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:

None

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	766.47	38.96	327	7027	93335	56191378
Aspartate aminotransferase increased	512.61	38.96	238	7116	82364	56202349
Liver function test increased	441.54	38.96	158	7196	27975	56256738
Bradycardia	429.33	38.96	198	7156	67306	56217407
Off label use	412.46	38.96	428	6926	555752	55728961
COVID-19 pneumonia	295.98	38.96	93	7261	11009	56273704
COVID-19	275.81	38.96	152	7202	74906	56209807
Infusion site extravasation	203.13	38.96	65	7289	8145	56276568
Acute kidney injury	183.08	38.96	189	7165	240574	56044139
Therapy cessation	179.17	38.96	82	7272	27182	56257531
Blood creatinine increased	174.16	38.96	116	7238	80075	56204638
Premature delivery	164.15	38.96	77	7277	26983	56257730
Respiratory failure	134.31	38.96	106	7248	94956	56189757
Transaminases increased	130.04	38.96	67	7287	28703	56256010
Glomerular filtration rate decreased	123.54	38.96	50	7304	12279	56272434
Sinus bradycardia	118.85	38.96	50	7304	13536	56271177
Death	118.41	38.96	181	7173	341245	55943468
Renal impairment	99.15	38.96	83	7271	80630	56204083
Acute respiratory failure	97.98	38.96	57	7297	30937	56253776
Hypoxia	93.50	38.96	68	7286	53829	56230884
Product preparation error	90.51	38.96	31	7323	4785	56279928
Cardiac arrest	90.32	38.96	81	7273	86233	56198480
Maternal exposure during pregnancy	90.03	38.96	117	7237	189436	56095277
Acute respiratory distress syndrome	87.49	38.96	47	7307	21879	56262834
Exposure during pregnancy	87.35	38.96	98	7256	136244	56148469
Extravasation	69.94	38.96	21	7333	2126	56282587
Oxygen saturation decreased	63.26	38.96	64	7290	79003	56205710
Therapy interrupted	62.66	38.96	40	7314	25585	56259128
Septic shock	59.50	38.96	55	7299	60780	56223933
Clinical trial participant	57.06	38.96	8	7346	10	56284703
Mucormycosis	56.62	38.96	19	7335	2755	56281958
Myopathy toxic	56.37	38.96	13	7341	469	56284244
Fatigue	55.90	38.96	17	7337	788535	55496178
Pain	55.45	38.96	10	7344	663174	55621539
Drug ineffective for unapproved indication	48.15	38.96	34	7320	25659	56259054
Pneumomediastinum	47.58	38.96	14	7340	1321	56283392
Shock	46.00	38.96	31	7323	21697	56263016
Bronchopulmonary aspergillosis	45.43	38.96	22	7332	8242	56276471
Product preparation issue	43.79	38.96	12	7342	876	56283837
Pneumonia bacterial	40.04	38.96	20	7334	8008	56276705
Pulseless electrical activity	39.52	38.96	19	7335	7005	56277708
Multiple organ dysfunction syndrome	39.07	38.96	41	7313	52729	56231984

