Molnupiravir is under clinical development by Merck and currently in Phase II for Respiratory Syncytial Virus (RSV) Infections. According to GlobalData, Phase II drugs for Respiratory Syncytial Virus (RSV) Infections does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Molnupiravir LoA Report. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Molnupiravir overview

Molnupiravir (Lagevrio, Lizuvira) is a potent ribonucleoside analog acts as an antiviral agent. It is formulated as hard capsules for oral route of administration. Lagevrio is indicated for treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults with a positive SARS-COV-2 diagnostic test and who have at least one risk factor for developing severe illness. Lagevrio is indicated for the treatment of mild to moderate coronavirus disease (COVID-19) in adults aged 18 years and older who are at increased risk of progressing to severe COVID19, hospitalization or death. Molnupiravir is indicated for the treatment of Covid-19 in adults who do not require supplemental oxygen and who are at increased risk of disease progression to severe cases. Lizuvira is indicated for the treatment of adult patients with COVID- 19, with SpO2 >93% and who have high risk of progression of the disease including hospitalization or death.

MK-4482 (EIDD-2801) is under development for the prevention and treatment of  respiratory syncytial virus infections, unspecified influenza virus infections and coronavirus disease 2019 (COVID-19) infection. It is administered through oral route. The drug candidate is an isopropylester prodrug of the ribonucleoside analog N4-hydroxycytidine (NHC, EIDD-1931) which acts by targeting replication of RNA viruses. It was under treatment of avian influenza, seasonal flu, ebola, SARS, MERS, pandemic influenza, Chikungunya, Venezuelan equine encephalitis, Eastern equine encephalitis.

Merck overview

Merck is a biopharmaceutical company focused on the discovery, development, manufacturing and marketing of prescription medicines, biologic therapies, vaccines, and animal health products. It offers prescription products for therapy areas related to cardiovascular, cancer, immune disorders, infectious, respiratory, and diabetes. The company provides animal health products such as vaccines, poultry products, livestock products and aquaculture products. Merck sells medicines to drug wholesalers, retailers, hospitals, government agencies and managed health care providers; and animal health products to veterinarians, distributors and animal producers. The company and its subsidiaries operate in the Americas, Europe, the Middle East, Africa, Asia Pacific, and Latin America. Merck is known as MSD outside the US and Canada and is headquartered in Kenilworth, New Jersey, the US.

For a complete picture of Molnupiravir’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 22 April 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.