Merck & Co., Inc. announced the initiation of the Phase 3 MOVe-NOW clinical trial to evaluate LAGEVRIOTM (molnupiravir), an investigational oral antiviral COVID-19 medicine, for the treatment of adults with COVID-19 at high risk for disease progression. This double-blind, placebo-controlled, global study is enrolling individuals who are at least 18 years of age, tested positive for SARS-CoV-2 infection, have had COVID-19 symptoms for four days or less, and are not hospitalized. Additionally, the study will only enroll adults who cannot receive nirmatrelvir/ritonavir (NMV/r) due to drug-drug interactions, allergy, previous adverse effects, or inaccessibility.

The MOVe-NOW study will use a different formulation of LAGEVRIO that includes two smaller 400-mg tablets per dose (four daily tablets) instead of the currently available four 200-mg capsules per dose (eight daily capsules). The smaller tablets are not currently approved for use in any country. LAGEVRIO is approved or authorized for use in several countries, including Japan, Australia, and available for use in the United States under emergency use authorization, for the treatment of certain adults who have been diagnosed with COVID-19.

To date, LAGEVRIO has been used by more than 8.3 million patients worldwide.