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	1537.84	33.53	686	11505	73970	31611183
Aspartate aminotransferase increased	871.86	33.53	441	11750	62278	31622875
Liver function test increased	796.70	33.53	264	11927	12450	31672703
Off label use	688.39	33.53	747	11444	346527	31338626
Bradycardia	465.70	33.53	304	11887	69023	31616130
COVID-19	391.48	33.53	250	11941	54571	31630582
COVID-19 pneumonia	335.90	33.53	140	12051	12515	31672638
Therapy cessation	284.03	33.53	131	12060	14924	31670229
Hepatic enzyme increased	251.59	33.53	162	12029	35746	31649407
Respiratory failure	242.20	33.53	243	11948	101206	31583947
Blood creatinine increased	230.46	33.53	223	11968	88855	31596298
Acute kidney injury	207.65	33.53	378	11813	279336	31405817
Infusion site extravasation	170.84	33.53	61	12130	3576	31681577
Transaminases increased	170.80	33.53	110	12081	24231	31660922
Hypoxia	128.01	33.53	125	12066	50188	31634965
Therapy interrupted	127.63	33.53	68	12123	10528	31674625
Drug ineffective for unapproved indication	123.78	33.53	80	12111	17710	31667443
Glomerular filtration rate decreased	120.43	33.53	68	12123	11797	31673356
Bronchopulmonary aspergillosis	116.82	33.53	70	12121	13564	31671589
Death	110.82	33.53	346	11845	360223	31324930
Product preparation error	106.37	33.53	36	12155	1796	31683357
Hypertransaminasaemia	105.35	33.53	45	12146	4259	31680894
Cardiac arrest	101.90	33.53	147	12044	88915	31596238
Acute respiratory failure	101.46	33.53	85	12106	27970	31657183
Pulseless electrical activity	97.80	33.53	49	12142	6678	31678475
Fatigue	93.94	33.53	10	12181	335196	31349957
Clinical trial participant	92.91	33.53	18	12173	81	31685072
Acute respiratory distress syndrome	92.15	33.53	76	12115	24464	31660689
Septic shock	91.93	33.53	120	12071	66038	31619115
Oxygen saturation decreased	80.84	33.53	97	12094	49018	31636135
Sinus bradycardia	80.73	33.53	53	12138	12034	31673119
Diarrhoea	75.92	33.53	21	12170	352388	31332765
Pneumothorax	75.52	33.53	58	12133	16852	31668301
COVID-19 treatment	70.04	33.53	17	12174	249	31684904
Cryptococcosis	69.21	33.53	28	12163	2310	31682843
Product preparation issue	66.81	33.53	17	12174	305	31684848
Pneumomediastinum	61.00	33.53	25	12166	2132	31683021
Toxicity to various agents	57.54	33.53	3	12188	181484	31503669
Haemodialysis	52.78	33.53	38	12153	10007	31675146
Palliative care	50.76	33.53	15	12176	478	31684675
Disseminated cryptococcosis	49.79	33.53	19	12172	1341	31683812
Shock	49.70	33.53	52	12139	22593	31662560
Pneumonia bacterial	49.69	33.53	37	12154	10259	31674894
Renal impairment	49.29	33.53	105	12086	86244	31598909
Headache	47.62	33.53	7	12184	183645	31501508
Nausea	47.57	33.53	30	12161	307917	31377236
Multiple organ dysfunction syndrome	47.36	33.53	90	12101	68113	31617040
Asthenia	47.17	33.53	14	12177	224741	31460412
Fall	44.07	33.53	9	12182	186080	31499073
Fibrin D dimer increased	43.98	33.53	23	12168	3423	31681730
Bronchopleural fistula	42.58	33.53	13	12178	464	31684689
Extravasation	41.92	33.53	18	12173	1724	31683429
Renal replacement therapy	40.27	33.53	8	12183	42	31685111
Blood bilirubin increased	40.09	33.53	58	12133	35078	31650075
Creatinine renal clearance decreased	39.89	33.53	21	12170	3168	31681985
Infection reactivation	39.40	33.53	16	12175	1332	31683821
Decreased appetite	39.34	33.53	6	12185	153211	31531942
Dizziness	38.96	33.53	14	12177	199133	31486020
Mucormycosis	38.59	33.53	25	12166	5545	31679608
SARS-CoV-2 test positive	38.53	33.53	23	12168	4418	31680735
Arthralgia	36.52	33.53	7	12184	151417	31533736
PaO2/FiO2 ratio decreased	36.40	33.53	7	12184	30	31685123
Rhinocerebral mucormycosis	35.60	33.53	11	12180	409	31684744
Abdominal pain	34.66	33.53	7	12184	145945	31539208

