A critical overview of current progress for COVID-19: development of vaccines, antiviral drugs, and therapeutic antibodies - Journal of Biomedical Science

]. To determine whether molnupiravir might be an orally efficacious for SARS-CoV-2 treatment, the therapeutic efficacy of the prodrug was evaluated in a ferret model, where it significantly reduced the virus titer within 12 h after dosing. On March 23, 2020, DRIVE and Ridgeback Biotherapeutics announced a licensing deal in which Ridgeback Biotherapeutics gained exclusively license to DRIVE's EIDD-2801 for conducting the necessary trials against COVID-19.

Scientists from Pfizer started the development of this treatment by screening their in-house compounds, and they identified an intravenously administered candidate, lufotrelvir , which had been originally developed to target SARS-CoV-1 in 2003. This potential antiviral agent was then tested in a Phase I clinical trial to explore its safety and efficacy in 2020.

In the development stage, nirmatrelvir was combined with ritonavir. The ritonavir inhibits cytochrome P450 activity to slow the metabolism of nirmatrelvir . This approach has been previously applied for HIV treatment. The results of a Phase I clinical trial revealed that the nirmatrelvir and ritonavir combination was safe and well tolerated. Moreover, the Phase III trial showed that nirmatrelvir/ritonavir decreased the risk of progression to severe COVID-19 by 89%.

The hit identification stage was performed by applying structure-based drug design based on identified interactions between known inhibitors and the binding site of 3CL protease. The scientists optimized the best hit compound according to interactions mapped from co-crystallization with 3CL protease.

In a Phase I clinical trial to test tolerability and safety, there were no major clinical adverse events identified. Unlike paxlovid, ensitrelvir does not require repeated dosing to achieve efficacious levels. In the Phase II/III clinical trial, the efficacy and safety of orally administered ensitrelvir were evaluated; patients with mild COVID-19 or asymptomatic SARS-CoV-2 infection were dosed once daily for five days.

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