2021
DOI: 10.1128/aac.02428-20
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Human Safety, Tolerability, and Pharmacokinetics of Molnupiravir, a Novel Broad-Spectrum Oral Antiviral Agent with Activity against SARS-CoV-2

Abstract: Molnupiravir, EIDD-2801/MK-4482, the prodrug of the active antiviral ribonucleoside analog ß-d-N4-hydroxycytidine (NHC; EIDD-1931), has activity against a number of RNA viruses including severe acute respiratory syndrome coronavirus 2, severe acute respiratory syndrome coronavirus, Middle East respiratory syndrome coronavirus, and seasonal and pandemic influenza viruses. Single and multiple doses of molnupiravir were evaluated in this first-in-human, phase 1, randomized, double-blind, placebo-controlled study … Show more

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Cited by 340 publications
(424 citation statements)
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“…The orally bioavailable, pro-drug counterpart of NHC 8 , Molnupiravir (EIDD-2801, MK-4482) was shown to result in an antiviral effect against SARS-CoV-2 in a Syrian hamster model 9 , in a mouse model 10 and in ferrets 11 . Data from a first-in-human, phase 1, randomized, double-blind, placebo-controlled study in healthy volunteers indicate that the drug is well tolerated and that plasma exposures exceed the expected efficacious doses based on scaling from animal models 12 . The drug is currently being assessed for its potential as an antiviral treatment of SARS-CoV-2 infection in Phase 2 clinical trials of infected patients (NCT04405570, NCT04405739).…”
Section: Main Textmentioning
confidence: 99%
“…The orally bioavailable, pro-drug counterpart of NHC 8 , Molnupiravir (EIDD-2801, MK-4482) was shown to result in an antiviral effect against SARS-CoV-2 in a Syrian hamster model 9 , in a mouse model 10 and in ferrets 11 . Data from a first-in-human, phase 1, randomized, double-blind, placebo-controlled study in healthy volunteers indicate that the drug is well tolerated and that plasma exposures exceed the expected efficacious doses based on scaling from animal models 12 . The drug is currently being assessed for its potential as an antiviral treatment of SARS-CoV-2 infection in Phase 2 clinical trials of infected patients (NCT04405570, NCT04405739).…”
Section: Main Textmentioning
confidence: 99%
“…Favipiravir is thought to block RdRp16 and is now in phase III trials. The nucleoside analogue molnupiravir, which also targets RdRp, reduces viral transmission and disease severity in ferrets and has been well tolerated in phase I clinical trials 17…”
Section: The Targetsmentioning
confidence: 99%
“…The phase I clinical trial data describing the safety, tolerability and pharmacokinetic profile of molnupiravir were recently published [24]. This paper describes how these data were generated along a significantly accelerated timeline.…”
Section: Introductionmentioning
confidence: 99%