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	802.81	39.41	326	5878	88033	50510887
Aspartate aminotransferase increased	537.62	39.41	237	5967	77761	50521159
Liver function test increased	462.29	39.41	157	6047	25449	50573471
Bradycardia	393.05	39.41	180	6024	64246	50534674
Off label use	248.45	39.41	296	5908	474130	50124790
COVID-19 pneumonia	222.57	39.41	69	6135	8326	50590594
Infusion site extravasation	217.69	39.41	65	6139	6911	50592009
Therapy cessation	184.70	39.41	81	6123	25930	50572990
Blood creatinine increased	184.00	39.41	115	6089	76045	50522875
Acute kidney injury	175.68	39.41	175	6029	227883	50371037
Transaminases increased	133.26	39.41	66	6138	27758	50571162
Glomerular filtration rate decreased	129.39	39.41	50	6154	11602	50587318
Death	125.15	39.41	175	6029	325204	50273716
Premature delivery	124.92	39.41	60	6144	23603	50575317
Respiratory failure	113.63	39.41	92	6112	91089	50507831
Sinus bradycardia	103.14	39.41	44	6160	13139	50585781
Renal impairment	97.74	39.41	78	6126	75583	50523337
Product preparation error	95.40	39.41	31	6173	4341	50594579
Acute respiratory failure	94.33	39.41	53	6151	28729	50570191
Hypoxia	84.32	39.41	61	6143	51062	50547858
Acute respiratory distress syndrome	80.58	39.41	43	6161	21056	50577864
Cardiac arrest	74.99	39.41	70	6134	83581	50515339
Therapy interrupted	73.96	39.41	40	6164	20112	50578808
Extravasation	72.71	39.41	21	6183	1981	50596939
Oxygen saturation decreased	65.07	39.41	61	6143	73187	50525733
Maternal exposure during pregnancy	59.69	39.41	85	6119	159693	50439227
Clinical trial participant	57.57	39.41	8	6196	10	50598910
Septic shock	49.58	39.41	47	6157	57128	50541792
Product preparation issue	48.07	39.41	12	6192	649	50598271
Exposure during pregnancy	46.07	39.41	65	6139	120950	50477970
Fatigue	45.84	39.41	15	6189	707586	49891334
Pain	43.70	39.41	9	6195	578894	50020026
Myopathy toxic	43.01	39.41	10	6194	399	50598521
Pulseless electrical activity	41.15	39.41	19	6185	6822	50592098
Shock	39.49	39.41	27	6177	20623	50578297

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	1589.95	33.61	674	9781	70270	29493802
Aspartate aminotransferase increased	892.14	33.61	429	10026	59296	29504776
Liver function test increased	815.77	33.61	259	10196	11626	29552446
Bradycardia	461.46	33.61	287	10168	65342	29498730
Off label use	416.82	33.61	518	9937	300282	29263790
Therapy cessation	296.52	33.61	130	10325	14332	29549740
Hepatic enzyme increased	252.60	33.61	154	10301	33645	29530427
Blood creatinine increased	247.53	33.61	219	10236	84883	29479189
Respiratory failure	226.51	33.61	221	10234	96910	29467162
Acute kidney injury	220.13	33.61	359	10096	264908	29299164
COVID-19 pneumonia	199.64	33.61	87	10368	9435	29554637
Transaminases increased	178.82	33.61	107	10348	22555	29541517
Infusion site extravasation	176.93	33.61	59	10396	3068	29561004
Therapy interrupted	148.20	33.61	68	10387	8318	29555754
Hypoxia	137.53	33.61	122	10333	47257	29516815
Glomerular filtration rate decreased	126.30	33.61	67	10388	11199	29552873
Death	118.25	33.61	324	10131	341760	29222312
Product preparation error	112.80	33.61	36	10419	1626	29562446
Acute respiratory failure	101.45	33.61	80	10375	26322	29537750
Pulseless electrical activity	97.70	33.61	47	10408	6387	29557685
Clinical trial participant	94.42	33.61	18	10437	81	29563991
Cardiac arrest	93.20	33.61	132	10323	85459	29478613
Hypertransaminasaemia	92.34	33.61	38	10417	3568	29560504
