remdesivir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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
0.10 g P

ADMET properties:

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

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
Alanine aminotransferase increased 725.05 37.09 330 8442 103440 63376810
Off label use 623.75 37.09 599 8173 673863 62806387
Aspartate aminotransferase increased 494.12 37.09 243 8529 90034 63390216
Bradycardia 491.95 37.09 227 8545 73000 63407250
Liver function test increased 416.11 37.09 160 8612 32651 63447599
COVID-19 pneumonia 275.99 37.09 95 8677 14114 63466136
Premature delivery 203.18 37.09 94 8678 30187 63450063
Infusion site extravasation 191.95 37.09 67 8705 10359 63469891
Respiratory failure 180.61 37.09 133 8639 101725 63378525
Acute kidney injury 180.44 37.09 201 8571 263214 63217036
Therapy cessation 166.07 37.09 82 8690 30375 63449875
Blood creatinine increased 160.88 37.09 117 8655 87727 63392523
Drug ineffective for unapproved indication 140.42 37.09 76 8696 33987 63446263
Death 130.37 37.09 205 8567 374176 63106074
Transaminases increased 129.32 37.09 70 8702 31297 63448953
Sinus bradycardia 125.86 37.09 54 8718 14497 63465753
Glomerular filtration rate decreased 116.64 37.09 50 8722 13391 63466859
Hypoxia 114.78 37.09 82 8690 59710 63420540
Maternal exposure during pregnancy 104.88 37.09 140 8632 219922 63260328
Renal impairment 98.36 37.09 88 8684 88267 63391983
Product preparation error 96.38 37.09 35 8737 6057 63474193
Acute respiratory failure 94.40 37.09 59 8713 34426 63445824
Acute respiratory distress syndrome 90.02 37.09 50 8722 23484 63456766
Cardiac arrest 87.20 37.09 84 8688 92461 63387789
Exposure during pregnancy 81.86 37.09 104 8668 155443 63324807
Septic shock 75.38 37.09 67 8705 66562 63413688
Bronchopulmonary aspergillosis 71.23 37.09 31 8741 8604 63471646
Mucormycosis 66.77 37.09 22 8750 2849 63477401
Extravasation 66.71 37.09 21 8751 2351 63477899
Pain 65.08 37.09 12 8760 740616 62739634
Myopathy toxic 64.92 37.09 15 8757 515 63479735
Oxygen saturation decreased 64.50 37.09 70 8702 88515 63391735
Fatigue 61.76 37.09 23 8749 888005 62592245
No adverse event 59.92 37.09 48 8724 41357 63438893
Pneumonia bacterial 59.14 37.09 28 8744 9437 63470813
Pneumomediastinum 58.88 37.09 17 8755 1419 63478831
Clinical trial participant 56.62 37.09 8 8764 10 63480240
Shock 56.39 37.09 37 8735 23426 63456824
Herpes simplex reactivation 53.52 37.09 13 8759 555 63479695
Pulseless electrical activity 52.42 37.09 24 8748 7497 63472753
Electrocardiogram QT prolonged 52.23 37.09 52 8720 59478 63420772
Therapy interrupted 52.09 37.09 40 8732 32415 63447835
Pulmonary mucormycosis 49.30 37.09 11 8761 322 63479928
Multiple organ dysfunction syndrome 48.73 37.09 49 8723 56703 63423547
SARS-CoV-2 test positive 44.78 37.09 22 8750 8034 63472216
Fall 42.68 37.09 3 8769 392331 63087919
Pneumothorax 42.41 37.09 27 8745 16234 63464016
Respiratory distress 42.11 37.09 36 8736 33915 63446335
Diarrhoea 41.19 37.09 24 8748 715342 62764908
Pulmonary trichosporonosis 39.95 37.09 7 8765 55 63480195
Product preparation issue 38.32 37.09 12 8760 1320 63478930

