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histrelin

Phase 3

Prostate Cancer | Small molecule | Oncology |BrainsWay Ltd.|Last Updated: Jan 2, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment138

FDA Designations

No designations recorded

Clinical trial landscape

histrelin · 1 trial · 2 indications

Phase 3 1
NCT01697384Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate CancerProstate Cancer
COMPLETED138 Analytics
PHASE3COMPLETED
Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Suppression of testosterone to chemical castration levels (<= 50 ng/dL)
52 weeks

Secondary Endpoints

PSA measurements
52 weeks
Pain measurements
52 weeks
QoL outcomes
52 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
one histrelin acetate 50 mg implantEXPERIMENTALThe test product was a histrelin acetate 50 mg hydrogel implant surgically placed subdermally into the inner aspect of the upper arm.

Interventions

NameTypeDescription
histrelin acetateDRUG52 week implant
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Eligibility Criteria

Age Range45 Years to N/A
SexMALE
Healthy VolunteersNo

Key Inclusion Criteria: * Male Age 45 or older * Histologically confirmed adenocarcinoma of the prostate * Disease Staging III or IV * Clinical indication for androgen suppression therapy * Serum testosterone at least 150 ng/dL at screening * WHO Performance Scale 0 to 3 * Life expectancy of at lea...

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Competitive Landscape -Prostate Cancer 254 trials

Frequently asked questions about histrelin

What is histrelin used for in prostate cancer?

Histrelin is a small molecule being studied for the treatment of advanced prostate cancer, specifically adenocarcinoma of the prostate. It is administered as a subdermal implant and is currently in Phase 3 clinical development for this indication.

What does histrelin target?

Histrelin is a gonadotropin-releasing hormone (GnRH) agonist. It works by suppressing the production of testosterone, which can help slow the growth of prostate cancer cells that depend on this hormone to proliferate.

Who is developing histrelin?

Histrelin is being developed by BrainsWay Ltd., a company publicly traded under the ticker symbol BWAY. The drug is currently in Phase 3 clinical trials for the treatment of advanced prostate cancer.

What phase is histrelin in?

Histrelin is in Phase 3 clinical development. A Phase 3 study evaluating the efficacy and safety of the histrelin subdermal implant in men with advanced prostate cancer has been completed.

What clinical trials is histrelin in?

Histrelin has been studied in a Phase 3 clinical trial identified as NCT01697384, titled "Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer." This trial enrolled 138 male participants aged 45 years and older and has been completed.