Remdesivir Approval Status

FDA Approved: No
Generic name: remdesivir
Company: Gilead Sciences, Inc.
Treatment for: COVID-19

Remdesivir is an investigational antiviral compound undergoing clinical trials in China, the United States, and the United Kingdom as a potential treatment for COVID-19.

• Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for any use.

• Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens that cause MERS and SARS, which are coronaviruses structurally similar to SARS-CoV-2, the coronavirus that causes COVID-19.

• Novel Coronavirus (2019-nCoV) was first identified in the city of Wuhan, in China’s Hubei province, in December 2019. On February 11, 2020, the World Health Organization (WHO) renamed the disease caused by the virus as COVID-19.

Clinical Studies

• The following clinical studies are in progress for the use of remdesivir as a potential treatment for COVID-19:
  • Severe 2019-nCoV Remdesivir RCT China-Japan Friendship Hospital – Beijing, China
  • Mild/Moderate 2019-nCoV Remdesivir RCT Jin Yin-tan Hospital – Wuhan, China
  • Adaptive COVID-19 Treatment Trial University of Nebraska Medical Center – Omaha NE, USA
  • Expanded Access Remdesivir (RDV; GS-5734™) U.S. Army Medical Research and Development Command
  • Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19) Gilead Sciences, Inc.
  • Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment Gilead Sciences, Inc.
  • Adaptive COVID-19 Treatment Trial National Institute of Allergy and Infectious Diseases (NIAID)