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	2250.87	32.09	990	18243	146490	70762721
Aspartate aminotransferase increased	1354.84	32.09	667	18566	126311	70782900
Liver function test increased	1164.94	32.09	411	18822	33436	70875775
Off label use	1075.00	32.09	1148	18085	741912	70167299
Bradycardia	854.23	32.09	488	18745	124127	70785084
COVID-19	628.66	32.09	378	18855	105379	70803832
COVID-19 pneumonia	563.10	32.09	215	19018	21754	70887457
Therapy cessation	464.91	32.09	212	19021	33464	70875747
Blood creatinine increased	424.10	32.09	333	18900	142668	70766543
Acute kidney injury	395.57	32.09	559	18674	474065	70435146
Respiratory failure	385.91	32.09	338	18895	168397	70740814
Infusion site extravasation	320.31	32.09	109	19124	7899	70901312
Transaminases increased	288.96	32.09	172	19061	46846	70862365
Death	280.41	32.09	497	18736	509564	70399647
Glomerular filtration rate decreased	237.91	32.09	115	19118	20641	70888570
Hypoxia	219.02	32.09	190	19043	93154	70816057
Therapy interrupted	193.28	32.09	106	19127	24696	70884515
Cardiac arrest	189.78	32.09	225	19008	159609	70749602
Sinus bradycardia	186.96	32.09	102	19131	23521	70885690
Acute respiratory failure	182.89	32.09	136	19097	53529	70855682
Drug ineffective for unapproved indication	171.54	32.09	115	19118	38423	70870788
Bronchopulmonary aspergillosis	169.85	32.09	92	19141	20910	70888301
Acute respiratory distress syndrome	159.79	32.09	113	19120	41141	70868070
Hepatic enzyme increased	158.92	32.09	204	19029	156786	70752425
Product preparation error	155.73	32.09	55	19178	4447	70904764
Septic shock	146.49	32.09	166	19067	112092	70797119
Clinical trial participant	145.74	32.09	26	19207	104	70909107
Renal impairment	145.59	32.09	187	19046	143750	70765461
Fatigue	144.79	32.09	25	19208	824294	70084917
Pulseless electrical activity	132.89	32.09	67	19166	13148	70896063
Hypertransaminasaemia	125.46	32.09	57	19176	8886	70900325
Oxygen saturation decreased	123.60	32.09	155	19078	116274	70792937
Premature delivery	113.01	32.09	71	19162	21233	70887978
Pneumothorax	107.54	32.09	74	19159	25772	70883439
Arthralgia	103.45	32.09	9	19224	503381	70405830
Diarrhoea	101.48	32.09	43	19190	783298	70125913
Pneumomediastinum	97.20	32.09	36	19197	3334	70905877
Pain	96.16	32.09	26	19207	628790	70280421
Shock	94.10	32.09	82	19151	40343	70868868
COVID-19 treatment	92.22	32.09	22	19211	432	70908779
Mucormycosis	90.57	32.09	44	19189	7970	70901241
Multiple organ dysfunction syndrome	89.86	32.09	128	19105	108387	70800824
Product preparation issue	88.89	32.09	25	19208	955	70908256
Headache	88.71	32.09	24	19209	580381	70328830
Haemodialysis	84.96	32.09	55	19178	17311	70891900
Pneumonia bacterial	84.61	32.09	54	19179	16587	70892624
Fall	81.06	32.09	12	19221	444084	70465127
Toxicity to various agents	75.38	32.09	8	19225	382164	70527047
Nausea	73.45	32.09	74	19159	852014	70057197
Palliative care	71.62	32.09	20	19213	744	70908467
Cryptococcosis	69.25	32.09	28	19205	3282	70905929
Weight decreased	68.17	32.09	4	19229	310484	70598727
SARS-CoV-2 test positive	67.23	32.09	37	19196	8664	70900547
Fibrin D dimer increased	67.17	32.09	35	19198	7348	70901863
Extravasation	65.15	32.09	27	19206	3370	70905841
Pain in extremity	64.34	32.09	7	19226	328075	70581136
Ischaemic hepatitis	62.29	32.09	26	19207	3303	70905908
Dizziness	57.55	32.09	27	19206	464114	70445097
No adverse event	55.08	32.09	55	19178	32098	70877113
Pulse absent	54.31	32.09	33	19200	9297	70899914
Heart rate decreased	54.04	32.09	75	19158	61940	70847271
Exposure during pregnancy	53.67	32.09	90	19143	87627	70821584
Hypotension	53.43	32.09	234	18999	404147	70505064
Malaise	52.42	32.09	26	19207	432906	70476305
Dialysis	52.40	32.09	41	19192	17361	70891850
Disseminated cryptococcosis	51.20	32.09	19	19214	1768	70907443
Drug hypersensitivity	50.44	32.09	6	19227	262453	70646758
Maternal exposure during pregnancy	49.98	32.09	102	19131	115243	70793968
Blood alkaline phosphatase increased	49.84	32.09	70	19163	58451	70850760
Infection reactivation	49.39	32.09	20	19213	2353	70906858
Asthenia	48.95	32.09	32	19201	457634	70451577
Paravenous drug administration	48.00	32.09	7	19226	3	70909208
Bronchopleural fistula	47.69	32.09	14	19219	624	70908587
Decreased appetite	47.62	32.09	12	19221	304768	70604443
Blood bilirubin increased	47.12	32.09	69	19164	59832	70849379
Abdominal pain	47.07	32.09	17	19216	342110	70567101
Oedema peripheral	46.98	32.09	4	19229	228087	70681124
Drug intolerance	46.37	32.09	4	19229	225683	70683528
Back pain	45.73	32.09	9	19224	271143	70638068
Cryptococcal meningoencephalitis	44.71	32.09	11	19222	247	70908964
Insomnia	44.37	32.09	4	19229	217802	70691409
Renal replacement therapy	43.85	32.09	10	19223	160	70909051
Pulmonary mucormycosis	41.79	32.09	14	19219	965	70908246
Myopathy toxic	41.63	32.09	14	19219	976	70908235
Rhinocerebral mucormycosis	41.16	32.09	13	19220	743	70908468
Anaemia	40.75	32.09	30	19203	403393	70505818
Vomiting	39.99	32.09	62	19171	593049	70316162
Pneumonia pseudomonal	39.68	32.09	22	19211	5224	70903987
Pneumonia staphylococcal	39.56	32.09	21	19212	4577	70904634
Respiratory distress	38.78	32.09	60	19173	54590	70854621
Creatinine renal clearance decreased	38.23	32.09	34	19199	17166	70892045
Subcutaneous emphysema	37.86	32.09	15	19218	1667	70907544
Constipation	37.43	32.09	11	19222	252427	70656784
International normalised ratio increased	36.88	32.09	73	19160	80653	70828558
Infusion site swelling	36.27	32.09	22	19211	6176	70903035
Hepatic function abnormal	35.39	32.09	65	19168	67931	70841280
Depression	34.84	32.09	6	19227	198968	70710243
Febrile neutropenia	33.98	32.09	7	19226	204311	70704900
Blood urea increased	33.41	32.09	51	19182	45858	70863353
PaO2/FiO2 ratio decreased	32.88	32.09	6	19227	28	70909183
Respiratory disorder	32.12	32.09	46	19187	39077	70870134

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:36044	antiviral drugs
CHEBI has role	CHEBI:50266	Prodrugs
CHEBI has role	CHEBI:149553	anticoronaviral drug

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)

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

External reference:

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