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 1489.87 30.75 692 13013 80123 34863103
Off label use 896.48 30.75 946 12759 418578 34524648
Aspartate aminotransferase increased 844.95 30.75 446 13259 67337 34875889
Liver function test increased 756.25 30.75 264 13441 14301 34928925
Bradycardia 513.65 30.75 336 13369 75082 34868144
COVID-19 pneumonia 299.97 30.75 142 13563 16825 34926401
Respiratory failure 276.99 30.75 272 13433 108300 34834926
Therapy cessation 266.59 30.75 131 13574 16842 34926384
Drug ineffective for unapproved indication 252.31 30.75 141 13564 23574 34919652
Hepatic enzyme increased 243.30 30.75 165 13540 38915 34904311
Blood creatinine increased 220.08 30.75 226 13479 94750 34848476
Acute kidney injury 190.95 30.75 388 13317 304600 34638626
Infusion site extravasation 162.71 30.75 62 13643 4282 34938944
Transaminases increased 161.47 30.75 111 13594 26712 34916514
Bronchopulmonary aspergillosis 141.92 30.75 82 13623 14577 34928649
Hypoxia 141.89 30.75 139 13566 54956 34888270
Septic shock 119.64 30.75 144 13561 71690 34871536
Glomerular filtration rate decreased 113.61 30.75 68 13637 12893 34930333
Therapy interrupted 112.70 30.75 69 13636 13628 34929598
Product preparation error 112.36 30.75 40 13665 2277 34940949
Death 110.71 30.75 374 13331 397675 34545551
Fatigue 109.23 30.75 10 13695 370643 34572583
Acute respiratory distress syndrome 107.90 30.75 86 13619 25883 34917343
Cardiac arrest 98.10 30.75 152 13553 96007 34847219
Acute respiratory failure 96.77 30.75 87 13618 30841 34912385
Pneumothorax 94.12 30.75 70 13635 19022 34924204
Pulseless electrical activity 93.68 30.75 49 13656 7162 34936064
Mucormycosis 93.62 30.75 46 13659 5896 34937330
Hypertransaminasaemia 93.13 30.75 45 13660 5561 34937665
Clinical trial participant 92.56 30.75 18 13687 81 34943145
Oxygen saturation decreased 89.73 30.75 108 13597 53710 34889516
Sinus bradycardia 88.40 30.75 58 13647 12905 34930321
Diarrhoea 85.04 30.75 24 13681 389888 34553338
Pneumonia bacterial 80.66 30.75 53 13652 11819 34931407
Rhinocerebral mucormycosis 79.29 30.75 22 13683 546 34942680
Pneumomediastinum 78.73 30.75 31 13674 2336 34940890
No adverse event 72.70 30.75 65 13640 22862 34920364
Cryptococcosis 67.76 30.75 28 13677 2391 34940835
Toxicity to various agents 65.97 30.75 3 13702 200359 34742867
COVID-19 treatment 63.94 30.75 16 13689 262 34942964
Multiple organ dysfunction syndrome 63.11 30.75 110 13595 76456 34866770
Product preparation issue 62.09 30.75 17 13688 401 34942825
Disseminated cryptococcosis 59.98 30.75 22 13683 1364 34941862
Nausea 57.44 30.75 31 13674 339877 34603349
Renal impairment 57.14 30.75 119 13586 94394 34848832
Weight decreased 53.88 30.75 4 13701 176297 34766929
Asthenia 51.69 30.75 16 13689 245235 34697991
SARS-CoV-2 test positive 51.64 30.75 31 13674 5902 34937324
Shock 51.26 30.75 55 13650 24124 34919102
Haemodialysis 50.53 30.75 38 13667 10488 34932738
Headache 48.21 30.75 10 13695 200625 34742601
Fall 46.95 30.75 11 13694 202874 34740352
Palliative care 44.88 30.75 15 13690 705 34942521
Dizziness 44.72 30.75 15 13690 218506 34724720
Extravasation 43.39 30.75 19 13686 1871 34941355
COVID-19 42.65 30.75 94 13611 77456 34865770
Arthralgia 41.83 30.75 8 13697 170033 34773193
Bronchopleural fistula 41.65 30.75 13 13692 490 34942736
Creatinine renal clearance decreased 41.14 30.75 22 13683 3359 34939867
PaO2/FiO2 ratio decreased 41.13 30.75 8 13697 36 34943190
Infection reactivation 40.81 30.75 17 13688 1481 34941745
Decreased appetite 40.57 30.75 8 13697 166384 34776842
Renal replacement therapy 39.96 30.75 8 13697 43 34943183
Abdominal pain 39.61 30.75 8 13697 163610 34779616
Fibrin D dimer increased 39.09 30.75 23 13682 4221 34939005
Condition aggravated 37.63 30.75 162 13543 192034 34751192
Malaise 37.58 30.75 13 13692 185812 34757414
Pain 37.01 30.75 17 13688 204658 34738568
Vomiting 35.71 30.75 27 13678 247594 34695632
Drug ineffective 35.47 30.75 302 13403 456449 34486777
Blood bilirubin increased 35.47 30.75 58 13647 38238 34904988
Febrile neutropenia 34.59 30.75 6 13699 136843 34806383
Aspergillus infection 33.51 30.75 32 13673 12222 34931004
SARS-CoV-2 RNA increased 32.51 30.75 6 13699 19 34943207
Cryptococcal meningoencephalitis 31.97 30.75 8 13697 131 34943095
Anaemia 31.69 30.75 27 13678 233308 34709918
Infusion related reaction 31.08 30.75 66 13639 52991 34890235
Pain in extremity 31.00 30.75 6 13699 126507 34816719
Oedema peripheral 30.84 30.75 5 13700 119807 34823419

