE, OR AN ANALOG OR SALT THEREOF, IS NOT RECOMMENDED

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 DISCN SOLUTION INTRAVENOUS Oct. 22, 2025 NEW CHEMICAL ENTITY
100MG/VIAL VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX POWDER INTRAVENOUS Oct. 22, 2025 NEW CHEMICAL ENTITY
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 DISCN SOLUTION INTRAVENOUS April 22, 2026 PEDIATRIC EXCLUSIVITY
100MG/VIAL VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX POWDER INTRAVENOUS April 22, 2026 PEDIATRIC EXCLUSIVITY
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 DISCN SOLUTION INTRAVENOUS July 13, 2026 CLINICAL STUDY INFORMATION ADDED TO LABEL ABOUT THE TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN PATIENTS WITH SEVERELY REDUCED RENAL FUNCTION (ESTIMATED GLOMERULAR FILTRATION RATE, EGFR < 30 ML/MIN)
100MG/VIAL VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX POWDER INTRAVENOUS July 13, 2026 CLINICAL STUDY INFORMATION ADDED TO LABEL ABOUT THE TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN PATIENTS WITH SEVERELY REDUCED RENAL FUNCTION (ESTIMATED GLOMERULAR FILTRATION RATE, EGFR < 30 ML/MIN)
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 DISCN SOLUTION INTRAVENOUS Jan. 13, 2027 PEDIATRIC EXCLUSIVITY
100MG/VIAL VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX POWDER INTRAVENOUS Jan. 13, 2027 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Replicase polyprotein 1ab Enzyme INHIBITOR EC50 8.52 SCIENTIFIC LITERATURE DRUG LABEL
NS5 Enzyme IC50 5.87 CHEMBL

External reference:

IDSource
3QKI37EEHE UNII
4039395 VANDF
4039396 VANDF
C4726677 UMLSCUI
CHEBI:145994 CHEBI
CHEMBL4065616 ChEMBL_ID
121304016 PUBCHEM_CID
DB14761 DRUGBANK_ID
10478 INN_ID
C000606551 MESH_SUPPLEMENTAL_RECORD_UI
D11472 KEGG_DRUG
10715 IUPHAR_LIGAND_ID
870518005 SNOMEDCT_US
870592005 SNOMEDCT_US
333266 MMSL
336406 MMSL
38322 MMSL
d09540 MMSL
018308 NDDF
2284718 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Veklury HUMAN PRESCRIPTION DRUG LABEL 1 61958-2901 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS NDA 33 sections
Veklury HUMAN PRESCRIPTION DRUG LABEL 1 61958-2901 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS NDA 33 sections
Veklury HUMAN PRESCRIPTION DRUG LABEL 1 61958-2902 INJECTION 5 mg INTRAVENOUS NDA 33 sections
Veklury HUMAN PRESCRIPTION DRUG LABEL 1 61958-2902 INJECTION 5 mg INTRAVENOUS NDA 33 sections