Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cetrorelix 78+78 · 1 trial · 1 indication
IPSS score of BPH symptoms based on a patient questionnaire assessing 7 items (incomplete voiding, frequency, intermittency, urgency, weak stream, hesitancy, nocturia) on a scale from 0 (best) to 5 (worst); total overall score range: 0 points (best) to 35 points (worst)
| Arm | Type | Description |
|---|---|---|
| Cetrorelix 78+78 | EXPERIMENTAL | - |
| Cetrorelix 78 + Placebo | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Cetrorelix 78+78 | DRUG | Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg) |
| Cetrorelix 78 + Placebo | DRUG | Cetrorelix 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + Placebo on Week 26 and Week 28 |
| Placebo | OTHER | Placebo on Week 0, Week 2, Week 26 and Week 28 |
Inclusion Criteria: * Benign Prostatic Hyperplasia, based on medical history * Voiding symptoms Exclusion Criteria: * Urgent need for prostate surgery or prior surgical treatment of the prostate or bladder * Major organ dysfunction * Eczema (atopic dermatitis) treated during the last 6 months * C...
Cetrorelix 78+78 is being developed for benign prostatic hypertrophy, also called BPH, a urological condition in men. It is a small molecule therapeutic candidate from COSCIENS Biopharma Inc. that has been studied in a Phase 3 clinical trial in patients with symptomatic BPH.
Cetrorelix 78+78 targets GNRHR, the gonadotropin-releasing hormone receptor. It acts as an antagonist at this receptor, meaning it blocks receptor signaling rather than activating it. This mechanism is the basis for its investigation in benign prostatic hypertrophy.
Cetrorelix 78+78 is being developed by COSCIENS Biopharma Inc., which trades under the ticker CSCI. The company is the sponsor of the clinical program evaluating this small molecule in benign prostatic hypertrophy.
Cetrorelix 78+78 is in Phase 3 development. It is an investigational drug and has not been approved by the FDA. The Phase 3 trial in benign prostatic hypertrophy has been completed, and no active trials are currently listed for this asset.
Cetrorelix 78+78 has been studied in one completed Phase 3 trial, NCT00663858, titled Cetrorelix Pamoate in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH). The trial enrolled 420 male participants aged 50 years and older across sites in Belarus, Bulgaria, Czechia, France, Germany, Italy, Netherlands, North Macedonia, Romania, and the United Kingdom.
The Phase 3 trial NCT00663858 was a randomized, double-blind, placebo-controlled study in patients with symptomatic benign prostatic hypertrophy. It enrolled 420 male participants aged 50 years and older and did not include healthy volunteers. The trial has been completed.