Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
antivirals	5376	1809249-37-3

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
0.12	g	P

ADMET properties:

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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value
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:

Date	Agency	Company
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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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:

Source	Code	Description
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

acyclovir brivudine cidofovir famciclovir ganciclovir idoxuridine molnupiravir penciclovir valaciclovir valganciclovir vidarabine

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

Disease	Relation	SNOMED_ID	DOID
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 level	Dissociation constant	Type (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 strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent 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 strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Replicase polyprotein 1ab	Enzyme		R1AB_SARS2	INHIBITOR	EC50	8.52		SCIENTIFIC LITERATURE	DRUG LABEL
NS5	Enzyme		A0A143MHK7_ZIKV		IC50	5.87		CHEMBL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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

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

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

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

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products: