Overview
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. Remdesivir (GS-5734) is an adenosine triphosphate analogue first described in the literature in 2016 as a potential treatment for Ebola. Broad antiviral activity of remdesivir is suggested by its mechanism of action, and to date, it has demonstrated in vitro activity against the Arenaviridae, Flaviviridae, Filoviridae, Paramyxoviridae, Pneumoviridae, and Coronaviridae viral families. Remdesivir activity against the Coronaviridae family was first demonstrated in 2017, leading to considerable interest in remdesivir as a possible treatment for COVID-19. Remdesivir was confirmed as a non-obligate chain terminator of RdRp from SARS-CoV-2 and the related SARS-CoV and MERS-CoV, and has been investigated in multiple COVID-19 clinical trials. After initially being granted an FDA Emergency Use Authorization (EUA) on May 1st, 2020, remdesivir was fully approved by the FDA for the treatment of COVID-19 on October 22, 2020. Remdesivir is currently marketed under the trademark name VEKLURY by Gilead Sciences Inc. Remdesivir was also approved by the European Commission on July 3, 2020. Remdesivir in combination with baricitinib for the treatment of COVID-19, was granted an FDA Emergency Use Authorization on November 19, 2020.
Indication
Remdesivir is indicated for the treatment of adult and pediatric patients 28 days of age and older and weighing at least 3 kg for coronavirus disease 2019 (COVID-19) infection requiring hospitalization. It is also indicated for the treatment of non-hospitalized patients with mild-to-moderate COVID-19, who are at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir was originally granted FDA Emergency Use Authorization (EUA) on May 1, 2020, for use in adults and children with suspected or confirmed COVID-19 in a hospital setting with an SpO2 ≤94%. Following the 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. 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. In Europe, remdesivir is approved for the treatment of adults and adolescents weighing at least 40 kg with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment). It is also indicated for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
Associated Conditions
- Coronavirus Disease 2019 (COVID‑19)
- Mild, moderate Novel Coronavirus Infectious Disease (COVID-19)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/10 | Phase 3 | Recruiting | |||
2025/03/13 | Phase 2 | Not yet recruiting | PENTA Foundation | ||
2025/03/06 | Phase 1 | Completed | Heronova Pharmaceuticals | ||
2025/02/10 | Phase 2 | Not yet recruiting | |||
2025/01/24 | Phase 4 | Recruiting | |||
2024/12/11 | Phase 3 | Completed | |||
2023/06/29 | Phase 1 | Recruiting | |||
2023/06/22 | Phase 4 | Recruiting | |||
2023/03/22 | Phase 3 | Completed | |||
2022/10/20 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Gilead Sciences, Inc. | 61958-2901 | INTRAVENOUS | 100 mg in 1 1 | 2/29/2024 | |
| Gilead Sciences, Inc. | 61958-2902 | INTRAVENOUS | 5 mg in 1 mL | 2/29/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/3/2020 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| VEKLURY® LYOPHILIZED POWDER FOR IV INFUSION 100MG/VIAL | SIN15950P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 100mg | 6/10/2020 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| VEKLURY remdesivir 100 mg powder for injection vial | 338419 | Medicine | A | 7/10/2020 |
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