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Veru Inc

Veru Inc logo
🇺🇸United States
Ownership
-
Employees
189
Market Cap
$122.9M
Website
Introduction

Veru, Inc. is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology, and ARDS. The company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin. Enobosarm, a selective androgen receptor modulator (SARM), is being developed for two indications: (i) Phase 2b clinical study of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness and (ii) subject to the availability of sufficient funding, Phase 3 clinical trial of enobosarm for the treatment of androgen receptor positive (AR+), estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in the 2nd line setting. Sabizabulin, a microtubule disruptor, is being developed as a Phase 3 clinical trial for the treatment of hospitalized patients with viral-induced ARDS. The company was founded by William R. Gargiulo, Jr., O. B. Parrish, and Harry Fisch in 1971 and is headquartered in Miami, FL.

Clinical Trials

13

Active:3
Completed:3

Trial Phases

3 Phases

Phase 1:4
Phase 2:5
Phase 3:4

Drug Approvals

1

FDA:1

Drug Approvals

ENTADFI

Approval Date
Jan 12, 2023
FDA

Clinical Trials

Distribution across different clinical trial phases (13 trials with phase data)• Click on a phase to view related trials

Phase 2
5 (38.5%)
Phase 1
4 (30.8%)
Phase 3
4 (30.8%)

Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt

Phase 2
Active, not recruiting
Conditions
Muscle Loss
Obesity
Interventions
First Posted Date
2024-02-28
Last Posted Date
2024-08-09
Lead Sponsor
Veru Inc.
Target Recruit Count
150
Registration Number
NCT06282458
Locations
🇺🇸

Pinnacle Trials, Anniston, Alabama, United States

🇺🇸

Cullman Clinical Trials, Cullman, Alabama, United States

🇺🇸

Artemis Institute for Clinical Research, San Diego, California, United States

and more 11 locations

Efficacy Evaluation of Sabizabulin Monotherapy Versus Active Control for Treatment of ER+HER2- Metastatic Breast Cancer

First Posted Date
2021-10-15
Last Posted Date
2023-03-24
Lead Sponsor
Veru Inc.
Registration Number
NCT05079360
Locations
🇺🇸

Alaska Oncology and Hematology, LLC., Anchorage, Alaska, United States

🇺🇸

Ironwood Cancer and Research Centers, Chandler, Arizona, United States

🇺🇸

Banner Health/ Banner MD Anderson Cancer Center, Gilbert, Arizona, United States

and more 22 locations

Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer

Phase 3
Terminated
Conditions
Metastatic Breast Cancer
Interventions
Drug: non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or Fulvestrant
First Posted Date
2021-10-04
Last Posted Date
2024-02-26
Lead Sponsor
Veru Inc.
Target Recruit Count
5
Registration Number
NCT05065411
Locations
🇺🇸

Ironwood Cancer & Research Centers, Chandler, Arizona, United States

🇺🇸

Banner MDACC, Gilbert, Arizona, United States

🇺🇸

Arizona Oncology Associates, PC-HOPE, Tucson, Arizona, United States

and more 23 locations

P2 Clinical Efficacy & Safety Study of V-111 Monotherapy & Sacituzumab Govitecan-hziy/V-111 Combo Therapy for mTNBC .

Phase 2
Withdrawn
Conditions
Metastatic Triple Negative Breast Cancer
Interventions
Drug: Sabizabulin/Sacituzumab govitecan-hziy Combo
First Posted Date
2021-08-17
Last Posted Date
2022-02-08
Lead Sponsor
Veru Inc.
Registration Number
NCT05008510

Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer

Phase 3
Terminated
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2021-05-03
Last Posted Date
2024-01-26
Lead Sponsor
Veru Inc.
Target Recruit Count
52
Registration Number
NCT04869943
Locations
🇺🇸

Ironwood Cancer and Research Centers, Chandler, Arizona, United States

🇺🇸

Banner Health/ Banner MD Anderson Cancer Center, Gilbert, Arizona, United States

🇺🇸

The Oncology Insitute of Hope and Innovation, Glendale, California, United States

and more 50 locations
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News

Veru's Enobosarm Shows Improved Safety Profile in Combination with Wegovy for Muscle-Preserving Obesity Treatment

Veru's enobosarm combined with Wegovy demonstrated reduced gastrointestinal side effects compared to Wegovy alone in a 168-person Phase 2 trial.

Veru's Enobosarm Shows Promise in Phase IIb Trial for Enhanced Weight Management

Phase IIb QUALITY trial demonstrates significant improvements in lean mass retention and fat loss when combining enobosarm with semaglutide, compared to placebo.

Veru's Enobosarm Preserves Lean Mass in Patients on Wegovy for Weight Loss

Veru's enobosarm significantly reduced lean mass loss in older, overweight or obese patients taking Wegovy, a GLP-1 receptor agonist, in a Phase 2b trial.

Veru's Enobosarm Shows Promise in Preserving Muscle Mass During Weight Loss with GLP-1 RAs

Veru Inc. announced positive topline results from its Phase 2b QUALITY study, where enobosarm significantly reduced lean mass loss in patients on WEGOVY.

Veru Inc. Initiates Phase 2b Trial of Enobosarm for Sarcopenic Obesity and Sells FC2 Business

Veru Inc. has commenced its Phase 2b QUALITY trial, evaluating enobosarm combined with semaglutide for sarcopenic obesity, with 168 patients enrolled.

Veru Initiates Phase 2 Trial of Enobosarm Plus Abemaciclib in AR+ ER+ HER2- Metastatic Breast Cancer

• Veru Inc. has commenced a Phase 2 clinical trial evaluating the combination of enobosarm and abemaciclib for AR+ ER+ HER2- metastatic breast cancer. • The trial aims to assess the efficacy and safety of the combination therapy in patients who have progressed on prior endocrine therapy and CDK4/6 inhibitors. • Enobosarm, a selective androgen receptor modulator (SARM), is being investigated for its potential to enhance the effectiveness of abemaciclib in this specific breast cancer subtype. • The study targets a patient population with androgen receptor-positive, estrogen receptor-positive, and HER2-negative metastatic breast cancer, addressing a significant unmet need.

Weight Loss Drug Race Heats Up: Zepbound Outperforms Wegovy, New Therapies Target Muscle Growth

Eli Lilly's Zepbound demonstrated superior weight loss compared to Novo Nordisk's Wegovy in a head-to-head trial, with Zepbound users losing over 20% of body weight versus Wegovy's under 14%.

Veru's Enobosarm Shows Potential in Meta-Analysis to Optimize Weight Loss by Preserving Muscle

A meta-analysis of four randomized clinical trials suggests that enobosarm may optimize weight loss by preserving muscle mass.

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