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
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