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 2156.69 29.91 998 21169 161572 79560649
Off label use 1488.85 29.91 1514 20653 905701 78816520
Aspartate aminotransferase increased 1308.23 29.91 676 21491 137965 79584256
Liver function test increased 1096.98 29.91 413 21754 39360 79682861
Bradycardia 957.27 29.91 546 21621 135011 79587210
COVID-19 pneumonia 517.63 29.91 220 21947 28629 79693592
Respiratory failure 465.91 29.91 392 21775 180519 79541702
Therapy cessation 437.65 29.91 212 21955 37350 79684871
Blood creatinine increased 401.11 29.91 337 21830 154720 79567501
Drug ineffective for unapproved indication 389.20 29.91 217 21950 51021 79671200
Acute kidney injury 375.25 29.91 580 21587 518824 79203397
Infusion site extravasation 300.16 29.91 111 22056 9997 79712224
Death 280.03 29.91 535 21632 565979 79156242
Transaminases increased 279.75 29.91 176 21991 51567 79670654
Hypoxia 253.53 29.91 218 21949 103025 79619196
Glomerular filtration rate decreased 225.39 29.91 115 22052 22587 79699634
Bronchopulmonary aspergillosis 224.44 29.91 114 22053 22180 79700041
Sinus bradycardia 202.74 29.91 111 22056 25136 79697085
Septic shock 190.13 29.91 201 21966 122600 79599621
Cardiac arrest 182.91 29.91 232 21935 171864 79550357
Acute respiratory distress syndrome 180.22 29.91 126 22041 43941 79678280
Acute respiratory failure 175.82 29.91 140 22027 59401 79662820
Therapy interrupted 170.30 29.91 107 22060 31234 79690987
Product preparation error 169.70 29.91 63 22104 5730 79716491
Fatigue 162.88 29.91 31 22136 929696 78792525
Mucormycosis 156.45 29.91 66 22101 8403 79713818
Renal impairment 155.56 29.91 205 21962 157578 79564643
No adverse event 153.60 29.91 107 22060 37085 79685136
Premature delivery 147.65 29.91 88 22079 23379 79698842
Clinical trial participant 145.09 29.91 26 22141 104 79722117
Pneumothorax 144.67 29.91 93 22074 28230 79693991
Pulseless electrical activity 141.31 29.91 72 22095 14088 79708133
Hepatic enzyme increased 136.69 29.91 208 21959 182402 79539819
Pneumonia bacterial 133.49 29.91 77 22090 19254 79702967
Oxygen saturation decreased 132.34 29.91 171 21996 128876 79593345
Pneumomediastinum 126.50 29.91 45 22122 3622 79718599
Arthralgia 121.79 29.91 10 22157 571793 79150428
Diarrhoea 121.09 29.91 47 22120 880442 78841779
Multiple organ dysfunction syndrome 116.55 29.91 155 22012 120091 79602130
Pain 113.84 29.91 28 22139 703774 79018447
Hypertransaminasaemia 111.39 29.91 58 22109 11866 79710355
Shock 104.81 29.91 91 22076 43457 79678764
Rhinocerebral mucormycosis 104.46 29.91 29 22138 1029 79721192
Headache 100.04 29.91 29 22138 653743 79068478
Nausea 91.94 29.91 79 22088 957117 78765104
Fall 90.10 29.91 14 22153 487615 79234606
SARS-CoV-2 test positive 87.15 29.91 49 22118 11667 79710554
Toxicity to various agents 82.83 29.91 10 22157 421530 79300691
Haemodialysis 81.44 29.91 55 22112 18113 79704108
Cryptococcosis 80.84 29.91 32 22135 3461 79718760
COVID-19 treatment 80.76 29.91 20 22147 450 79721771
Product preparation issue 79.29 29.91 25 22142 1385 79720836
Weight decreased 73.40 29.91 7 22160 355191 79367030
Pulmonary mucormycosis 71.14 29.91 22 22145 1143 79721078
Pain in extremity 70.74 29.91 9 22158 364529 79357692
Fibrin D dimer increased 69.31 29.91 38 22129 8616 79713605
Dizziness 69.10 29.91 30 22137 526411 79195810
COVID-19 67.80 29.91 141 22026 157533 79564688
Palliative care 66.31 29.91 20 22147 955 79721266
Extravasation 65.20 29.91 28 22139 3722 79718499
Malaise 62.58 29.91 29 22138 489840 79232381
