Remdesivir: First Approval

Drugs. 2020 Sep;80(13):1355-1363. doi: 10.1007/s40265-020-01378-w.


The antiviral agent remdesivir (Veklury®; Gilead Sciences), nucleotide analogue prodrug, has broad-spectrum activity against viruses from several families. Having demonstrated potent antiviral activity against coronaviruses in preclinical studies, remdesivir emerged as a candidate drug for the treatment of the novel coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, during the current global pandemic. Phase III evaluation of remdesivir in the treatment of COVID-19 commenced in early 2020 and has thus far yielded promising results. In late May 2020, Taiwan conditionally approved the use of remdesivir in patients with severe COVID-19. This was followed by a rapid succession of conditional approvals in various countries/regions including the EU and Canada. Preceding these conditional approvals, an emergency use authorization for remdesivir had been granted in the USA (on 1 May 2020) and a special approval for emergency use was granted in Japan (on 7 May 2020). This article summarizes the milestones in the development of remdesivir leading to its first conditional approval for the treatment of COVID-19.

Publication types

  • Review

MeSH terms

  • Adenosine Monophosphate / analogs & derivatives*
  • Adenosine Monophosphate / pharmacology
  • Alanine / analogs & derivatives*
  • Alanine / pharmacology
  • Antiviral Agents / pharmacology
  • Betacoronavirus / drug effects
  • COVID-19
  • Coronavirus Infections* / drug therapy
  • Coronavirus Infections* / epidemiology
  • Drug Development*
  • Humans
  • Pandemics*
  • Pneumonia, Viral* / drug therapy
  • Pneumonia, Viral* / epidemiology
  • SARS-CoV-2


  • Antiviral Agents
  • remdesivir
  • Adenosine Monophosphate
  • Alanine