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.
NCT05008510 ↗	P2 Clinical Efficacy & Safety Study of V-111 Monotherapy & Sacituzumab Govitecan-hziy/V-111 Combo Therapy for mTNBC .	Not yet recruiting	Veru Inc.	Phase 2	To compare the following: 1. The efficacy of sabizabulin monotherapy to sacituzumab govitecan-hziy monotherapy 2. The efficacy of sacituzumab govitecan-hziy/sabizabulin combination therapy to sacituzumab govitecan-hziy monotherapy These comparisons will be made in the efficacy in the treatment of metastatic triple negative breast cancer (mTNBC) in patients previously treated with at least two systemic chemotherapies for metastatic disease as measured by radiographic progression free survival (rPFS) as the primary endpoint.
NCT05079360 ↗	Efficacy Evaluation of Sabizabulin Monotherapy Versus Active Control for Treatment of ER+HER2- Metastatic Breast Cancer	Not yet recruiting	Veru Inc.	Phase 2	To demonstrate the efficacy of sabizabulin in the treatment of estrogen receptor positive (ER+) metastatic breast cancer (MBC) as measured by radiographic progression free survival (rPFS).

Clinical Trial Conditions for VERU-111

Condition Name

Condition Name
Intervention	Trials
Metastatic Castration-resistant Prostate Cancer	1
Metastatic Triple Negative Breast Cancer	1
Respiratory Distress Syndrome, Adult	1
SARS-CoV Infection	1

Condition MeSH

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

Clinical Trial Locations for VERU-111

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for VERU-111

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for VERU-111

Sponsor Name

Sponsor Name
Sponsor	Trials
Veru Inc.	6

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	6