Drug hypersensitivity 61.46 29.91 6 22161 298910 79423311
Disseminated cryptococcosis 61.35 29.91 22 22145 1812 79720409
Maternal exposure during pregnancy 59.74 29.91 123 22044 136415 79585806
Ischaemic hepatitis 59.27 29.91 26 22141 3638 79718583
Drug intolerance 57.89 29.91 4 22163 264115 79458106
Abdominal discomfort 57.36 29.91 3 22164 250724 79471497
Abdominal pain 56.40 29.91 19 22148 389550 79332671
Aspergillus infection 56.39 29.91 45 22122 19116 79703105
Herpes simplex reactivation 56.00 29.91 15 22152 464 79721757
Pneumonia staphylococcal 55.16 29.91 27 22140 4847 79717374
Subcutaneous emphysema 54.34 29.91 20 22147 1774 79720447
Asthenia 54.33 29.91 38 22129 511651 79210570
Vomiting 51.35 29.91 66 22101 665762 79056459
Pulse absent 51.14 29.91 33 22134 10070 79712151
Insomnia 50.18 29.91 5 22162 245165 79477056
Exposure during pregnancy 50.12 29.91 96 22071 101036 79621185
Infection reactivation 50.05 29.91 21 22146 2636 79719585
Oedema peripheral 49.47 29.91 6 22161 252282 79469939
Cryptococcal meningoencephalitis 49.42 29.91 12 22155 248 79721973
Dialysis 49.36 29.91 41 22126 18421 79703800
Back pain 49.24 29.91 12 22155 304168 79418053
Decreased appetite 49.04 29.91 17 22150 342401 79379820
Hepatic function abnormal 48.66 29.91 79 22088 73028 79649193
Paravenous drug administration 47.82 29.91 7 22160 3 79722218
Myopathy toxic 47.66 29.91 16 22151 1082 79721139
Anaemia 47.28 29.91 33 22134 444982 79277239
Heart rate decreased 46.82 29.91 76 22091 70240 79651981
Blood alkaline phosphatase increased 46.80 29.91 72 22095 63592 79658629
Bronchopleural fistula 46.48 29.91 14 22153 665 79721556
Hypotension 46.37 29.91 243 21924 440074 79282147
Renal replacement therapy 42.92 29.91 10 22157 172 79722049
Respiratory distress 42.91 29.91 66 22101 58273 79663948
Constipation 42.37 29.91 13 22154 283037 79439184
Blood bilirubin increased 40.63 29.91 69 22098 66163 79656058
International normalised ratio increased 40.23 29.91 79 22088 84642 79637579
Fungaemia 39.10 29.91 21 22146 4570 79717651
Pneumonia cryptococcal 38.83 29.91 15 22152 1520 79720701
PaO2/FiO2 ratio decreased 38.49 29.91 7 22160 31 79722190
Peripheral swelling 37.54 29.91 14 22153 269603 79452618
Musculoskeletal stiffness 37.34 29.91 3 22164 175005 79547216
Muscle spasms 37.26 29.91 3 22164 174727 79547494
Pneumonia pseudomonal 36.73 29.91 22 22145 5889 79716332
Paraesthesia 35.04 29.91 4 22163 176319 79545902
Diffuse alveolar damage 35.00 29.91 18 22149 3586 79718635
Creatinine renal clearance decreased 34.61 29.91 34 22133 18968 79703253
Diverticulitis intestinal perforated 34.53 29.91 9 22158 250 79721971
Pulmonary trichosporonosis 34.32 29.91 7 22160 62 79722159
Abdominal pain upper 34.00 29.91 10 22157 223809 79498412
Product use in unapproved indication 33.41 29.91 148 22019 250211 79472010
Hypoaesthesia 33.40 29.91 5 22162 179347 79542874
Respiratory disorder 33.34 29.91 51 22116 44805 79677416
Blood urea increased 32.84 29.91 53 22114 48737 79673484
Post-acute COVID-19 syndrome 32.61 29.91 10 22157 505 79721716
Depression 32.36 29.91 10 22157 216780 79505441
Condition aggravated 32.32 29.91 244 21923 500880 79221341
Febrile neutropenia 32.15 29.91 12 22155 230987 79491234
Tachypnoea 32.05 29.91 42 22125 32021 79690200
Infusion site swelling 31.09 29.91 22 22145 7804 79714417
Contusion 30.52 29.91 3 22164 148773 79573448
Mechanical ventilation 30.35 29.91 15 22152 2749 79719472
Rash 30.31 29.91 73 22094 578285 79143936
SARS-CoV-2 viraemia 30.30 29.91 6 22161 45 79722176

