The still-experimental oral antiviral drug has been compared to Tamiflu but would be for COVID-19 not the flu.
Merck’s experimental antiviral drug showed a quick reduction in SARS-CoV-2 in a phase 2 study.
At day 5, there was a reduction in positive viral culture in subjects who received molnupiravir, an investigational antiviral agent, compared with placebo. None of the 47 study volunteers in the molnupiravir group have positive viral cultures where as six of the 25 (24%) of those in the placebo group did. This finding was a secondary endpoint of the study.
Related: FDA authorizes new COVID-19 treatment, more vaccine doses on the way
“The secondary objective findings in this study, of a quicker decrease in infectious virus among individuals with early COVID-19 treated with molnupiravir, are promising,” said William Fischer, the study’s lead investigator and associate professor of medicine at the University of North Carolina School of Medicine, in a press release from Merck and Ridgeback Biotherapeutics, a biotech start-up in Miami.
Molnupiravir is an oral antiviral agent. The Wall Street Journal described molnupiravir as “a kind of Tamiflu” for COVID-19.
The preliminary data was presented during the 2021 Conference on Retroviruses and Opportunistic Infections on March 6. Results from the treatment’s Phase 2/3 study are expected in May.
Roy Baynes
“We continue to make progress in our Phase 2/3 clinical programs evaluating molnupiravir both outpatient and hospital settings and plan to provide updates when appropriate,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
Related: Biden stimulus plan beefs up COVID-19 vaccinations and testing
This multi-center Phase 2a study included 202 non-hospitalized adults who had signs or symptoms of COVID-19 within 7 days and confirmed active SARS-CoV-2 infection.
The primary efficacy objective was reduction in time to viral negativity measured by reverse transcriptase polymerase chain reaction (RT-PCR) analysis of nasopharyngeal swabs.
No safety concerns were identified, according to Merck. Of the four serious adverse events reported, none were considered to be study drug related.
At a time where there is unmet need for antiviral treatments against SARS-CoV-2, we are encouraged by these preliminary data,” said Wendy Painter, chief medical officer of Ridgeback Biotherapeutics.
Read more: FDA okays first combo COVID-19 and flu test
Get the latest industry news, event updates, and more from Managed healthcare Executive.
PBM-Offered Genomics Testing Could Reshape Prescribing of Medications
August 1st 2025Two PBMs, True Rx Health Strategies and Capital Rx, are using pharmacogenomics — how a person’s DNA affects their response to medications — to reduce the trial-and-error of prescribing medications, saving employers and patients time and money.
Read More
FDA Extends Review of Blenrep Combinations in Multiple Myeloma
August 1st 2025Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing and tolerability. The new action date is Oct. 23, 2025.
Read More
Sarepta to Pause Shipments of the Gene Therapy Elevidys
August 1st 2025Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators while they address a safety labeling update about the risk of acute liver disease related to Elevidys.
Read More