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

ADMET properties:

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

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
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 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	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 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	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:

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
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|

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	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 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	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:

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	Unclassified		A0A143MHK7_ZIKV		IC50	5.87		CHEMBL

External reference:

ID	Source
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:

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	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