CLINICAL TRIALS PROFILE FOR VERU-111

Clinical Trials for VERU-111

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT03752099 ↗	To Evaluate Safety and Tolerability of VERU-111 in Men With Advanced Metastatic Castration Resistant Prostate Cancer	Active, not recruiting	Veru Inc.	Phase 1/Phase 2	Phase 1b - To assess the safety/tolerability of VERU-111 and to determine the maximum tolerated dose of VERU-111 in patients with metastatic, castration resistant prostate cancer who have failed a novel androgen blocking agent therapy (mCRPC). Phase 2 - To estimate the PSA50 response rate, defined as a decline in PSA to ≥50% of baseline level, confirmed with a second measurement at least 3 weeks apart (PCWG3).
NCT04388826 ↗	COVID-19 Treatment of Severe Acute Respiratory Syndrome With Veru-111	Completed	Veru Inc.	Phase 2	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 22. Respiratory failure is defined as non-invasive ventilation or high-flow oxygen, intubation and mechanical ventilation, or ventilation with additional organ support (e.g., pressors, RRT, ECMO).
NCT04842747 ↗	VERU-111 in the Treatment of SARS-Cov-2 Infection by Assessing Its Effect on the Proportion of Patients Who Die on Study	Recruiting	Veru Inc.	Phase 3	To demonstrate the 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).
NCT04844749 ↗	Efficacy Evaluation of VERU-111 for mCRPC in Patients Who Have Failed at Least One Androgen Receptor Targeting Agent	Recruiting	Veru Inc.	Phase 3	To demonstrate the efficacy of VERU-111 (Sabizabulin) in the treatment of metastatic castration-resistant prostate cancer in patients who have failed prior treatment with at least one androgen receptor targeting agent as measured by radiographic progression-free survival.

Clinical Trial Conditions for VERU-111

Condition Name

Condition Name for
Intervention	Trials
Androgen Resistant Prostatic Cancer	1
Metastatic Breast Cancer	1
Metastatic Castration Resistant Prostate Cancer	1
Metastatic Castration-resistant Prostate Cancer	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Coronavirus Infections	2
Prostatic Neoplasms	2
Severe Acute Respiratory Syndrome	2
Breast Neoplasms	2

Clinical Trial Locations for VERU-111

Trials by Country

Trials by Country for
Location	Trials
United States	60
Brazil	2
Mexico	2
Argentina	1
Colombia	1

Trials by US State

Trials by US State for
Location	Trials
Texas	4
New Jersey	4
Florida	4
Washington	3
Ohio	3

Clinical Trial Progress for VERU-111

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	3
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Not yet recruiting	2
Recruiting	2
Active, not recruiting	1

Clinical Trial Sponsors for VERU-111

Sponsor Name

Sponsor Name for
Sponsor	Trials
Veru Inc.	6

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	6