Lagevrio FDA Approval Status
Last updated by Judith Stewart, BPharm on April 4, 2022.
FDA Approved: No (Emergency Use Authorization)
Brand name: Lagevrio
Generic name: molnupiravir
Dosage form: Capsules
Company: Merck
Treatment for: COVID-19
Lagevrio (molnupiravir) is an investigational oral antiviral agent for the treatment of COVID-19.
- The U.S. FDA has issued an EUA for the emergency use of the unapproved Lagevrio, a nucleoside analogue that inhibits SARS-CoV-2 replication by viral mutagenesis for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by FDA are not accessible or clinically appropriate.
- Lagevrio is not FDA-approved for any use including for use for the treatment of COVID-19.
- Prior to initiating treatment with Lagevrio, carefully consider the known and potential risks and benefits.
Development timeline for Lagevrio
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
