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Veru-944

Phase 2

Prostate Cancer Metastatic | Small molecule | Oncology |Veru Inc.|Trials Updated: Dec 3, 2021

Veru-944 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Aug 2018

Veru-944 target and mechanism

Molecular targetestrogen receptor
Target classReceptor
ModalitySmall molecule

Also known as Zuclomiphene citrate

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment93

FDA Designations

No designations recorded

Veru-944 clinical trials

Veru-944 · 1 trial · 1 indication

Phase 2 1
NCT03646162Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate CancerProstate Cancer Metastatic
COMPLETED93 Analytics
PHASE2COMPLETED
Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer
Prostate Cancer MetastaticUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Frequency of Moderate to Severe Hot Flashes at 6 Weeks
6 weeks

Percentage of change in frequency of moderate to severe hot flashes at 6 weeks

Secondary Endpoints

Percentage Change in Severity of Moderate to Severe Hot Flashes at 6 Weeks
6 weeks
Change of Frequency of Moderate to Severe Hot Flashes at Week 12
Weeks 12
Change in Severity of Moderate to Severe Hot Flashes at Week 12
Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Veru-944 10 mgEXPERIMENTALVeru-944 10 mg daily
Veru-944 50 mgEXPERIMENTALVeru-944 50 mg daily
PlaceboPLACEBO_COMPARATORPlacebo daily

Interventions

NameTypeDescription
Veru-944DRUGTreat hot flashes (vasomotor symptoms) in men with advanced prostate cancer on ADT
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites24

Inclusion Criteria 1. Be over 18 years of age; 2. Be able to communicate effectively with the study personnel; 3. Have histologically confirmed prostate cancer; 4. Have been treated with an LHRH agonist or LHRH antagonist for at least the 3 months prior to randomization; 5. Be continued on an LHRH ...

Countries:United States
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Competitive Landscape -Prostate Cancer 252 trials (matched to "Prostate Cancer Metastatic")

Frequently asked questions about Veru-944

What is Veru-944 used for?

Veru-944 is being developed to treat hot flashes in men with advanced prostate cancer. It is an investigational small molecule studied in a Phase 2 trial of 93 male patients with metastatic prostate cancer. It is not approved for any indication and remains in clinical development.

What does Veru-944 target?

Veru-944 targets the estrogen receptor. By acting on this receptor, the drug is designed to reduce hot flashes in men undergoing treatment for advanced prostate cancer. The estrogen receptor is the molecular target identified for this small molecule.

Who is developing Veru-944?

Veru-944 is being developed by Veru Inc., a biopharmaceutical company whose common stock trades on the Nasdaq under the ticker symbol VERU. Veru Inc. is the sponsor of the clinical program evaluating Veru-944 in metastatic prostate cancer.

What phase is Veru-944 in?

Veru-944 is in Phase 2 development. The completed Phase 2 study evaluated the drug in men with advanced prostate cancer. Veru-944 is investigational and has not been approved by the FDA for any indication.

What clinical trials is Veru-944 in?

Veru-944 has been studied in one clinical trial, NCT03646162, titled Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer. This Phase 2 trial enrolled 93 participants in the United States and is now completed.

How was the Veru-944 Phase 2 trial designed?

The Phase 2 trial NCT03646162 was a randomized, double-blind, placebo-controlled study of Veru-944 in men with metastatic prostate cancer. It enrolled 93 male participants aged 18 years and older across sites in the United States and has been completed.