![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » Pfizer Initiates Early-Stage Study Evaluating Oral COVID-19 Antiviral
Pfizer Initiates Early-Stage Study Evaluating Oral COVID-19 Antiviral
March 26, 2021
Pfizer is conducting a U.S. phase 1 trial of an oral COVID-19 antiviral, PF-07321332, a protease inhibitor that can stop the virus from replicating. An oral drug would be much easier to administer than an intravenous formulation — a significant advantage during the pandemic.
The investigational drug demonstrated strong in vitro antiviral activity against SARS-CoV-2, as well as activity against other coronaviruses, Pfizer said.
The early-stage trial will evaluate the antiviral’s safety, tolerability and pharmacokinetic ability at multiple doses. The study aims to enroll just 60 participants and is expected to conclude by the end of May, according to ClinicalTrials.gov.
Pfizer is also investigating an intravenously administered protease inhibitor, called PF-07304814, in a phase 1b study evaluating hospitalized COVID-19 patients. That study aims to enroll 72 patients and will conclude in early July.
Upcoming Events
-
21Oct