ARTICLE | Regulation
How fast can first-in-human trials move? Molnupiravir set 16-week benchmark
The COVID-19 program compressed a process estimated to take 46 weeks by eliminating white space across regulatory review, trial start-up and execution
August 26, 2026 10:37 PM UTC
Five days after U.K. regulators cleared the first-in-human trial of molnupiravir, the first volunteer received a dose.
About 16 weeks after the protocol was initially sent to MHRA and a research ethics committee, researchers had completed 16 Phase I cohorts: eight single ascending dose cohorts, seven multiple ascending dose cohorts, and one food-effect cohort. Under standard timelines, the process would have taken an estimated 46 weeks...