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Cetrorelix Pamoate

Phase 3

Benign Prostatic Hypertrophy | Small molecule | Urology |COSCIENS Biopharma Inc.|Trials Updated: Apr 5, 2011

Cetrorelix Pamoate development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since May 2001

Cetrorelix Pamoate target and mechanism

Molecular targetGNRHR
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment528

FDA Designations

No designations recorded

Cetrorelix Pamoate clinical trials

Cetrorelix Pamoate · 1 trial · 1 indication

Phase 3 1
NCT00670306Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH)Benign Prostatic Hypertrophy
COMPLETED528 Analytics
PHASE3COMPLETED
Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH)
Benign Prostatic HypertrophyUnlock trial analytics

Study Endpoints

Primary Endpoints

IPSS Change From Baseline
Baseline and Week 26

International Prostate Symptom Score (IPSS) Patient Questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total range: 0 - 35 points; absolute change from baseline to Week 26

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cetrorelix 78 mgEXPERIMENTALDrug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.

Interventions

NameTypeDescription
Cetrorelix PamoateDRUGCetrorelix Pamoate IM, 52 mg week 0, 26 mg week 2,
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Eligibility Criteria

Age Range50 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites69

Inclusion Criteria: * Benign Prostatic Hyperplasia, based on medical history * Voiding symptoms * Uroflow (max) 5-15mL/sec Exclusion Criteria: * Urgent need for prostate surgery * History of allergic reaction to peptide * Major organ dysfunction * Prior surgical treatment of the prostate or bladd...

Countries:United StatesCanada
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Frequently asked questions about Cetrorelix Pamoate

What is Cetrorelix Pamoate?

Cetrorelix Pamoate is an investigational small molecule developed by COSCIENS Biopharma Inc. (ticker CSCI) for symptomatic benign prostatic hypertrophy, also called benign prostatic hyperplasia or BPH. It is a gonadotropin-releasing hormone receptor antagonist being studied in a Phase 3 clinical program in urology.

What is Cetrorelix Pamoate used for in benign prostatic hypertrophy?

Cetrorelix Pamoate is being developed to treat symptomatic benign prostatic hypertrophy (BPH) in men. The Phase 3 study enrolled men aged 50 years and older with symptomatic BPH in the United States and Canada. It is investigational and has not been approved for this or any other use.

What does Cetrorelix Pamoate target?

Cetrorelix Pamoate targets GNRHR, the gonadotropin-releasing hormone receptor, and acts as an antagonist at that receptor. By blocking this receptor, the drug is designed to suppress gonadotropin signaling. This mechanism underlies its development for symptomatic benign prostatic hypertrophy.

Who makes Cetrorelix Pamoate?

Cetrorelix Pamoate is being developed by COSCIENS Biopharma Inc., which trades under the ticker CSCI. The company is the sponsor of the Phase 3 clinical program evaluating the drug in symptomatic benign prostatic hypertrophy.

What phase is Cetrorelix Pamoate in?

Cetrorelix Pamoate is in Phase 3 development for symptomatic benign prostatic hypertrophy. It is investigational and has not been approved by the FDA. One Phase 3 trial has been completed, and no trials are currently listed as active.

What clinical trials is Cetrorelix Pamoate in?

Cetrorelix Pamoate has been studied in one Phase 3 trial, NCT00670306, titled Cetrorelix Pamoate IM Regimens in Patients With Symptomatic Benign Prostatic Hyperplasia (BPH). The completed study enrolled 528 men aged 50 years and older in the United States and Canada and was uncontrolled.