- Ensitrelvir achieved the primary endpoint in the Phase 3 part of the Asian Phase 2/3 clinical trial, demonstrating a significant reduction vs placebo in the time to resolution of five typical Omicron-related symptoms. This study was conducted in a predominantly vaccinated patient population with mild/moderate COVID-19, irrespective of risk factors for severe complications.
- Ensitrelvir also showed a significant reduction in viral RNA on day 4 (following the third dose) relative to placebo (a greater than 1.4 log10 copies/mL vs. placebo for change from baseline on day 4).
- With the results of this study, conducted during the Omicron phase of the pandemic, ensitrelvir has become the first investigational oral antiviral to demonstrate a statistically significant effect compared to placebo in the time to resolution of symptoms.
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About ensitrelvir fumaric acid (S-217622)
1. Press release on February 7,2022
Shionogi Presents Phase 2/3 Clinical Trial Results (Phase 2a Part) for the COVID-19 Therapeutic Drug S-217622
2. Press release on February 25,2022
Notice Regarding the Signing of a Basic Agreement with the Ministry of Health, Labor and Welfare for Domestic Supply of S-217622, a Therapeutic Drug for COVID-19
3. Press release on April 24,2022
New Data for Shionogi’s COVID-19 Once-Daily Oral Antiviral S-217622 Show Rapid Virus Clearance