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Phase 3, Randomized, Placebo-Controlled, Efficacy and Safety Study of VERU-111 for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS)

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Trial Profile

Phase 3, Randomized, Placebo-Controlled, Efficacy and Safety Study of VERU-111 for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 20 Apr 2023

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At a glance

  • Drugs Sabizabulin (Primary) ; Sabizabulin (Primary)
  • Indications COVID 2019 infections; SARS-CoV-2 acute respiratory disease
  • Focus Registrational; Therapeutic Use
  • Acronyms VERU-111
  • Sponsors Veru Healthcare
  • Most Recent Events

    • 26 Jan 2023 According to Valeo media release, the company announced today that the New Drug Submission filing has been done to the Health Canada and it has been accepted by Health Canada for review.
    • 09 Nov 2022 According to a Veru Healthcare media release, the company has announced that the PADAC advisory committee concluded the benefits of sabizabulin do not outweigh the known and potential risks. However, there was additional discussion around the clinical trial design aspects of an additional clinical trial as a potential post authorization requirement. FDA will consider the input of the advisory committee as part of their review of the EUA and render a decision on the EUA.
    • 24 Oct 2022 Results presented in a Veru Healthcare media release.
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