Trial Profile
Phase 3 confirmatory study in hospitalized COVID-19 patients at high risk for ARDS
Status:
Planning
Phase of Trial:
Phase III
Latest Information Update: 28 Sep 2023
Price :
$35
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At a glance
- Drugs Sabizabulin (Primary)
- Indications COVID 2019 infections
- Focus Registrational; Therapeutic Use
Most Recent Events
- 26 Sep 2023 According to a Veru Inc media release, the Company and FDA reached agreement on the design of Phase 3 clinical trial study to evaluate sabizabulin plus standard of care treatment in an expanded patient population, hospitalized adult patients who have broadly any type of virus causing ARDS. The Phase 3 study may suffice as a single study for NDA submission. The company plans to conduct all comers study instead of second phase 3 study. Enrollment expected in Q4 2023.
- 11 Sep 2023 According to a Veru Inc media release, In April 2023, the Company reached agreement with FDA on design of the Phase 3 confirmatory COVID-19 clinical trial to evaluate sabizabulin in hospitalized moderate to severe COVID-19 patients at high risk for ARDS
- 10 Aug 2023 According to a Veru Inc media release, the company plans to meet FDA to reach agreement on the design of a proposed expanded Phase 3 confirmatory study evaluating sabizabulin 9mg for the treatment of hospitalized adult patients who have any kind of viral lung infection and on oxygen support who are at high risk for ARDS. The FDA has granted a meeting with Veru for September 2023.