Viralstop
viralstopivir
ApprovedStatus: Approved
Therapeutic Area: Infectious Disease•Manufacturer: AntiViral Inc
Overview
Description
A broad-spectrum antiviral targeting RNA-dependent RNA polymerase for respiratory viral infections.
Mechanism of Action
Inhibits viral RNA-dependent RNA polymerase (RdRp), preventing viral replication.
Indication
Treatment of COVID-19 and influenza in high-risk patients.
Market Projections
Financial outlook and market data
$4500M
Estimated Revenue
$20.0B
Market Size
5.2%
Growth Rate
2025
Peak Sales Year
Projected Revenue Growth
20242030
Clinical Development Timeline
Progress through clinical trial phases
✓
Preclinical
Completed
✓
Phase I
Completed
✓
Phase II
Completed
✓
Phase III
Completed
✓
Approved
Completed
| Phase | Status | Timeline | Participants | Primary Endpoint | Results |
|---|---|---|---|---|---|
| Preclinical | Completed | 2020-02 - 2020-05 | - | - | Potent activity against multiple coronaviruses |
| Phase I | Completed | 2020-06 - 2020-08 | 100 | Safety | Acceptable safety profile |
| Phase II | Completed | 2020-09 - 2020-12 | 400 | Time to recovery | 3-day reduction in recovery time |
| Phase III | Completed | 2021-01 - 2021-09 | 3,000 | Hospitalization or death | 65% reduction in hospitalization |
| Approved | Completed | 2021-12 | - | - | - |
Regulatory Approval Status
Approval status across different regions
U
United States
ApprovedAgency: FDA
Date: 2021-12
Emergency Use Authorization, full approval 2022
E
European Union
ApprovedAgency: EMA
Date: 2022-01
J
Japan
ApprovedAgency: PMDA
Date: 2022-02
U
United Kingdom
ApprovedAgency: MHRA
Date: 2022-01