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Veklury(remdesivir)
Veklury (remdesivir) is a small molecule pharmaceutical. Remdesivir was first approved as Veklury on 2020-07-03. It is used to treat coronavirus infections and virus diseases in the USA. It has been approved in Europe to treat dna virus infections. It is known to target ORF1a polyprotein;ORF1ab polyprotein.
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COVID-19
FDA Novel Drug Approvals 2020
Case Study: COVID-19
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
Trade Name
FDA
EMA
Veklury
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Remdesivir
Tradename
Company
Number
Date
Products
VEKLURYGilead SciencesN-214787 RX2020-10-22
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
vekluryNew Drug Application2022-03-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
coronavirus infectionsEFO_0007224D018352B34.2
virus diseasesD014777B34
Agency Specific
FDA
EMA
Expiration
Code
REMDESIVIR, VEKLURY, GILEAD SCIENCES INC
2025-10-22NCE
2025-04-25NPP
2025-01-21D-183
Patent Expiration
Patent
Expires
Flag
FDA Information
Remdesivir, Veklury, Gilead Sciences Inc
114911692041-05-28U-3484, U-3485
106752962038-07-10DP
112666812038-07-10U-2984, U-3249, U-3367, U-3368
106953612036-09-16U-2984, U-3249, U-3367, U-3368
110072082036-09-16U-2984, U-3249, U-3367, U-3368
113829262036-09-16U-3367, U-3368
97243602035-10-29DS, DP
99499942035-10-29DP
114923532031-12-08DP
100659582031-09-16DP
80082642029-09-06DS, DP
RE467622029-04-22DS, DP
83186822029-04-22DS, DP
ATC Codes
J: Antiinfectives for systemic use
J05: Antivirals for systemic use
J05A: Direct acting antivirals
J05AB: Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05AB16: Remdesivir
HCPCS
No data
Clinical
Clinical Trials
75 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Covid-19D000086382U07.13182941259
PneumoniaD011014EFO_0003106J18213
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Respiratory distress syndromeD012128EFO_1000637J801235
Sars-cov-2D00008640233
Severe acute respiratory syndromeD045169EFO_0000694J12.8111
EbolavirusD029043111
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
X-linked combined immunodeficiency diseasesD053632EFO_100145111
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Nerve degenerationD009410HP_000218011
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Viral pneumoniaD011024EFO_0007541J12.922
Critical illnessD01663811
Cytokine release syndromeD000080424D89.8311
CoronavirusD01793411
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameREMDESIVIR
INN
Description
Remdesivir is a carboxylic ester resulting from the formal condensation of the carboxy group of N-[(S)-{[(2R,3S,4R,5R)-5-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-5-cyano-3,4-dihydroxytetrahydrofuran-2-yl]methoxy}(phenoxy)phosphoryl]-L-alanine with the hydroxy group of 2-ethylbutan-1-ol. A broad-spectrum antiviral prodrug with potent in vitro antiviral activity against a diverse panel of RNA viruses such as Ebola virus, MERS-CoV and SARS-CoV. It is currently in Phase III clinical trials for the treatment of Covid-19 in adults. It has a role as an antiviral drug, a prodrug and an anticoronaviral agent. It is a carboxylic ester, a pyrrolotriazine, a nitrile, a phosphoramidate ester, a C-nucleoside and an aromatic amine. It is functionally related to a GS-441524.
Classification
Small molecule
Drug classantivirals: adenosine analogs acting as RNA polymerase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCC(CC)COC(=O)[C@H](C)N[P@](=O)(OC[C@H]1O[C@@](C#N)(c2ccc3c(N)ncnn23)[C@H](O)[C@@H]1O)Oc1ccccc1
Identifiers
PDB
CAS-ID1809249-37-3
RxCUI2284718
ChEMBL IDCHEMBL4065616
ChEBI ID
PubChem CID121304016
DrugBankDB14761
UNII ID
Target
Agency Approved
No data
Alternate
ORF1ab
ORF1ab
Organism
SARS coronavirus Tor2
Gene name
ORF1ab
Gene synonyms
NCBI Gene ID
Protein name
ORF1a polyprotein;ORF1ab polyprotein
Protein synonyms
ORF1ab polyprotein, polyprotein pp1a, polyprotein pp1ab, replicase 1AB
Uniprot ID
Mouse ortholog
Variants
Clinical Variant
No data
Financial
Veklury - Gilead Sciences
$
£
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 25,719 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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224 adverse events reported
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