| Drug Name |
Remdesivir |
| Drug ID |
BADD_D02588 |
| Description |
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent of coronavirus disease 2019 (COVID-19), which is a respiratory disease that is capable of progressing to viral pneumonia and acute respiratory distress syndrome (ARDS); COVID-19 can be fatal. Like other RNA viruses, SARS-CoV-2 depends on an RNA-dependent RNA polymerase (RdRp) enzyme complex for genomic replication, which can be inhibited by a class of drugs known as nucleoside analogues.[A222398]
Remdesivir (GS-5734) is an adenosine triphosphate analogue first described in the literature in 2016 as a potential treatment for Ebola.[A191379, A222393] Broad antiviral activity of remdesivir is suggested by its mechanism of action,[A222398] and to date, it has demonstrated _in vitro_ activity against the _Arenaviridae_, _Flaviviridae_, _Filoviridae_, _Paramyxoviridae_, _Pneumoviridae_, and _Coronaviridae_ viral families.[A222393] Remdesivir activity against the _Coronaviridae_ family was first demonstrated in 2017,[A191382] leading to considerable interest in remdesivir as a possible treatment for COVID-19.[A191427, A198810] Remdesivir was confirmed as a non-obligate chain terminator of RdRp from SARS-CoV-2 and the related SARS-CoV and MERS-CoV,[A222398] and has been investigated in multiple COVID-19 clinical trials.[L12174, L12177]
Based on aggregate data, remdesivir was granted an FDA Emergency Use Authorization (EUA) on May 1st, 2020.[L13236] The FDA subsequently granted full approval for remdesivir as a COVID-19 treatment on October 22, 2020, while simultaneously updating the EUA to cover those patients not included under the approved indication.[L18438] Remdesivir is currently marketed under the trademark name VEKLURY® by Gilead Sciences Inc.[L18438]
Remdesivir in combination with [baricitinib] for the treatment of COVID-19, was granted an FDA Emergency Use Authorization on 19 Novermber 2020.[L22619] |
| Indications and Usage |
Remdesivir is indicated for the treatment of adult and pediatric patients aged 12 years and over weighing at least 40 kg for coronavirus disease 2019 (COVID-19) infection requiring hospitalization. Under this indication, remdesivir should only be administered in a hospital or other healthcare setting capable of providing acute care comparable to an inpatient hospital setting.[L18438]
Remdesivir was originally granted FDA Emergency Use Authorization (EUA)[L12609] on May 1, 2020, for use in adults and children with suspected or confirmed COVID-19 in a hospital setting with an SpO2 ≤94%.[L13239] Following FDA approval, this EUA was revised to cover hospitalized pediatric patients between 3.5 and 40 kg, as well as those under 12 years of age that weigh at least 3.5 kg, with suspected or laboratory-confirmed COVID-19.[L13236]
Under both the on-label and EUA indications, patients not needing invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) should be treated for 5 days (including the loading dose on day 1) and may be extended up to 10 days if they do not show improvement. Patients requiring invasive mechanical ventilation or ECMO should be treated for 10 days.[L13239, L18438] |
| Marketing Status |
approved; investigational |
| ATC Code |
J05AB16 |
| DrugBank ID |
DB14761
|
| KEGG ID |
D11472
|
| MeSH ID |
C000606551
|
| PubChem ID |
121304016
|
| TTD Drug ID |
D01ICI
|
| NDC Product Code |
61958-2902; 59116-6490; 68225-117; 63552-171; 59997-0006; 69766-091; 61958-2901; 54014-5734; 72761-031 |
| UNII |
3QKI37EEHE
|
| Synonyms |
remdesivir | l-alanine, N-((S)-hydroxyphenoxyphosphinyl)-, 2-ethylbutyl ester, 6-ester with 2-C-(4-aminopyrrolo(2,1-f)(1,2,4)triazin-7-yl)-2,5-anhydro-d-altrononitrile | 2-ethylbutyl (2S)-2-(((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) amino) propanoate | Veklury | GS-5734 | GS 5734 |
