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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

DateArticle
Jun  7, 2022Merck and Ridgeback Announce New Data For Investigational Lagevrio (molnupiravir) From Phase 3 MOVe-OUT Study
Apr  1, 2022Merck and Ridgeback to Present Data Demonstrating That Treatment With Lagevrio (molnupiravir) Was Associated With More Rapid Elimination of Infectious SARS-CoV-2 Than Placebo
Jan 28, 2022Merck and Ridgeback’s Molnupiravir, an Investigational Oral Antiviral COVID-19 Medicine, Demonstrated Activity Against Omicron Variant in In Vitro Studies
Dec 23, 2021Merck and Ridgeback’s Molnupiravir Receives U.S. FDA Emergency Use Authorization for the Treatment of High-Risk Adults With Mild to Moderate COVID-19
Dec 16, 2021Merck and Ridgeback Announce Publication of Phase 3 Study of Molnupiravir, an Investigational Oral Antiviral COVID-19 Treatment, in the New England Journal of Medicine
Nov 30, 2021Merck and Ridgeback Statement on Positive FDA Advisory Committee Vote for Investigational Oral Antiviral Molnupiravir for Treatment of Mild to Moderate COVID-19 in High Risk Adults
Nov 26, 2021Merck and Ridgeback Biotherapeutics Provide Update on Results from MOVe-OUT Study of Molnupiravir, an Investigational Oral Antiviral Medicine, in At Risk Adults With Mild-to-Moderate COVID-19
Nov  9, 2021Merck and Ridgeback Announce U.S. Government to Purchase 1.4 Million Additional Courses of Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of Mild-to-Moderate COVID-19 in At Risk Adults
Nov  4, 2021Merck and Ridgeback’s Molnupiravir, an Oral COVID-19 Antiviral Medicine, Receives Authorization in the U.K.
Oct 11, 2021Merck and Ridgeback Announce Submission of Emergency Use Authorization Application to the U.S. FDA for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of Mild-to-Moderate COVID-19 in At Risk Adults
Oct  1, 2021Merck and Ridgeback’s Investigational Oral Antiviral Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent Compared to Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis of Phase 3 Study
Sep  1, 2021Merck and Ridgeback Biotherapeutics Announce Initiation of Pivotal Phase 3 MOVe-AHEAD Study Evaluating Molnupiravir for Post-Exposure Prophylaxis of COVID-19 Infection
Jul 12, 2021Interim Results from Phase 2/3 Studies of Molnupiravir, an Investigational Oral Antiviral Therapeutic for Mild to Moderate COVID-19, Presented at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID)
Jun  9, 2021Merck Announces Supply Agreement with U.S. Government for Molnupiravir, an Investigational Oral Antiviral Candidate for Treatment of Mild to Moderate COVID-19
Apr 15, 2021Merck and Ridgeback Biotherapeutics Provide Update on Progress of Clinical Development Program for Molnupiravir, an Investigational Oral Therapeutic for the Treatment of Mild-to-Moderate COVID-19
Mar  6, 2021Ridgeback Biotherapeutics and Merck Announce Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir
Jun 19, 2020Ridgeback Biotherapeutics Announces Launch of Phase 2 Trials Testing EIDD-2801 as Potential Treatment for COVID-19
May 26, 2020Merck and Ridgeback Bio Collaborate to Advance Development of Novel Antiviral Candidate, EIDD-2801
Apr  6, 2020FDA Clears the Way for Ridgeback Biotherapeutics to begin Human Testing of a Promising Potential Treatment for COVID-19

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.