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
CHEBI has role CHEBI:36044 antiviral drugs
CHEBI has role CHEBI:50266 Prodrugs
CHEBI has role CHEBI:149553 anticoronaviral drug
FDA EPC N0000193948 SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor

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 RX SOLUTION INTRAVENOUS 10695361 Sept. 16, 2036 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (AT LEAST 12 YEARS OF AGE AND 40 KG) REQUIRING HOSPITALIZATION
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX SOLUTION INTRAVENOUS 10695361 Sept. 16, 2036 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (AT LEAST 28 DAYS OF AGE AND 3 KG) REQUIRING HOSPITALIZATION
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX SOLUTION INTRAVENOUS 10695361 Sept. 16, 2036 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (AT LEAST 12 YEARS OF AGE AND 40 KG)
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX SOLUTION INTRAVENOUS 10695361 Sept. 16, 2036 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (AT LEAST 28 DAYS OF AGE AND 3 KG)
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX SOLUTION INTRAVENOUS 11007208 Sept. 16, 2036 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (AT LEAST 12 YEARS OF AGE AND 40 KG) REQUIRING HOSPITALIZATION
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX SOLUTION INTRAVENOUS 11007208 Sept. 16, 2036 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (AT LEAST 28 DAYS OF AGE AND 3 KG) REQUIRING HOSPITALIZATION
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX SOLUTION INTRAVENOUS 11007208 Sept. 16, 2036 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (AT LEAST 12 YEARS OF AGE AND 40 KG)
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX SOLUTION INTRAVENOUS 11007208 Sept. 16, 2036 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (AT LEAST 28 DAYS OF AGE AND 3 KG)
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX SOLUTION INTRAVENOUS 11382926 Sept. 16, 2036 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (AT LEAST 28 DAYS OF AGE AND 3 KG) REQUIRING HOSPITALIZATION
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX SOLUTION INTRAVENOUS 11382926 Sept. 16, 2036 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (AT LEAST 28 DAYS OF AGE AND 3 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 (AT LEAST 12 YEARS OF AGE AND 40 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 ADULTS AND PEDIATRIC PATIENTS (AT LEAST 28 DAYS OF AGE AND 3 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 (AT LEAST 12 YEARS OF AGE AND 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 NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (AT LEAST 28 DAYS OF AGE AND 3 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 (AT LEAST 12 YEARS OF AGE AND 40 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 ADULTS AND PEDIATRIC PATIENTS (AT LEAST 28 DAYS OF AGE AND 3 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 (AT LEAST 12 YEARS OF AGE AND 40 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 NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (AT LEAST 28 DAYS OF AGE AND 3 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 (AT LEAST 28 DAYS OF AGE AND 3 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 (AT LEAST 28 DAYS OF AGE AND 3 KG)
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX SOLUTION INTRAVENOUS 11266681 July 10, 2038 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (AT LEAST 12 YEARS OF AGE AND 40 KG) REQUIRING HOSPITALIZATION
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX SOLUTION INTRAVENOUS 11266681 July 10, 2038 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (AT LEAST 28 DAYS OF AGE AND 3 KG) REQUIRING HOSPITALIZATION
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX SOLUTION INTRAVENOUS 11266681 July 10, 2038 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (AT LEAST 12 YEARS OF AGE AND 40 KG)
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX SOLUTION INTRAVENOUS 11266681 July 10, 2038 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (AT LEAST 28 DAYS OF AGE AND 3 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 (AT LEAST 12 YEARS OF AGE AND 40 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 ADULTS AND PEDIATRIC PATIENTS (AT LEAST 28 DAYS OF AGE AND 3 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 (AT LEAST 12 YEARS OF AGE AND 40 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 NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (AT LEAST 28 DAYS OF AGE AND 3 KG)
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX SOLUTION INTRAVENOUS 11491169 May 28, 2041 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (AT LEAST 28 DAYS OF AGE AND 3 KG) REQUIRING HOSPITALIZATION AND FOR WHOM CONCOMITANT USE OF CHLOROQUINE, OR AN ANALOG OR SALE THEREOF, IS NOT RECOMMENDED
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX SOLUTION INTRAVENOUS 11491169 May 28, 2041 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (AT LEAST 28 DAYS OF AGE AND 3 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 (AT LEAST 28 DAYS OF AGE AND 3 KG) REQUIRING HOSPITALIZATION AND FOR WHOM CONCOMITANT USE OF CHLOROQUINE, OR AN ANALOG OR SALE 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 (AT LEAST 28 DAYS OF AGE AND 3 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 RX SOLUTION INTRAVENOUS Jan. 21, 2025 3-DAY DOSING REGIMEN FOR THE TREATMENT OF COVID-19 IN ADULTS AND PEDIATRIC PATIENTS (>12 YEARS AND WEIGHING AT LEAST 40 KG) WITH POSITIVE RESULTS OF DIRECT SARS-COV-2 VIRAL TESTING, WHO ARE NOT HOSPITALIZED AND HAVE MILD-TO-MODERATE COVID-19, AND ARE AT HIGH RISK FOR PROGRESSION TO SEVERE COVID-19, INCLUDING HOSPITALIZATION OR DEATH
100MG/VIAL VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX POWDER INTRAVENOUS Jan. 21, 2025 3-DAY DOSING REGIMEN FOR THE TREATMENT OF COVID-19 IN ADULTS AND PEDIATRIC PATIENTS (>12 YEARS AND WEIGHING AT LEAST 40 KG) WITH POSITIVE RESULTS OF DIRECT SARS-COV-2 VIRAL TESTING, WHO ARE NOT HOSPITALIZED AND HAVE MILD-TO-MODERATE COVID-19, AND ARE AT HIGH RISK FOR PROGRESSION TO SEVERE COVID-19, INCLUDING HOSPITALIZATION OR DEATH
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX SOLUTION INTRAVENOUS April 25, 2025 NEW PATIENT POPULATION
100MG/VIAL VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX POWDER INTRAVENOUS April 25, 2025 NEW PATIENT POPULATION
100MG/20ML (5MG/ML) VEKLURY GILEAD SCIENCES INC N214787 Oct. 22, 2020 RX 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