Septic shock	92.19	33.61	112	10343	62448	29501624
Acute respiratory distress syndrome	91.36	33.61	71	10384	22864	29541208
Oxygen saturation decreased	89.30	33.61	94	10361	44843	29519229
Fatigue	80.82	33.61	9	10446	316812	29247260
Product preparation issue	72.58	33.61	17	10438	232	29563840
Sinus bradycardia	69.38	33.61	46	10409	11557	29552515
COVID-19 treatment	66.35	33.61	16	10439	249	29563823
Diarrhoea	64.45	33.61	19	10436	332679	29231393
Bronchopulmonary aspergillosis	55.28	33.61	41	10414	12303	29551769
Renal impairment	53.64	33.61	100	10355	81233	29482839
Haemodialysis	53.63	33.61	37	10418	9917	29554155
Palliative care	52.98	33.61	15	10440	447	29563625
Toxicity to various agents	49.50	33.61	3	10452	173658	29390414
Drug ineffective for unapproved indication	46.00	33.61	39	10416	14175	29549897
COVID-19	45.86	33.61	60	10395	35954	29528118
Fibrin D dimer increased	45.19	33.61	22	10433	3066	29561006
Bronchopleural fistula	44.18	33.61	13	10442	445	29563627
Extravasation	44.10	33.61	18	10437	1654	29562418
Blood bilirubin increased	43.98	33.61	57	10398	33836	29530236
Pneumothorax	42.34	33.61	39	10416	15803	29548269
Creatinine renal clearance decreased	42.30	33.61	21	10434	3053	29561019
Renal replacement therapy	40.94	33.61	8	10447	42	29564030
Headache	39.44	33.61	7	10448	174000	29390072
Asthenia	38.58	33.61	14	10441	215236	29348836
Arthralgia	38.06	33.61	3	10452	139614	29424458
SARS-CoV-2 test positive	38.02	33.61	20	10435	3279	29560793
Shock	37.61	33.61	42	10413	21362	29542710
PaO2/FiO2 ratio decreased	36.99	33.61	7	10448	30	29564042
Fall	36.31	33.61	9	10446	177169	29386903
Nausea	35.72	33.61	30	10425	289225	29274847
Dialysis	35.07	33.61	29	10426	10179	29553893

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	2327.96	35.54	977	15437	138054	64344264
Aspartate aminotransferase increased	1393.60	35.54	654	15760	119134	64363184
Liver function test increased	1203.18	35.54	405	16009	30565	64451753
Bradycardia	808.33	35.54	452	15962	117767	64364551
Off label use	649.57	35.54	796	15618	632010	63850308
Therapy cessation	478.80	35.54	210	16204	32279	64450039
Blood creatinine increased	447.35	35.54	328	16086	135454	64346864
Acute kidney injury	396.38	35.54	526	15888	448714	64033604
COVID-19 pneumonia	369.80	35.54	144	16270	16360	64465958
Respiratory failure	346.04	35.54	303	16111	160880	64321438
Infusion site extravasation	335.81	35.54	107	16307	6730	64475588
Transaminases increased	296.84	35.54	168	16246	44426	64437892
Death	294.08	35.54	475	15939	482230	64000088
Glomerular filtration rate decreased	248.23	35.54	114	16300	19458	64462860
Therapy interrupted	221.06	35.54	106	16308	19930	64462388
Hypoxia	215.94	35.54	179	16235	87970	64394348
Hepatic enzyme increased	184.88	35.54	195	16219	129748	64352570
Acute respiratory failure	178.46	35.54	127	16287	49807	64432511
Product preparation error	165.47	35.54	55	16359	3950	64478368
Cardiac arrest	164.25	35.54	199	16215	153865	64328453
Sinus bradycardia	159.68	35.54	89	16325	22804	64459514
Acute respiratory distress syndrome	150.68	35.54	104	16310	38831	64443487
Renal impairment	148.13	35.54	177	16237	134840	64347478
Clinical trial participant	147.39	35.54	26	16388	104	64482214
Septic shock	135.45	35.54	150	16264	105287	64377031
Pulseless electrical activity	133.24	35.54	65	16349	12674	64469644
Oxygen saturation decreased	131.73	35.54	149	16265	107027	64375291
Fatigue	119.77	35.54	23	16391	748707	63733611
Hypertransaminasaemia	113.99	35.54	49	16365	7142	64475176
