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Also known as Sabizabulin, Bisindole
Veru-111 · 2 trials · 2 indications
Efficacy of VERU-111 in the treatment of SARS-Cov- 2 Infection by assessing its effect on the proportion of patients who die on study (prior to Day 60).
To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of subjects that are alive without respiratory failure at Day 29. Respiratory failure is defined as endotracheal intubation and mechanical ventilation, extracorporeal membrane oxygenation, high-flow nasal cannula oxygen delivery, noninvasive positive pressure ventilation, clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision making is driven solely by resource limitation
| Arm | Type | Description |
|---|---|---|
| 9mg of VERU-111 Oral daily | EXPERIMENTAL | 9mg of VERU-111 |
| Placebo Capsule once daily | NO_INTERVENTION | Subjects in the Placebo treatment group will receive standard of care, plus a placebo capsule for 21 days or until released from hospital. |
| Veru-111 18 mg | EXPERIMENTAL | Veru-111 18mg capsules |
| Placebo | PLACEBO_COMPARATOR | Placebo capsules |
| Name | Type | Description |
|---|---|---|
| VERU-111 | DRUG | Subjects in the VERU-111 treatment groups will receive standard of care, plus oral daily VERU-111 9mg for 21 days or until released from hospital. |
Inclusion Criteria: * Provide informed consent from the subject or the subject's Legally Authorized Representative (LAR) * Aged ≥18 years * Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test * Patients with a WHO Ordinal Scale for ...
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Veru-111 is an investigational small molecule developed by Veru Inc. (ticker: VERU) for respiratory conditions, specifically Adult Respiratory Distress Syndrome and SARS-CoV-2 infection. It has been studied in clinical trials but is not approved for any indication.
Veru-111 was studied as a treatment for SARS-CoV-2 infection, with the goal of assessing its effect on the proportion of patients who die on study. It was also evaluated in patients with Adult Respiratory Distress Syndrome. It remains investigational and is not approved for these uses.
Veru-111 targets alpha and beta tubulin, which are proteins involved in microtubule function. By binding to these targets, it is thought to interfere with processes essential for viral replication and cellular function, though its exact mechanism in respiratory disease is still under investigation.
Veru-111 is being developed by Veru Inc., a biopharmaceutical company that trades under the ticker symbol VERU. Veru Inc. is responsible for the clinical development of the drug.
Veru-111 has been tested in Phase 2 and Phase 3 clinical trials. The Phase 3 trial (NCT04842747) has been completed, and a Phase 2 trial (NCT04388826) has also been completed. The drug is still investigational and has not been approved by the FDA.
Veru-111 has been studied in two completed clinical trials: NCT04842747, a Phase 3 trial in SARS-CoV-2 infection that enrolled 204 patients, and NCT04388826, a Phase 2 trial in Adult Respiratory Distress Syndrome that enrolled 39 patients. Both trials were randomized, double-blind, and placebo-controlled.