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Molnupiravir FDA Approval Status

Molnupiravir FDA Approval Status

Release Time: 2021-10-25

News Source: SenovaTech

Author: Operation Dept.

Molnupiravir (EIDD-2801/MK-4482) is an investigational, orally bioavailable form of a potent ribonucleoside analog in development for the treatment of COVID-19.

1.Molnupiravir works as an antiviral agent by inhibiting the replication of the SARS-CoV-2 virus, the causative agent of COVID-19.

2.Molnupiravir has been shown to be active in several models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission, as well as SARS-CoV-1 and MERS.

3.Preliminary findings from a Phase 2a Trial demonstrated that molnupiravir was highly effective at reducing nasopharyngeal SARS-CoV-2 infectious virus and viral RNA, with a favorable safety and tolerability profile.

Development Timeline for molnupiravir----

Jul 12, 2021--- Interim 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)

Apr 15, 2021--- Merck 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, 2021--- Ridgeback Biotherapeutics and Merck Announce Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir

Jun 19, 2020--- Ridgeback Biotherapeutics Announces Launch of Phase 2 Trials Testing EIDD-2801 as Potential Treatment for COVID-19

May 26, 2020--- Merck and Ridgeback Bio Collaborate to Advance Development of Novel Antiviral Candidate, EIDD-2801

Apr  6, 2020--- FDA Clears the Way for Ridgeback Biotherapeutics to begin Human Testing of a Promising Potential Treatment for COVID-19

Pls note:This aritcle has no commerical purpose.

Reference: https://www.drugs.com/history/molnupiravir.html