Arthralgia	99.04	35.54	3	16411	442257	64040061
Product preparation issue	97.29	35.54	25	16389	719	64481599
Premature delivery	89.69	35.54	57	16357	18532	64463786
Haemodialysis	86.49	35.54	54	16360	17023	64465295
Diarrhoea	83.53	35.54	40	16374	722664	63759654
COVID-19 treatment	83.52	35.54	20	16394	427	64481891
Bronchopulmonary aspergillosis	81.00	35.54	54	16360	19031	64463287
Palliative care	75.01	35.54	20	16394	666	64481652
Toxicity to various agents	73.15	35.54	5	16409	363508	64118810
Pain	73.05	35.54	25	16389	553486	63928832
Shock	72.10	35.54	67	16347	38173	64444145
Drug ineffective for unapproved indication	71.52	35.54	61	16353	31072	64451246
Headache	69.71	35.54	24	16390	529443	63952875
Fibrin D dimer increased	69.18	35.54	34	16380	6731	64475587
Extravasation	68.53	35.54	27	16387	3153	64479165
Fall	68.20	35.54	12	16402	416814	64065504
Ischaemic hepatitis	64.52	35.54	26	16388	3220	64479098
SARS-CoV-2 test positive	62.52	35.54	31	16383	6255	64476063
COVID-19	61.05	35.54	79	16335	65061	64417257
Heart rate decreased	59.95	35.54	72	16342	54995	64427323
Pneumonia bacterial	57.75	35.54	40	16374	14995	64467323
Pulse absent	57.54	35.54	33	16381	8913	64473405
Weight decreased	57.26	35.54	4	16410	285735	64196583
Pneumothorax	56.60	35.54	48	16366	24250	64458068
Nausea	55.97	35.54	71	16343	785729	63696589
Dialysis	55.74	35.54	41	16373	16879	64465439
Blood alkaline phosphatase increased	53.90	35.54	69	16345	56210	64426108
Pain in extremity	53.48	35.54	7	16407	303078	64179240
Hypotension	52.81	35.54	214	16200	380760	64101558
Multiple organ dysfunction syndrome	52.16	35.54	93	16321	101320	64380998
Blood bilirubin increased	51.14	35.54	68	16346	57485	64424833
Bronchopleural fistula	49.19	35.54	14	16400	596	64481722
Paravenous drug administration	48.44	35.54	7	16407	3	64482315
Dizziness	47.77	35.54	25	16389	430138	64052180
Cryptococcal meningoencephalitis	47.55	35.54	11	16403	201	64482117
Renal replacement therapy	45.40	35.54	10	16404	145	64482173
Creatinine renal clearance decreased	45.39	35.54	34	16380	14387	64467931
Mucormycosis	44.35	35.54	26	16388	7315	64475003
Drug hypersensitivity	43.15	35.54	5	16409	237810	64244508
Malaise	42.57	35.54	24	16390	396223	64086095
Abdominal pain	41.31	35.54	14	16400	312361	64169957
Back pain	41.31	35.54	7	16407	250164	64232154
Respiratory distress	40.72	35.54	58	16356	52273	64430045
Infusion site swelling	40.15	35.54	22	16392	5443	64476875
Oedema peripheral	39.22	35.54	4	16410	210313	64272005
Asthenia	39.16	35.54	31	16383	428013	64054305
Insomnia	38.95	35.54	3	16411	197833	64284485
Constipation	38.80	35.54	6	16408	229331	64252987
Decreased appetite	38.26	35.54	12	16402	281277	64201041
Vomiting	37.90	35.54	51	16363	551066	63931252
Anaemia	37.79	35.54	25	16389	378655	64103663
International normalised ratio increased	37.40	35.54	70	16344	79097	64403221
Pneumonia pseudomonal	36.75	35.54	20	16394	4883	64477435
Pneumonia staphylococcal	35.90	35.54	19	16395	4387	64477931

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/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/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
2284718	RXNORM
333266	MMSL
336406	MMSL
38322	MMSL
d09540	MMSL
870518005	SNOMEDCT_US
870592005	SNOMEDCT_US
4039395	VANDF
4039396	VANDF
018308	NDDF
C000606551	MESH_SUPPLEMENTAL_RECORD_UI
10478	INN_ID

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	61958-2902	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