Bioactivity Summary:

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

External reference:

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Veklury HUMAN PRESCRIPTION DRUG LABEL 1 61958-2901 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS UNAPPROVED DRUG OTHER 27 sections
Veklury HUMAN PRESCRIPTION DRUG LABEL 1 61958-2901 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS UNAPPROVED DRUG OTHER 27 sections
Veklury HUMAN PRESCRIPTION DRUG LABEL 1 61958-2901 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS UNAPPROVED DRUG OTHER 27 sections
Veklury HUMAN PRESCRIPTION DRUG LABEL 1 61958-2901 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS UNAPPROVED DRUG OTHER 27 sections
Veklury HUMAN PRESCRIPTION DRUG LABEL 1 61958-2901 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS UNAPPROVED DRUG OTHER 27 sections
Veklury HUMAN PRESCRIPTION DRUG LABEL 1 61958-2902 INJECTION 5 mg INTRAVENOUS UNAPPROVED DRUG OTHER 27 sections
Veklury HUMAN PRESCRIPTION DRUG LABEL 1 61958-2902 INJECTION 5 mg INTRAVENOUS UNAPPROVED DRUG OTHER 27 sections
Veklury HUMAN PRESCRIPTION DRUG LABEL 1 61958-2902 INJECTION 5 mg INTRAVENOUS UNAPPROVED DRUG OTHER 27 sections
Veklury HUMAN PRESCRIPTION DRUG LABEL 1 61958-2902 INJECTION 5 mg INTRAVENOUS UNAPPROVED DRUG OTHER 27 sections
Veklury HUMAN PRESCRIPTION DRUG LABEL 1 61958-2902 INJECTION 5 mg INTRAVENOUS UNAPPROVED DRUG OTHER 27 sections