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 |
---|---|
infections | D007239 |
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 |
---|---|---|---|---|
VEKLURY | Gilead Sciences | N-214787 RX | 2020-10-22 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
veklury | New Drug Application | 2022-03-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
coronavirus infections | EFO_0007224 | D018352 | B34.2 |
virus diseases | — | D014777 | B34 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
REMDESIVIR, VEKLURY, GILEAD SCIENCES INC | |||
2025-10-22 | NCE | ||
2025-04-25 | NPP | ||
2025-01-21 | D-183 |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Remdesivir, Veklury, Gilead Sciences Inc | |||
11491169 | 2041-05-28 | U-3484, U-3485 | |
10675296 | 2038-07-10 | DP | |
11266681 | 2038-07-10 | U-2984, U-3249, U-3367, U-3368 | |
10695361 | 2036-09-16 | U-2984, U-3249, U-3367, U-3368 | |
11007208 | 2036-09-16 | U-2984, U-3249, U-3367, U-3368 | |
11382926 | 2036-09-16 | U-3367, U-3368 | |
9724360 | 2035-10-29 | DS, DP | |
9949994 | 2035-10-29 | DP | |
11492353 | 2031-12-08 | DP | |
10065958 | 2031-09-16 | DP | |
8008264 | 2029-09-06 | DS, DP | |
RE46762 | 2029-04-22 | DS, DP | |
8318682 | 2029-04-22 | DS, DP |
HCPCS
No data
Clinical
Clinical Trials
75 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Covid-19 | D000086382 | U07.1 | 3 | 18 | 29 | 4 | 12 | 59 | |
Pneumonia | D011014 | EFO_0003106 | J18 | — | — | 2 | 1 | — | 3 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | 1 | 2 | 3 | — | — | 5 |
Sars-cov-2 | D000086402 | — | — | 3 | — | — | 3 | ||
Severe acute respiratory syndrome | D045169 | EFO_0000694 | J12.81 | — | — | 1 | — | — | 1 |
Ebolavirus | D029043 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
X-linked combined immunodeficiency diseases | D053632 | EFO_1001451 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Nerve degeneration | D009410 | HP_0002180 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | — | — | — | 2 | 2 |
Critical illness | D016638 | — | — | — | — | 1 | 1 | ||
Cytokine release syndrome | D000080424 | D89.83 | — | — | — | — | 1 | 1 | |
Coronavirus | D017934 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | REMDESIVIR |
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 class | antivirals: 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-ID | 1809249-37-3 |
RxCUI | 2284718 |
ChEMBL ID | CHEMBL4065616 |
ChEBI ID | — |
PubChem CID | 121304016 |
DrugBank | DB14761 |
UNII ID | — |
Target
Variants
Clinical Variant
No data
Financial
Veklury - Gilead Sciences
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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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